Project will exploit DiaGenic platform to compare expression profiles in patients at different disease stages.

Pfizer and DiaGenic have agreed to an explorative R&D collaboration that aims to identify biomarkers of the early stages of Alzheimer disease (AD) using the latter’s gene-expression technology and its blood samples from ongoing clinical trials.

The ultimate aim is to identify gene-expression patterns indicative of different stages of disease, from early mild cognitive impairment (MCI) through to full-blown AD. To this end the firms will carry out a joint modular study comparing longitudinal changes in blood-based gene-expression patterns in subjects with stable MCI, progressive MCI (prodromal AD), and full AD.

The agreement gives Pfizer a nonexclusive, worldwide license to use DiaGenic’s MCI test and AD tests for its R&D programs. “MCI progression biomarkers will be very useful in drug discovery, in clinical trials as surrogate markers of treatment efficacy, as well as being very valuable as diagnostic tests in clinical practice,” suggests DiaGenic CEO Erik Christensen, M.D.

DiaGenic specializes in the development of peripheral blood-based diagnostic tests based on gene-expression signatures for the early detection of diseases. The firm’s first two products, ADtect® for the early detection of AD and BCtect® for the early detection of breast cancer, have received regulatory approval for Europe and are being launched in selected markets.

The firm’s pipeline is focused on its gene expression-based MCItect™ test for identifying patients with MCI that will convert to AD and its PDtect® test for the early diagnosis of Parkinson disease.

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