Singulex Collaborate with CHDI Foundation to Develop Biomarker Assays for Huntington’s Disease

Singulex, Inc. has announced a collaboration agreement with CHDI Foundation, a nonprofit biomedical research organization exclusively dedicated to rapidly developing drugs that will slow the progression of Huntington’s disease (HD). The collaboration will use Singulex’s proprietary Erenna® Immunoassay System to develop biomarkers to further Huntington’s disease research.

An article published online April 7th in the Journal of Clinical Investigation (JCI) outlines research from an international team of scientists who developed a new ultra-sensitive assay using the Singulex SMCTM Technology Erenna Immunoassay system that is able to detect mutant huntingtin protein (mHTT) in the cerebrospinal fluid (CSF) of HD patients, including some who carry the HD mutation but have not yet developed symptoms. The Singulex assay combines fluorescent antibodies with a laser detection chamber to count individual molecules of mHTT with a very low detection threshold, including both high specificity for mHTT and sensitivity to the femtomolar level.

“This research demonstrates the value of our SMC technology and its ability to measure previously undetectable levels of potential biomarkers, providing new insights into disease,” said Paul Wheeler, PhD, Vice President of Life Science Sales and Marketing at Singulex. “We are hopeful that this initial research and our further collaboration with CHDI will lead to the discovery of accepted biomarkers for use in the development and testing of new potential therapies for Huntington’s disease.”

In addition to detecting the protein in CSF for the first time, the researchers found that the level of mHTT was higher in people with more advanced disease. Additionally, the concentration of mHTT predicted the severity of movement and cognitive problems in patients.

“Quantifying disease-specific proteins in cerebrospinal fluid has been critical to the study and treatment of other neurodegenerative disorders, but until now mutant huntingtin protein has never been measured in CSF since it is present at such very low levels,” said Douglas Macdonald, PhD, Director of Drug Discovery and Development at CHDI. “With this new assay we hope that mutant huntingtin will prove to be a useful biomarker for the upcoming trials of huntingtin-lowering therapeutics.”