Therapy Areas: Oncology
DiaCarta COVID-19 Tests Rank Top 3 Among FDA SARS-CoV-2 Reference Panel Tests, According to FDA Report
21 September 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, US-based molecular diagnostics company DiaCarta's QuantiVirus SARS-CoV-2 Test and QuantiVirus SARS-CoV-2 Multiplex Test both rank within the top 3 for product sensitivity, the company said.

With limit of detection 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.

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.

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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