Henry Ford Health System to conduct first large U.S. study of hydroxychloroquine’s ability to prevent COVID-19

Despite false assertions by the President to the contrary, any potential treatments to counter or prevent COVID-19 are still only at the stage of early investigations, which include one-off treatment with special individual case authorizations, and small-scale clinical examinations. Nothing so far has approached the level of scrutiny needed to actually say anything definitively about their actual ability to treat COVID-19 or the SARS-CoV-2 virus that causes it, but the first large-scale U.S. clinical study for one treatment candidate is seeking volunteers and looking to get underway.

The study will be conducted by the Henry Ford Health System, which is seeking 3,000 volunteers from healthcare and first responder working environments. Depending on response, the researchers behind the study are looking to begin as early as next week. Study lead researcher Dr. William W. O’Neil said in a press release announcing the study that the goal is to seek a more definitive scientific answer to the question of whether or not hydroxychloroquine might work as a preventative medicine to help protect medical frontline workers with greater risk exposure from contracting the coronavirus.

Hydroxychloroquine (as well as chloroquine) has been in the spotlight as a potential COVID-19 treatment due mostly to repeated name-check that President Trump has given the drug during his daily White House coronavirus task force press briefings. Trump has gone too far in suggesting that the drug, which is commonly used both as an anti-malarial, and in the treatment of rheumatoid arthritis and lupus, could be an effective treatment and should be thrust into use. At one point, he claimed that he FDA had granted an emergency approval for its use as a COVID-19 treatment, but Dr. Anthony Fauci clarified that it was not approved for that use, and that clinical studies still need to be performed to evaluate how it works in addressing COVID-19.

Studies thus far around hydroxychloroquine have been small-scale, as mentioned. One, conducted by researchers in France, produced results that indicated the drug was effective in treating those already infected, particularly when paired with a specific antibiotic. Another, more recent study from China showed that there was no difference in terms of viral duration or symptoms when comparing treatment with hydroxychloroquine with treatment using standard anti-viral drugs, already a common practice in addressing cases of the disease.

This Henry Ford study looks like it could provide better answers to some of these questions around the drug, though the specific approach of seeking to validate prophylactic (preventative) use will mean treatment-oriented applications will still have to be studied separately. The design of the study will be a true blind study, with participants split into three groups that receive “unidentified, specific pills” (possibly anti-virals or some equivalent); hydroxychloroquine; or placebo pills, respectively. They won’t know which they’ve received, and they’ll be contacted by researchers running the study weekly, then in-person both at week four and week eight to determine if they have any symptoms of COVID-19, or any side effects from the medication. They’ll get regular blood draws, and the results will be compared to see if there’s any difference between each cohort in terms of how many contracted COVID-19.

These are frontline healthcare workers, so in theory they should unfortunately be at high risk of contracting the disease. That, plus the large sample size, should provide results that provide much clearer answers about hydroxychloroquine’s potential preventative effects. Even after the study is complete, other competing large-scale trials would ideally be run to prove out or cast doubt on these results, but we’ll be a better position than we are now to say anything scientifically valid about the drug and its use.

Modsy confirms layoffs, 10 months after announcing its $37M Series C

Modsy, an e-commerce company that creates 3D renderings of customized rooms, has confirmed to TechCrunch that it laid off a number of staff. In addition, several of its executives, including CEO Shanna Tellerman, will take a 25% pay cut. TechCrunch first heard about the layoffs from a source. The company’s confirmation of cuts comes amid a wave of layoffs in the technology and startup communities

In a statement from the CEO Shanna Tellerman to TechCrunch, Modsy said that “[i]n an effort to maintain a sustainable business during these unprecedented circumstances, we made a round of necessary layoffs and ended a number of designer contracts this week.” The company reaffirmed belief in its “long-term growth plans” in the same statement.

Modsy did not immediately respond when asked about how many individuals were impacted by this layoff. Update: The company declined to share the number of employees impacted.

The startup is backed by investors including TCV, Comcast Ventures, Norwest Venture Partners, GV, BBG Ventures, according to Crunchbase data. It has raised $70.8 million in known capital to date. 

Modsy bets on individuals looking to glam up their homes by better visualizing the new furniture they want to buy. Users can enter the measurements of their living room and add budget and style preferences, and Modsy will help them with custom designs and finding furniture that fits — literally.

The layoffs show that customer appetite might be changing. Last week, home improvement platform Houzz confirmed that it has scratched plans to create in-house furniture for sale. It also laid off 10 people across three locations: the U.K., Germany and China. Houzz is comparatively larger than Modsy, with a roughly $4 billion valuation. But scratching its in-house plan that would have likely brought in more capital is yet another data point in how e-commerce companies are struggling right now to get consumers to spend on items other than beans, booze and bread starters.

In retrospect there were rumblings that the company was cutting staff. A number of recent reviews from its Glassdoor page note layoffs, with one review from March 25, 2020 calling them “mass” in nature; our original source on the company’s recent cuts also noted their breadth.

You can find other social media posts concerning the company’s layoffs, some noting more than one wave. TechCrunch has not confirmed if the recent layoffs are the first of two, or merely the first set of cuts. 

A little over 10 months ago the company was in a very different mood. Back in May of 2019, flush with new capital, Modsy’s CEO said that the “home design space, the inspiration category is thriving.” 

Pinterest just IPO’d, and it seems as if every TV channel is entering the home design category,” she said. “Meanwhile, e-commerce sites have barely changed since the introduction of the Internet.”

Forward launches ‘Forward At Home’ primary care service to address COVID-19 healthcare crunch

The global coronavirus pandemic has already caused a tremendous strain on healthcare resources around the world, and it’s leading to a shift in how healthcare is offered. Startup Forward, which debuted in 2016 and has since expanded its tech-focused primary care medical practice to locations in major cities across the U.S., is launching a new initiative called ‘Forward At Home’ that reflects those changes and adapts its care model accordingly.

Forward’s primary differentiator is its focus on what it terms a patient’s ‘baseline,’ which is established by an in-person visit they make when they join that employs a body scanner at a doctor’s office to take a number of readings and produce an interactive chart displayed on-screen in the doctor’s exam room. Forward founder and CEO Adrian Aoun, who previously led special projects at Google before building the health tech company, said that as the company has ramped its efforts to support patients during the COVID-19 pandemic, including through in-clinic and drive-through testing, it also wanted to address the ongoing need for care for non-COVID patients.

“If people aren’t leaving their homes, and frankly, you don’t really want them to leave their homes unless you need them to, you have to figure out how to do all that remotely,” Aoun said in an interview, referring to Forward’s comprehensive biometric data gathering process. “So we’ve we’ve implemented a bunch of different things as rapidly as possible. The first is, how do we collect some biometrics – so we put together a kit that has a bunch of sensors in it that we actually mail to you. This includes an EKG, a connected thermometer, connected blood pressure cuff and a pulse oximeter.”

This approach provides a whole new level of remote care, over and above what’s typically defined as “telemedicine,” which generally amounts to little more than video calls with doctors, Aoun points out. Forward’s approach includes automated vitals monitoring for alerting a doctor if a patient needs intervention, and a patient has access to all their own data in the app as well. The Forward At Home product also take their exam room smart display and brings it to their mobile devices, presenting it for shared consultation between doctor and patient during viral visits, which are available 24/7 to Forward members.

At launch, the service also includes home visits to collect urine and blood samples, as an added measure designed specifically to help patients adhere to CDC and health agency guidelines around self-isolation while also getting a detailed and thorough level of care. Aoun says that this part of the offering doesn’t make sense at scale, and will likely revert to in-clinic visits once the COVID-19 crisis passes.

The rest of the model, though spurred into deployment because of the coronavirus conditions, and the need to limit the number of people going in to medical facilities and hospital all across the country unless they absolutely need to, is here to stay, however. Aoun says that Forward’s goal has always been to address the need for tech-friendly, advanced and comprehensive primary care for everyone, but that it took an approach similar to Tesla’s by addressing the top end of the market first in order to be able to fund development of more broadly available services later on.

Meanwhile, the need to shift as much care as possible to in-home is pressing, and evidence from countries around the world is increasingly pointing to how important that is to stopping the spread.

“The big thing to flatten the curve, the whole point of it, is that the hospitals are going to be overrun,” Aoun said. “So you want to take as many cases as you can, where they don’t actually have to be in the ICU, and treat them outside of the ICU – that’s your first principle. Then your second principle is, and China kind of discovered this early […] they started moving to getting people out of the hospitals, as much as possible for a second reason, which is not that the hospitals are overloaded, but that the hospitals are one of the fastest ways to spread COVID-19.”

That’s a perspective also supported by lessons shared from Italian medical professionals in their effort to deal with the COVID-19 situation there, which has essentially decimated large parts of their medical facility infrastructure.

Forward is also still continuing the other work it’s doing to address COVID-19 needs, including providing its risk assessment screening tool to all, as well as offering testing via clinics and drive-throughs to members, as well as mental health support. It’s also looking to expand its drive-through testing to new sites across the U.S. The Forward At Home initiative, meanwhile, will help ensure that clients who have other pressing health needs aren’t left behind while the effort to combat COVID-19 continues.

Venture-backed Celularity receives FDA approval for early trials of a new cell therapy for COVID-19

Celularity, the venture-backed developer of novel cell therapies for cancer treatments, has received an initial clearance from the Food and Drug Administration to begin early-stage clinical trials on a potential treatment for COVID-19.

The company, which has raised at least $290 million to date (according to Crunchbase), uses “Natural Killer” (NK) cell therapies to boost the immune system’s disease-fighting response.

For Celularity, those NK cells are derived from stem cells cultivated from placental tissue, which hospitals typically treat as medical waste.

Backed by the venture investment firm Section 32, and strategic investors including Celgene, now a division of Bristol Myers; United Therapeutics, a biomedical technology developer; Human Longevity, the troubled venture-backed startup founded by genomics J. Craig Venter; and Sorrento Therapeutics, a publicly traded biomedical company; Celularity was pursuing a number of applications of the novel cell therapy, but its initial focus was on cancer treatments.

The real breakthrough for the company, and one of the reasons why it’s attracted so much capital, is that its cell therapies don’t need to be cultivated from a patient donor — a lengthy and expensive process. Celularity is able to produce NK cells and store them, so that they can be ready for transfusion when they’re needed.

With the the FDA’s clearance, Celularity is going to begin a small, 86-person trial to test the efficacy of its CYNK-001 immunotherapy to treat COVID-19 infected adults, the company said.

There are at least two studies underway in China that are also testing whether Natural Killer cells can be used to treat COVID-19.

NK cells are a type of white blood cell that are part of the body’s immune system. Unlike t-cells, which target particular pathogens, NK cells typically work to support the immune system by identifying and destroying cells in the body that appear to be stressed, either from an infection or a mutation.

The therapy seems to be successful in treating certain types of cancer, and the company’s researchers speculate that it can provide similar results in stopping the ability of the novel coronavirus which causes COVID-19 to spread throughout the body.

However, there are some potential roadblocks and risks to pursuing the NK therapy. Chiefly, COVID-19 is deadly in part because it can push the immune system into overdrive. The “cytokine storm” that results from the infection means that the body starts attacking healthy cells in the lungs which leads to organ failure and death. If that’s the case, then boosting the immune response to COVID-19 might be dangerous for patients.

There’s also the possibility that NK cells might not be able to detect which cells are infected with the coronavirus which causes COVID-19, rendering the therapy ineffective.

“Studies have established that there is robust activation of NK cells during viral infection regardless of the virus class,” said Celularity’s Chief Scientific Officer, Xiaokui Zhang, in a statement. “These functions suggest that CYNK-001 could provide a benefit to COVID-19 patients in terms of limiting SARS-CoV-2 replication and disease progression by eliminating the infected cells.”

An EU coalition of techies is backing a “privacy-preserving” standard for COVID-19 contacts tracing

A European coalition of techies and scientists drawn from at least eight countries, and led by Germany’s Fraunhofer Heinrich Hertz Institute for telecoms (HHI), is working on contacts-tracing proximity technology for COVID-19 that’s designed to comply with the region’s strict privacy rules — officially unveiling the effort today.

China-style individual-level location-tracking of people by states via their smartphones even for a public health purpose is hard to imagine in Europe — which has a long history of legal protection for individual privacy. However the coronavirus pandemic is applying pressure to the region’s data protection model, as governments turn to data and mobile technologies to seek help with tracking the spread of the virus, supporting their public health response and mitigating wider social and economic impacts.

Scores of apps are popping up across Europe aimed at attacking coronavirus from different angles. European privacy not-for-profit, noyb, is keeping an updated list of approaches, both led by governments and private sector projects, to use personal data to combat SARS-CoV-2 — with examples so far including contacts tracing, lockdown or quarantine enforcement and COVID-19 self-assessment.

The efficacy of such apps is unclear — but the demand for tech and data to fuel such efforts is coming from all over the place.

In the UK the government has been quick to call in tech giants, including Google, Microsoft and Palantir, to help the National Health Service determine where resources need to be sent during the pandemic. While the European Commission has been leaning on regional telcos to hand over user location data to carry out coronavirus tracking — albeit in aggregated and anonymized form.

The newly unveiled Pan-European Privacy-Preserving Proximity Tracing (PEPP-PT) project is a response to the coronavirus pandemic generating a huge spike in demand for citizens’ data that’s intended to offer not just an another app — but what’s described as “a fully privacy-preserving approach” to COVID-19 contacts tracing.

The core idea is to leverage smartphone technology to help disrupt the next wave of infections by notifying individuals who have come into close contact with an infected person — via the proxy of their smartphones having been near enough to carry out a Bluetooth handshake. So far so standard. But the coalition behind the effort wants to steer developments in such a way that the EU response to COVID-19 doesn’t drift towards China-style state surveillance of citizens.

While, for the moment, strict quarantine measures remain in place across much of Europe there may be less imperative for governments to rip up the best practice rulebook to intrude on citizens’ privacy, given the majority of people are locked down at home. But the looming question is what happens when restrictions on daily life are lifted?

Contacts tracing — as a way to offer a chance for interventions that can break any new infection chains — is being touted as a key component of preventing a second wave of coronavirus infections by some, with examples such as Singapore’s TraceTogether app being eyed up by regional lawmakers.

Singapore does appear to have had some success in keeping a second wave of infections from turning into a major outbreak, via an aggressive testing and contacts-tracing regime. But what a small island city-state with a population of less than 6M can do vs a trading bloc of 27 different nations whose collective population exceeds 500M doesn’t necessarily seem immediately comparable.

Europe isn’t going to have a single coronavirus tracing app. It’s already got a patchwork. Hence the people behind PEPP-PT offering a set of “standards, technology, and services” to countries and developers to plug into to get a standardized COVID-19 contacts-tracing approach up and running across the bloc.

The other very European flavored piece here is privacy — and privacy law. “Enforcement of data protection, anonymization, GDPR [the EU’s General Data Protection Regulation] compliance, and security” are baked in, is the top-line claim.

“PEPP-PR was explicitly created to adhere to strong European privacy and data protection laws and principles,” the group writes in an online manifesto. “The idea is to make the technology available to as many countries, managers of infectious disease responses, and developers as quickly and as easily as possible.

“The technical mechanisms and standards provided by PEPP-PT fully protect privacy and leverage the possibilities and features of digital technology to maximize speed and real-time capability of any national pandemic response.”

Hans-Christian Boos, one of the project’s co-initiators — and the founder of an AI company called Arago –discussed the initiative with German newspaper Der Spiegel, telling it: “We collect no location data, no movement profiles, no contact information and no identifiable features of the end devices.”

The newspaper reports PEPP-PT’s approach means apps aligning to this standard would generate only temporary IDs — to avoid individuals being identified. Two or more smartphones running an app that uses the tech and has Bluetooth enabled when they come into proximity would exchange their respective IDs — saving them locally on the device in an encrypted form, according to the report.

Der Spiegel writes that should a user of the app subsequently be diagnosed with coronavirus their doctor would be able to ask them to transfer the contact list to a central server. The doctor would then be able to use the system to warn affected IDs they have had contact with a person who has since been diagnosed with the virus — meaning those at risk individuals could be proactively tested and/or self-isolate.

On its website PEPP-PT explains the approach thus:

Mode 1
If a user is not tested or has tested negative, the anonymous proximity history remains encrypted on the user’s phone and cannot be viewed or transmitted by anybody. At any point in time, only the proximity history that could be relevant for virus transmission is saved, and earlier history is continuously deleted.

Mode 2
If the user of phone A has been confirmed to be SARS-CoV-2 positive, the health authorities will contact user A and provide a TAN code to the user that ensures potential malware cannot inject incorrect infection information into the PEPP-PT system. The user uses this TAN code to voluntarily provide information to the national trust service that permits the notification of PEPP-PT apps recorded in the proximity history and hence potentially infected. Since this history contains anonymous identifiers, neither person can be aware of the other’s identity.

Providing further detail of what it envisages as “Country-dependent trust service operation”, it writes: “The anonymous IDs contain encrypted mechanisms to identify the country of each app that uses PEPP-PT. Using that information, anonymous IDs are handled in a country-specific manner.”

While on healthcare processing is suggests: “A process for how to inform and manage exposed contacts can be defined on a country by country basis.”

Among the other features of PEPP-PT’s mechanisms the group lists in its manifesto are:

  • Backend architecture and technology that can be deployed into local IT infrastructure and can handle hundreds of millions of devices and users per country instantly.
  • Managing the partner network of national initiatives and providing APIs for integration of PEPP-PT features and functionalities into national health processes (test, communication, …) and national system processes (health logistics, economy logistics, …) giving many local initiatives a local backbone architecture that enforces GDPR and ensures scalability.
  • Certification Service to test and approve local implementations to be using the PEPP-PT mechanisms as advertised and thus inheriting the privacy and security testing and approval PEPP-PT mechanisms offer.

Having a standardized approach that could be plugged into a variety of apps would allow for contacts tracing to work across borders — i.e. even if different apps are popular in different EU countries — an important consideration for the bloc, which has 27 Member States.

However there may be questions about the robustness of the privacy protection designed into the approach — if, for example, pseudonymized data is centralized on a server that doctors can access there could be a risk of it leaking and being re-identified. And identification of individual device holders would be legally risky.

Europe’s lead data regulator, the EDPS, recently made a point of tweeting to warn an MEP (and former EC digital commissioner) against the legality of applying Singapore-style Bluetooth-powered contacts tracing in the EU — writing: “Please be cautious comparing Singapore examples with European situation. Remember Singapore has a very specific legal regime on identification of device holder.”

A spokesman for the EDPS told us it’s in contact with data protection agencies of the Member States involved in the PEPP-PT project to collect “relevant information”.

“The general principles presented by EDPB on 20 March, and by EDPS on 24 March are still relevant in that context,” the spokesman added — referring to guidance issued by the privacy regulators last month in which they encouraged anonymization and aggregation should Member States want to use mobile location data for monitoring, containing or mitigating the spread of COVID-19. At least in the first instance.

“When it is not possible to only process anonymous data, the ePrivacy Directive enables Member States to introduce legislative measures to safeguard public security (Art. 15),” the EDPB further noted.

“If measures allowing for the processing of non-anonymised location data are introduced, a Member State is obliged to put in place adequate safeguards, such as providing individuals of electronic communication services the right to a judicial remedy.”

We reached out to the HHI with questions about the PEPP-PT project and were referred to Boos — but at the time of writing had been unable to speak to him.

“The PEPP-PT system is being created by a multi-national European team,” the HHI writes in a press release about the effort. “It is an anonymous and privacy-preserving digital contact tracing approach, which is in full compliance with GDPR and can also be used when traveling between countries through an anonymous multi-country exchange mechanism. No personal data, no location, no Mac-Id of any user is stored or transmitted. PEPP-PT is designed to be incorporated in national corona mobile phone apps as a contact tracing functionality and allows for the integration into the processes of national health services. The solution is offered to be shared openly with any country, given the commitment to achieve interoperability so that the anonymous multi-country exchange mechanism remains functional.”

“PEPP-PT’s international team consists of more than 130 members working across more than seven European countries and includes scientists, technologists, and experts from well-known research institutions and companies,” it adds.

“The result of the team’s work will be owned by a non-profit organization so that the technology and standards are available to all. Our priorities are the well being of world citizens today and the development of tools to limit the impact of future pandemics — all while conforming to European norms and standards.”

The PEPP-PT says its technology-focused efforts are being financed through donations. Per its website, it says it’s adopted the WHO standards for such financing — to “avoid any external influence”.

Of course for the effort to be useful it relies on EU citizens voluntarily downloading one of the aligned contacts tracing apps — and carrying their smartphone everywhere they go, with Bluetooth enabled.

Without substantial penetration of regional smartphones it’s questionable how much of an impact this initiative, or any contacts tracing technology, could have. Although if such tech were able to break even some infection chains people might argue it’s not wasted effort.

Notably, there are signs Europeans are willing to contribute to a public healthcare cause by doing their bit digitally — such as a self-reporting COVID-19 tracking app which last week racked up 750,000 downloads in the UK in 24 hours.

But, at the same time, contacts tracing apps are facing scepticism over their ability to contribute to the fight against COVID-19. Not everyone carries a smartphone, nor knows how to download an app, for instance. There’s plenty of people who would fall outside such a digital net.

Meanwhile, while there’s clearly been a big scramble across the region, at both government and grassroots level, to mobilize digital technology for a public health emergency cause there’s arguably greater imperative to direct effort and resources at scaling up coronavirus testing programs — an area where most European countries continue to lag.

Germany — where some of the key backers of the PEPP-PT are from — being the most notable exception.

Pre-school EdTech startup Lingumi raises £4m, adds some free services during Covid-19

At these difficult times, parents are concerned for their children’s education, especially given so much of it has had to go online during the Covid-19 pandemic. But what about pre-schoolers who are missing out?

Pre-school children are sponges for information but don’t get formal training on reading and writing until they enter the classroom when they are less sponge-like and surrounded by 30 other children. Things are tougher for non-English speaking children who’s parents want them to learn English.

Lingumi, a platform aimed at toddlers learning critical skills, has now raised £4 million in a funding round led by China-based technology fund North Summit Capital – a fund run by Alibaba’s former Chief Data Scientist Dr Min Wanli – alongside existing investors LocalGlobe, ADV, and Entrepreneur First.

The startup, launched in 2017, is also announcing the launch of daily free activity packs and videos to support children and families during the COVID-19 outbreak, and has pledged to donate 20% of its sales during this period to the Global Children’s Fund.

Lingumi’s interactive courses offer one-to-one tutoring with a kind ‘social learning’ and its first course helps introduce key English grammar and vocabulary from the age of 2.

Instead of tuning into live lessons with tutors, which are typically timetabled and expensive, Lingumi’s lessons are delivered through interactive speaking tasks, teacher videos, and games. At the end of each lesson, children can see videos of Lingumi friends speaking the same words and phrases as them. Because the kids are watching videos, Lingumi is cheaper than live courses, and thus more flexible for parents.

The company launched the first Lingumi course in China last year, focused on teaching spoken English to non-English speakers. The platform is now being used by more than 100,000 families globally, including in mainland China, Taiwan, UK, Germany, Italy, and France. More than 1.5 million English lessons have taken place in China over the past six months, and 40% of active users are also playing lessons daily. Lingumi says its user base grew 50% during China’s lockdown and it has had a rapid uptake in Europe.

“Lingumi’s rapid expansion in the Chinese market required a strategic local investor, and Dr Min and the team had a clear-sighted understanding of the technology and scale opportunity both in China, and globally.”

Dr Wanli Min, general partner at North Summit Capital, commented: “It is only the most privileged children who can access native English speakers for one-on-one tutoring… Lingumi has the potential to democratize English learning and offer every kid a personalized curriculum empowered by AI & Lingumi’s ‘asynchronous teaching; model.”

Competitors to include Lingumi include live teaching solutions like VIPKid, and learning platforms like Jiliguala in China, or Lingokids in the West.

The Station: Bird and Lime layoffs, pivots in a COVID-19 era and a $2.2 trillion deal

Hello folks, welcome back (or hi for the first time) to The Station, a weekly newsletter dedicated to the all the ways people and packages move around this world. I’m your host, Kirsten Korosec, senior transportation reporter at TechCrunch.

I also have started to publish a shorter version of the newsletter on TechCrunch . That’s what you’re reading now. For the whole enchilada — which comes out every Saturday — you can subscribe to the newsletter by heading over here, and clicking “The Station.” It’s free!

Before I get into the thick of things, how is everyone doing? This isn’t a rhetorical question; I’m being earnest. I want to hear from you (note my email below). Maybe you’re a startup founder, a safety driver at an autonomous vehicle developer, a venture capitalist, engineer or gig economy worker. I’m interested in how you are doing, what you’re doing to cope and how you’re getting around in your respective cities.

Please reach out and email me at kirsten.korosec@techcrunch.com to share thoughts, opinions or tips or send a direct message to @kirstenkorosec.

Micromobbin’

the station scooter1a

It was a rough week for micromobility amid the COVID-19 pandemic. Bird laid off about 30% of its employees due to the uncertainty caused by the coronavirus.

In a memo obtained by TechCrunch, Bird CEO Travis VanderZanden said:

The unprecedented COVID-19 crisis has forced our leadership team and the board of directors to make many extremely difficult and painful decisions relating to some of your teammates. As you know, we’ve had to pause many markets around the world and drastically cut spending. Due to the financial and operational impact of the ongoing COVID-19 crisis, we are saying goodbye to about 30% of our team.

The fallout from COVID-19 isn’t limited to Bird. Lime is also reportedly considering laying off up to 70 people in the San Francisco Bay Area.

Meanwhile, Wheels deployed e-bikes with self-cleaning handlebars and brake levers to help reduce the risk of spreading the virus. NanoSeptic’s technology, which is powered by light, uses mineral nano-crystals to create an oxidation reaction that is stronger than bleach, according to the company’s website. NanoSeptic then implements that technology into skins and mats to turn anything from a mousepad to door handles to handlebars into self-cleaning surfaces.

The upshot to all of this: COVID-19 is turning shared mobility on its head. That means lay offs will continue. It also means companies like Wheels will try to innovate or pivot in hopes of staying alive.

While some companies pulled scooters off city streets, others changed how they marketed services. Some turned efforts to gig economy workers delivering food. Others, like shared electric moped service Revel, are focusing on healthcare workers.

Revel is now letting healthcare workers in New York rent its mopeds for free. To qualify, they just need to upload their employee ID. For now, the free rides for healthcare workers is limited to Brooklyn, Queens and a new service area from upper Manhattan down to 65th street. Revel expanded the area to include hospitals in one of the epicenters of the disease.

Revel is still renting its mopeds to the rest of us out there, although they encourage people to only use them for essential trips. As you might guess, ridership is down significantly. The company says it has stepped up efforts of disinfecting and cleaning the mopeds and helmets. Revel also operates in Austin, New York City, Oakland, and Washington. It has suspended service in Miami per local regulations.

Megan Rose Dickey (with a cameo from Kirsten Korosec)

Deal of the week

money the station

Typically, I would highlight a large funding round for a startup in the “deal of the week” section. This week, I have broadened my definition.

On Friday, the House of Representatives passed a historic stimulus package known as the Coronavirus Aid, Relief, and Economic Security or “CARES” act. President Donald Trump signed it hours later. The CARES act contains an unprecedented $2.2 trillion in total financial relief for businesses, public institutions and individuals hit hard by the COVID-19 pandemic.

TechCrunch has just started what will be a multi-day dive into the 880-page document. And in the coming weeks, I will highlight anything related or relevant to the transportation industry or startups here.

I’ll focus today on three items: airlines, public transit and small business loans.

U.S. airlines are receiving $58 billion. It breaks down to about $25 billion in loans for commercial carriers, $25 billion in payroll grants to cover the 750,000 employees who work in the industry.  Cargo carriers will receive $4 billion in loans and $4 billion in grants. These loans come with some strings attached. Airlines will have to agree not to lay off workers through the end of September. The package forbids stock buybacks and issuing dividends to shareholders for a year after paying off one of the loans.

Public transit has been allocated $24.9 billion. The CARES Act provides almost three times the FY 2020 appropriations for this category, according to the American Public Transportation Association. The funds are distributed through a formula that puts $13.79 billion to urban, $2 billion to rural, $7.51 billion towards state of good repair and $1.71 billion for high-density state transit. APTA notes that these funds are for operating expenses to prevent, prepare for, and respond to COVID-19 beginning on January 20, 2020.

Amtrak received an additional $1 billion in grants, that directs $492 million of those funds towards the northeast corridor. The remaining goes to the national network.

Small business loans are a critical piece of the bill, and an area where many startups may be focused. There is a lot to unpack here, but in basic terms the act provides $350 billion in loans that will be administered by the Small Business Administration to businesses with 500 or fewer employees. These loans are meant to cover an eligible borrower’s payroll, rent, utilities expenses and mortgage interest for up to eight weeks. If the borrower maintains its workforce, some of the loan may be forgiven.

Venture-backed startups seeking relief may run into problems qualifying. It all comes down to how employees are counted. Normally, SBA looks at a company’s affiliates to determine if they qualify. So, a startup owned by a private equity firm is considered affiliated with the other companies in that firm’s portfolio, which could push employment numbers far beyond 500. That rule also seems to apply to venture-backed startups, in which more than 50% of voting stock is held by the VC.

The guidance on this is still spotty. But Fenwick & West, a Silicon Valley law firm, said in recent explainer that the rule has the “potential to be problematic for startups because the SBA affiliation rules are highly complex and could cause lenders to group together several otherwise unaffiliated portfolio companies of a single venture capital firm in determining whether a borrower has no more than 500 employees.”

One final note: The SBA has waived these affiliation rules for borrowers in the food services and food supply chain industry. It’s unclear what that might mean for those food automation startups or companies building autonomous vehicles for food delivery.

More deal$

COVID-19 has taken over, but deals are still happening. Here’s a rundown of some of partnerships, acquisitions and fundraising round that got our attention.

  • Lilium, the Munich-based startup that is designing and building vertical take-off and landing (VTOL) aircraft and aspires to run in its own taxi fleet, has raised $240 million in a funding round led by Tencent. This is being couched as an inside round with only existing investors, a list that included participation from previous backers such as Atomico, Freigeist and LGT. The valuation is not being disclosed. But sources tell us that it’s between $750 million and $1 billion.
  • Wunder Mobility acquired Australia-based car rental technology provider KEAZ. (Financial terms weren’t disclosed, but as part of the deal KEAZ founder and CTO Tim Bos is joining Wunder Mobility) KEAZ developed a mobile app and back-end management tool that lets rental agencies, car dealerships, and corporations provide shared access to vehicles.
  • Cazoo, a startup that buys used cars and then sells them online and delivers to them your door, raised $116 million funding. The round was led by DMG Ventures with General Catalyst, CNP (Groupe Frère), Mubadala Capital, Octopus Ventures, Eight Roads Ventures and Stride.VC also participating.
  • Helm.ai came out of stealth with an announcement that it has raised $13 million in a seed round that includes investment from A.Capital Ventures, Amplo, Binnacle Partners, Sound Ventures, Fontinalis Partners and SV Angel. Helm.ai says it developed software for autonomous vehicles that can skip traditional steps of simulation, on-road testing and annotated data set — all tools that are used to train and improve the so-called “brain” of the self-driving vehicle.
  • RoadSync, a digital payment platform for the transportation industry, raised a $5.7 million in a Series A led by Base10 Partners with participation from repeat investor Hyde Park Venture Partners and Companyon Ventures. The company developed cloud-based software that lets businesses invoice and accept payments from truck drivers, carriers and brokers. Their platform is in use at over 400 locations nationwide with over 50,000 unique transactions monthly, according to RoadSync.
  • Self-driving truck startup TuSimple is partnering with automotive supplier ZF to develop and produce autonomous vehicle technology, such as sensors, on a commercial scale. The partnership, slated to begin in April, will cover China, Europe and North America.

A final word

Remember, the weekly newsletter features even more mobility news and insights. I’ll leave ya’ll with this one chart from Inrix. The company has launched a U.S. traffic synopsis that it plans to publish every Monday. The chart shows traffic from the week of March 14 to March 20. The upshot: COVID-19 reduced traffic by 30% nationwide.

inrix traffic drop from covid

Detroit Auto Show canceled in preparation for FEMA to turn venue into field hospital

The North American International Auto Show, which was scheduled for June in Detroit, has been canceled as the COVID-19 pandemic continues to spread and the city prepares to repurpose the TCF Center into a temporary field hospital.

NAIAS is held each year in the TCF Center, formerly known as the Cobo Center. Organizers said they expected the Federal Emergency Management Agency to designate the TCF Center as a field hospital.

“Although we are disappointed, there is nothing more important to us than the health, safety and well-being of the citizens of Detroit and Michigan, and we will do what we can to support our community’s fight against the coronavirus outbreak,” NAIAS Executive Director Rod Alberts said in an emailed statement.

The NAIAS is the latest in a long line of events and conventions that have been canceled as COVID-19, the disease caused by the coronavirus, has spread from China to Europe, and now the U.S. and the rest of the world.

More than 100 convention centers and facilities around the country are being considered to potentially serve as temporary hospitals. Alberts said it became clear that TCF Center would be an inevitable option to serve as a care facility.

The NAIAS, also known as the Detroit Auto Show, will be held in June 2021. Organizers are discussing plans for a fundraising activity later this year to benefit the children’s charities that were designated as beneficiaries of the 2020 Charity Preview event.

This year’s show was highly anticipated because it had moved from January to summer, following years of encouragement to schedule it during the warmer months.

All tickets purchased for the 2020 NAIAS show, including tickets for the Public Show, Industry Preview and Charity Preview will be fully refunded, organizers said. Charity Preview ticket holders will be given the option of a refund, or the opportunity to donate the proceeds of their refund to one of the nine designated Charity Preview beneficiaries. The NAIAS ticket office will be in contact with all ticket holders, according to the organizers.

How Huawei is dividing Western nations

The relationship between the United Kingdom and Australia is not usually a flashpoint in international relations. After all, the two allies share a common language, ancestry, and monarch. So what caused a dustup recently that saw a senior Australian parliamentarian rebuke the British foreign secretary, and for a group of Australian MPs to then cancel a trip to London in protest?

The answer is fears over Huawei, the Chinese telecom giant at the center of the 5G next-generation wireless debate. Australian officials were miffed when the British government recommended that the company be allowed to play a limited role in the U.K.’s 5G deployment despite calling it a “high risk” supplier due to its close ties to the Chinese government (the company’s founder, Ren Zhengfei, served for many years as an engineer in the People’s Liberation Army). The Australian government, a fellow member of the Five Eyes intelligence alliance (which includes the two countries plus the United States, Canada, and New Zealand), disagreed back in 2017 when it barred Huawei on national security grounds.

Now, two close allies are at cross purposes about the very future of the internet. What’s at stake is not just who equips the future of telecom infrastructure, but the very values that the internet itself holds.

Two countries, ocean(s) apart

It’s not just Australia and Britain that find themselves separated by an ocean (or two). In America, Huawei has become the Trump Administration’s favorite company to hate. In a speech at this year’s Munich Security Conference, Defense Secretary Mark Esper called the company “today’s poster child” for “nefarious activity” while another White House official compared the company to “the Mafia.”  It should come as no surprise that the company is the target of trade restrictions, a criminal action against its CFO, and a concerted diplomatic campaign. 

America’s concerns are twofold. First, that critical infrastructure provided by a Chinese company with such close ties to the country’s central leadership is an unacceptable security risk. Second, that arresting Huawei’s increasing dominance risks surrendering any chance for American leadership in 5G technology.

National security considerations have predominantly driven policymakers in Australia. More alert by geography to the strategic risks posed by China, Canberra moved early and decisively to bar Huawei from participating in its 5G networks at all. “The fundamental issue is one of trust between nations in cyberspace,” writes Simeon Gilding, until recently the head of the Australian Signals Directorate’s signals intelligence and offensive cyber missions.

That lack of trust between China and Australia is compounded by the difficult geopolitics of the Asia-Pacific. “It’s not hard to imagine a time when the U.S. and China end up in some sort of conflict,” says Tom Uren of the Australian Strategic Policy Institute (ASPI). “If there was a shooting war, it is almost inevitable that the U.S. would ask Australia for assistance and then we’d be in this uncomfortable situation if we had Huawei in our networks that our critical telecommunications networks would literally be run by an adversary we were at war with.”

Gilding warned, “It’s simply not reasonable to expect that Huawei would refuse a direction from the Chinese Communist Party.” And no matter what reassurances Huawei executives have given, they just simply haven’t been able to ally those concerns. Beijing didn’t help Huawei’s case when it passed its 2017 Intelligence Law, which obliges all Chinese companies and individuals to assist with intelligence efforts if asked. “People were always afraid [that might happen],” adds Uren, “and having it in writing really solidified those concerns.”

As a result, Canberra’s policy to ban Huawei has been largely uncontroversial. With the exception of some of the country’s telecom companies, “the decision [to ban Huawei] has bipartisan backing,” says Simon Jackman, CEO of the US Studies Centre at the University of Sydney.

Calling out London

American officials wish their British counterparts shared Australia’s outlook – and haven’t been shy about saying so. Secretary of State Mike Pompeo urged the UK to “relook” at the decision and lobbied Prime Minister Boris Johnson on the issue on a recent trip to London. Meanwhile, Defense Secretary Esper has made clear that electing to use Huawei could threaten allies’ access to American intelligence. “If countries choose to go the Huawei route,” Mr. Esper told reporters on the sidelines of the Munich Security Conference, “it could well jeopardize all the information sharing and intelligence sharing we have been talking about, and that could undermine the alliance, or at least our relationship with that country.”

U.S. Secretary of State Mike Pompeo leaves 10 Downing Street after a meeting with British Prime Minister Boris Johnson on 30 January 2020 in London, England. (Photo by WIktor Szymanowicz/NurPhoto via Getty Images)

British officials not only believe this to be a bluff – the Five Eyes intelligence alliance is much too strong in their view – but have a different assessment of the risk Huawei poses. “Everyone’s perception of the Huawei risk is particular to them,” says Nigel Inkster, a former deputy chief of MI6 now at the London-based International Institute for Strategic Studies (IISS).

The U.K. goes even further though. Experts in the British government, which started using Huawei in its 3G and 4G networks back in 2003, believe that not only can the risks be mitigated, but they are being overstated in the first place. “The Australian approach is driven by the kind of worst-case analysis of the risk 5G could pose in effect on the brink of war,” says Inkster. “I don’t think the U.K. envisages going to war with China any time soon.”

Inkster and other top officials remain confident in the Huawei Cyber Security Evaluation Centre (HCSEC), which was established by the National Cyber Security Centre (NCSC) back when Huawei was first introduced into Britain’s telecom networks. “We’ve never ‘trusted’ Huawei,” wrote NCSC Technical Director Dr. Ian Levy in a January 2020 blogpost. As a result, the U.K. has “always treated them as a ‘high risk vendor’ and worked to limit their use in the UK and put extra mitigations around their equipment and services.”

Levy and the government’s other cybersecurity experts believe that their system will continue to work. “The basic cyber security measures that have been used for 3/4G also apply to 5G,” argues Marcus Willett, who also served as the first Director of Cyber at GCHQ, Britain’s signals-intelligence agency. “If Huawei had been playing games, we would have discovered it by now,” says Pauline Neville-Jones, a Conservative member of the House of Lords, and previously security minister and cybersecurity advisor in former British Prime Minister David Cameron’s government.

British regulations already restrict Huawei and other high-risk vendors in several ways, including capping their market share at 35% and ensuring their equipment is continuously evaluated by HCSEC. In addition, by preventing Huawei’s 5G kit from being used near sensitive sites and limiting it to the periphery of the network (as opposed to the core), British officials are confident that they can contain any additional risk.

That’s not to say Huawei doesn’t face stiff opposition from some corners. Even if you mitigated the risk, it’s “quite a leap to allow the Chinese to be intimately involved in something as sensitive as this,” one U.K. retired diplomat, who spoke on condition of anonymity due to the sensitivity of the topic, told me. And the company is no one’s first choice. “If the U.K. didn’t have Huawei in its system, it wouldn’t choose to have Huawei now,” Lady Neville-Jones told me. “But we are in a different place [than Australia] and we have set up a system which we believe enables us to manage the risk. And by God, we will be on alert. We’re not stupid. [But] you say to yourself, at the end of the day, do you trust your technical people or not? And there’s never been a complaint on backdoors or traps.” Indeed, government experts have often caught coding errors she adds. “I suspect the result of [British inspections] is that technically Huawei is a better company than it might otherwise have been.”

The British position is also rooted in game theory. “Even if you could [bring down the network], when would you do it?” asks Willett, formerly of GCHQ. “It is effectively a ‘one shot’ capability – if used by China, it would undermine the position of all Chinese companies in the world tech market. China would therefore presumably save the ‘one shot’ for war or near-war, in which case it would need to be sure it would work. That is not easy.”

Australian experts are skeptical, though. “I think [the British] are overconfident in their ability to mitigate [the risk],” Uren, the ASPI expert, told me. His view – widely shared in Australia – is that defenders always think they can defend a system until they can’t, and giving a Chinese company access to the network is already a concession too far. “Cybersecurity is all about raising the costs for the attacker,” writes Gildling, the former Australian official. “Network access through vendors — which need to be all over 5G networks to maintain their equipment — effectively reduces the access cost to zero.”

The economic equation in Europe

It’s hard to understate the difference geography makes, though. In America and Australia — Pacific powers — China is physically present. For Europeans — including Britain — the risks of a rising China don’t carry the same emotional weight.

“The idea of China being a direct security threat is still somewhat abstract,” says Dr. Janka Oertel of the European Council on Foreign Relations. With the exception of countries like Poland and Estonia which are reliant on U.S. military support and thus more willing to toe Washington’s line, “European governments have just begun to asses the risk China can pose in the cyber realm.” Partly to allay those rising concerns, Huawei about a year ago established a a Cyber Security Transparency Centre in Brussels, the de facto capital of the European Union. Unlike Britain’s HCSEC, however, it is not an independent evaluation center and it is not designed to carry out the same functions.

Economics dominate the conversation on the continent more than national security concerns. The fragmented telecom market in Europe (105 mobile operators versus just four in America), has also proven beneficial to Huawei. In a competitive environment where cost has become everything, the state-subsidized Huawei is often able to underprice its competitors. Even in Britain, security concerns were weighed against the fact that “stripping out [the Huawei components already in the system] and starting again would carry enormous costs,” Inkster told me.

Still, Oertel thinks the debate in Europe is being debated on the wrong grounds. “It’s really hard to say Huawei is cheaper than Ericsson or Nokia. No one has the numbers because these are all contracts between private companies. We’re talking a lot of hypotheticals.” Her concern is that while Huawei might seem cheaper now, that might change if it’s able to squeeze out competitors and raise prices.

The battle isn’t over yet, though. Ericsson and Nokia maintain that they are competitive on technology and cost. Indeed, Ericsson is already running 27 5G networks in 15 countries and was just selected by the Danish government to build the country’s 5G network, displacing existing Huawei equipment. Meanwhile in Germany, the government’s move toward using Huawei has run into sharp opposition in the Bundestag, the German federal parliament. Norbert Röttgen, a prominent member of Chancellor Angela Merkel’s own party, helped draft a bill that would bar any “untrustworthy” company from “both the core and peripheral networks.”

Norbert Roettgen, CDU at the Bundespressekonferenz the occasion of the candidacy for the CDU chairmanship, on February 18, 2020 in Berlin, Germany. (Photo by Felix Zahn/Photothek via Getty Images)

The Trump Administration is still concerned enough about Huawei’s potential ability to dominate 5G worldwide that it is actively campaigning for a Western alternative. “We are encouraging allied and U.S. tech companies to develop alternative 5G solutions,” Defense Secretary Esper said in Munich, where he also exhorted fellow security officials to “develop our own secure 5G network … so we don’t regret our decisions later.” 

Other American officials have suggested even more extraordinary measures. Declaring in a February speech that nothing less than “our economic future is at stake,” Attorney General William Barr (who also served formerly as a long-time lawyer for U.S. telecom and TechCrunch parent company Verizon) bluntly called on the U.S. and its allies to “actively consider” a proposal for the government and U.S. companies to take a controlling stake in Nokia and Ericsson. “Putting our large market and financial muscle behind one or both of these firms would make it a far more formidable competitor.”

Ericsson dismisses these comments. “Personally, I find it odd that Barr is even thinking like this really,” Gabriel Solomon, a senior Ericsson executive in Europe, told me. “We were first to commercial deployment in four continents. We are in a very competitive market.”

Indeed, that echoes a common view in Europe: that the goal of American policy on Huawei is less about security and more about market share – and making sure America, not China, owns the future of 5G. And that has its own risks. “Cutting out Huawei altogether potentially moves us toward a kind of bipolar, bifurcated internet, which if taken to logical extreme would have some very serious adverse implications for everyone in terms of cost, a slowdown in innovation, and general reduction in intellectual and technical interchange,” says Inkster, the former MI6 official.

Things would be easier, Europeans say, if America presented an obvious alternative. Without one, America’s allies feel they have little choice but to use Huawei if they don’t want to fall behind technologically. “The West has got itself in a mess,” says the retired British diplomat. “It is a striking failure of political cooperation and coordination that we should find ourselves in this position.”

There is still optimism on both sides of the Atlantic that a Western solution can be found. As Röttgen of Germany wrote in a tweet in February:

Rather than pick a champion, another solution would be to level the playing field. “Telecoms security doesn’t pay,” concedes Dr. Levy of HCSEC. And “externalising the security costs of particular choices (including vendor) will help operators make better security risk management decisions.” Another option: better national screening investment mechanisms that would limit the ability of state-owned enterprises to operate unfairly.

But to get there requires coordination and cooperation – and that isn’t necessarily as forthcoming as you might expect. Germans still remember that the NSA hacked Chancellor Merkel’s phone – and the Trump Administration’s trade war has targeted Europe almost as much as it has China. Röttgen cautioned that cooperation on 5G was connected: “[W]e must know that tariffs against Brussels are off the table,” he said in the same tweet. “Partners don’t threaten one another.” Meanwhile, Huawei is earning goodwill by sending medical equipment to Europe to help combat the COVID-19 pandemic.

“Technology was supposed to unite us,” laments Jackman, the Australian professor; “instead it’s driving us apart not just from our rivals, but our allies, too.”

The FDA just okayed multiple 15-minute blood tests to screen for coronavirus, but there are caveats

On Thursday, the FDA amended their emergency policy around diagnostic testing for SARS-CoV-2, the novel coronavirus that causes COVID-19. Following on a change made March 16, the agency opened the door for a number of specific private entities and labs to develop and distribute tests that can provide results on the spot in as little as 15 minutes – but there are some pretty big caveats to keep in mind as you hear about more of these coming to market.

The tests, which are ‘serological,’ meaning they identify the presence of antibodies in a person’s blood, differ considerably from the molecular testing that is currently in use under Emergency Use Authorization (EUA) by FDA-approved labs and drive-through testing sites. The serological tests show that a person has developed antibodies to SARS-CoV-2, which means they very likely came into contact with it (and either have it, or have already recovered from having it). The molecular tests actually detect the presence of viral DNA in the blood stream, which is a much more definitive indicator that they currently have an active infection (at least at the time the swab was taken).

Serological tests have still been used widely in countries where the response to the COVID-19 pandemic has been shown to be effective, including in China, Taiwan and Singapore. They’ve also been used in different communities in the U.S., based on earlier guidelines around private lab diagnostics, but on March 26 the FDA named 29 entities who had provided notification to the agency as required and are now therefore able to distribute their tests.

It’s important to note that these tests have not been reviewed or validated by the FDA, unlike those molecular tests that are included in the organizations emergency use category. Instead, the FDA “does not intend to object to the development and distribution by commercial manufacturers” of these tests, provided they meet a number of criteria, including qualifying the results of their reported test results with the following information:

  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

The FDA specifically notes in its emergency use FAQ that these entities have reported their own validation of these tests, and that they won’t be pursuing Emergency Use Authorization. That said, there’s now nothing stopping the entities on this list from distributing their tests, which means they will be able to be put to use in testing Americans and painting a larger picture of the potential spread of the novel coronavirus – with the caveat noted above that the FDA doesn’t consider these tests used alone to be positive confirmation of a definite SARS-CoV-2 case, or conversely, a sure indicator that someone doesn’t have the virus.

Still, in the absence of better options like expanded available of the tests that are approved under the EUA, these serological tests (many of which can provide on-site results with just a pinprick of blood) will be useful in painting a more accurate picture of the overall spread and reach of the coronavirus, especially for smaller clinics, GP clinics and local labs that don’t have priority access to the equipment and supplies needed for the molecular testing efforts.

For instance, ne test on this list, the Healgen Scientific COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device, requires no instrumentation and can provide results in just 15 minutes. Distributor Ideal Rehab Care is working with its legal representation Fox Rothschild to begin importing the tests from Singapore for use “as soon as possible.”

The FDA updating its website with Healgen as one of the entities that have notified it of intent to use its serological test is what unlocked the ability for the company to begin distribution: It’s still illegal for anyone not on this list to do so, and the FDA still also specifically prohibits the use of at-home serological tests on its official guidelines.