DiaCarta Receives CE/IVD for its New COVID 19 Test that Identifies Delta Plus and New Variants
Pleasanton, California, August 12, 2021.
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.
This new multiplex qPCR-based test can be run on commonly available qPCR cyclers, thereby, bypassing the need to perform expensive and time-consuming Next-generation sequencing (NGS). The test demonstrates enhanced sensitivity and specificity and is powered by DiaCarta’s proprietary XNA based Molecular Clamping Technology. This technology uses innovative synthetic Xenonucleic acid molecular oligomers (XNA) that hybridize with target DNA sequences and can be employed as molecular clamps in quantitative real-time polymerase chain reactions (qPCR). The XNA tightly bound to the wild-type sequences specifically enables only the mutant sequences to be accurately amplified.
“Expensive and time-consuming NGS assays are currently the only option to detect new and emerging COVID-19 variants which are causing widespread global alarm, and creating an urgent need for cost-effective testing platforms that can quickly and accurately detect variants,” said Aiguo (Adam) Zhang, Ph.D., Founder and CEO of DiaCarta Inc. “Our new test shows that our XNA technology can do both – precisely detect known and emerging SARS-CoV-2 mutations and provide an expeditious, inexpensive solution for variant surveillance. We are grateful for receiving the CE/IVD mark for this test as it will allow us to bring this test to the large European population to help them in their immuno-surveillance efforts.”
DiaCarta is also pursuing an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) for this unique and rapid SARS-CoV-2 variant detection test.
About DiaCarta Inc.
DiaCarta is a molecular diagnostics company that has developed innovative technologies that transform patient care by providing effective precision diagnostics using liquid biopsy. In addition to its FDA EUA approved QuantiVirus™ SARS-CoV-2 Tests, DiaCarta offers a range of testing services, from single-gene QClamp® qPCR tests to its OptiSeq™ XNA-NGS panels. The company is well positioned as a leader in the new ‘liquid biopsy’ In Vitro Diagnostics field with high-precision detection of ctDNA. Its novel XNA technology provides high level of sensitivity as it clamps the wild-type sequence and amplifies the mutant target sequence. Using this technology, the company has developed its highly sensitive, early detection ColoScape™ Colorectal Cancer test using blood. Powered by its SuperbDNA™ technology that provides high level of detection by amplifying the signal and requiring 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 Pleasanton, California the company is ISO certified, GMP-compliant and offers CLIA certified laboratory services to its customers. www.diacarta.com
Ram Vairavan, Ph.D.
SVP of BD
Olipriya Das, Ph.D.
SOURCE DiaCarta Inc.
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.