Merck and Luminex Corp. have signed a collaboration and license agreement to develop a companion diagnostic to help screen patients for Merck's clinical development program for MK-8931, a novel oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor and Merck's lead candidate for Alzheimer's disease (AD). Financial terms were not disclosed.
 
Luminex will be responsible for development, regulatory submission and commercialization of the candidate companion diagnostic, which will employ its xMAP Technology to measure concentrations of two candidate biomarkers (Aβ42 and t-tau) in cerebrospinal fluid (CSF) samples from patients with mild cognitive impairment (MCI).
 
“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. “We look forward to working with Luminex to advance our ongoing clinical development program for MK-8931.”
 
“This collaboration has the potential to deliver a novel companion diagnostic to identify patients at increased risk of developing Alzheimer’s disease,” said Patrick J. Balthrop, president and chief executive officer of Luminex. “We are pleased to leverage our technologies and development capabilities and look forward to expanding our activity into the companion diagnostic segment of personalized medicine.”