Press release

DiaCarta’s COVID-19 Test Ranks Top 10 Among All FDA EUA Tests Based on Limit of Detection

Sep 14, 2020 | Press Releases

Richmond, California, September 2, 2020.

Based on evaluation of all the FDA EUA approved kits before July 27, 2020, DiaCarta’s QuantiVirusTM SARS-CoV-2 Multiplex Test ranks among the top 10 kits in terms of low limit of detection (LoD). DiaCarta is the top 6 company, after Perkin Elmer, Roche, Quest, RTA and BD Biosciences. The QuantiVirusTM SARS-CoV-2 Test, another RT-qPCR-based DiaCarta kit granted with FDA EUA, is top 20 on the list. The evaluation was conducted by MacKay et al. in Nature Biotechnology published on August 20.

Why is low LoD a big deal? According to Arnaout R et al., for every 10-fold increase in LoD, there is a 13% increase in false-negativity. This means tests with higher LoD significantly lower the test sensitivity, although clinical sensitivity and specificity are both over 95% for all 157 tests on the list. Surprisingly, the LoD for these tests spans 5 orders of magnitude from 0.009 to more than 100 copies per mL of sample.

“We are proud to have two viral RNA tests approved by the FDA EUA and CE-marked, both of which are highly sensitive,” Said Dr. Ramanathan Vairavan, Senior Vice President, Commercial Operations at DiaCarta, Inc. “These tests are critical for COVID-19 infection screening as we reopen the economy.”

In addition, DiaCarta has also developed the QuantiVirusTM Anti-SARS-CoV-2 IgG test, which is also filed with FDA and is CE-marked. This sensitive antibody test, once approved by FDA EUA, will add great value identifying potential blood donors for COVID-19 plasma therapy authorized by FDA EUA on August 23, although the risk reduction from the therapy may be relative rather than absolute, according to Dr. Steven Hahn, the FDA commissioner.

To help speed up COVID-19 screening, DiaCarta has validated these tests at our own CLIA lab. With three types of sample collection kits available (nasal, oral, and saliva), DiaCarta offers seamless COVID-19 testing services for healthcare providers, public health departments, businesses, and schools.

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.

Register and Learn!

Join our mailing list to receive the latest news and updates from our team.

You have Successfully Subscribed!

X