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

by | 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. 

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

SOURCE DiaCarta Inc.

Lead Source

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 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.

Register and Learn!

Join our mailing list to receive the latest news and updates from our team.

You have Successfully Subscribed!

X