FDA Grants Breakthrough Device Designation to Amadix's Blood Test PreveCol for CRC

The FDA has granted Breakthrough Device Designation to PreveCol, a blood test for early colorectal cancer detection developed by Amadix. PreveCol excels in identifying precancerous lesions more effectively than existing tests. This approval marks a significant step in enhancing early cancer diagnoses.

Spanish biotech company Amadix has announced that its pioneering blood test, PreveCol®, has been awarded Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), marking a significant milestone in the fight against colorectal cancer. This recognition establishes Amadix as the first European company to attain such a designation for the early detection of colorectal cancer.

PreveCol is designed for the early detection of biomarkers in the blood associated with colorectal neoplasia. The test is intended to screen adults of any sex, aged 45 years or older, who do not show apparent symptoms. A positive result may indicate the presence of colorectal cancer and/or advanced precancerous lesions, and should be followed by a diagnostic colonoscopy.

Rocío Arroyo, CEO of Amadix, expressed her enthusiasm about this achievement: “To gain this recognition from the FDA is an important milestone for our company. It motivates us to continue working to bring PreveCol® to American patients as soon as possible. We will continue preventing the onset of colorectal cancer and the complications derived from the current treatments.”

The FDA's Breakthrough Devices Program aims to expedite the development and review process of innovative medical devices that promise more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. The inclusion of PreveCol® in this program underscores its potential to substantially benefit patients by enhancing early detection capabilities.

About Author: Tracy Mokwe

With over 3 years of experience as a medical laboratory scientist and writer, I am passionate about translating complex scientific information into clear and accessible content. My expertise lies in medical sciences, laboratory science and research, digital health, AI, and cybersecurity in healthcare.