Amadix colorectal cancer preventive screening blood test receives FDA breakthrough device designation
PreveCol® is certified in the United States as a blood test for oncology diagnosis that is more effective at detecting precancerous lesions than existing alternatives.
Amadix becomes the first company in Europe to announce certification in the early detection of colorectal cancer.
MADRID , Jan. 23, 2024 /PRNewswire/ — Spanish biotech company Amadix announced today that its colorectal cancer screening blood testPreveCol ® from the U.S. Food and Drug Administration (FDA) It has received breakthrough device designation . This milestone makes Amadix the first European company to receive certification in the early detection of colorectal cancer .
PreveCol® has been shown to have the potential to provide significant benefit to patients , with diagnostic performance superior to currently approved colorectal cancer screening tests in the United States.
FDA’s The Breakthrough Devices Program is designed by expediting the evaluation and premarket approval process to make new medical devices available to patients and healthcare providers in a timely manner . The Breakthrough Devices Program embodies FDA’s commitment to device innovation to provide more effective treatments or diagnostics for life-threatening or irreversible human diseases.
” Receiving FDA clearance is a major milestone for our company. It motivates us to continue our efforts to make PreveCol® available to patients in the United States as soon as possible . We will continue to work on preventing the occurrence of colorectal cancer while reducing the risks that current treatments may cause. complications, ” said Amadix CEO Rocío Arroyo.
