Qiagen is on the move. The Hilden, Germany-based company has become a prime partner for companion diagnostics (CDx) development, having inked master collaboration agreements with more than 25 pharma and biotech companies. Up to now, all of these deals have focused on developing next generation-sequencing (NGS)-based CDx assays to identify candidates for new cancer drugs and treatments. But now Qiagen is extending its genetic testing profile beyond oncology to neurology biomarkers.

The New Qiagen-Neuron23 Parkinson’s CDx Collaboration

On Sept. 14, Qiagen announced that it had signed a new collaboration with precision medicine firm Neuron23. The San Francisco-based company is in the process of developing a small-molecule drug to inhibit the leucine-rich repeat kinase (LRRK2) gene, mutations of which have been linked to Parkinson’s disease. The drug is still in the late stages of preclinical development, but Neuron23 is already looking ahead to its potential use in clinical settings. So, it’s asking Qiagen to develop a blood-based NGS assay to identify individuals who may be candidates for the treatment.

It seems like a shrewd move for the up-and-coming biotech. Building the test before clinical trials begin will enable Neuron23 and Qiagen to submit the treatment and CDx product to the FDA for approval at the same time. It will also give the partners an opportunity to use and improve the test during the actual trials.

“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,” noted Neuron23 CEO Nancy Stagliano, PhD.

Specifically, Qiagen will develop and validate an NGS assay to detect a 50 single nucleotide polymorphism (SNP) biomarker discovered by Neuron23 to predict how Parkinson’s patients will respond to LRRK2 inhibitor treatment. The assay will run on Illumina’s NextSeq 500 System under Qiagen’s existing collaboration with Illumina.

Qiagen and Neuron23 have also agreed to keep working together to develop other CDx tests in the future. The up-and-coming biotech has essentially secured Qiagen as its partner for developing companion tests for its future drug products, whatever those may be.

Financial terms of the agreement weren’t disclosed.

A Bold Move for Qiagen

As for Qiagen, the collaboration is pretty much “been-there, done-that” territory. The company has already won FDA approval for 10 companion diagnostics developed in collaboration with other drug makers. The difference is that this time, Qiagen will be leaving its oncology backyard to concentrate on developing precision medicine CDx tests for neurology.

Driven by the growing incidences of severe neurological disorders such as Parkinson’s, epilepsy, stroke, and brain tumors, as well as depression, autism, dementia, and other disorders, the global neurological biomarkers market is projected to exhibit compound annual growth rates of 12.47 percent over the next four years—an estimated $6.0 billion. Key companies in the space include Abbott Laboratories, Myriad Genetics, Alseres Pharmaceuticals, Inc., AbaStar MDx, Inc., Diagenic ASA, Proteome Sciences, Psynova Neurotech, Athena Diagnostics, Bio-Rad Laboratories, Acumen Pharmaceuticals, Banyan Biomarkers, Inc., Immunarray Pvt. Ltd., Quanterix, and Thermo Fisher Scientific.

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Here’s a summary of key strategic diagnostic deals announced in September 2022:

Strategic Alliances, Partnerships, & Collaborations

Distribution, Sales, & Marketing Agreements

Licenses

Government Contracts