Benzinga | Dec 7, 2021 12:49PM EST

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 (NYSE: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.