EXAS Gains FDA Nod for Cologuard Plus, Progresses With CRC Screening

Core Insights - Exact Sciences (EXAS) received FDA approval for its next-generation multitarget stool DNA test, Cologuard Plus, marking a significant advancement in colorectal cancer (CRC) screening [1] - Cologuard Plus demonstrates high sensitivity and specificity, outperforming its predecessor and traditional methods [2][3] - The test is expected to launch in 2025 with Medicare coverage, aiming for widespread adoption in CRC screening [4] Company Developments - The pivotal BLUE-C study showed Cologuard Plus has a sensitivity of 95% for colorectal cancer and 43% for advanced precancerous lesions, with a specificity of 94% [2] - Cologuard Plus reduces false positive rates by over 30%, decreasing unnecessary follow-up colonoscopies [2] - The test is designed for first-line screening in average-risk adults aged 45 and older, emphasizing early detection [3] Market Outlook - The global cancer diagnostics market is projected to grow at a CAGR of 8.5% from 2023 to 2033, driven by technological advancements and demand for efficient diagnostic solutions [5] - Competitors like Myriad Genetics (MYGN) and Veracyte (VCYT) are also expanding their offerings in the cancer diagnostics space, focusing on hereditary cancer testing and advanced genomic tests respectively [6][8] - Illumina (ILMN) continues to strengthen its position in cancer genomics with partnerships and improved reimbursement for next-generation sequencing [9][10]