MedTech Dive September 16, 2024
Exact’s test could compete with Guardant Health’s Shield blood test, which received approval from the Food and Drug Administration in July.
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. ...