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

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– Earlier research using Singulex’s Huntington’s disease research immunoassay outlined in Journal of Clinical Investigation –

– Assay measures build-up of a harmful mutant protein in cerebrospinal fluid during the progression of Huntington’s disease –

Alameda, Calif. – April 9, 2015 – Singulex, Inc., the developer and leading provider of Single Molecule Counting technology for clinical diagnostics and scientific discovery, today 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.”

About Huntington’s disease
Huntington’s disease is a hereditary, neurodegenerative brain disorder for which there is currently no cure. It is caused by a single gene mutation that results in the production of harmful mutant huntingtin protein. The mutated gene was identified in 1993 but until now it has not been possible to quantify the mutant protein in the nervous system of living Huntington’s disease patients. Huntington’s disease causes abnormal involuntary movements, psychiatric symptoms, and dementia. Complications such as pneumonia, heart disease, and physical injury from falls reduce life expectancy to around twenty years from the point at which symptoms begin. Physical symptoms can begin at any age but usually begin between 35 and 44 years of age. There are approximately 30,000 Americans living symptomatically with Huntington’s disease.

About CHDI Foundation, Inc.
CHDI Foundation, Inc. is a privately-funded nonprofit biomedical research organization that is exclusively dedicated to rapidly discovering and developing therapies that slow the progression of Huntington’s disease (HD). As a collaborative enabler, CHDI seeks to bring the right partners together to identify and address critical scientific issues and move drug candidates to clinical evaluation as quickly as possible. Our scientists work closely with a network of more than 600 researchers in academic and industrial laboratories around the world in the pursuit of these novel therapies, providing strategic scientific direction to ensure that our common goals remain in focus. More information about CHDI can be found at www.chdifoundation.org.

About Singulex, Inc.
Singulex is the developer and leading provider of Single Molecule Counting technology for clinical diagnostics and scientific discovery. Singulex’s proprietary SMCTM technology enables physicians and scientists to detect biomarkers of disease that were previously undetectable. Powered by SMCTM technology, Singulex’s ultrasensitive immunoassay solutions and lab testing services are transforming patient care from reactive disease treatment to proactive health management and fueling the discovery and development of new therapeutics.

Singulex provides SMCTM technology to leading pharmaceutical R&D laboratories, clinical research organizations (CROs) and academic institutions around the world through its Research-Use-Only Erenna® Immunoassay System. The Singulex Clinical Lab Testing Services consist of a CLIA-licensed and CAP-accredited laboratory that currently provides a comprehensive menu of advanced cardiovascular disease testing utilizing SMCTM technology. Singulex currently is developing the Sgx ClarityTM System, a fully-automated in vitrodiagnostics system that will bring the benefits of SMCTM technology to hospital and reference labs worldwide. For further information, please visit www.singulex.com.

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Source: Singulex, Inc.

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