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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.

Lead Source

DiaCarta SARS-CoV-2 Test Detecting 3 Viral Genes Receives US FDA Emergency Use Authorization & Test Manufacturing Expanded to 500K COVID-19 Tests/Week

DiaCarta Inc, a precision molecular diagnostic company in CA, announced Thursday the US FDA granted Emergency Use Authorization for DiaCarta’s proprietary QuantiVirus™ PCR diagnostic (Dx) test specifically detecting three different genes of SARS-CoV-2, the virus causing the COVID-19 pandemic. DiaCarta recently expanded manufacturing capacity to 500,000 tests per week and is planning to expand to even larger (4x) scale manufacturing to meet the increasing demand for PCR tests to monitor COVID-19.

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

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 Conformitè Europëenne (CE) Mark for its product.

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