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Qiagen, Neuron23 Partner for NGS-Based Parkinson's Disease Companion Diagnostic

NEW YORK – Qiagen announced on Wednesday that it has signed a collaboration agreement with Neuron23, a San Francisco-based precision medicine firm, to develop a companion diagnostic test.

The next-generation sequencing test will help to determine whether a patient is likely to respond to Neuron23's brain penetrating leucine-rich repeat kinase (LRRK2) inhibitor treatment for Parkinson's disease. Financial terms of the agreement were not disclosed.

Qiagen will develop and validate a NGS assay to detect a 50 SNP biomarker signature that Neuron23 has discovered with the aim of predicting LRRK2 inhibitor response for Parkinson's disease patients.

The assay will be developed to run on Illumina's NextSeq 500 System as part of a collaboration between Qiagen and Illumina and use a workflow leveraging Qiagen's instrumentation, IVD sample preparation, library preparation, and bioinformatics.

Mutations in the LRRK2 gene are one of the most common causes of familial Parkinson's disease, the firms said in a statement.

Neuron23's LRRK2 drug candidate is in the late stages of preclinical development, and the Qiagen partnership will also support further clinical development. It also covers options for the future development of additional companion diagnostics, subject to further clinical development.

"The collaboration with Neuron23 shows the rapid momentum precision medicine is gaining in disease areas outside oncology," said Jonathan Arnold, VP and head of oncology and precision diagnostics at Qiagen.

Nancy Stagliano, CEO of Neuron23, said that the development of a companion diagnostic "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 also expands Qiagen's NGS testing portfolio for precision medicine beyond oncology into neurology applications, the firms said. Qiagen has formed similar CDx development and commercialization agreements with more than 25 other pharma and biotech firms, offering "a deep pipeline of potential future products to advance precision medicine."

The firm currently has 10 PCR-based CDx indications that are cleared by the US Food and Drug Administration including Therascreen EGFR for non-small cell lung cancer, Therascreen KRAS for colorectal cancer and NSCLC, Therascreen FGFR for urothelial cancer, Therascreen PIK3CA for breast cancer based on tissue or plasma samples, and the Therascreen BRAF kit for colorectal cancer.