Mellitus

Mellitus, LLC is a Boston, Massachusetts diagnostics company developing a novel in vitro diagnostic (IVD) test that measures glycated CD59 (GCD59), a biomarker with stated potential clinical utility in the screening, diagnosis and monitoring of diabetes, in stratification of complications risk, and as a clinical trial assay for pharmaceutical development. The company was founded in October 2011 and is incorporated as an LLC.

The first product application of the technology targets gestational diabetes, where the company positions its test as a replacement for the existing multi-step screening process with a single, simpler test. Company materials describe an ambition for the assay to eventually become a standard method for managing diabetes more broadly. As of its Gust profile the company was at a prototype-ready stage and stated an aim of FDA clearance in 2018.

Leadership and scientific founders are drawn from Harvard Medical School and Brigham and Women's Hospital. Co-founder Jose Halperin, M.D., directs the Laboratory for Translational Research in the Division of Hematology at Brigham and Women's Hospital and has worked on the role of the complement regulator CD59 in diabetes complications; co-founder Michael Chorev, Ph.D., a peptide chemist at the same institution, led development of the key reagents used in GCD59 diagnosis. Joyce Lonergan is listed as CEO and co-founder, with additional executives covering finance (Kathy Welch, CPA), research and development (Shailendra Kumar, Ph.D., EVP R&D), technology, and commercial functions, plus named advisors including Alissa Dangel, M.D. and Thomas J. Musci, M.D. and board member Xing Zhao.

Founding story

Mellitus was founded in October 2011 in Boston by Harvard Medical School / Brigham and Women's Hospital researchers Jose Halperin, M.D. and Michael Chorev, Ph.D., who had collaborated for more than 15 years on GCD59 and the development of a diagnostic test based on it. Halperin's research focused on the complement system and the complement regulator CD59 in the pathogenesis of diabetes complications, while Chorev led development of the key reagents used in glycated CD59 measurement. Halperin holds over 40 awarded or filed patents, several licensed by Harvard University to companies commercializing his inventions.

Traction

As profiled on Gust, the company was at a prototype-ready stage with zero employees recorded and stated a goal of FDA clearance in 2018. A third-party profile lists employee count in the 1-50 range and records executive and advisory board updates dated October 2023.

Latest developments

Third-party executive tracking records dated October 3, 2023 list Thomas J. Musci, M.D. and Alissa Dangel, M.D. as advisors and Xing Zhao as a board member. Shailendra Kumar, Ph.D. is listed as Executive Vice President of Research and Development, leading product development, and Kathy Welch, CPA, joined as Head of Finance from Danforth Advisors.