Four different diagnostic companies were planning to send tests for the coronavirus infections at home to their customers this week, but are instead pausing to roll out avoid the displeasure from Food and Drug Administration (FDA) bureaucrats. Companies even destroy samples returned from customers rather than testing them to meet FDA guidelines.
The companies had started their tests based on their interpretation of the latest FDA Emergency authorization, (EUA) who says that any laboratory certified to the appropriate quality control standards can perform coronavirus testing. They all used such labs.
For example, to meet FDA testing guidelines TechCrunch reports that the California-based Carbon Health has sent a message to their coronavirus home test customers stating that “we sincerely regret informing you that you will not receive a test result. If you have already returned your kit, the copy will be destroyed by Curative, Inc . [their lab testing partner] using standard removal of biohazard material. If you have not received your kit yet, please discard it upon receipt. “
Based in Austin, Everlywell expanded to perform 250,000 of its coronavirus tests at home per week. Since the FDA’s EUA does not prevent private labs from developing and deploying coronavirus tests for clinical use, the company is committed to providing COVID-19 tests available for hospital and caregivers, as a way to circumvent the FDA’s regulatory roadblock. Carbon Health offers their coronavirus tests walk-in clinics.
The fact that these tests are self-managed is uncomfortable may make their results less accurate, but the fact that the FDA allows their use by health care providers indicates that these tests work and in no way fraudulent. The FDA must now put an end to the COVID-19 tests at home.