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Covid Tests Can Signal Presence of Omicron Variant, FDA Says

Dec. 3, 2021, 11:10 PM

Molecular Covid-19 tests developed by Thermo Fisher Scientific, Alphabet Inc.‘s Verily Life Sciences, and nearly two dozen other companies may be able to detect the omicron variant, the Food and Drug Administration announced Friday.

Omicron, which has spread to at least seven U.S. states, reduces the sensitivity of one genetic target in several molecular tests, the FDA said in an update on its website. That target, which covers a portion of a spike gene, wouldn’t pick up the virus—signaling the presence of the new strain.

Genetic sequencing would be needed to confirm the presence of omicron when tests identify this pattern, the agency noted.

It added that the mutation likely won’t impact the tests’ overall ability to detect the virus that causes Covid-19 because these molecular tests are designed to detect multiple genetic targets.

Thermo Fisher’s TaqPath Covid-19 testing kit “is able to detect the presence of SARS-CoV-2 in samples that include” the omicron variant, the company said in an emailed statement. The company said in a press release Nov. 29 that “by surveying across multiple genes,” its test “can report accurate results even in the case where one of the targets is impacted by a mutation.”

Several unknowns on the transmission and severity of the omicron variant remain, though the strain’s rapid spread across South Africa has prompted concern that existing Covid-19 vaccines may not offer sufficient protection.

A World Health Organization scientist said Thursday that key global data findings on the omicron variant could be coming “within days.”

—With assistance from Jeannie Baumann

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Karl Hardy at khardy@bloomberglaw.com

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