Sysmex America and DiaCarta are highlighting developments that may signal increased fecal immunochemical testing (FIT) in colorectal cancer (CRC) screening worldwide in 2025.
First, Sysmex has signed an agreement with Italy-based Sentinel Diagnostics that grants rights to distribute and service Sentinel's Sentifit 270 and 800 analyzers for CRC screening in Canada.
With distribution and service to begin during the first quarter of 2025, the agreement expands Sysmex's partnership with Sentinel to address unmet lab testing needs with efficiency, according to Sysmex.
The two Sentifit automated analyzers, respectively, are designed for medium- and high-volume fecal occult blood and calprotectin testing. Using an immunochemical testing method, the 270 model is designed for a throughput of up to 270 tests per hour. The 800 analyzer designed for a throughput of 550 tests per hour, according to Sysmex.
Meanwhile, molecular diagnostics firm DiaCarta has announced the publication of prospective clinical trial data on its blood-based test for triaging FIT-positive patients in CRC screening. The company said the findings show that the QuantiDNA blood test that analyzes patients' plasma samples reduces the need for colonoscopy examinations by 33% and is noninferior to the standard of care in detecting significant colorectal lesions.
"In Europe, all patients diagnosed as FIT positive are referred for colonoscopy, but, according to data collected from within the screening programs, 75% of them turn out to be negative afterward," said Dr. Mauro Scimia, DiaCarta's medical director and senior business director in Italy, and senior authors of the paper that was published December 13 in the Journal of Molecular Pathology.
Clinical laboratory test developers have been busy rolling out more noninvasive CRC screening tests as potential alternatives to the gold-standard colonoscopy. Noninvasive options range from blood tests, stool tests, and computed tomography colonography. Of the 22.3 million CRC screening tests performed in 2021 (by one study's estimates), FIT made up some 9.8 million.
In 2023, the Centers for Medicare and Medicaid Services (CMS) expanded the regulatory definition of CRC screening tests. The change reportedly brought CMS coverage in line with that of private insurance plans.
