Exact Sciences Corp.  has released new performance data for its blood-based colorectal cancer (CRC) screening test. The results indicate an 88.3% sensitivity for CRC and 31.2% for advanced precancerous lesions, with a specificity of 90.1% for negative samples confirmed by colonoscopy.

This data was presented at the European Society for Medical Oncology (ESMO) Congress in a session titled, “Organ-specific performance of a multi-analyte, multi-cancer early detection (MCED) blood test in a prospectively collected cohort.”

The company has emphasized its commitment to advancing screening technology by integrating a novel set of markers into the test. The study designed to optimize the test algorithm involved over 3,000 blood samples, including nearly 2,900 from the pivotal BLUE-C study.

These samples, pre-specified with the FDA, are excluded from final clinical validation. The study also included more than 90 advanced precancerous lesions and 60 colorectal cancer samples. The upcoming BLUE-C study results are anticipated to show some decrease in sensitivity for advanced precancerous lesions and overall CRC.

The findings suggest the potential of a new blood-based panel of methylated DNA markers and an innovative marker class to detect advanced precancerous lesions and cancers. Exact Sciences plans to incorporate this marker class into a new testing platform and conduct additional studies to support FDA submission.

The BLUE-C study results are expected in the first half of 2025. If approved, the test could provide a new screening option for 60 million unscreened individuals in the U.S., supported by Exact Sciences’ commercial infrastructure and ExactNexus™ technology platform, facilitating seamless electronic ordering and results for over 350 health systems.

In addition, Exact Sciences presented data from its MCED blood test, evaluating the performance of methylation and protein biomarkers using samples from the ASCEND 2 study.

The analysis showed an overall sensitivity of 54.8% with 98.5% specificity for cancers without standard screening options (excluding lung) and 63.7% for six high-risk cancers with short survival rates (esophagus, liver, lung, ovarian, pancreatic, and stomach).

These results highlight the potential of using multiple biomarkers to detect various cancers, including those without established screening options.





Source: businesswire.com

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