FDA Designates Amadix's Blood Test as Breakthrough Device for Colorectal Cancer Screening

24 January 2024 | Wednesday | Regulatory


Amadix, a Spanish biotech company, announced today that PreveCol®, its colorectal cancer screening blood test, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). With this milestone, Amadix becomes the first European company to announce this recognition for early detection of colorectal cancer.
Image Source : Public Domain

Image Source : Public Domain

  • PreveCol®, a blood test for oncological diagnosis, has obtained US recognition for its efficacy in detecting precancerous lesions compared to existing alternatives in the United States.
  • Amadix becomes the first European company to announce this recognition for early detection of colorectal cancer.

PreveCol® has demonstrated to have the potential to offer a great 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.

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