FDA grants breakthrough device designation to Amadix’s blood test for colorectal cancer
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The FDA has granted breakthrough device designation to Amadix’s PreveCol, a blood test for early detection of colorectal cancer, intended to screen adults aged 45 years or older without apparent symptoms, according to a company release.
Amadix noted that it is the first European company to receive recognition from the FDA for the efficacy of its blood test in the detection of precancerous lesions compared with currently available alternatives.
“To gain this recognition from the FDA is an important milestone for our company,” Rocío Arroyo, CEO of Amadix, said in the release. “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.”
According to the company, the PreveCol test is intended to aid in early detection of blood biomarkers correlated with colorectal neoplasia . A positive test result may indicate the presence of either CRC or advanced precancerous lesions and should be followed by diagnostic colonoscopy .
The FDA grants breakthrough designation to expedite development of drugs or devices intended to treat serious conditions and supported by clinical evidence indicating that the product may demonstrate substantial improvement over currently available drugs or devices. Breakthrough designation is intended to accelerate drug/device development, assessment and review for premarket approval, 510(k) clearance and de novo marketing authorization, while still meeting FDA standards for safety and effectiveness.
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