Exact Sciences’ Cologuard Plus Test Approved by FDA for Colorectal Cancer Screening

Exact Sciences Corp. has received a significant boost in its fight against colorectal cancer (CRC). The FDA has approved their latest innovation, the Cologuard Plus test, a next-generation multi-target stool DNA test. This approval opens the door for adults aged 45 and older who are at average risk for CRC to utilize this advanced screening tool.

The approval is based on the robust findings of the BLUE-C study, one of the most extensive prospective, head-to-head studies ever conducted in CRC screening. This study encompassed nearly 19,000 average-risk participants and revealed some impressive results. Cologuard Plus demonstrated remarkable sensitivity, detecting 95% of cancers overall and 43% of advanced precancerous lesions. This impressive performance was achieved with a high specificity of 94%, indicating a low rate of false positives.

Furthermore, the BLUE-C study highlighted the superior performance of Cologuard Plus compared to independent fecal immunochemical tests. This next-generation test outshines its predecessor in terms of overall CRC sensitivity, treatable-stage CRC sensitivity (stages I-III), high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.

Cologuard Plus will be built upon the success of the original Cologuard test, which has been used over 17 million times. The original Cologuard test is a first-line screening option for adults 45 and older at average risk for CRC.

When Cologuard Plus launches in 2025, it will be backed by Exact Sciences’ commercial organization and its ExactNexus technology platform. This platform will facilitate orders from over 350 health systems. The non-invasive nature of the test is expected to lead to coverage by Medicare.

In terms of specificity, Cologuard Plus demonstrates 91% specificity, including non-advanced findings, 93% specificity, including no findings, and 94% specificity when age-weighted to the U.S. population with no findings on colonoscopy.

It is important to note that in July of this year, the FDA approved Guardant Health Inc.’s GH Shield blood test for CRC screening in adults 45 and older at average risk. This blood test was the first approved by the FDA as a primary screening option for CRC, giving healthcare providers a new non-invasive option alongside other recommended screening methods.

This approval of Cologuard Plus represents a significant advancement in CRC screening, offering another valuable tool for early detection and prevention. The potential for increased access to this advanced test, coupled with its strong performance, makes it a promising development in the fight against colorectal cancer.

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