Regulatory confusion is leaving some life-sciences startups in limbo as they race to unveil COVID-19 test kits, underlining a scattered federal response that has left the nation's coronavirus testing capacity lagging far behind other developed countries.
Guidelines from the Food and Drug Administration on who could and couldn't provide home testing kits have sent mixed signals. On Feb. 29, the FDA allowed select private labs to run new coronavirus tests, something previously done only by the Centers for Disease Control and Prevention. More coronavirus news: Continuing coverage from PitchBook
Soon after that, a series of medical testing startups with private lab partnerships scrambled to develop at-home swab sample collection kits for so-called polymerase chain reaction tests, which can detect specific genetic material contained in the coronavirus. These tests would be sold for zero profit.
But on Saturday, the FDA updated its guidelines for private labs, prohibiting them from collecting sample swabs via mailed-in home kits—just as several venture capital-backed companies prepared to bring them to market.
As a result, mail-order sample collection no longer appears a viable solution to the nation's testing lag. (As of Sunday, the US had tested only about 72,800 people, while South Korea—about 16% of the size of the US in population—had tested more than 330,000, according to the CDC.) Self-sample collection could be especially important for the 46 million Americans living in rural communities with reduced access to hospitals and drive-through testing centers, like those cropping up in urban areas.
For some of these startups, the change in rules came just as their products were debuting. On Friday, Carbon Health, a brick-and-mortar and online clinic startup based in San Francisco, was gearing up to mail out 100—and in two weeks, 1,000—swab kits each day, allowing customers to self-collect a sample for coronavirus testing in a lab. The FDA's updated guidance the next day forced them to abandon the operation immediately.
The 50 kits Carbon Health already sent out will be destroyed by its lab partner Curative Inc. The company has refunded its customers and urged them to visit one of its 10 in-person California clinics for testing there instead.
"We are truly sorry for the frustration and disappointment this has caused," the company wrote in an email to customers who had already ordered kits.
California-based Nurx, better known for its birth-control pill delivery and at-home tests for sexually transmitted infections, had intended to begin selling its self-collection kits Monday. The company had offered the test alongside its lab partner, Molecular Testing Labs. Now, that plan is on pause.
"Molecular continues to have high confidence in the test characteristics and accuracy of its self-collection COVID-19 test," Nurx wrote on its website.
Everlywell, an Austin startup that offers at home testing kits for concerns ranging from fertility to food sensitivity, planned to make 30,000 COVID-19 self-swabbing kits available Monday. In response to the FDA's updated guidance, the company decided to allocate its initial supply of kits to hospitals and healthcare companies with workers in high-risk settings, the company wrote on its website. The swabs will be administered by healthcare providers.
However, a reported partnership between Amazon's employee healthcare arm and a Gates Foundation-backed initiative may have found a way to circumvent the FDA's latest decree on mailed sample collection. In a test program with the Seattle Coronavirus Assessment Network, specially trained Amazon Care drivers will hand-deliver self-collection kits to Seattle-area households, then pick up and transfer them to FDA-approved labs.
Startup Scanwell, which offers testing for urinary tract infections, is also taking a different route. The California-based company is awaiting FDA approval for a finger-stick test, which would allow customers to see if they test positive or negative for COVID-19 antibodies in about 15 minutes on a smartphone app. This is different from the PCR swab tests, which are in increasingly short supply. China has widely used blood testing in healthcare settings during the pandemic, according to Scanwell's chief medical officer, Jack Jeng.
Scanwell's test is not yet on the market, though the expedited FDA approval process should take no more than six to eight weeks, Jeng said. US regulators approved blood testing for the novel coronavirus in healthcare settings March 16.
"We still have to validate that this test performs at home as well as it does with a healthcare worker doing it ... in the lab, but it's a much lower bar than what it would have been if the FDA did not change their approaches to this kind of rapid test," Jeng said.
3/24/20: The story was updated correct Carbon Health's clinic count, to include Everlywell's response and to clarify that China has widely used blood testing, but not in at-home settings.