DiaCarta, Inc., Awarded $2 Million NCI Contract to Pursue Regulatory Approval of Innovative Cancer Radiation Response Blood Test
DIACARTA, Inc., a precision diagnostic company and leading developer of products for nucleic acid-based detection assays, announced today that it has received a $2 million National Cancer Institute (NCI) Small Business Innovation Research (SBIR) contract to continue development of its RadTox™ cfDNA radiation therapy toxicity monitoring test kit for cancer patients.
While radiation is required by 70
“This will be a breakthrough ‘first-in-class’ IVD test in the field of radiation therapy and one of the first cfDNA tests to be supported by the NCI for real-time detection of normal tissue responses to radiation,” commented Aiguo Zhang, Ph.D., Founder and CEO of DiaCarta, Inc. “We are therefore delighted to have been awarded this contract following successful completion of the $300,000 SBIR Phase I contract in June of this year.”
DiaCarta’s RadTox™ cfDNA Test, a platform diagnostic that monitors circulating cell-free DNA (cfDNA) in patient plasma during radiation therapy, runs on either luminometers or bead-based instrumentation found in many clinical reference laboratories and testing
DiaCarta has been invited to present RadTox™ cfDNA Test at the BIO Investor Forum in San Francisco on October 17-18, 2018, as part of the company’s commitment to a partnering and co-development strategy for the program.
“We are fulfilling an unmet medical need in cancer radiation therapy by enabling the direct monitoring of side effect severity and
TECHNOLOGY PLATFORM
Super branched DNA (SuperbDNA™) hybridization technology is a widely used signal amplification clinical platform to quantitatively detect specific nucleic acid sequences directly from the source without the need for DNA/RNA purification or RT-PCR. With a wide dynamic range, bDNA is sensitive enough to reliably detect very few target molecules using DiaCarta’s kits and reagents formatted on a luminometer or bead-based platform. DiaCarta’s SuperbDNA™ technology offers sensitivity for detection of over 4,000 target genes.
ABOUT DIACARTA
DiaCarta, a translational genomics and personalized diagnostics company based in Richmond, California, was established in 2011 to provide highly sensitive and advanced technologies that will improve the way molecular diagnostics and translational genomics impact healthcare treatment plans and the well-being of individuals around the world. DiaCarta offers a range of testing services, from single-gene QClamp® qPCR tests to its OptiSeq™ XNA-NGS panels. The company is well positioned as a leader in the new ‘liquid biopsy’ IVD (in vitro diagnostic) field with high-precision detection of cfDNA. DiaCarta is ISO13485 certified and manufactures IVD kits under
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 Receives CE-IVD Mark for Its SARS-CoV-2 Flu A/B Combo Test
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology and infectious disease tests announced today that the company has received CE-IVD mark for their newly developed QuantiVirus™ SARS-CoV-2 & Flu A/B Test.
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.