FDA Grants Breakthrough Device Designation to Metabiomics Test for Early Detection of Colon Polyps and Colon Cancer
CARLSBAD, Calif., September 4, 2019 – Prescient Metabiomics, a privately held company and a subsidiary of Prescient Medicine Holdings, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted the company’s submission for Breakthrough Device designation to its LifeKit® Prevent Colorectal Neoplasia Test. This Breakthrough Device designation is the first 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). In contrast, other non-invasive tests on the market primarily detect full-blown cancer, not precancerous adenomas, and require programs that rely heavily on colonoscopies to achieve colon cancer prevention.
The LifeKit® Prevent Test deploys patented metagenomics technologies intended to identify microbial DNA and RNA biomarkers that are associated with neoplasia in the lower gastrointestinal tract. Using a non-invasive collection swab, the microbial biomarkers in the stool are analyzed. A positive result indicates the presence of colorectal adenomas or CRC, which should be followed by a diagnostic colonoscopy and polypectomy as appropriate.
A “Breakthrough Device” is an important designation by the FDA because it expedites the review process for medical devices that meet the designation criteria and offers more effective diagnosis of life-threatening diseases and conditions. The Breakthrough Device Program (BDP) offers manufacturers an opportunity to engage with the FDA’s experts to efficiently address topics during the pre-market review phase. Prescient Metabiomics anticipates that FDA support through the BDP will greatly reduce the regulatory timeline required for completing clinical trials and achieving FDA clearance.
“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,” says Keri Donaldson, MD, Chief Executive Officer of Prescient Medicine Holdings, Inc. “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.”
About Colon Cancer and LifeKit® Prevent
Colorectal cancer (CRC) is the third-most common type of cancer and the second leading cause of cancer death in the United States, with over 137,000 new cases and 56,000 deaths annually. The U.S. spends $14 billion each year for the diagnosis and treatment of CRC with costs largely due to delayed detection. While 14 million colonoscopies are performed annually, two-thirds of Americans do not follow screening guidelines and 60 percent of CRC cases are not detected until later stages. Using non-invasive tests to augment colonoscopy has been shown to increase adherence to CRC screening programs. Estimates suggest that broader CRC screening could save 18,800 lives in the U.S. annually.
Previously completed clinical research indicates that LifeKit® Prevent may be more convenient for patients and healthcare providers to use than currently available CRC diagnostic tests. Based on current findings, LifeKit® Prevent is highly accurate for detecting colon cancer and, more importantly, for detecting precancerous adenomas that are missed by existing non-invasive tests. A positive result from LifeKit® Prevent will provide a stronger case to motivate reluctant, high-risk patients to undergo a colonoscopy resulting in the removal of precancerous adenomas to prevent further progression to carcinogenesis and reduce the morbidity and mortality of CRC.
Prescient Metabiomics is an early stage molecular diagnostics company that is developing in-vitro diagnostics, screening tests, and health assays that leverage breakthroughs in next-generation DNA sequencing, computational systems biology, and human microbiome sciences. Over the past 15 years, the company’s founders have developed a powerful technology platform for interrogating the human gut microbiome. Prescient Metabiomics is a subsidiary of Prescient Medicine Holdings, Inc. To learn more, visit us at www.metabiomics.com
About SOLVD Health
SOLVD Health (formerly Prescient Medicine) is a privately held company focused on preventing disease by making contextual health information accessible to everyone. Through the development of insights-based health tools, we are enabling individuals and their providers to make better decisions about their health and the health of their families. We accomplish this by translating complex biological signals into actionable patient data that can point the way to better health. To learn more about us, our solutions, and our career opportunities, visit us on LinkedIn, on Twitter, or at www.solvdhealth.com.
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