Exact Sciences (NASDAQ:EXAS) shares rose in Wednesday pre-market trading after the molecular diagnostics company specializing in the detection of early-stage cancers announced positive top-line results from its pivotal BLUE-C study.
The company said the results show that its next-generation Cologuard test demonstrated 94% sensitivity for colorectal cancer at 91% specificity, raising the bar in non-invasive screening.
Additionally, it noted that Cologuard met all study endpoints and improved every top-line metric, including a 30% lower false positive rate when compared to DeeP-C, the US Food and Drug Administration (FDA) registrational trial for Cologuard.
"Cologuard is a groundbreaking innovation in non-invasive cancer detection. Next-generation Cologuard will set a new performance standard," commented the company’s chairman and CEO Kevin Conroy in a statment.
“We are harnessing deep scientific insights, advanced technology, and over a decade of research and development to detect colorectal cancer with greater sensitivity and significantly improve the false positive rate. Once approved, next-generation Cologuard will meaningfully enhance the patient experience, and it comes at a critical time – when there are 60 million Americans not up to date with screening," he added.
BLUE-C is a multi-center, prospective study (NCT04144738) of more than 20,000 adults, 40 years of age and older.
The trial was designed to evaluate the performance of next-generation Cologuard (multi-target stool DNA or mt-sDNA).
In the coming months, the company said it plans to release additional analyses of the BLUE-C data and complete its application to the FDA for approval of next-generation Cologuard by the end of 2023.
Exact Sciences’ stock was 6% higher at $100 ahead of the US market open.
Contact the author at stephen.gunnion@proactiveinvestors.com