FDA Enlists Thermo Fisher, Google-Backed Verily COVID-19 Tests Likely To Be Affected By Omicron

On Friday, the FDA published a list of molecular tests for COVID-19 that may be affected by mutations in the omicron variant of concern.

  • The agency's list focuses on coronavirus tests impacted by S-gene dropout, an occurrence that is most commonly associated with Thermo Fisher Scientific Inc's TMO TaqPath test kits. 
  • When TaqPath is used on a variant with a deletion in the spike gene, such as alpha and omicron, it only detects two of the three target genes.
  • Since the S-gene is detectable in the dominant delta variant, the FDA asks laboratories with "access to quick turnaround whole-genome sequencing services" to consider sequencing samples affected by dropout. 
  • FDA has identified 26 molecular tests affected by S-gene dropout. The best-known tests on the list are three versions of TaqPath from Thermo Fisher.
  • The other 23 tests listed by the FDA include a product from Verily Life Sciences, backed by Alphabet Inc (Google) (NASDAQ: GOOG.
  • Like TaqPath, the Verily product tests for three parts of the SARS-CoV-2 genome, meaning it can deliver a positive result by identifying the ORF1ab region and nucleocapsid gene even if there is a deletion in the S-gene. 
  • Price Action: TMO shares are up 1.09% at $629.01 during the market session on the last check Tuesday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: NewsHealth CareFDAGeneralBriefsCOVID-19 CoronavirusDiagnostics
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!