Precision molecular diagnostic company DiaCarta has announced new positive clinical trial data for its QuantiDNA blood test in colorectal cancer (CRC) screening programmes.
The blood-based test triaged faecal immunochemical test (FIT)-positive patients in CRC screening.
According to California-based DiaCarta, the QuantiDNA test from patients’ plasma reduced the need for colonoscopy examinations by 33% for FIT-positive CRC patients during the study.
It also demonstrated comparable effectiveness to the standard of care in detecting significant colorectal lesions.
DiaCarta Italy medical director and senior business director Mauro Scimia said: “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.
“We utilised 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.”
The trial, conducted from 2019 to 2022, enrolled 711 individuals of both genders, aged 50-74 from a CRC screening programme in Naples, Italy.
The cross-sectional study aimed to assess the role of the plasma-based test in comparison to the standard colonoscopy approach.
All FIT-positive participants received both the blood test and a colonoscopy, with data analysis ensuring a comparison between the standard of care and the alternative approach.
The trial was approved by the Ethical Committee in December 2018 and independently validated by TechnoSTAT Clinical Services. US-based Mednet provided and held the database.
DiaCarta president and CEO Adam Zhang said: “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.”
DiaCarta specialises in precision diagnostics through liquid biopsy. Its XNA technology ensures sensitivity by clamping the wild-type sequence and amplifying the mutant target sequence.
Using this technology, the molecular diagnostic company has developed a highly sensitive blood-based Colorectal Cancer early detection test.
Additionally, powered by its isobDNA technology, DiaCarta has introduced the RadTox pan-cancer blood test, which personalises radiation and chemotherapy treatments by assessing tumour response.
In February this year, DiaCarta partnered with OncoAssure, an Irish medical diagnostics company, to introduce the latter’s prostate cancer lab-developed test.
