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 But the majority of these of offerings have since been rescinded or hang in doubt thanks to new warnings and regulatory clarifications issued this weekend by the FDA.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 its service to go live today, and its website still has materials promoting the test for use by individuals – although clicking on this option generates a message that the service is "not yet available for individual purchase."
MobiHealthNews has reached out to both of these companies for comment, 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 – 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.
Keep Reading >>
.