Exact Sciences Advances Toward FDA Submission with Promising Blood-Based Colorectal Cancer Screening Test

ESMO 2024 Presentation:
Exact Sciences presented data at the European Society for Medical Oncology (ESMO) Congress 2024, showcasing the performance of its blood-based colorectal cancer (CRC) screening test.

Sensitivity and Specificity:
The test demonstrated sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at a specificity of 90.1% for negative samples confirmed by colonoscopy.

Study Design:
The study included over 3,000 blood samples, with approximately 2,900 blinded, prospectively collected samples from the pivotal BLUE-C study, and more than 90 advanced precancerous lesions and 60 case-collected colorectal cancer samples.

FDA Submission Plans:
Exact Sciences plans to use these results to support an FDA submission and approval, aiming to make the blood-based CRC screening test available broadly, potentially providing another testing option for 60 million unscreened individuals in the United States.

Multi-Cancer Early Detection (MCED) Data:
The company also presented data from its MCED blood test, showing an overall sensitivity of 54.8% with 98.5% specificity for cancers without standard-of-care screening options and 63.7% for the six most aggressive cancers with the shortest survival rates.

Clinical Significance:
The findings highlight the potential clinical value of using multiple biomarkers to detect various cancer types, particularly the most aggressive and those without recommended screening options.