DiaCarta Reports Positive Clinical Trial Data For Its Blood Based Test to Triage FIT-Positive Patients Enrolled in CRC Screening Programs

PLEASANTON, Calif., Jan. 3, 2025 /PRNewswire/ -- DiaCarta Inc., a precision molecular diagnostic company, has announced the publication of its prospective clinical trial data on its blood-based test for triaging FIT (fecal immunochemical test)-positive patients in colorectal cancer (CRC) screening.The study data was published in the Journal of Molecular Pathology on December 13, 2024. The findings reveal that in triaging FIT-positive patients in CRC screening, the QuantiDNA™ test from patients' plasma reduces the need for colonoscopy examinations by 33% and is non-inferior to the standard of care in detecting significant colorectal lesions.

The prospective clinical trial was designed for the Triage of FIT+ Patients Enrolled in a Colorectal Cancer Screening Program. During the period 2019–2022, 711 individuals of both genders, aged 50–74, participating in a CRC screening program organized by the ASL NA 3 SUD, a public healthcare company operating in the district of Naples (Italy), were enrolled in a cross-sectional study aimed at investigating the possible role of the plasma-based test. According to the study protocol, all participants with a FIT+ (or FOBT+) test, willing to sign an informed consent and eligible for the study, received both the blood-based test and a colonoscopy. Data analysis strategy ensured a comparison between the standard of care and the alternative approach. The study was approved by the Ethical Committee in December 2018. Statistical analysis was conducted internally and independently validated by TechnoSTAT Clinical Services (Bnei Brak, Israel). The database was provided and held by Mednet, Inc. (Minnetonka, MN, USA).

"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, as well as one of the senior authors of this paper. "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. This approach helps alleviate the burden on healthcare providers and reduces patients' anxiety while they wait for long colonoscopy queues."

"We are very pleased with the clinical trial results. 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," Dr. Adam (Aiguo) Zhang, President and CEO of DiaCarta, added. "This clinical trial represents a major milestone in "bringing the test into clinical practice."

About DiaCarta
DiaCarta is a molecular diagnostics company that has developed innovative technologies that transform patient care by providing effective precision diagnostics using liquid biopsy. Its novel XNA technology provides high level of sensitivity as it clamps the wild-type sequence and amplifies the mutant target sequence. Using this technology the company has developed its highly sensitive early detection Colorectal Cancer test using blood. Powered by its isobDNA™ technology that provides high level of detection by amplifying the signal and requiring no RNA/DNA extraction or amplification the company has developed its revolutionary RadTox™ pan-cancer blood test that personalizes radiation and Chemotherapy serving to assess tumor response and enhancing patient care. The tests are currently available at DiaCarta Cap/CLIA lab covered by medical insurances. Based in Pleasanton California, the company is ISO certified GMP-compliant and offers CLIA-certified laboratory services to its customers. www.diacarta.com

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SOURCE DiaCarta, Inc