Biotechnology tools provider Fluidigm Corp. (FLDM:NASDAQ) yesterday announced 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, designed to be run on the Fluidigm® Biomark™ HD microfluidics platform."
The company stated that because the Advanta Dx SARS-CoV-2 RT-PCR Assay is saliva-based, it does not require collection via an uncomfortable and invasive nasopharyngeal swab. The firm noted that its saliva test for COVID-19 is very easy to administer and is available now for immediate shipment.
The company noted that the clinical study associated with the EUA submission successfully demonstrated a 100% correlation between the saliva results from the Advanta Dx SARS-CoV-2 RT-PCR Assay and the results from currently authorized assays of paired nasopharyngeal tested samples.
Andrew Lukowiak Ph.D., CEO of Millennium Health, one of several high-complexity labs certified under the Clinical Laboratory Improvement Amendments (CLIA) in the U.S. that has been evaluating the Advanta Dx SARS-CoV-2 RT-PCR Assay in advance of authorization, remarked, "Accessible and accurate testing programs that include a non-invasive, saliva-based collection option will be essential throughout duration of the COVID-19 pandemic. In addition to the attractive sample input we chose the Fluidigm workflow because it combines extraordinary throughput per system with a robust supply chain from a trusted large-scale supplier. We believe this approach will enhance testing coverage in critical populations."
The firm explained that "the Advanta Dx SARS-CoV-2 RT-PCR test on the Biomark HD platform provides throughput advantages that reduce the impact of capacity‑constrained supply chains and can generate as many as 6,000 test results per day on a single system."
The company's President and CEO Chris Linthwaite commented, "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...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. The ease of use for health care providers and patients alike will enable improved testing access to the global population."
"In the U.S., 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," CEO Linthwaite added.
Fluidigm advised that "it was recently selected by the National Institutes of Health, National Institute of Biomedical Imaging and Bioengineering, for a proposed project under the agency's Rapid Acceleration of Diagnostics program which fast-tracks development and commercialization of innovative technologies to significantly increase U.S. testing capacity for SARS-CoV-2."
Fluidigm Corp. is headquartered in South San Francisco, Calif., and is focused on addressing medical needs in the areas of cancer, immunology and immunotherapy. The firm utilizes its proprietary CyTOF® and microfluidics technologies to create and market multi-omic based solutions that improve health and treat diseases, identify biomarkers to aid in the decision making process and accelerate development of effective therapies.
Fluidigm Corp. began the day with a market capitalization of around $626.9 million with approximately 71.32 million shares outstanding and a short interest of about 10.0%. FLDM shares opened nearly 31% higher today at $11.50 (+$2.71, +30.83%) over yesterday's $8.79 closing price and reached a new 52-week high price this morning of $12.45. The stock has traded today between $10.56 and $12.45 per share and is currently trading at $11.97 (+$3.18, +36.18%).
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