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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

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.

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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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DiaCarta and MIODx Join Forces to Develop a Diagnostic Test to Predict Patient Responses to Immunotherapy

MIODx and DiaCarta announced today that they have entered into an agreement for the development of a diagnostic test for immunotherapy. The test is based on MIODx’s ClonoMap™ immune sequencing platform, and is designed to predict patient response to immunotherapy, which will be developed and validated at DiaCarta’s CLIA labs in both the San Francisco Bay Area and Nanjing, China.

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DiaCarta Receives NCI Contract for a Circulating Free DNA (cfDNA) Test to Monitor Radiation Response in Cancer Patients

California-based molecular diagnostics company DiaCarta, Inc., has received a SBIR contract from the National Cancer Institute (NCI). This contract will fund a collaborative program between DiaCarta and University of Florida Health Cancer Center to convert RadTox QuantiDNATM into a cutting-edge test that monitors radiation response in cancer patients.

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