As TechCrunch notes several companies were developing at-home medical and health diagnostics who have passed a screening but who believe they might have contracted the new coronavirus. This flurry of activity include biotechnology startups Everlywell, Carbon Health and Nurx. The kits involve the taking of a swab sample and then posting the sample back to a laboratory for analysis.
Despite this rush to market, the U.S. Food and Drug Administration (FDA) has changed the ‘Emergency Use Authorization’ guidelines to specifically block the use of at-home sample collection. The reason for the FDA’s decision relates to kit accuracy and user safety.
Some commentators have expressed concern with the FDA’s decision. This includes Lux Research Associate Danielle Bradnan, who tells Digital Journal that she finds the Agency’s decision “baffling”.
In addition, Bradnan says: “All processing of at-home testing kits for SARS-CoV-2 (the virus that causes COVID-19) will stop to comply with the alert. While the U.S. FDA is trying to achieve a delicate balance, trying to facilitate as many tests as possible while ensuring safety and accuracy, it is unclear why it is doing this.”
Bradnan says that the samples sent in by citizens would have been tested at an appropriate, certified laboratory: “For many testing sites, samples have to be shipped to an independent CLIA lab, where testing is done independently by certified laboratory specialists.”
She notes that: “This process is identical to the process of at-home testing companies, which mainly serve as infrastructural support for sampling. Historically, for this reason, the FDA has chosen not to step in with this testing – be it for allergy, fertility, or STI testing. This decision is baffling.”
One of the startups, Carbon Health is continuing with testing at its physical clinics.
