Helix Specialty Diagnostics Partners with Genomic LTC DX to Provide COVID-19 Testing with Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay on Biomark HD Platform - Seite 2

“Rapid and reliable COVID-19 testing, made available to all who need it, is essential for a sustained response to the pandemic. As the total number COVID-19 cases in the United States exceeds 25 million, we are gratified by the opportunity to partner with Genomic LTC DX and Fluidigm to meet the needs of our clients.”

“Fluidigm is committed to provide the technology to enable simple, affordable and accessible testing capability to help keep colleges and universities open and keep high-risk residents of long-term facilities healthy,” said Chris Linthwaite, Fluidigm President and CEO. “We are proud of our collaborations in Missouri in recent months, starting with Washington University in St. Louis, and later with the State of Missouri, which has deployed four Fluidigm systems to various locations. Furthermore, we are excited to expand into the private-sector testing market through Helix Specialty Diagnostics and Genomic LTC DX to expand testing capacity for the state.

“Our saliva-based PCR test combines an affordable, kitted solution with sample collection that is far easier as compared to invasive swabs, and often preferable for both the health care providers collecting samples and the various community populations. Furthermore, our test has demonstrated 100 percent agreement with paired samples from authorized nasopharyngeal assays. While antigen testing can be an important element of pandemic response, it is not enough, as PCR virus detection provides greater sensitivity.”

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 impact the regions of the viral genome targeted by the assay’s primers and probes.

Intended Use

The Advanta Dx SARS-CoV-2 RT-PCR Assay is a real-time Reverse Transcription (RT) PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in saliva specimens collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to Laboratories which are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high complexity tests.