FDA staff reviewers found no major concerns about the accuracy and safety of Grail's blood test designed to detect more than 50 cancers ahead of an advisory committee meeting. The company's shares surged 35% on the news.
Researchers at Dana-Farber Cancer Institute and 23andMe Research Institute have identified a rare inherited mutation in the Epidermal Growth Factor Receptor (EGFR) gene that increases lung cancer risk by 25-fold, helping explain why 10-20% of U.S. lung cancer cases occur in people who never smoked.
A prospective study of 1,785 individuals across four countries shows the PANXEON exosome-based biomarker, combined with CA 19-9 levels, achieves high sensitivity for detecting early-stage pancreatic ductal adenocarcinoma. The investigational test, developed by researchers at City of Hope, could enable detection when the disease is more treatable.
The FDA has approved SimpleScreen CRC, a blood-based screening test for colorectal cancer, marking the second such test to receive approval. The less invasive option aims to improve screening uptake as colorectal cancer cases rise approximately 3 percent annually in adults under 50.
The Health Resources and Services Administration released new guidelines Monday expanding cervical cancer screening options to include self-collected vaginal samples for HPV testing, offering an alternative to traditional Pap smears for women ages 30-65 at average risk. Most private insurance plans will be required to cover the testing without cost sharing.
