DiaCarta Inc. has announced positive clinical trial data for its blood-based test designed to triage FIT (fecal immunochemical test)-positive patients in colorectal cancer (CRC) screening programs. The study, published in the Journal of Molecular Pathology, reveals that the QuantiDNA™ test, utilizing patients' plasma, reduces the necessity for colonoscopy examinations by 33% while maintaining non-inferiority to the standard of care in detecting significant colorectal lesions.
The prospective clinical trial, conducted between 2019 and 2022, enrolled 711 individuals aged 50–74 participating in a CRC screening program organized by ASL NA 3 SUD in Naples, Italy. Participants with a positive FIT (or FOBT) test underwent both the blood-based test and a colonoscopy. The study protocol ensured a comparison between the standard of care and the alternative approach using DiaCarta's test. Ethical Committee approval was obtained in December 2018, and statistical analysis was independently validated by TechnoSTAT Clinical Services.
Reducing Colonoscopy Burden
Dr. Mauro Scimia, DiaCarta's Medical Director and Senior Business Director in Italy, noted that in Europe, 75% of FIT-positive patients referred for colonoscopy turn out to be negative. "We utilized the straightforward, non-invasive, and well-tolerated blood-based test to triage FIT+ patients, significantly reducing the number of patients who truly require colonoscopy," Dr. Scimia stated. "This approach helps alleviate the burden on healthcare providers and reduces patients' anxiety while they wait for long colonoscopy queues."
Advancing Cancer Testing with Liquid Biopsy
Dr. Adam (Aiguo) Zhang, President and CEO of DiaCarta, expressed satisfaction with the clinical trial results, stating, "The clinical performance of the simple blood-based test in triaging CRC screening aligns perfectly with our mission to advance cancer testing through liquid biopsy." He added that the trial represents a major milestone in bringing the test into clinical practice.
DiaCarta's QuantiDNA™ test leverages the company's proprietary XNA technology, which enhances sensitivity by clamping the wild-type sequence and amplifying the mutant target sequence. This technology facilitates highly sensitive early detection of colorectal cancer through blood samples. Additionally, DiaCarta's isobDNA™ technology powers the RadTox™ pan-cancer blood test, which personalizes radiation and chemotherapy by assessing tumor response, thereby enhancing patient care.
