Molecular diagnostics company Exact Sciences Corp. (NASDAQ:EXAS) announced on Friday that it has received FDA approval for its next-generation multitarget stool DNA test, Cologuard Plus.
This test is approved for adults aged 45 and older at average risk for colorectal cancer (CRC). Approval followed findings from the pivotal BLUE-C study, one of the largest prospective studies in CRC screening, involving nearly 19,000 participants.
Cologuard Plus demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no colonoscopy findings. Additionally, it significantly outperformed an independent fecal immunochemical test in various sensitivity metrics.
CRC, often preventable yet frequently undetected, remains the second deadliest cancer in the US Cologuard Plus builds on the success of the original Cologuard test, which has been utilized over 17 million times. Launching in 2025, the test will leverage Exact Sciences' commercial organization and ExactNexus technology platform, ensuring seamless integration for over 350 health systems.
FDA grants priority review to Innoviva's zoliflodacin for treatment of gonorrhea
AB Science secures Canadian patent for AB8939, completing global IP coverage for AML treatment
US FDA approves expanded indication for AbbVie's MAVYRET (glecaprevir/pibrentasvir) in acute HCV
Creo Medical secures FDA clearance for SpydrBlade Flex in US market
Psilera collaborates with Hesperos for PSIL-006 preclinical modelling for frontotemporal dementia
Myosin Therapeutics' MT-125 cleared by US FDA to initiate first-in-human trial in glioblastoma
Ondine's Steriwave proven effective against deadly Mucor fungus
AB Science receives EMA approval to extend Masivet shelf life to four years
Hemispherian's GLIX1 receives positive EU opinion for orphan designation in glioma
Arvinas and Pfizer submit FDA application for vepdegestrant in ESR1-mutated breast cancer
NRx Pharmaceuticals files ANDA for preservative-free IV ketamine
Innovent's IBI363 granted second breakthrough therapy designation in China
Implantica reports positive NICE guidance for RefluxStop procedure in UK hospitals