75 persons detected with new United Kingdom mutant strain in India

Still, it characterized the impact to overall testing accuracy as "low" and cited no episodes of actual false-negative results.

Dr. James A. Hayward, president, and CEO, Applied DNA, stated in a press release issued on January 8, 2021, "Using our Assay Kit, we have already identified variants of SARS-CoV-2 via S-gene dropout, sequenced the identified variants with partners and identified common genetic progenitors that are shared by B.1.1.7 and other emerging SARS-CoV-2 variants".

"At this time, we believe the data suggests that the now authorized COVID-19 vaccines may still be effective against this strain", FDA Commissioner Stephen Hahn, M.D., said in a statement.

The SARS-CoV-2 virus is like all viruses and can mutate over time. Therefore, tests that rely on multiple regions of the genome may be less impacted than those that only rely on a single region, the FDA said. At this time, we believe the data suggests that the now authorized COVID-19 vaccines may still be effective against this strain. "The FDA will continue to keep health care providers and the public informed of any new information as it becomes available", Hahn added.

The agency has alerted clinical laboratory staff and health care providers to the possible false negative results from any molecular test, and has asked them to consider such results in combination with clinical observations, and repeat testing with a different test if COVID-19 is still suspected.

Thermo Fisher Scientific Inc's TaqPath COVID-19 combo kit and Applied DNA Sciences' Linea COVID-19 assay kit were found to have significantly reduced sensitivity due to certain mutations, including the B.1.1.7 variant or the so-called United Kingdom variant, according to the agency.

It also noted that the detection pattern used with the TaqPath and Linea tests when certain genetic variants are present may even help detect new variants in patients, potentially helping to reduce spread. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.