DiaCarta’s Novel XNA Technology Rapidly Detects Raging New SARS-CoV-2 Variants
Richmond, California, April 22, 2021.
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 (https://doi.org/10.1101/2021.04.01.21254484) 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).
In this study, a total of 278 previously tested SARS-CoV-2 positive samples, originating primarily from the San Francisco Bay Area, were analyzed. The SARS-CoV-2 Spike-gene D614G mutation was detected in 58 of the 139 samples collected in January 2021 (41.7%) and in 78 of the 139 samples collected in February (56.1%). Notably, while the N501Y mutation was not detected in the samples from January, seven of the February samples tested positive for both the N501Y and D614G mutations. The results suggest a relatively recent and rampant spreading of the UK variant (B.1.1.7) in Northern California. This new molecular clamping technology is highly sensitive and specific and can accelerate large scale testing for SARS-CoV-2 variants to fight this global pandemic.
“Next generation sequencing (NGS) has been the standard method of detection for SARS-CoV-2 variants. However, the NGS-based assays are expensive, time consuming and not widely available, thereby limiting their utility in large scale surveillance for SARS-CoV-2 variants,” said Michael Sha, Ph.D., Chief Technology Officer and Senior Vice President of R&D at DiaCarta Inc. “There has been an urgent need for testing platforms that can detect these variants rapidly and cost-effectively. This study demonstrates that DiaCarta’s XNA technology can do both – accurately detect known and emerging SARS-CoV-2 mutations and provide a rapid, cost-effective solution for SARS-CoV-2 variant surveillance.”
DiaCarta is pursuing an Emergency Use Authorization (EUA) with the U.S. Food and Drugs 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 Richmond, California the company is ISO certified, GMP-compliant and offers CLIA certified laboratory services to its customers. www.diacarta.com
Richard Brand, CFO, DiaCarta
Olipriya Das, Ph.D., Russo Partners
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
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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.