Press release

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.

Lead Source

DiaCarta Receives U.S. FDA Emergency Use Authorization for its Monkeypox Test Kit

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.

DiaCarta Announces Successful Completion of Oncuria® Validation Study with Nonagen Bioscience

DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics company, and Nonagen Bioscience Corporation (“Nonagen”), a cancer diagnostics company, today announced the successful completion of the validation study of Oncuria® multiplex bladder cancer immunoassay as a laboratory developed test (“LDT”). DiaCarta also announced that it has begun receiving patient urine samples for testing in its CLIA certified lab in Pleasanton, California.

DiaCarta to Become a Publicly Listed Company Through Merger with HH&L Acquisition Co.

DiaCarta, Ltd., a precision molecular diagnostics company and developer of novel oncology and infectious disease tests, and HH&L Acquisition Co. (NYSE: HHLA.U, HHLA, HHLA WS) (“HH&L”), a publicly traded special purpose acquisition company (“SPAC”), today announced that they entered into a definitive business combination agreement (the “Business Combination Agreement”) that is expected to result in DiaCarta becoming a publicly listed company (the “Transaction” or “Business Combination”). The Transaction is expected to provide DiaCarta with access to the approximately $414 million cash from HH&L’s IPO proceeds held in trust, assuming no redemptions by HH&L’s shareholders and prior to the payment of transaction expenses, and potential additional financing to catalyze DiaCarta’s growth. The Transaction implies a pre-money equity value of $460 million for DiaCarta on a fully diluted basis and is expected to close in the first quarter of 2023. The Transaction positions DiaCarta to capitalize on significant future growth within existing and new markets.

DiaCarta Expands Board Leadership with Industry Veteran

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.

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