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

This recognition positions Amadix as the first European company to achieve such status for early detection of colorectal cancer. PreveCol® has demonstrated substantial potential to provide significant benefits to patients, showing better diagnostic efficacy compared to currently approved colorectal cancer screening tests in the US.

The FDA's Breakthrough Devices Program is designed to expedite the assessment and premarket approval process for novel medical devices, ensuring timely access for patients and healthcare providers. 

This program underscores the FDA's commitment to fostering innovation in devices that contribute to more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases.

Amadix CEO Rocío Arroyo expressed the significance of gaining FDA recognition and said, "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."