After receiving an emergency use authorization from the Food and Drug Administration (FDA) last month, Fluidigm (FLDM 3.35%) reported that its saliva-based test for the novel coronavirus that causes COVID-19 is being run at two Clinical Laboratory Improvement Amendments (CLIA) certified labs. The tests, which go by the unweildly name, Advanta Dx SARS-CoV-2 RT-PCR Assay, are being processed by ImmunoGenomics, based in metropolitan Houston, and Vero Diagnostics, of Research Triangle Park, North Carolina.
These aren't the first labs to start testing Fluidigm's saliva-based test. A Fluidigm representative told The Motley Fool, "We highlighted ImmunoGenomics and Vero Diagnostics because they are representative of the small- and medium-sized labs that are running our test. In addition, large public health organizations and major academic centers are adopting our saliva-based test."
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Unlike most coronavirus tests, the Advanta Dx SARS-CoV-2 RT-PCR Assay doesn't require a swab to be stuck up the patient's nose, which many patients have reported as uncomfortable. Instead, a little saliva is all that's required for the machine to determine if the novel coronavirus is present. The data package submitted to the FDA showed 100% agreement between the saliva test and the nasal test.
The test runs on Fluidigm's Biomark HD system, so any CLIA certified lab with the machine should be able to run the test. The system can run up to 6,000 samples per day per system, although both ImmunoGenomics and Vero Diagnostics are currently only running about 3,000 of Fluidigm's saliva tests per day.
