Prescient Metabiomics, a subsidiary of Prescient Medicine, has secured the US Food and Drug Administration (FDA) Breakthrough Device designation for its LifeKit Prevent Colorectal Neoplasia Test.
The FDA Breakthrough Device designation marks the first designation for a non-invasive diagnostic test designed to detect pre-cancerous polyps and early-stage carcinomas, and help identification of carcinogenesis and prevention of colorectal cancer (CRC).
Prescient Medicine Holdings MD and chief executive officer Keri Donaldson said: “We are excited to deliver LifeKit Prevent, a non-invasive diagnostic test that not only will aid in detecting CRC, but also help identify patients at risk for advanced adenomas. By identifying patients most at risk for precancerous lesions, we can stop cancer before it starts and save lives.
“This important innovation, developed on our robust R&D and machine learning platforms, will allow more targeted and effective treatments earlier. The FDA’s decision confirms the unique aspects of our technology and the potential benefit of our test in addressing the large and increasing population of people at risk of developing CRC.”
LifeKit Prevent deploys metagenomics technologies to identify microbial DNA and RNA biomarkers
Prescient Metabiomics said that the other available non-invasive tests primarily detect full-blown cancer, but not precancerous adenomas, and include procedures that require colonoscopies to prevent colon cancer.
It has designed the LifeKit Prevent Test to deploy patented metagenomics technologies to identify microbial DNA and RNA biomarkers associated with neoplasia in the lower gastrointestinal tract.
A positive result from the analysis of microbial biomarkers in the stool are collected using a non-invasive collection swab indicates the presence of colorectal adenomas or CRC, followed by appropriate diagnostic colonoscopy and polypectomy tests.
According to a previous clinical research, LifeKit Prevent is set to be more convenient for patients and healthcare providers to use, compared to currently available CRC diagnostic tests.
In addition, the LifeKit Prevent is said to offer more accurate detection of colon cancer and precancerous adenomas that are undetected by the existing non-invasive tests.
The company said that a positive result from LifeKit Prevent would help motivate hesitant, high-risk patients to go through a colonoscopy to prevent further progression to carcinogenesis and reduce the morbidity and mortality of CRC.
