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

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 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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