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Merck, Luminex Partner to Advance Companion Test for Alzheimer's Drug

NEW YORK (GenomeWeb News) – Merck and Luminex said they will work together to develop a companion test for Merck's investigational BACE inhibitor for Alzheimer's disease, MK-8931.

The diagnostic, which will operate on Luminex's xMAP platform, will be used to stratify patients into clinical trials involving MK-8931. According to the companies, Luminex will be in charge of developing, garnering regulatory approval, and commercializing the companion test.

Researchers involved in development of the drug will use the test to identify patients with mild cognitive impairment who are at heightened risk of developing Alzheimer's based on the concentration levels of the biomarkers amyloid-beta42 and t-tau in their cerebral spinal fluid. "Recent clinical evidence supports the hypothesis that the measurement of the investigational biomarkers A-beta42 and t-tau in [cerebral spinal fluid] may be useful in identifying patients at greater risk of developing Alzheimer's disease," Luminex and Merck said in a joint statement announcing their collaboration.

The companies did not disclose the financial terms of the deal.

"This collaboration has the potential to deliver a novel companion diagnostic to identify patients at increased risk of developing Alzheimer's disease," Luminex President and CEO Patrick Balthrop said in a statement. He added that the firm "look[s] forward to expanding our activity into the companion diagnostic segment of personalized medicine."

MK-8931 inhibits the beta amyloid precursor protein site cleaving enzyme, or BACE, which is thought to be implicated in the production of amyloid beta. This peptide causes the accumulation of amyloid plaque that many researchers believe to be the underlying cause of Alzheimer's disease. As such, Merck is betting that as a BACE inhibitor, MK-8931 will block the formation of amyloid plaque deposits in the brain and delay or prevent Alzheimer's disease.

In a Phase I study, MK-8931 reduced the levels of beta amyloid in the cerebral spinal fluid of Alzheimer's patients and healthy volunteers without dose-limiting side effects. Based on the results from this early study, Merck has initiated a Phase II/III trial, called EPOCH, to investigate the safety and efficacy of MK-8931 in patients with mild-to-moderate Alzheimer's.

Alzheimer's Disease International estimates that there are more than 5 million people in the US currently living with the disease, which commonly causes dementia. A diagnosis of Alzheimer's can only be confirmed by looking at the histopathological features and beta amyloid deposits in the brain after a person has died. Currently, there are no available treatments that prevent the disease.