New IVD Assays


 A New Generation of Cancer IVD Assays

Milagen has developed a new generation of IVD products targeting unmet needs in cancer diagnostics.

Milagen novel IVD products are serum-based non-invasive immunodiagnostic assays based on proprietary cancer biomarkers developed through proprietary technologies, with clinical applications in cancer diagnosis, surveillance, and possibly early detection.

 Clinical Applications

Presently, there are no markers in clinical use that are expressed in the early stages of cancer, and recommended current screening methods all have their limitations.

Serum-based biomarkers presently in clinical use (CEA, CA-15.3, CA-19, CA-27.29, CA-125, etc.), are found elevated in advanced stages of disease, and are primarily used for cancer management, yet not for detection of early disease.

In contrast, Milagen cancer biomarkers are expressed in EARLY stage of cancer, when resection and treatments are more effective, leading to higher survival rates.

Therefore, not only Milagen biomarkers can find application in cancer diagnosis and surveillance, but Milagen early stage cancer biomarkers have the potential to be used as aid in early detection, possibly as adjunct to current screening methods.

Non-invasive IVD Assays

Milagen novel proprietary biomarkers are secreted in biological fluids (serum and urine) making them ideal non invasive immunodiagnostic products.

These IVD products are serum-based immunodiagnostic ELISA assays, and insofar are non-invasive, cost-effective, and compatible with diagnostic technology platforms currently in use in clinical laboratories.

Our novel IVD products possess all the features of a diagnostic assay for cancer surveillance, recurrence and possibly cancer early detection.