Press release

DiaCarta, Inc., Awarded $2 Million NCI Contract to Pursue Regulatory Approval of Innovative Cancer Radiation Response Blood Test

Oct 15, 2018 | Press Releases

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 percent of cancer patients, there is currently no reliable methodology for determining its adverse effects during treatment. Under the two-year, Phase II NCI Agreement, DiaCarta’s clinical laboratory scientists in California will collaborate with Dr. Paul Okunieff, Co-Principal Investigator leading clinical aspects, and his Radiation Oncology Team at the University of Florida Health Cancer Center (UFHCC). Using the RadTox™ cfDNA Test, the teams will analyze blood specimens collected from up to 500 patients undergoing radiotherapy for prostate cancer at multiple U.S. clinical sites.

“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 centers. RadTox™ cfDNA Test has the potential to be scaled and simply integrated into the workflow of radiation therapy centers. Once extensive clinical validation is completed, DiaCarta will pursue regulatory approval to market RadToxTM cfDNA Test kits worldwide.

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 tumor response within days of treatment initiation,” said Dr. Okunieff, Chair of the Department of Radiation Oncology at the UF College of Medicine. “This NCI-supported contract puts us in a powerful position to begin development of quantitative and precision ‘liquid biopsies.’ It is a very exciting opportunity for the UF Department of Radiation Oncology and the Okunieff Lab to make a real difference in the quality and safety of care for individual cancer patients.”

Dr. Okunieff, a co-founder of DiaCarta, owns stock and serves on the board of directors.


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.


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 cGMP, such as EGFR, BRAF, KRAS, NRAS, EML4-ALK, ROS-1, PIK3CA, and the highly sensitive ColoScapeTM colorectal cancer mutation detection kits. With over 18,000 square feet dedicated to a GMP-compliant lab space as well as CLIA and ISO 13485 certifications, a clinical laboratory facility in Nanjing, and offices in Shanghai, China, DiaCarta is changing the landscape of molecular diagnostics. For more information, visit

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DiaCarta Receives Accreditation by the College of American Pathologists (CAP)

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

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.