DiaCarta Inc. has filed for EUA with the FDA and has received CE mark for its highly sensitive QuantiVirus™ SARS-CoV-2 Test Kit
Richmond, California, March 24, 2020.
DiaCarta Inc., a precision molecular diagnostic company, announced today that it has filed for Emergency Use Authorization (EUA) with the US FDA for its QuantiVirus™ SARS-CoV-2 test and has validated the COVID-19 diagnostic test in its own CLIA certified lab in Richmond, CA to provide testing services for healthcare providers and patients. DiaCarta recently received Conformité Européenne (CE) Mark for its product.
The in vitro diagnostic test based on Real-Time PCR technology is developed for specific detection of SARS-CoV-2 viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum from patients suspected with coronavirus infection. Three genes of SARS-CoV-2 including N, Orf1ab and E genes are targeted in the real-time PCR (qRT-PCR) assay to ensure high degree of sensitivity and accuracy. The analytical sensitivity is 1-5 copy/uL of SARS-CoV-2 viral RNA for patient sample with a 95% confidence. Clinical validation of the assay showed 96.7% sensitivity and a specificity of 100%, with no cross-reaction to different types of non-SARS-CoV-2 species.
“We are pleased that we can offer our QuantiVirusTM SARS-CoV-2 product to healthcare providers and as a CLIA validated test to our customers” said Dr. Ram Vairavan, Senior Vice President of DiaCarta Inc., “as it will help to fulfil an urgent need, as the coronavirus pandemic continues to shut down daily life across the globe”.
About DiaCarta Inc.,
DiaCarta is a molecular diagnostics company that has developed innovative technologies that transforms patient care by providing effective precision diagnostics using liquid biopsy. Its novel XNA technology provides high level of sensitivity as it binds to the wild-type sequence and enables only the mutant target sequence to get amplified. Using this technology, the company has developed its highly sensitive ColoScape™ Colorectal Cancer Mutation test. Powered by its SuperbDNA™ technology that provides high level of detection as it amplifies the signal and requires no RNA/DNA extraction or amplification, the company has developed its revolutionary RadTox™ test that personalizes radiation therapy, mitigates adverse events and enhances patient care. Based in Richmond, California the company is GMP-compliant and offers CLIA certified laboratory services to its customers. www.diacarta.com
Ram Vairavan PhD
Senior Vice President, DiaCarta Inc.
2600 Hilltop Drive
Richmond, CA 94906
According to the recent FDA SARS-CoV-2 Reference Panel Comparative Data released on September 15, among all the FDA EUA tests with returned results, DiaCarta’s QuantiVirusTM SARS-CoV-2 Test and QuantiVirus™ SARS-CoV-2 Multiplex Test both rank within the top 3 for product sensitivity.
DiaCarta’s QuantiVirus™ SARS-CoV-2 Multiplex Test ranks among the top 10 kits in terms of low limit of detection (LoD). DiaCarta is the top 6 company, after Perkin Elmer, Roche, Quest, RTA and BD Biosciences.
DiaCarta Receives Regulatory COFEPRIS Approval in Mexico & ICMR Approval in India for its FDA EUA Approved QuantiVirus™ SARS-CoV-2 Test
DiaCarta Inc., a precision molecular diagnostics company with a unique, patented XNA technology platform for the development of novel liquid biopsy tests, announced today that its QuantiVirus™ SARS-CoV-2 test has been approved for distribution in Mexico.
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