Mellitus is developing the next gold standard for diabetes testing. The Mellitus patented Technology is based on the measurement of a novel biomarker called Glycated CD59 (GCD59). Mellitus’ Founders discovered the role of GCD59 in the complications of diabetes and developed the Mellitus GCD59 Test. The Company has developed a prototype test using an immunoassay format that is amenable to automated systems. The test components, including a novel peptide calibrator and the peptide immunogens for the capture and detection antibodies, are proprietary to Mellitus
Mellitus' first product candidate is a test for Gestational Diabetes Mellitus (GDM). GDM causes serious adverse pregnancy outcomes affecting babies and mothers; screening is standard of care worldwide. The Mellitus Test replaces a complex, unreliable, inefficient screening process with a simple, reliable, efficient test that is user-friendly for practitioners and patients. GDM represents a $650-700MM annual U.S. market opportunity. The global testing opportunity is about 10-fold larger than in the US. Mellitus aims for FDA clearance in 2017.
GDM is the entry point for the $20B+ overall diabetes market. GCD59 can also be measured in urine, sweat and saliva, opening the door for point of care and wearable devices that are very much needed for the early diagnosis and management of diabetes worldwide. Mellitus foresees that the Mellitus Test will revolutionize the market and become the standard to screen, diagnose and manage everyone with diabetes.