Exact Sciences announced it received a breakthrough device designation from the FDA for its blood-based test for liver cancer alongside new data demonstrating its sensitivity for early-stage disease.
In addition, the Madison, Wisconsin-based company—maker of the at-home colon cancer screening test Cologuard—finalized its merger with cancer test developer Genomic Health, a $2.8 billion buyout deal first declared in late July.
“Today marks a pivotal step toward building the world’s leading advanced cancer diagnostics company,” Exact Sciences Chairman and CEO Kevin Conroy said in a statement. “With a best-in-class R&D, clinical, and commercial organization and a global infrastructure, we are well positioned to increase adoption of our existing tests and accelerate the development and launch of future cancer diagnostics.”
Exact Sciences’ new study showed 80% sensitivity and 90% specificity for hepatocellular carcinoma (HCC) by evaluating four methylated DNA and two protein biomarkers in blood samples from 443 participants, including 135 with cancer. In early-stage HCC, the test demonstrated 71% sensitivity at the same specificity.
The latter results compare favorably to more-common liver cancer tests that search for elevated levels of alpha-fetoprotein in the blood, which show 45% sensitivity and 90% specificity at that stage on their own and can be paired with ultrasound to increase detection sensitivity to 63%, according to the company. The results were presented at the American Association for the Study of Liver Diseases in Boston.
"A growing number of patients around the world are considered high risk for developing HCC," said Conroy. "A more sensitive and convenient blood-based test could help catch the disease earlier, which may lead to better outcomes.”
Exact Sciences plans to make its liver cancer blood test available in the second half of next year alongside the generation of real-world evidence to support its inclusion in cancer screening guidelines.