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DiaCarta Inc. has filed for EUA with the FDA and has received CE mark for its highly sensitive QuantiVirus™ SARS-CoV-2 Test Kit

Mar 25, 2020 | Press Releases

Richmond, California, March 24, 2020.

DiaCarta Inc., a precision molecular diagnostic company, announced today that it has filed for Emergency Use Authorization (EUA) with the US FDA for its QuantiVirus™ SARS-CoV-2 test and has validated the COVID-19 diagnostic test in its own CLIA certified lab in Richmond, CA to provide testing services for healthcare providers and patients. DiaCarta recently received Conformité Européenne (CE) Mark for its product.

The in vitro diagnostic test based on Real-Time PCR technology is developed for specific detection of SARS-CoV-2 viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum from patients suspected with coronavirus infection.  Three genes of SARS-CoV-2 including N, Orf1ab and E genes are targeted in the real-time PCR (qRT-PCR) assay to ensure high degree of sensitivity and accuracy. The analytical sensitivity is 1-5 copy/uL of SARS-CoV-2 viral RNA for patient sample with a 95% confidence. Clinical validation of the assay showed 96.7% sensitivity and a specificity of 100%, with no cross-reaction to different types of non-SARS-CoV-2 species.

“We are pleased that we can offer our QuantiVirusTM SARS-CoV-2 product to healthcare providers and as a CLIA validated test to our customers” said Dr. Ram Vairavan, Senior Vice President of DiaCarta Inc., “as it will help to fulfil an urgent need, as the coronavirus pandemic continues to shut down daily life across the globe”.

About DiaCarta Inc.,

DiaCarta is a molecular diagnostics company that has developed innovative technologies that transforms patient care by providing effective precision diagnostics using liquid biopsy.  Its novel XNA technology provides high level of sensitivity as it binds to the wild-type sequence and enables only the mutant target sequence to get amplified. Using this technology, the company has developed its highly sensitive ColoScape™ Colorectal Cancer Mutation test. Powered by its SuperbDNA™ technology that provides high level of detection as it amplifies the signal and requires 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 GMP-compliant and offers CLIA certified laboratory services to its customers. www.diacarta.com

Contact:
Ram Vairavan PhD
Senior Vice President, DiaCarta Inc.
2600 Hilltop Drive
Richmond, CA 94906
rvairavan@diacarta.com

Lead Source

DiaCarta Receives Accreditation by the College of American Pathologists (CAP)

May 10, 2023 |

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

Jan 12, 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.

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