Benzinga | Nov 24, 2020 08:34AM EST

Fluidigm Annonces India's Central Drugs Standard Control Organisation Has Granted Commercial License For Co.'s Advanta Dx SARS-CoV-2 RT-PCR Assay

SOUTH SAN FRANCISCO, Calif., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Fluidigm Corporation (NASDAQ:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that the Central Drugs Standard Control Organisation (CDSCO) in India has licensed importation and commercial sale of the Fluidigm(r) Advanta(tm) Dx SARS-CoV-2 RT-PCR Assay in that country for COVID-19 testing. The CDSCO license was granted to Premas Life Sciences, a Delhi based life sciences distribution company.



In India, the CDSCO leads regulatory approval for vaccines, diagnostics, prophylactics, and therapeutics designed to prevent or treat diseases including COVID-19. The Fluidigm test is one of the first saliva-based tests for COVID-19 to be licensed in India. The license granted to Premas Life Sciences provides for the Fluidigm assay to be used to track positive cases of COVID-19 using laboratories designated/approved by the Indian Council of Medical Research or the relevant state or central government.

"Premas Life Sciences has a passion for delivering game-changing technologies across an array of research and diagnostic areas," said Praveen Gupta, Managing Director of Premas Life Sciences. "Fluidigm's much-needed noninvasive saliva-based test comes at a critical time in the pandemic, and we are pleased to be able to facilitate availability of the Advanta assay in India."

India's reported coronavirus cases have surpassed 9 million, a total so far exceeded only by the United States.

"Since announcing our Emergency Use Authorization in the United States for saliva-based PCR testing, we have seen growing interest in our technology," said Chris Linthwaite, Fluidigm President and CEO. "License to market our Advanta Dx SARS-CoV-2 RT-PCR Assay in the world's second-most populous nation will enable an effective and scalable way to get noninvasive saliva-based testing across India as a possible second wave of infections approaches.

"We are now in discussions with potential customers, which include private testing labs as well as academic institutions and government medical centers. We are honored for the opportunity to advance the availability of noninvasive saliva-based COVID-19 testing in India at this critical time."

The Fluidigm assay does not require collection via invasive nasopharyngeal swab. The company's clinical study submitted to the U.S. Food and Drug Administration demonstrated 100 percent agreement between saliva results from the Advanta assay and results from paired nasopharyngeal samples tested with authorized assays.

The Advanta Dx SARS-CoV-2 RT-PCR Assay on the high-throughput Fluidigm Biomark(tm) HD system features an integrated testing platform and a reliable supply chain that can be combined with commonly available automation platforms.