DiaCarta’s Multivariant COVID-19 Test Accurately Detects the Omicron Variant
Pleasanton, California, November 30, 2021.
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. This new multiplex qPCR-based test namely QuantiVirus™ SARS-CoV-2 Variant Detection 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 (South Africa), Gamma (Brazil), Delta (India), Delta Plus (India), Epsilon (California) and the Kappa (India) variants as well as the recently identified Omicron variants. Having obtained CE/IVD marking the company is commercializing this test globally.
Last week, the World Health Organization (WHO) classified a new SARS-CoV-2 variant, the B.1.1.529, as a Variant of Concern and classified it the Omicron variant. Till date, this variant is regarded as the most heavily mutated variant of the SARS-CoV-2 virus, exhibiting more than 10 mutations in the Spike protein, compared with two mutations in the Delta variant in the receptor binding domain, that is employed by the virus to initiate contact with host cells. Since the identification of the Omicron variant in Botswana last week, it was subsequently detected in South Africa with confirmed cases nearing 100 and rising. Within a week, cases have been emerging in Israel, Hong Kong and most recently in Europe. As the Omicron variant mutations are similar to those in the Delta variant, the expectation is that it will transmit rapidly across the world.
“We are extremely excited that our proprietary XNA technology has enabled the rapid development of a diagnostic test to identify the Omicron variant that is estimated by the WHO & CDC to be highly mutated, highly transmissible and extremely virulent,” said Ram Vairavan, Ph.D., Senior Vice President of Commercial Operations at DiaCarta. “Moreover, DiaCarta’s novel test can run on commonly available qPCR cyclers, thereby, bypassing the need to perform expensive and time-consuming Next-Generation Sequencing – a huge advantage as this rapid cost-effective solution will be highly beneficial in global surveillance to contain this rapidly spreading variant.”
DiaCarta’s proprietary XNA based Molecular Clamping Technology uses innovative synthetic Xenonucleic acid molecular oligomers that hybridize with only target wild-type DNA sequences. The XNA oligomers act as molecular clamps that by blocking the wild-type sequences, only enables the accurate amplification of mutant sequences using quantitative real-time polymerase chain reactions (qPCR).
“DiaCarta’s XNA technology is extremely sensitive to detecting point mutations and can be widely applied to multiple diseases,” added Aiguo ‘Adam’ Zhang, Ph.D., CEO of DiaCarta. “The ability of our test in detecting a new COVID-19 variant validates this multi-prong applicability of DiaCarta’s proprietary XNA technology and we look forward to advancing it in many different directions.”
He further said “DiaCarta’s existing QuantiVirus™ SARS-CoV-2 Test that has US FDA’s Emergency Use Authorization, targets sequences that are distant from the highly mutated regions frequently detected in the newly emerging variants, which is why this test can reliably detect all newly emerging and existing SARS-CoV-2 variant strains, including the new Omicron variant strain.”
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.
SOURCE DiaCarta Inc.
DiaCarta and HMC/HML Team up for Customizing Lab Development Test Validations and Compliances in the US Market
DiaCarta announced that the company has formed strategic partnership with Hopkins MedTech Compliance and Hopkins MedTech Lab Services.
DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics company, today announced the termination of its Business Combination Agreement with HH&L Acquisition Co.
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, 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, 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.