DiaCarta Receives Accreditation by the College of American Pathologists (CAP)
DiaCarta, Ltd. (“DiaCarta”), a novel molecular diagnostic test developer for cancer and infectious diseases, today announced that it has received accreditation by the College of American Pathologists (CAP) for its CLIA certified lab. This accreditation is awarded to facilities that meet the high standards of quality, accuracy, and consistency in laboratory services required by CAP and underscores DiaCarta’s leadership and commitment to excellence.
DiaCarta Announces Five Abstracts Accepted for Presentation at AACR Annual Meeting 2023
DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics company, today announced that it will present five data posters at the American Association of Cancer Research (AACR) Annual Meeting 2023, which convenes in Orlando, Florida from April 14-19, 2023.
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.
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.
Former AstraZeneca Personalized Healthcare Strategy Leader Named Senior Vice President of Companion Diagnostics at DiaCarta
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy, today announced the appointment of Hongjun “Harry” Yang, Ph.D., former Executive Personalized Healthcare Strategy Leader at AstraZeneca, as Senior Vice President of Companion Diagnostics (CDx) at DiaCarta.
DiaCarta’s Novel XNA Technology Rapidly Detects Raging New SARS-CoV-2 Variants
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced the publication of a study entitled “A Rapid SARS-CoV-2 Variant Detection by Molecular-Clamping Based RT-qPCR” in MedRxiV that demonstrates the enhanced sensitivity and specificity using its proprietary XNA based Molecular Clamping Technology that uses innovative synthetic Xenonucleic acid molecular oligomers (XNA) that hybridize with target wild-type DNA sequences, acting as molecular clamps, to enable the accurate amplification of mutant sequences only, using quantitative real-time polymerase chain reactions (qPCR).
DiaCarta Announces Publication in Nature Scientific Reports Demonstrating cfDNA Biomarker Algorithm Predicts Response and Outcome of Chemotherapy
DiaCarta Inc., a precision molecular diagnostics company with proprietary technologies for the development of novel liquid biopsy oncology tests, announced today the publication of a study in Nature Scientific Reports that demonstrates that DiaCarta’s cfDNA biomarker algorithm could function as a prognostic biomarker and efficacy predictor for non-small cell lung cancer (NSCLC) patients.
FDA Report: DiaCarta COVID-19 Tests Rank Top 3 Among FDA SARS-CoV-2 Reference Panel Tests
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 COVID-19 Test Ranks Top 10 Among All FDA EUA Tests Based on Limit of Detection
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.
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.
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.
CIO Bulletin Announces DiaCarta Inc. As One of the 30 Fastest Growing Companies of 2018
DiaCarta announced that CIO Bulletin has named it among the 30 Fastest Growing Companies of 2018. The positioning is based on DiaCarta’s revenue growth, financial status, openness to innovation, global collaboration and partnership, flagship products launching, regulatory progress and ability to forecast future business and technology trends.