DiaCarta Receives CE-IVD Mark for Its SARS-CoV-2 Flu A/B Combo Test
PLEASANTON, Calif., July 20, 2022
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology and infectious disease tests announced today that the company has received CE-IVD mark for their newly developed QuantiVirus™ SARS-CoV-2 & Flu A/B Test. The QuantiVirus™ SARS-CoV-2 & Flu A/B Detection Test is a Real-Time PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 and Influenza viruses in nasopharyngeal swab or saliva from individuals suspected of COVID-19 and/or Influenza. The clinical Positive Predictive Agreement (PPA) is 99.7% and Negative Predictive Agreement (NPA) is 99.9% for SARS-CoV-2, and 100% and 100%, respectively, for Flu A and B tests. By obtaining the CE-IVD mark, the company plans to commercialize this product for diagnostic testing purpose in countries that require CE marking for medical devices. DiaCarta is preparing for FDA EUA and 510k submissions.
“Complementing our two FDA EUA COVID 19 RT-PCR tests, based on our test design we continue to identify all new emerging SARS-CoV-2 variants including the now prevalent BA 5 sub-variant. This new multiplex test combining COVID-19 with FLU A/B allows simultaneous detection of all 3 viruses in one single reaction tube enabling laboratories to detect and differentiate diseases with similar clinical symptoms”. said Dr. Aiguo Zhang, the CEO and President of DiaCarta.
DiaCarta is a molecular diagnostics company that has developed innovative technologies that transform patient care by providing effective precision diagnostics using liquid biopsy. In addition to its FDA EUA approved QuantiVirus™ SARS-CoV-2 Tests, DiaCarta offers a range of testing services, from QClamp® qPCR tests to its OptiSeq™ XNA-NGS panels. Its novel XNA technology provides high level of sensitivity as it clamps the wild-type sequence and amplifies the mutant target sequence. Using this technology, the company has developed its highly sensitive, early detection ColoScape™ Colorectal Cancer test using blood. Powered by its SuperbDNA™ technology that provides high level of detection by amplifying the signal and requiring no RNA/DNA extraction or amplification, the company has developed its revolutionary RadTox™ test that personalizes radiation and Chemotherapy, serving to assess tumor response, and enhancing patient care. Based in Pleasanton, California the company is ISO certified, GMP-compliant and offers CLIA certified laboratory services to its customers.
Anne K. Vallerga, Ph.D., M.B.A.
Vice President of External Affairs
SOURCE DiaCarta Inc.
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