Amadix has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for PreveCol, its new blood test for colorectal cancer screening.
The Spanish molecular diagnostics company designed PreveCol for the early detection of biomarkers associated with colorectal neoplasia, in the patients’ blood.
The test is indicated to screen adults aged 45 years and above, without apparent symptoms.
A positive result may indicate the presence of colorectal cancer and/or Advanced Precancerous Lesions and should be followed by a diagnostic colonoscopy.
PreveCol has shown superior benefits to patients, with better diagnostic efficacy than currently approved colorectal cancer screening tests in the US, said the diagnostics company.
Amadix CEO Rocío Arroyo said: “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.”
With the FDA breakthrough designation, Amadix becomes the first European company to achieve the designation for early detection of colorectal cancer.
US FDA’s breakthrough devices programme is intended to provide timely access to novel medical devices by expediting the assessment and premarket approval process.
In February 2022, Amadix announced that its PreveCol blood-based test can detect colorectal cancer before its symptoms appear.
In May last year, the Spanish molecular diagnostics company teamed up with HM Hospitales to promote its test for early detection of colorectal cancer in asymptomatic people.
In November last year, the CEMTRO clinic in Madrid, Spain incorporated the PreveCol test.
