DiaCarta Receives Regulatory COFEPRIS Approval in Mexico & ICMR Approval in India for its FDA EUA Approved QuantiVirus™ SARS-CoV-2 Test
Richmond, California, July 15, 2020.
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. In compliance with guidelines established by the World Health Organization, the Ministry of Health in Mexico through the Institute of Diagnostic and Epidemiological Reference (InDRE), similar to the US CDC, evaluated the DiaCarta SARS-CoV-2 test and granted approval of the product as it fulfilled all requirements in terms of test sensitivity, specificity and non-interference to other respiratory viruses. With this approval, the regulatory body of the Mexican Government, namely COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) has authorized immediate marketing of the product in Mexico.
DiaCarta also announced that its QuantiVirus™ SARS-CoV-2 RT-PCR test kit has been successfully evaluated by the Indian Council of Medical Research (ICMR). The evaluation showed 100% sensitivity and 100% specificity without any interference with other respiratory viruses and has been cleared for sale in the Indian market.
“With an urgent global need for the availability of highly sensitive and specific tests to minimize the risk of false-negative results and mitigate the ongoing transmission of the deadly virus, we are pleased that our test has met the stringent requirements of the regulatory agencies in Mexico and India and has received regulatory approvals,” said Dr. Ramanathan Vairavan, Senior Vice President at DiaCarta. He further said that “with increasing incidence of COVID-19 around the globe, there is a need for cost-efficient tests that are easy to perform on commonly available qPCR platforms. At DiaCarta, we are committed to working with governmental and private institutions to increase test availability and arrest the spread of the coronavirus. In addition, the DiaCarta CLIA certified laboratory in the San Francisco Bay Area has been actively engaged to provide COVID-19 testing to support America’s Back to Work and Back to School initiatives.”
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 ISO certified, GMP-compliant and offers CLIA certified laboratory services to its customers. www.diacarta.com
DiaCarta Expands Board Leadership with Industry Veteran
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy, today announced the appointment of Jack Kaye, retired Partner with Deloitte LLP, as an independent board member who will serve as the Chairman of the Company’s Audit Committee.
DiaCarta Enters a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to Develop Cancer Tests based on its Novel XNA Technology
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced that the company, under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health, will collaborate on the evaluation and development of DiaCarta’s proprietary xeno-nucleic acid (XNA) molecular clamping technology. NCI and DiaCarta will collaborate on the following projects: (1) the investigation of low frequency mutation events in cancers and rare diseases using DiaCarta’s proprietary xeno-nucleic acid (XNA) molecular clamping technology, and (2) the development of XNA probes for in situ cancer cell detection. The duration of the CRADA will be 2 years from the effective start date.
DiaCarta’s Multivariant COVID-19 Test Accurately Detects the Omicron Variant
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy announced today that the company has developed a novel test to detect the newest COVID-19 Omicron variant, based on its proprietary XNA technology.
DiaCarta and the Scientific World Mourns the Passing of CSO, Michael J. Powell, Ph.D.
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel virology and oncology tests, mourns the passing of Michael “Mike” J. Powell, Ph.D., Chief Scientific Officer of DiaCarta.
DiaCarta Receives CE/IVD for its New COVID 19 Test that Identifies Delta Plus and New Variants
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced that its new QuantiVirus™ SARS-CoV-2 Variant Detection Test received the CE/IVD marking and therefore, can now be commercialized within the EU and rest of the world. This new test screens for the SARS-CoV-2 virus and simultaneously identifies and differentiates all the new mutating COVID 19 variants including the Alpha (UK), Beta (S. Africa), Gamma (Brazil), Delta (India), Delta Plus (India), Epsilon (California) and the Kappa (India) variants.