Fluidigm has received the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its Advanta Dx SARS-CoV-2 RT-PCR Assay to detect SARS‑CoV‑2 virus nucleic acid.
The biological research equipment provider said that its new Advanta Dx SARS-CoV-2 RT-PCR Assay is a real-time reverse transcription (RT) PCR test intended for the detection of nucleic acid from the SARS-CoV-2.
The assay has been developed to test the saliva specimens collected in a sterile container from individuals suspected of Covid-19 by a health care provider. The test is designed to run on the Fluidigm Biomark HD microfluidics platform, and does not require extraction of sample through invasive methods.
The company said that its new RT-PCR test provides enhanced throughput, as the microfluidics technology enables processing of more samples per batch than conventional microwell plate-based PCR technology. Biomark HD platform can provide 6,000 test results per day on each system.
Millennium Health CEO Andrew Lukowiak said: “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.”
NIH selected Fluidigm for the Rapid Acceleration of Diagnostics (RADx) programme
The company has developed the new Advanta Dx assay in partnership with the researchers at McDonnell Genome Institute and The Washington University School of Medicine.
The company was recently selected by the National Institutes of Health (NIH), National Institute of Biomedical Imaging and Bioengineering, for a project under the agency’s Rapid Acceleration of Diagnostics (RADx) programme, aimed at improving testing capacity in the US for SARS-CoV-2.
Fluidigm president and CEO Chris Linthwaite said: “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. Fluidigm is excited to commercialize this easily administered saliva-based Covid-19 test during a critical phase of the pandemic.”
