Exact Diagnostics, a Fort Worth-based biotech startup, announced it is offering U.S. labs SARS CoV-2 Standard to validate COVID-19 assay results. The launch of the SARS CoV-2 Standard provides a well-defined standard for validating tests, helping more labs keep pace with the rising demand for testing.
Exact Diagnostics will provide labs with the first 200 standards at no cost to be used for research into COVID-19. Having the standard is valuable to research labs because the SARS CoV-2 Standard and SARS CoV-2 Negative contain genomic DNA, which allows labs to validate the molecular assay process including extraction, amplification, and detection.
The Clinical Laboratory Improvement Amendments (CLIA) federal regularly standards require that clinical laboratories establish and document their performance specifications for laboratory-developed tests to ensure the accuracy and preciseness of results before the test is implemented.
The offer to aid labs in coronavirus research fits into Exact Diagnostics mission of developing and manufacturing diagnostic products that help ensure the validity and consistency of test results. Co-founded in 2015 by Richie Petronis and Jerry Boonyaratanakorkit, the company produces and sells samples of viruses that labs can use to test their own equipment. The duo wanted to provide better services and produce a better product for the quality assurance market.
The company recently announced its acquisition by California-based molecular diagnostic query control manufacturer Bio-Rad Laboratories for a reported $60 million.
It is currently located at the UNT Health Science Center in Fort Worth, but at the time of the acquisition, we told you about the team purchasing the Katy Depot building at East Vickery Boulevard and Jones in Fort Worth. The building will become the future home of the startup, along with expanding biotech companies and medical innovators. The reuse project for the former railroad freight station will be led by Exact Diagnostics and Robert Kelly Architects.
Exact Diagnostics was founded in 2016 by Richie Petronis and Jerry Boonyaratanakorkit and produces and sells samples of viruses to be used by labs testing their own equipment. The startup is a client of TechFW and won the group’s Impact Award in 2017.
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