Shares of Fluidigm (NASDAQ:FLDM) soared on Wednesday after the biotechnology tools provider said its new saliva-based test for SARS‑CoV‑2 -- the virus that causes COVID-19 -- received emergency use authorization from the U.S. Food and Drug Administration (FDA). As of 1:13 a.m. EDT, Fluidigm's stock was up more than 35%.
Since it uses saliva samples, Fluidigm's test is easier to perform for medical professionals -- and far more comfortable for patients -- than tests that require nasal swabs. Yet Fluidigm said its test, called the Advanta Dx SARS-CoV-2 RT-PCR Assay, generated results that were in 100% agreement with the results from paired nasal-swab samples tested with other FDA-authorized assays.
Additionally, Fluidigm said its test has production advantages that will ease the strain on the healthcare industry's supply chains. Its Biomark HD platform can produce as many as 6,000 test results per day on a single system.
"We have seen extraordinarily strong customer interest in our high-throughput saliva-based test, including many new purchases of Biomark HD systems to enable its adoption," Fluidigm CEO Chris Linthwaite said in a press release. "We have a high degree of confidence that this new test will not only enhance testing capacity but will also significantly improve speed to results and scale."
Fluidigm's assay is not the only saliva-based coronavirus test that's been authorized for emergency use by the FDA. A diagnostic test created by the Yale School of Public Health and funded in part by the NBA was granted an emergency use authorization earlier this month. Moreover, Yale's test is expected to cost only about $10 per sample.
Still, with COVID-19 case counts continuing to rise in the U.S. and around the world, there will likely be room for multiple diagnostic options. For its part, Fluidigm expects to see strong and sustained demand for its assay. "In the United States, Emergency Use Authorization for our test coincides with the total number of COVID-19 cases exceeding 5.7 million, underscoring the need for scalable and easy-to-administer testing," Linthwaite said.