FDA Grants Breakthrough Device Designation to Amadix´s preventive screening blood test for Colorectal Cancer

FDA's Breakthrough Devices Program is intended to provide patients and health care providers with timely access to novel medical devices by expeditingthe 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. FDA'sBreakthrough Devices Program  is intended to provide patients and health care providers with...

FDA's Breakthrough Devices Program is intended to provide patients and health care providers with timely access to novel medical devices by expeditingthe 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.

About PreveCol®

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.

More information 

About Amadix

AMADIX is a leading molecular diagnostics company focused on liquid biopsy, developing innovative diagnostic tests for early cancer detection in blood. The mission of the company is extending people´s lives, developing disruptive technologies to detect the tumor years in advance before the symptoms appear. https://amadix.com/

CONTACT

Agathe Cortes

Communication Director

acortes@amadix.com

+34 663 07 09 28

View original content:https://www.prnewswire.co.uk/news-releases/fda-grants-breakthrough-device-designation-to-amadixs-preventive-screening-blood-test-for-colorectal-cancer-302039322.html