Amadix, a Spanish biotech company, announced that PreveCol, its colorectal cancer screening blood test, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). 

The PreveCol cancer test 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. PreveCol has demonstrated to have the potential to offer a great significant benefit to patients, the company says. A positive result may indicate the presence of colorectal cancer and/or advanced precancerous lesions and should be followed by a diagnostic colonoscopy.

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.

Further reading: How At-Home Colorectal Cancer Screenings Pose Challenges

“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,” says Rocío Arroyo, Amadix CEO.