NEW YORK – Shares of Fluidigm were up around 5 percent in Monday morning trading on Nasdaq in response to an announcement by the US Department of Health and Human Services (HHS) that it would use Fluidigm's saliva-based molecular SARS-CoV-2 test as part of a federal surge testing program.
Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay received US Food and Drug Administration Emergency Use Authorization in August and has received $34 million in financial support from the National Institutes of Health Rapid Acceleration of Diagnostics Initiative.
On Friday, HHS said that it has begun providing the test at a surge testing site in Waco, Texas, the first community to offer saliva testing for COVID-19 through the federal Community-Based Testing Site (CBTS) program, also initiated on Friday.
The CBTS program provides COVID-19 "surge testing sites" for a limited period in areas where there has been a recent and significant increase in the number of new COVID-19 cases and hospitalizations. The program is administered by HHS in partnership with local communities and private companies.
HHS noted that clinical studies conducted by Fluidigm have shown that its test is comparable to other molecular-level tests using nasal swab samples. The agency has traditionally provided nasal swab tests from other manufacturers to surge testing sites, which it says remain a choice for community officials.
The Fluidigm integrated microfluidics platform that runs the saliva test can generate as many as 6,000 results per day. HHS has shipped 10,000 Fluidigm saliva tests to select Waco sites. The tests are being offered through eTrueNorth and processed by Millennium Health, a CLIA-certified high-complexity lab.
In a note to investors on Monday, Piper Sandler's Steven Mah wrote that "given that ... HHS has traditionally provided nasal swab testing to surge testing sites (which still remain a choice for community officials), we consider this an encouraging in-road into wider adoption of Fluidigm's saliva-based test, which provides an easier sampling alternative, as it is less invasive and does not require swabs or special collection devices. We continue to believe COVID-19 testing is durable, and that the marketplace is large enough for multiple players." Accordingly, Piper Sandler reiterated its Overweight rating on the stock with a $12 price target.