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 Receives U.S. FDA Emergency Use Authorization for its Monkeypox Test Kit
DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its QuantiVirus™ MPXV test, which is a PCR test for the qualitative detection of DNA from monkeypox virus (MPXV) in lesion swabs collected from individuals suspected of monkeypox infection.
DiaCarta Announces Successful Completion of Oncuria® Validation Study with Nonagen Bioscience
DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics company, and Nonagen Bioscience Corporation (“Nonagen”), a cancer diagnostics company, today announced the successful completion of the validation study of Oncuria® multiplex bladder cancer immunoassay as a laboratory developed test (“LDT”). DiaCarta also announced that it has begun receiving patient urine samples for testing in its CLIA certified lab in Pleasanton, California.
DiaCarta to Become a Publicly Listed Company Through Merger with HH&L Acquisition Co.
DiaCarta, Ltd., a precision molecular diagnostics company and developer of novel oncology and infectious disease tests, and HH&L Acquisition Co. (NYSE: HHLA.U, HHLA, HHLA WS) (“HH&L”), a publicly traded special purpose acquisition company (“SPAC”), today announced that they entered into a definitive business combination agreement (the “Business Combination Agreement”) that is expected to result in DiaCarta becoming a publicly listed company (the “Transaction” or “Business Combination”). The Transaction is expected to provide DiaCarta with access to the approximately $414 million cash from HH&L’s IPO proceeds held in trust, assuming no redemptions by HH&L’s shareholders and prior to the payment of transaction expenses, and potential additional financing to catalyze DiaCarta’s growth. The Transaction implies a pre-money equity value of $460 million for DiaCarta on a fully diluted basis and is expected to close in the first quarter of 2023. The Transaction positions DiaCarta to capitalize on significant future growth within existing and new markets.
DiaCarta Receives CE-IVD Mark for Its SARS-CoV-2 Flu A/B Combo Test
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.
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.