NEW YORK (GenomeWeb) – Molecular diagnostics firm DiaCarta has received a $2 million Small Business Innovation Research contract from the National Cancer Institute (NCI) to develop its RadTox cell-free DNA (cfDNA) radiation toxicity monitoring test kit for cancer patients.
Under the two-year agreement, DiaCarta's clinical laboratory scientists will partner with a team at the University of Florida Health Cancer Center to analyze blood samples collected from about 500 patients undergoing radiotherapy for prostate cancer at several clinical sites.
DiaCarta's RadTox assay monitors circulating cfDNA in a patient's plasma during radiation therapy and runs on either luminometers or bead-based instruments. According to the firm, the assay has the potential to be scaled and easily integrated into the workflow of radiation therapy centers.
DiaCarta noted that it plans to pursue regulatory approval to market the assay worldwide after it has completed clinical validation on the assay.
"We are fulfilling an unmet need in cancer radiation therapy by enabling the direct monitoring of side effect severity and tumor response within days of treatment initiation," Paul Okunieff, a DiaCarta cofounder, chair of radiation oncology at UF College of Medicine, and co-principal investigator on the project, said in a statement. "This NCI-supported contract puts us in a powerful position to begin development of quantitative and precision liquid biopsies."
The new grant comes after the partners completed a $300,000 Phase I SBIR contract to validate the RadTox QuantiDNA assay to monitor cfDNA in patient plasma. Â
DiaCarta raised $45 million in a Series B funding round earlier this year to develop its XNA technology platform and expand its diagnostic products for non-invasive early detection and monitoring of cancers.
In July, DiaCarta inked a distribution agreement with Arrow Diagnostics to offer its CE-marked qPCR-based ColoScape colorectal cancer assay in Italy, San Marion, and Vatican City.