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DiaCarta SARS-CoV-2 Test Detecting 3 Viral Genes Receives US FDA Emergency Use Authorization & Test Manufacturing Expanded to 500K COVID-19 Tests/Week

by | Apr 13, 2020 | Press Releases

Richmond, California, April 9, 2020.

DiaCarta Inc, a precision molecular diagnostic company in CA, announced Thursday the US FDA granted Emergency Use Authorization for DiaCarta’s proprietary QuantiVirus™ PCR diagnostic (Dx) test specifically detecting three different genes of SARS-CoV-2, the virus causing the COVID-19 pandemic. DiaCarta recently expanded manufacturing capacity to 500,000 tests per week and is planning to expand to even larger (4x) scale manufacturing to meet the increasing demand for PCR tests to monitor COVID-19.

The QuantiVirus™ test detects all currently known strains of SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs and sputum samples. The three viral RNA-encoded genes are the N, Orf1ab and E genes detected by real-time quantitative Reverse Transcriptase PCR assay enabling high sensitivity and specificity with a limit of detection of 100 copies/mL without any detectable cross-reactivity to other human respiratory pathogens.

Customers, including US reference labs and hospitals with high-complexity molecular Dx laboratories can now use QuantiVirus™ kits to detect SARS-CoV-2 within 2 hours following RNA extraction. “We are already supporting laboratories in the US and overseas to meet their increasing testing needs,” said Ram Vairavan PhD, DiaCarta Senior Vice President, “as our Dx reagent kit can be used with commonly available PCR instruments, such as Applied Biosystems 7500 and QuantStudio 5. We have validated this Dx test in our CLIA lab and are serving current needs of global organizations offering SARS-CoV-2 testing to front line providers.” DiaCarta announced earlier that it has received Conformitè Europëenne (CE) Mark for its product.

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™ early detection Colorectal Cancer test using blood. 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

Lead Source

DiaCarta Inc. has filed for EUA with the FDA and has received CE mark for its highly sensitive QuantiVirus™ SARS-CoV-2 Test Kit

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 Conformitè Europëenne (CE) Mark for its product.

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