The FDA has granted breakthrough device designation to Amadix’s PreveCol, a blood test designed for the early detection of colorectal cancer. This test is intended to screen adults aged 45 years or older who do not show apparent symptoms. Amadix is notable for being the first European company to receive FDA recognition for the efficacy of its blood test in detecting precancerous lesions, compared to currently available alternatives.
Rocío Arroyo, CEO of Amadix, expressed that this recognition from the FDA is a significant milestone for the company. The PreveCol test aims to aid in the early detection of blood biomarkers correlated with colorectal neoplasia. A positive test result may indicate the presence of either colorectal cancer (CRC) or advanced precancerous lesions, which should be followed by a diagnostic colonoscopy.
The FDA’s breakthrough designation is aimed at expediting the development of drugs or devices intended to treat serious conditions. It is supported by clinical evidence indicating that the product may demonstrate substantial improvement over existing drugs or devices. This designation is intended to accelerate the development, assessment, and review process for premarket approval, 510(k) clearance, and de novo marketing authorization, while still adhering to FDA standards for safety and effectiveness.