RICHMOND, Calif.--(BUSINESS WIRE)--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 RadToxTM 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 RadToxTM 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 RadToxTM 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. RadToxTM 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 RadToxTM 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.”

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