Regional CLIA-certified labs among growing nnumber of customers expanding SARS-CoV-2 testing with fluidigm technology
Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that ImmunoGenomics, based in metropolitan Houston, and Vero Diagnostics of Research Triangle Park, North Carolina, are among the Clinical Laboratory Improvement Amendments (CLIA) certified labs now offering testing services using the Advanta™ Dx SARS-CoV-2 RT-PCR Assay on the Fluidigm® Biomark™ HD system.
Fluidigm recently 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. 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 SARS-CoV-2 RT-PCR Assay and results from paired nasopharyngeal samples tested with authorized assays.
“As a scientist-owned-and-operated, CLIA-certified lab, we believe saliva-based testing for COVID-19 via high-throughput PCR is the gold standard of detection for private, public and government testing environments,” said Twinkle Patel, ImmunoGenomics President and CEO. “The Fluidigm workflow enables high-throughput processing of samples using established methods certified by the Centers for Disease Control and Prevention and the World Health Organization. This extraordinary throughput is coupled with a robust supply chain and a high degree of accuracy.” ImmunoGenomics currently processes approximately 3,000 samples per day using the Advanta Dx SARS-CoV-2 RT-PCR Assay.
“The extraction-free nature of the Fluidigm assay is enabling our lab to eliminate bottlenecks and streamline processing of samples,” said Ritesh Shah, Managing Partner and Founder of Vero Diagnostics. “We are processing approximately 3,000 samples per day for medical centers, skilled nursing facilities, urgent care clinics and others. Invasive nasopharyngeal swab-based testing is not sustainable in situations in which regular testing is required. We believe the saliva-based model is the future of COVID testing.”
“There are many reasons why high-throughput saliva-based PCR testing is such a powerful tool in grappling with this global health crisis,” said Chris Linthwaite, Fluidigm President and CEO. “In addition to small- and medium-sized labs, large public health organizations and major academic centers are adopting our saliva-based test. Health care providers can collect samples far more easily than with the invasive nasopharyngeal swab and still have the samples processed with a test that has been demonstrated to be in 100 percent agreement with authorized nasopharyngeal assays. Furthermore, the Fluidigm test offers rapid turnaround time and avoids supply chain constraints of other approaches.
“We are grateful for the opportunity to play a major role in the response to this pandemic, and we are very pleased with the level of customer interest in our solution.”
The Advanta Dx SARS-CoV-2 RT-PCR Assay is for In Vitro Diagnostic Use. It is for Use Under Emergency Use Authorization Only. Rx Only. It has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. It has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. It is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Other Fluidigm products are For Research Use Only. Not for use in diagnostic procedures.
Source: Company Press Release