Under the agreement, Qiagen will develop a clinical trial assay that will detect a combination of biomarkers discovered by Neuron23 that together predict the responsiveness of Parkinson's disease to the LRRK2 inhibitor, Qiagen said in a statement. LRRK2 gene mutations are one of the most common causes of familial Parkinson's disease.

Once developed, the diagnostic assay will be integrated into a next-generation sequencing workflow utilizing Qiagen's "Sample to Insight" capabilities. Parallel development of the assay and the therapeutic drug will allow Qiagen to submit the application to the U.S. Food and Drug Administration for premarket approval of the companion diagnostic test in tandem with Neuron23's new drug application for the LRRK2 inhibitor, currently in the late stages of preclinical development.

More than 25 other companies also have master collaboration agreements with Qiagen to develop companion diagnostic tests for candidate drugs.

"Qiagen's blood-based test will help to identify patients with Parkinson's disease who are likely to respond to Neuron23's LRRK2 inhibitor," said Nancy Stagliano, PhD, CEO of Neuron23. "The development of a companion diagnostic identifying this sub-population of Parkinson's disease patients will de-risk the clinical development of Neuron23's LRRK2 inhibitor and help identify individuals who may benefit from this disease-modifying therapy."

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