NEW YORK – The latest update to the National Comprehensive Cancer Network guidelines for colorectal cancer (CRC) screening include Geneoscopy's ColoSense test, a stool-based multitarget RNA biomarker assay, and Guardant Health's Shield blood-based cell-free DNA test.
Inclusion of these assays in the guidelines supports their role as a screening alternative for individuals aged 45 years and older who are at average risk for CRC. The NCCN guidelines recommend testing with either of the assays every three years.
ColoSense is designed to detect CRC and advanced adenomas from patient stool samples. It is the only screening test approved by the US Food and Drug Administration that uses stool RNA biomarkers, which are not subject to age-related methylation, Geneoscopy said.
The assay, which is performed at Geneoscopy's laboratory, comprises the ColoSense collection kit, test kit, and software. It uses the Polymedco iFOBT Analyzer, BioMérieux's EMAG Nucleic Acid Extraction System, and Bio-Rad's QXDx Droplet Digital PCR System.
The test's inclusion in the NCCN guidelines is based on data from the company's CRC-PREVENT study, results of which were published in 2023 in the Journal of the American Medical Association. Nearly two-thirds of CRC-PREVENT participants had never undergone CRC screening or scheduled a colonoscopy at the time of enrollment. The study showed that ColoSense could detect CRC with 94 percent sensitivity, identifying 100 percent of stage I CRC cases. Additionally, ColoSense detected 46 percent of advanced adenomas, when colorectal cancer is most preventable.
"The NCCN guidelines heavily impact both the clinical adoption and insurance coverage of screening tests," Geneoscopy Chief Commercial Officer Matt Sargent said in a statement. "Achieving this milestone as a first-line test marks a pivotal step forward in our mission to bring ColoSense to market as an accurate, accessible screening solution for millions of Americans. NCCN guideline inclusion also positions ColoSense for future inclusion in other major guidelines."
Guardant's Shield, meanwhile, was approved by the FDA as a primary CRC screening option in July 2024.
Shield is a test that analyzes blood samples for cfDNA and other biomarkers to identify signs of colorectal cancer or precancer. The next-generation sequencing test is performed using physician-collected blood samples that are shipped to Guardant's laboratories.
NCCN cited Guardant's ECLIPSE study evaluating the performance of Shield compared to a screening colonoscopy. One of the largest studies of its kind and published in March 2024 in the New England Journal of Medicine, ECLIPSE demonstrated that the Shield blood test had a sensitivity of 83 percent in detecting CRC.
"With a simple blood draw, Shield provides a more convenient and pleasant screening option for the millions of eligible Americans who are forgoing their recommended screening for colorectal cancer," Guardant Health co-CEO AmirAli Talasaz said in a statement. "This major guideline inclusion from the National Comprehensive Cancer Network is just the first for Shield, and we believe a pivotal step for more patients to benefit from this test."
