Should consumers be allowed to collect their own specimens for a COVID-19 test? At least five companies announced plans in mid-March to sell COVID-19 tests directly to consumers and have them collect their specimens at home, then return the samples to the the labs doing the testing. This scheme came to a quick end, however, on March 20 when the federal Food and Drug Administration (FDA) issued an alert to consumers to be aware of, among other things, “unauthorized, fraudulent COVID-19 kits.” The next day, the FDA updated its website’s FAQ for diagnostic testing and expressly stated that “the policies outlined in the Policy for Diagnostic Tests for Coronavirus Disease-2019 do not apply to at-home testing, including self-collection of samples to be sent to a clinical laboratory.”
MORE ON: CONSUMER TESTS FOR COVID-19
In the days preceding the FDA’s clarification on consumer self-collection of samples for COVID-19 tests, at least five companies had issued public statements that they were offering COVID-19 tests for consumers. These companies were Carbon Health, Everlywell, myLAB Box, Nurx and its laboratory partner Molecular Testing Labs, and Scanwell Health. The FDA’s swift action on this COVID-19 test issue may be a reaction to the sustained criticism from clinical laboratory professionals, the news media, and others about how the agency was slow to expedite the process CLIA-certified clinical laboratories must use to meet regulatory requirements for developing and validating COVID-19 tests intended for use in patient care.
MIGHT SARS-COV-2 CHANGE HOW LDTS ARE REGULATED?
One unresolved issue in the clinical laboratory industry is FDA regulation of laboratory- developed tests (LDTs). Clinical labs, in vitro diagnostic (IVD) companies, and others regularly challenge efforts by FDA officials to expand their agency’s regulation of LDTs. The current outbreak of the novel coronavirus is getting the full attention of the public, the news media, and Congress. Once the current COVID-19 outbreak subsides, all sides may view LDT regulation very differently, and in ways that might lead to a consensus on how LDTs should be regulated.
• Pathologist Stephen Schwartz, MD, PhD, 78, a Professor of Pathology at the University of Washington in Seattle, died of COVID-19 on March 17, after being admitted to the hospital for that disease. Schwartz joined UW 54 years ago, in 1967, as a pathology resident and became an assistant professor in 1973.
• Laboratory for Advanced Medicine of Irvine, Calif., announced that its new Chief Operating Officer is Benjamin Oyler. Oyler previously held executive positions at Ancestry.com, Design Ink Corporation, and Del Sol.
• Prelude Corporation, of Laguna Hills, Calif., appointed Edwin C. Hendrick as Chief Commercial Officer. He earlier served at GenomeDX Biosciences, US Labs, Ventana Medical Systems, and Abbott Laboratories.
DARK DAILY UPDATE
Have you caught the latest e-briefings from DARK Daily? If so, then you’d know …
… how Taiwan—just 81 miles from mainland China—acted swiftly to contain the outbreak of SARS-CoV-2. As early as Jan. 20, it screened arriving passengers from China for infection. It successfully introduced COVID-19 tests early in the outbreak.
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That’s all the insider intelligence for this report. Look for the next briefing on Monday, April 20, 2020.