FDA Issues EUA for COVIDSeq Diagnostic

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Illumina Inc’s COVIDSeq Test, according to a statement the firm released.

COVIDSeq is a qualitative test for the detection of SARS-CoV-2 RNA from nasopharyngeal swabs or oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal wash/aspirates, nasal aspirates, and bronchoalveolar lavage specimens.

Emergency use of the diagnostic is limited to authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests.

The EUA was made on the basis of the public health emergency declared on February 4, 2020, by the Secretary of the US Department of Health and Human Services (HHS).

HHS signaled that circumstances justify the emergency use of in vitro diagnostics for detection and/or diagnosis of SARS-CoV-2.

“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product,” the FDA’s authorization letter read.

SARS-CoV-2 nucleic acid is detectable in respiratory samples during the acute phase of infection. Clinical assessment and review of other diagnostic information is necessary to comprehensively determine the probability of viral acquisition. Positive results also do not rule out co-infection with other viruses.

To use the product, SARS-CoV-2 nucleic acid is extracted, isolated and purified from respiratory specimens. The purified nucleic acid undergoes reverse transcription, target amplification, library preparation, library pooling, sequencing, and analysis.

The COVIDSeq Positive Control HT consists of ssRNA fragments that provide coverage of greater than 99.9% of the SARS-CoV-2 viral genome bases.

The company will be required to evaluate analytical sensitivity and reactivity of the product using FDA-recommended reference materials. Illumina will also be required to monitor adverse events, including false results, for reporting to FDA.

The product is authorized for the length of circumstances justifying the emergency use of in vitro diagnostics for detection of SARS-CoV-2.