Amadix, a Spanish biotech company, has announced that PreveCol, its colorectal cancer screening blood test, has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).
With this milestone, Amadix becomes the first European company to announce this recognition for early detection of colorectal cancer (pictured).
PreveCol has been demonstrated to have the potential to offer a significant benefit to patients and has proven to have better diagnostic efficacy than currently approved colorectal cancer screening tests in the US.
FDA's Breakthrough Devices Program is intended to provide patients and health care providers with timely access to novel medical devices by expediting the assessment and premarket approval process. The Breakthrough Devices Program reflects the FDA´s commitment to device innovation leading to more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases.
"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,” said Rocío Arroyo, Amadix CEO.
PreveCol® is aimed at the early detection of biomarkers in blood associated with colorectal neoplasia. The Spanish test is indicated to screen adults of either sex, 45 years or older, without apparent symptoms. A positive result may indicate the presence of colorectal cancer and/or advanced precancerous lesions and should be followed by diagnostic colonoscopy.