Benzinga | Dec 7, 2021 08:43AM EST

Fluidigm Confirms Its Advanta Dx SARS-CoV-2 PCR Assay Detects Omicron Variant

No Published Viral Mutations to Date, Including Omicron Variant, Meaningfully Impact the Regions of the Viral Genome Targeted by the Assay

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2021 (GLOBE NEWSWIRE) -- Fluidigm Corporation (NASDAQ:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today confirmed that Omicron variant B.1.1.529, designated by the World Health Organization as a Variant of Concern, does not impact the capability of the Fluidigm(r) Advanta(tm) Dx SARS-CoV-2 RT-PCR Assay to detect the virus that causes COVID-19, based on in silico analyses of the most current databases.

Fluidigm continually conducts in silico analyses to determine the effectiveness of the Advanta Dx Assay design to detect SARS-CoV-2. To date, none of the published viral mutations meaningfully impacts the regions of the viral genome targeted by the assay's primers and probes.

"Accurate detection of SARS-CoV-2 Variants of Concern can help assess the spread of circulating variants and determine their potential impact on therapeutics, vaccines and public health programs," said Chris Linthwaite, President and CEO. "Since the early days of the pandemic, Fluidigm technology has helped advance SARS-CoV-2 research, treatment and diagnostic programs with simple, affordable and accessible testing. Since August 2020, millions of samples have been tested for COVID-19 using our assay, offering easy, noninvasive sample collection, accuracy and speed to results."

The Advanta Dx SARS-CoV-2 RT-PCR Assay, designed to be run on the company's Biomark(tm) platform, is an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus in individuals suspected by their health care providers of having COVID-19. The assay does not require collection via invasive nasopharyngeal swab, and the company's submission to the FDA demonstrated 100 percent agreement between saliva results from the Advanta Dx Assay and results from paired nasopharyngeal samples tested with an authorized assay.