A screening device for the early detection of cancer in the blood
Milagen developed and validated Igo4Check, a screening blood test for the early detection of the 4 major cancers: breast, colorectal, lung, and prostate. It is currently going through the regulatory process.
Pre-PMA submission was discussed with the FDA for the inclusion/exclusion criteria, the number of patients for each cancer type, and the intended use.
Igo4Check test is indicated for the screening of the average-risk asymptomatic population for the early detection of the 4 major cancers. Milagen is pursuing a Breakthrough Device designation with the FDA.