Alfa Scientific Designs Wins 510(k) Clearance for Fecal Blood Test

Alfa Scientific Designs received 510(k) clearance for its iFOB with Driven Flow immunoassay for identifying human blood in feces, a possible symptom of pre-cancerous polyps and colorectal cancer.

The test requires just one drop of sample solution wand can provide a result in one minute, about five times faster than standard lateral flow assays.

Colorectal cancer is the third most common cancer diagnosed in the U.S. and the second leading cause of cancer death despite a high cure rate. Early diagnosis yields a 90 percent cure rate.