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FDA Authorizes First Genomic Sequencing COVID-19 Test

On June 10, 2020, the FDA issued an emergency use authorization (EUA) for the first molecular diagnostic test that can generate information about the genomic sequence of the COVID-19 virus.

The EUA was issued to Illumina, Inc. of San Diego, California, for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from individuals suspected of having COVID-19. Using genomic sequencing means that the test can generate information about the genomic sequence of the virus present, which can then be used for research purposes to monitor if and how the virus mutates in the future.

To be technical, the Illumina test requires “nasopharyngeal swab, oropharyngeal swap, nasal aspirate, or bronchoalveolar lavage” specimens, which then undergo several processes including “reverse transcription, target amplification, library preparation, library pooling, sequencing, and analysis.”  If a positive result is achieved, this will be “indicative” of the presence of the SARS-CoV-2 nucleic acid – i.e., that you are infected with the COVID-19 virus – but it does not necessarily rule out a bacterial infection or a co-infection with other viruses.  A negative result does not preclude an infection, and FDA cautions that a negative result should not be used as the sole basis for patient management decisions.  Rather it should be combined with clinical observations, patient history, and epidemiological information.

The EUA covering this Illumina test can be found here.

The FDA as of June 10 has issued EUAs authorizing 131 tests, which include 111 molecular tests (one of which is the Illumina test), 19 antibody/serology tests, and 1 antigen test. A listing of these authorized tests can be found on the FDA’s website here. If you have taken a COVID-19 test or are planning to do so in the future, you might want to consult this site to make sure that your test has been authorized by the FDA in an EUA.

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