Press release

DiaCarta Receives CE-IVD Mark for Its SARS-CoV-2 Flu A/B Combo Test

Jul 20, 2022 | Press Releases

PLEASANTON, Calif., July 20, 2022

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. The QuantiVirus™ SARS-CoV-2 & Flu A/B Detection Test is a Real-Time PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 and Influenza viruses in nasopharyngeal swab or saliva from individuals suspected of COVID-19 and/or Influenza. The clinical Positive Predictive Agreement (PPA) is 99.7% and Negative Predictive Agreement (NPA) is 99.9% for SARS-CoV-2, and 100% and 100%, respectively, for Flu A and B tests. By obtaining the CE-IVD mark, the company plans to commercialize this product for diagnostic testing purpose in countries that require CE marking for medical devices. DiaCarta is preparing for FDA EUA and 510k submissions.

“Complementing our two FDA EUA COVID 19 RT-PCR tests, based on our test design we continue to identify all new emerging SARS-CoV-2 variants including the now prevalent BA 5 sub-variant. This new multiplex test combining COVID-19 with FLU A/B allows simultaneous detection of all 3 viruses in one single reaction tube enabling laboratories to detect and differentiate diseases with similar clinical symptoms”. said Dr. Aiguo Zhang, the CEO and President of DiaCarta.

About DiaCarta:

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 QClamp® qPCR tests to its OptiSeq™ XNA-NGS panels. 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 and Chemotherapy, serving to assess tumor response, and enhancing patient care. Based in Pleasanton, California the company is ISO certified, GMP-compliant and offers CLIA certified laboratory services to its customers. 

Anne K. Vallerga, Ph.D., M.B.A.
Vice President of External Affairs

SOURCE DiaCarta Inc.

Lead Source

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 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.