Merck and Luminex signed a collaboration and license agreement to develop a companion diagnostic device that will be evaluated to help screen patients for recruitment into Merck’s clinical development program for MK-8931, an oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor for Alzheimer’s disease (AD).

Luminex will be responsible for development, regulatory submission, and commercialization of the candidate companion diagnostic device, which will employ the xMAP® technology to measure concentrations of two candidate biomarkers (Aβ42 and t-tau) in cerebrospinal fluid samples from patients with mild cognitive impairment (MCI). The candidate device will be evaluated as a means to identify subjects with MCI who have a higher risk of developing AD to support patient selection for Merck’s therapeutic BACE inhibitor clinical program.

“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,” said Darryle D. Schoepp, Ph.D., senior vice president, head of Neuroscience and Ophthalmology at Merck Research Laboratories.

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