Milagen developed and validated Igo4Check, a wide-population screening blood test for the early detection of the 4 major cancers in asymptomatic patients over the age of 45: 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.

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Current standard-of-care for wide-population cancer screening is mainly imaging-based (mammography, colonoscopy, etc.). This creates bottlenecks and friction due to issues of staffing, availability, cost and inconvenience to the patient. As a result, the compliance rate is low.

 

Our intention is to gain FDA approval for our test as another option for patients, with the intention of improving compliance rates and improving the rate at which cancer is detected in its earliest stages - when treatment is most effective.