Prescient Metabiomics reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) Breakthrough Device designation for its LifeKit Prevent Colorectal Neoplasia Test.

This is the first such designation for a non-invasive diagnostic test that is designed to detect pre-cancerous polyps, as well as early-stage carcinomas, with the potential to aid in the interception of carcinogenesis and prevention of colorectal cancer (CRC). Other non-invasive tests on the market primarily detect full-blown cancer, not pre-cancerous adenomas, and require programs that rely heavily on colonoscopies to achieve colon cancer prevention, the company said.

CRC is the third most common type of cancer and the second leading cause of cancer death in the US.

The LifeKit Prevent Test deploys patented metagenomics technologies to identify and analyse microbial DNA and RNA biomarkers that are associated with neoplasia in the lower gastrointestinal tract. A positive result indicates the presence of colorectal adenomas or CRC, which should be followed by a diagnostic colonoscopy and polypectomy as appropriate.

Based on current findings from the clinical research, the test is highly accurate for detecting colon cancer and precancerous adenomas that are missed by existing non-invasive tests. A positive result will provide a stronger case to motivate reluctant, high-risk patients to undergo a colonoscopy resulting in the removal of precancerous adenomas and reduce the mortality of CRC.

Prescient Metabiomics is an early-stage molecular diagnostics company and a subsidiary of Prescient Medicine Holdings Inc.