The CellMax biomimetic platform (CMx) demonstrated high specificity and sensitivity for colorectal cancer (CRC) and for precancerous lesions, according to research being presented at the 2018 Gastrointestinal Cancers Symposium in San Francisco, California.
Although CRC is highly preventable — especially when detected as precancerous lesions — current screening methods have low sensitivity for precancerous lesions and are inconvenient, leading to high rates of noncompliance.
CMx is a microfluidic biochip that reduces non-specific binding and quantifies the number of circulating tumor cells (CTCs). For this blinded, prospective study, researchers enrolled 620 patients: 428 patients with stage I to IV CRC, adenoma, or polyps, and 120 healthy subjects as controls. Two mL of peripheral whole blood were drawn from each patient and analyzed by CMx.
Patients underwent standard screening protocols (eg, biopsy, colonoscopy) to determine disease status. An age-regression model that correlated CTCs to clinical status was used to assess the probability of CRC risk.
The CMx had an 88% accuracy rate in disease detection for precancerous lesions and all stages of disease. The test’s specificity was 97.3%.
The test’s sensitivity was, however, lowest for precancerous lesions (76.6%).
The authors concluded that this study was the first to “show high sensitivity in the detection of precancerous colorectal lesions. The simple blood draw required can be easily integrated into a patient’s routine physical, increasing test compliance.”
Tsai WS, Nimgaonkar A, Segurado O, et al. Prospective clinical study of circulating tumor cells for colorectal cancer screening. Oral presentation at: 2018 Gastrointestinal Cancers Symposium; January 18-20, 2018; San Francisco, CA.