Fluidigm Files for FDA Emergency Use Authorization for Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Test for COVID-19
Extraction-Free, Real-Time PCR Workflow with Capacity of Up to 6,000 Tests per Day
Easy-to-Administer Saliva Test Would Eliminate Need for Invasive Nasopharyngeal Swab
High-Throughput Assay Developed in Collaboration with
The Advanta™ Dx SARS-CoV-2 RT-PCR Assay is intended for use by high‑complexity labs certified under the Clinical Laboratory Improvement Amendments in
“Rapid, reliable testing that is widely available to the public is essential in combatting the COVID-19 pandemic,” said
The Advanta Dx SARS-CoV-2 RT-PCR test on the Biomark HD platform provides throughput and cost advantages that reduce the impact of capacity‑constrained supply chains. The company’s microfluidics technology enables processing of more samples per batch and uses a fraction of expensive testing reagents per sample as compared to more traditional, microwell plate-based PCR technology.
“There’s an urgent need to simplify testing for COVID-19 so that people who are infected can be easily and quickly identified,” said
“Our high-throughput saliva-based test enhances testing capacity and simplifies COVID-19 testing while eliminating the need for hard-to-source components such as extraction kits,” said
“The Fluidigm approach bends the cost curve, increases ultrahigh-throughput testing capability per system, eliminates the expense and complexity of extraction, and provides a less invasive sample collection process that could open testing access to large numbers of people,” Linthwaite said. “We believe frequent testing of a large percentage of the population is the best path forward, and a critical foundation for getting the global economy back to work.
“We are truly honored for the opportunity to collaborate with
The Advanta Dx SARS-CoV-2 RT-PCR Assay is the subject of an EUA filing with the FDA. The FDA may require additional data, validation and/or testing, and may not ultimately provide authorization. An EUA, if granted, does not constitute FDA clearance or approval, but would allow use by authorized laboratories only while the EUA is in effect.
Forward-Looking Statements for
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding the anticipated uses and features of the Advanta™ Dx SARS-CoV-2 RT-PCR Assay if Fluidigm’s Emergency Use Authorization is approved by the FDA, its anticipated commercial availability, and its potential impact on COVID-19 testing trends, public health, and the economy. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results, including but not limited to risks relating to the potential adverse effects of the coronavirus pandemic on our business and operating results during 2020; our ability and/or the ability of the research institutions utilizing our products and technology to obtain Emergency Use Authorization from the FDA and any other requisite approvals to use our products and technology for diagnostic testing purposes; potential changes in priorities or requirements for Emergency Use Authorizations; potential limitations of any Emergency Use Authorization; challenges inherent in developing, manufacturing, launching, marketing, and selling new products; risks relating to company research and development and distribution plans and capabilities; interruptions or delays in the supply of components or materials for, or manufacturing of,
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Source: Fluidigm Corporation