WASHINGTON (dpa-AFX) - Exact Sciences Corp. (EXAS) announced the U.S. launch of CancerguardT, its multi-cancer early detection or MCED blood test, now available as a laboratory-developed test or LDT.
Cancerguard is the first commercial MCED test to analyze multiple biomarker classes, capable of detecting over 50 cancer types, including hard-to-screen cancers such as pancreatic, ovarian, and liver cancers-responsible for over 80% of annual U.S. cancer diagnoses.
In development studies, Cancerguard achieved 64% overall sensitivity (68% across six of the deadliest cancers) and detected over one-third of stage I-II cancers, with a 97.4% specificity to minimize false positives. Modeling suggests combining Cancerguard with current screening methods could cut stage IV diagnoses by 42% and lower cancer mortality by 18% over 10 years.
The test integrates with provider workflows, EMRs, and Exact Sciences' care navigation system, including patient support for positive results. It is recommended annually for adults aged 50-84 with no recent cancer history and costs $689, with FSA/HSA eligibility and payment plans available.
Exact Sciences partnered with Quest Diagnostics to make blood collection available at 7,000 locations nationwide and via at-home services. Broader consumer telehealth access begins October 2025. CEO Kevin Conroy called Cancerguard 'the next bold step' in Exact Sciences' mission to detect cancer earlier, building on Cologuard's success.
The launch follows nearly a decade of development and studies like DETECT-A and ASCEND 2 involving 20,000 participants. Exact Sciences is enrolling up to 25,000 more in the Falcon registry to strengthen regulatory submissions, payer discussions, and future guideline inclusion.
Wednesday EXAS closed at $54.77, down 1.16%, and is trading after hours at $54.80, up 0.05%, on the NasdaqCM.
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