QIAGEN has signed an agreement with American biotech company Neuron23 for the development of a companion diagnostic for the latter’s brain penetrant leucine-rich repeat kinase (LRRK2) inhibitor for Parkinson’s disease.

To predict the responsiveness of the brain disorder to an LRRK2 inhibitor, QIAGEN will create and validate a clinical trial assay to find a combination of biomarkers discovered by Neuron23.

The collaboration will underpin the clinical development of the biotech company’s drug candidate, which is now in the last phases of preclinical development.

It also includes options for the development of other companion diagnostics in the future, which will be subject to further clinical development.

QIAGEN said that the assay for the partnership will be integrated into a next-generation sequencing (NGS) workflow that will make use of the company’s Sample to Insight capabilities. These include instrumentation, library preparation, sample preparation for in vitro diagnostics (IVDs), and bioinformatics.

QIAGEN oncology and precision diagnostics head and vice president Jonathan Arnold said: “The collaboration with Neuron23 shows the rapid momentum precision medicine is gaining in disease areas outside oncology.

“Our expertise in blood- and NGS-based molecular testing from Sample to Insight will enable Neuron23 to run a clinical trial for a drug candidate that may have the potential to modify the course of an inexorable neurodegenerative disease in a genetically defined population.”

The company revealed that Illumina’s NextSeq 500 System will be used to create the workflow as part of a partnership between the two firms.

Based on the artificial intelligence (AI)-enabled drug development and biomarker platform of Neuron23, a complex signature of 50 single nucleotide polymorphisms (SNPs) will be targeted for US and European populations. This will be extended to additional SNPs that prevail in Asian populations, said QIAGEN.

Neuron23 CEO Nancy Stagliano said: “QIAGEN’s blood-based test will help to identify patients with Parkinson’s disease who are likely to respond to Neuron23’s LRRK2 inhibitor.

“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.”

The collaboration with Neuron23 will also help QIAGEN expand its NGS testing range for precision medicine beyond oncology into neurology applications.

Neuron23 has now joined a group of over 25 pharma and biotech firms that have master collaboration agreements with QIAGEN for companion diagnostic tests for their drug candidates.