Fluidigm’s Covid-19 Saliva Test Receives Emergency FDA Authorization

Fluidigm (FLDM) has announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS‑CoV‑2 virus.

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The Covid-19 test is designed to be run on the company’s Biomark HD microfluidics platform.

As it is saliva-based, the Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via invasive nasopharyngeal swab. The clinical study submitted for the EUA showed 100% agreement between the saliva results from the FLDM assay and the results from paired nasopharyngeal samples.

According to FLDM, its microfluidics technology enables processing of more samples per batch than more traditional, microwell plate-based PCR technology. The Biomark HD platform can generate 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,” commented Chris Linthwaite, CEO of Fluidigm. “Fluidigm is excited to commercialize this easily administered saliva-based COVID-19 test during a critical phase of the pandemic.”

Indeed, Fluidigm was recently selected by the National Institutes of Health for a proposed $37M project under the agency’s Rapid Acceleration of Diagnostics (RADx) program. RADx fast-tracks development and commercialization of innovative technologies to significantly increase U.S. testing capacity for SARS-CoV-2.

The Advanta Dx SARS-CoV-2 RT-PCR Assay was developed with scientists at the McDonnell Genome Institute and the Department of Genetics at the Washington University School of Medicine in St. Louis. (See FLDM stock analysis on TipRanks).

Shares in FLDM have spiked over 150% year-to-date, and the stock scores a bullish Strong Buy Street consensus. That’s with 3 recent back-to-back buy ratings. Meanwhile the average analyst price target indicates 37% further upside potential from current levels.

Earlier this month, Piper Sandler’s Steven Mah boosted his price target on Fluidigm from $9 to $12. The analyst noted that the company has used its high-throughput and low-cost microfluidics platform to “pivot opportunistically” to Covid-19 testing.