Last week saw a number of diagnostic testing startups, telehealth providers and others announce new services that would deliver at-home COVID-19 testing-kits to consumers. But the majority of these of offerings have since been rescinded or hang in doubt thanks to new warnings and regulatory clarifications issued this weekend by the FDA.

On Friday evening, the agency released an alert to consumers warning of "unauthorized fraudulent COVID-19 test kits," which specifically noted that "the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19."

A day later the FDA also updated the diagnostic testing FAQ on its website, clarifying that a recently updated policy – which permits testing by Clinical Laboratory Improvement Amendments (CLIA)-certified labs that had not yet acquired Emergency Use Authorization (EUA) for their COVID-19 diagnostic – does not apply to at-home COVID-19 testing, "including self-collection of samples to be sent to a clinical laboratory." This diagnostic testing policy was first published on February 29, and updated March 16.

Some of the at-home diagnostic companies told STAT on Saturday that there were still ambiguities as to whether their offerings would be affected. Since the publishing of the FAQ later that day, however, telehealth startup Nurx and tech-heavy primary care provider Carbon Health have confirmed that their at-home sample collection and testing services have been put on hold.

"Given new guidance from the FDA specific to self-collection laboratory testing on March 21, Nurx and our laboratory partner Molecular Testing Labs have made the responsible decision to pause on providing any additional self-collection COVID-19 tests," Nurx said in an email statement to MobiHealthNews, which noted that the company's offering was in accordance to FDA guidance prior to the most recent update. "Molecular is in direct communication with the FDA regarding this most recent guidance and they continue to have high confidence in the test characteristics and accuracy of its self-collection COVID-19 test."

In a blog post updated yesterday, Carbon Health Medical Director Dr. Caesar Djavaherian said that it was notified of the updated FAQ by its lab partner and immediately discontinued distribution of its COVID-19 sample collection kits. The company is also contacting 50 patients who were slated to receive the at-home kits so that they may be offered expedited in-person testing.

"The FDA supports at home sample collection but requires additional data to validate its accuracy," Djavaherian wrote in the blog post. "We continue to perform a large number of COVID-19 tests in our clinics and are continually looking for additional ways to expand our testing capacity to meet the needs of our patients. We remain hopeful that the FDA will approve at home sample collection as one of the tools to address this pandemic."

At-home sample collection kits and subsequent lab testing services were also promoted last week by myLAB Box and Everlywell. The latter company said at the time that its service was scheduled to go live today for individuals; however, statements from the company posted and updated over the course of the weekend saw Everlywell shift its test kit supply from widespread availability to professional use only. The company's statement also stressed that it's practices were in line with the FDA's guidance prior to the agency's weekend warning and FAQ.

MobiHealthNews has reached out to myLAB Box for comment on its service, and will update this story with any response.

SOME AT-HOME OPTIONS STILL MOVING FORWARD

At least one home diagnostics startup does not seem to be fazed by the FDA's recent clarifications.

Scanwell Health, which is best known for its smartphone-based urinary tract infection-screening platform, was among those that announced a new at-home COVID-19 diagnostic service last week. But their product – a rapid serology test licensed exclusively from Chinese firm INNOVITA – wasn't set to launch for another six to eight weeks, due to the company's decision to seek an EUA up front.

"When we started evaluating an at-home novel coronavirus test, [our at-home urine testing] experience really helped us understand how to approach this in the right way," Dr. Jack Jeng, chief medical officer at Scanwell, told MobiHealthNews. "Weeks ago we already started looking into what it meant to get this test to the patient in their home, and from the beginning we realized that means we do need to get FDA approval for this. We believed going through the EUA process was the way to do this, so we never considered doing it any other way."

While Scanwell appears to have made the correct call in hindsight, some of the company's confidence in its six-to-eight-week projection comes from its use of a serology test rather than a reverse transcriptase polymerase chain reaction (RT-PCR)-testing method being employed in most labs. The former measures for the presence of COVID-19 antibodies in a blood serum sample, while the latter detects the presence of the virus itself in a respiratory specimen sample.

Among the benefits of the serology approach, Jeng explained, is that patients can scan their sample through a mobile platform and won't need to mail their kits to a lab – thus reducing burden among these facilities and providing patients with a quicker result. Scanwell's platform and serology sample-collection is also a much easier process to talk a patient through, and limits the risk of an improperly collected sample affecting test results.

"You can imagine if the specimen is not collected correctly, the results may not be accurate and that can really impact what the doctor's recommendation is. If the patient thinks they don't have the disease because the test is negative, because the sample is collected inappropriately, they may go out in the world and risk transmitting it to others. So you can see the kind of balance the FDA has to do, the role they have to play in making sure the tests are safe and reliable."

The challenge of consistent specimen collection is also likely to be central to another at-home sample-collection project recently launched in Washington State's King County. Backed by the Gates Foundation, Amazon, the region's public health authority and local health systems, the Seattle Coronavirus Assessment Network (SCAN) will be mailing swab kits to the homes of community members regardless of whether or not they are demonstrating symptoms of the novel coronavirus.

The goal of the project is to generate a population-level understanding of how the disease has spread within the Greater Seattle area. In addition, Jeng said that the research effort could provide healthcare officials with a better idea of whether untrained individuals are up to the task of at-home sample collection for RT-PCR testing.

"The Gates Foundation [trial aims to] validate that patients can do this safely and effectively at home, because obviously there are differences between when someone does it on themself or when a healthcare worker does it," he said. "I don't know if you've had any experience receiving a test like this, but it's not the most comfortable process. It feels like you're putting a swab into the base of your brain."

A DIFFICULT SPOT FOR REGULATORS

Jeng acknowledged that the FDA's shifting guidances may have led to some confusion among testing services looking to stem the spread of COVID-19 in the U.S., but was generally sympathetic to the challenges this emergency has presented for the regulator.

"I think the FDA is in a very difficult spot right now with the COVID-19 crisis. They have to balance the safety of patients with reliable testing and access to the tests needed in this growing crisis," he said. "The FDA has already shown extraordinary measures by allowing testing to proceed with a EUA [or pending EUA] as opposed to a full review."

Nurx, which had to cancel its offering in light of the guidance's ambiguity, acknowledged in its statement that this was a "rapidly evolving situation" and ultimately deferred to the agency's decision-making process.

"We still fully agree with FDA’s position in its recent guidance that there is 'public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection.' Our goal in providing a COVID-19 home testing and online consultation service was to leverage our substantial clinical, technical, and operational expertise to address this unprecedented pandemic," the company said. "As a healthcare company, we believe we are uniquely positioned to responsibly contribute and safely connect people with testing, education and care but the most important action we can take at this time is to support public trust in the FDA during this public health emergency."

Nurx also noted in its statement that the company is "exploring additional ways to be supportive to both healthcare workers on the front lines and patients," noting that its bread and butter telehealth birth control prescriptions have seen a 40% increase over the past week.

Carbon Health's Djavaherian similarly noted that the company is continuing to conduct COVID-19 tests in its clinics and remains hopeful that at-home sample collection will soon be feasible, but in the meantime is "continually looking for additional ways to expand our testing capacity to meet the needs of our patients."

And, in addition to its ongoing EUA bid, Jeng said that Scanwell is working to send its serology tests out for professional use (as permitted in the March 16 policy update). He said that these kind of efforts – much like the at-home testing services – reflect a genuine interest within the diagnostic sector to help patients and front-line providers during the global crisis.

"It's hard for me to comment on what other companies, their decisions and what they were thinking, but I think in general everyone wants to help in this growing crisis and everyone wants to do their part," he said. "At the end of the day, the more methods of performing this test we can bring to market, the better it is for all of us. We're just happy we can play a role in doing this, and I think it's great that the FDA is clarifying how these things should be done."