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Exact Sciences' Blood-Based Colon Cancer Screening Data Surpasses Expectations at ESMO

NextEdge Admin

16 Sep 2024

2 min 8 sec

Exact Sciences shared promising data from its blood-based colorectal cancer (CRC) screening test, reporting 88% sensitivity for CRC and 31% for advanced adenomas, with a specificity of 90%. These findings, based on over 3,000 blood samples, were presented at the European Society for Medical Oncology Congress, leading to a 4% rise in Exact's stock to $68.16.

The study, which included 2,900 prospectively collected samples from the firm's BLUE-C trial, aimed to optimize the final test algorithm for real-world screening. Of the samples, 90 were advanced adenomas, a critical target for early cancer detection. The company, however, cautioned that the test’s sensitivity in its upcoming pivotal BLUE-C study could be lower. Final clinical validation results, expected in 2025, will guide the test’s submission to the FDA.

Exact’s main competitor, Guardant Health, which has already received FDA approval for its blood-based CRC test, saw its stock drop 9% following the news. Exact has emphasized adenoma detection as a key differentiator, especially for its stool-based Cologuard test.

Analysts remain cautiously optimistic. Vijay Kumar from Evercore noted that the test’s specificity is unlikely to decline significantly, while sensitivity might see a modest decrease. Dan Brennan of TD Cowen reported that the results surpassed investor expectations, though Exact has indicated the performance may diminish slightly in its pivotal trial.