Madrid (ots/PRNewswire) – Amadixa Spanish biotech company, today announced that PreveCol®, the blood test he developed for colon cancer, from the Food and Drug Administration (FDA) has received the designation “groundbreaking” in the USA. This makes Amadix that first European companieswhose method for early detection of colon cancer was called “groundbreaking.”
- PreveCol®, a blood test for cancer diagnosis that is more effective than existing alternatives in the US, has been recognized in the US for detecting precancerous lesions.
- Amadix is the first European company to receive the designation “breakthrough” for its method for the early detection of colon cancer.
PreveCol® has shown that it has the potential to beneficial for patients to be. It shows one better diagnostic effectiveness than the currently approved screening tests for colon cancer in the United States.
The Breakthrough Devices Program The FDA aims to provide patients and healthcare professionals with rapid access to new medical devices by The evaluation and market approval process is accelerated. Through the Breakthrough Devices Program, FDA demonstrates its commitment to innovation and supporting the development of more effective treatment and diagnostic options for life-threatening or incurable diseases.
„This recognition by the FDA is an important milestone for our company. It motivates us to continue working on PreveCol® and to bring this product to the American market as quickly as possible. Our goal is to prevent the onset of colon cancer and the complications resulting from current treatments” explained Rocío Arroyo, CEO of Amadix.
Information about PreveCol®
PreveCol® dient zur early detection of biomarkers in blood, which are associated with colorectal neoplasia. This test from a Spanish company is aimed at adults of all genders who are older than 45 years and have no symptoms.
A positive result indicates the presence of colorectal cancer cells and/or advanced precancerous lesions. The diagnosis should be clarified by a subsequent colonoscopy.
Information about Amadix
AMADIX is one of the leading molecular diagnostics companies. The focus is on liquid biopsy and the development of innovative diagnostic methods for early cancer detection through blood tests. The company’s mission is to extend people’s lives using disruptive technologies by detecting tumors years before the first symptoms appear. https://amadix.com/
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