Merck, Luminex collaborate to develop companion diagnostic device

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Merck, referred to as MSD outside the US and Canada, and Luminex have signed a deal to develop a companion diagnostic device to support patient selection for the clinical development program of investigational drug MK-8931 to treat Alzheimer’s disease (AD).

MK-8931 is an oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor. Under the agreement, Luminex will leverage xMAP technology in developing the candidate device to measure concentrations of Aß42 and t-tau candidate biomarkers in cerebrospinal fluid samples from patients with mild cognitive impairment.

Along with the development activities, Luminex is responsible for regulatory submission and commercialization of the resulting product.

Luminex president and CEO Patrick Balthrop said, “This collaboration has the potential to deliver a novel companion diagnostic to identify patients at increased risk of developing Alzheimer’s disease.”

Merck Research Laboratories neuroscience and ophthalmology head, senior vice president Darryle Schoepp said, “Evaluation of biomarkers that may provide an indicator of disease onset and enable earlier diagnosis is an important goal toward facilitating early intervention and potentially improving the treatment of Alzheimer’s disease.”

Merck is currently conducting a global, multi-center Phase II/III clinical trial, EPOCH, to evaluate the safety and efficacy of MK-8931 versus placebo in patients with mild-to-moderate AD and has plans to initiate a trial in prodromal subjects.