NEW YORK (GenomeWeb) – Pennsylvania-based JBS Science said today that it has received a $3 million Small Business Innovation Research Phase IIB Bridge Award from the National Cancer Institute to help commercialize its first liquid biopsy product, a urine DNA screening test for the early detection of hepatocellular carcinoma (HCC).
According to the company, HCC usually goes undetected until it's in its later stages, despite surveillance programs for high-risk populations such as individuals with chronic hepatitis, cirrhosis, and fatty liver disease. But survival rates can be as high as 40 percent if HCC is detected early.
Serum AFP, one currently used biomarker, has shown limited sensitivity especially for early stage cancers, leaving significant room for improvement. JBS said it has developed a technology for isolating cancer-derived DNA in urine, along with specialized PCR assays to identify circulating tumor DNA biomarkers that it believes will offer more accurate and sensitive detection of these cancers. In a blinded pre-validation study, the company said the approach raised sensitivity to 89 percent when added to serum AFP.
JBS said it has already partnered with James Hamilton of Johns Hopkins University Medical Center and Hie-Won Hann of Thomas University Hospital to advance development of the test. And using the new three-year NCI funding award, the firm plans to conduct a blinded validation study in collaboration with two additional clinical collaborators: Harvard University's Daryl Lau and the University of Pennsylvania's Terence Gade.
Awardees of NCI Bridge grants are required to allocate third-party investment to match the funding prior to submitting an application. For JBS, the $3 million match is being provided by an investment group led by Chinese firm Richen-Forge Holding. Its subsidiary, Richen-Forge Science & Technology, is also acting as a strategic partner in the commercialization of the JBS HCC test, first in China and then in other parts of Asia.