Thermo Fisher Verily On FDA List Of COVID-19 Tests Affected By Ommicron Variant - Market News
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Thermo Fisher Verily On FDA List Of COVID-19 Tests Affected By Ommicron Variant

Thermo Fisher Verily On FDA List Of COVID-19 Tests Affected By Ommicron Variant

Dive briefing:

  • FDA published on Friday a list of molecular testing for COVID-19 potentially affected by mutations in the ommicron variety of care that continues to spread around the world.
  • The agency’s list focuses on coronavirus tests affected by S gene failure, an event most commonly associated with Thermo Fisher Scientific’s TaqPath test kits. When TaqPath is used on a variant with a deletion in the spike gene, such as alpha and omicron, it detects only two of the three target genes.
  • Since the S gene is detectable in the dominant delta variant, the FDA is asking labs that “have access to rapid turnaround services for whole genome sequencing” to consider sequencing samples affected by dropouts. Thermo Fisher already has praised his test because it has an “S gene advantage” that can aid in early identification of ommicron. While the S-gene dropout can “signal” that omicron is present, the FDA reiterated that the presence of the pattern does not mean a person with SARS-CoV-2 has omicron.

Dive Insight:

S-gene dropout first appeared on regulators’ radars when the alpha variant spread at the beginning of the year. At the time, the dropout of the S gene allowed researchers to roughly monitor the movement of other SARS-CoV-2 viruses by alpha by looking at the proliferation of tests yielding positive results for some, but not all target genes.

Since delta has an S gene that is detectable with tests like TaqPath, the drop in S gene dropouts showed how that variant steadily replaced alpha. Now the same data can demonstrate the rate at which ommicron is replacing delta and allow for the targeted sequencing of samples to confirm they are the new variant.

The approach is only viable with tests that check for multiple genes. If a test checked only for the S gene, it would give a negative result when used on a sample containing alpha or ommicrons.

FDA has identified 26 molecular tests affected by S gene dropout. The best-known tests on the list are three versions of Thermo Fisher’s TaqPath.

TaqPath labs handle about a third of all specimens tested in England, putting the test at the heart of the effort to track the changes from alpha to delta to ommicron. Of Thermo Fisher Generation Having delivered more than $1.5 billion worth of COVID-19 testing in the third quarter alone, TaqPath is likely to be widely used in other markets as well.

The other 23 tests listed by the FDA include a Verily Life Sciences product. Just like TaqPath, the real product tests for three parts of the SARS-CoV-2 genome, which means that it can give a positive result by identifying the ORF1ab region and the nucleocapsid gene, even if there is a deletion in the S gene. FDA asks clinical lab personnel and health care providers to be aware that S gene dropout is consistent with omicron, but does not recommend changes beyond targeted sequencing, if possible.

While the available tests detect ommicron, developers are working on products specific to the variant. TIB Molbiol, that Roche recently acquired, has developed three research test kits that: designed to detect ommicron mutations. The kits run on LightCycler and cobas z 480 analysers. Roche said the tests could help researchers “with improved variant detection and viral research.”

The tests are for research purposes only. Roche compared all of its PCR tests with the publicly available omicron sequences and found that they all correctly identify the new variant.

Makers of both PCR and Rapid Antigen Tests have said their tests can detect ommicrons. FDA said on Nov. 30 that it seems likely that the most widely used tests in the U.S. should detect the variant, according to its preliminary assessment.

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Anna Wintour

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