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FDA Report: DiaCarta COVID-19 Tests Rank Top 3 Among FDA SARS-CoV-2 Reference Panel Tests

by | Oct 6, 2020 | Press Releases

Richmond, California, September 21, 2020.

According to the recent FDA SARS-CoV-2 Reference Panel Comparative Data released on September 15, among all the FDA EUA tests with returned results, DiaCarta’s QuantiVirusTM SARS-CoV-2 Test and QuantiVirusTM SARS-CoV-2 Multiplex Test both rank within the top 3 for product sensitivity. With limit of detection (LoD) at 600 NDU/ml, these tests are 300 to 900-folds better than the least sensitive tests listed (180,000 NDU/ml VTM Swabs and 540,000 NDU/ml Dry Swabs). Product sensitivity is extremely important for accurate testing. A highly sensitive test is less susceptible to false results.

The FDA designs the reference panel to directly compare the analytical sensitivity and cross-reactivity among all FDA EUA nucleic acid-based SARS-CoV-2 tests. The panel, which is composed of standardized material, was distributed to developers of 137 tests by August 17 for comparison studies.

“Both of our tests rank within the top 3 for sensitivity, allowing our tests to provide more accurate and reliable results,” said Dr. Ram Vairavan, Senior Vice President of Commercial Operations. “These tests and our CLIA services made great contributions to reopening of the economy.”

DiaCarta’s qRT-PCR COVID-19 tests were granted with FDA emergency use authorization in April and July, respectively. These tests have been used in global testing labs. In addition, DiaCarta’s CLIA lab has provided a high-throughput seamless testing service for organizations which do not have the testing capability. The rapid-result service is especially valued by domestic and international travelers who need to present testing results at departure.

About DiaCarta:

DiaCarta is a molecular diagnostics company that has developed innovative technologies to transform patient care. Its novel XNA technology provides ultra-sensitivity for ColoScape™ Colorectal Cancer Test. Powered by SuperbDNA™ technology, the company has developed revolutionary RadTox™ test that personalizes radiation therapy to mitigate adverse events. Based in Richmond, California, the company is ISO certified, GMP-compliant and offers CLIA certified laboratory services.

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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.

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