Dive Brief:
- Exact Sciences released data from a study of its blood-based colorectal cancer screening test that showed sensitivities of 88.3% for colorectal cancer and 31.2% for advanced precancerous lesions. Specificity, a measure of how well a test identifies people who do not have cancer, was 90.1% for negative samples confirmed by colonoscopy.
- The results, presented Monday at the European Society for Medical Oncology Congress in Barcelona, move the test “one step closer” to giving patients at average risk another non-invasive screening option for colorectal cancer, Paul Limburg, Exact’s chief medical officer for screening, said in a statement.
- Exact, which makes the Cologuard fecal immunochemical test (FIT) test for colorectal cancer, said it is completing additional studies to support a Food and Drug Administration submission for the blood-based test.
Dive Insight:
Blood tests to detect cancer are intended to boost screening rates and early detection of the disease by offering a more convenient alternative to colonoscopy. Research shows that millions of people are not up to date with colorectal cancer screening recommendations.
Exact aims to compete with Guardant Health’s Shield blood test, which gained FDA approval in July as a primary screening option for colorectal cancer in average-risk adults who are age 45 and older.
“A blood-based colorectal cancer screening test that can detect advanced precancerous lesions at a level comparable to the FIT test would be a breakthrough in this field,” Limburg said.
Exact reported last year that its next-generation Cologuard test demonstrated 94% sensitivity for colorectal cancer at 91% specificity.
TD Cowen analyst Dan Brennan called the results for Exact’s blood-based test better than expected, based on the Wall Street firm’s survey of investor expectations that pegged the test’s sensitivity at 83% for colorectal cancer and about 20% to 21% for advanced precancerous lesions known as adenomas, with a specificity rate of 90%.
Exact’s analysis was based on more than 3,000 blood samples, including about 2,900 blinded, prospectively collected samples from the company’s pivotal BLUE-C study that will be submitted to the FDA.
In the BLUE-C study results, performance degradation is expected for advanced precancerous lesions and overall colorectal cancer sensitivity, Exact said.
TD Cowen’s Brennan said the degree of degradation that will be seen in that data will be important in the FDA submission.
“While these results are better than investor expectations per our survey, the whole focus is what they portend for the final FDA readout, and how much degradation we could see from partial case control to final readout,” Brennan wrote.
Analysts noted the company now expects the BLUE-C results in the first half of 2025, later than initially forecast for the fourth quarter of this year.
Leerink Partners analyst Puneet Souda, in a report to clients, emphasized the importance of the BLUE-C results and said further degradation cannot be ruled out.