NEW YORK – Solvd Health said on Wednesday that it is preparing to launch a prospective US clinical trial of its noninvasive colorectal cancer screening test, LifeKit Prevent.
The assay is being developed in partnership with Metabiomics, a subsidiary of the Carlsbad, California-based firm. It is an in vitro diagnostic test that uses Metabiomics' MultiTag DNA sequencing technology to detect and analyze microbial genomic biomarkers in human stool samples that are strongly associated with specific stages of CRC progression.
The test is intended to aid in the detection of precancerous and cancerous lesions (colorectal neoplasia), including advanced adenomas and carcinomas, in an average-risk screening population in accordance with recognized screening guidelines, Solvd Health said.
According to the clinical trial's website, Solvd and Metabiomics are looking to enroll about 12,000 participants beginning in June 2021. Subjects 40 years of age and older who are scheduled for a screening colonoscopy will be enrolled, and their stool samples will be tested at a central laboratory using the LifeKit Prevent Colorectal Neoplasia Test and a commercially available fecal immunochemical test. After sample collection, subjects will undergo a screening colonoscopy per standard of care. The companies estimate that the trial will wrap up in December 2022.
"Colonoscopy is the current gold standard for colorectal cancer screening because it accurately detects cancer as well as precancerous adenomas," Solvd Health CEOÂ Keri Donaldson said in a statement. "However, because it is highly invasive, patient compliance rates are poor. Currently available noninvasive alternatives have been shown to effectively detect cancer, but not precancerous adenomas. Early research has shown that our test is effective at detecting both, which could be a game changer for colorectal cancer screening."
In 2019, LifeKit Prevent received Breakthrough Device designation by the US Food and Drug Administration.