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Qiagen Moves into Neurology with Recent Collaboration

by | Sep 30, 2022 | Deals-lir, Essential, Laboratory Industry Report

The Hilden, Germany-based company is extending its genetic testing profile beyond oncology to neurology biomarkers.

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

Qiagen Companion Diagnostics to Receive FDA Clearance*

·       Therascreen EGFR for non-small cell lung cancer (NSCLC)
·       Therascreen KRAS for colorectal cancer
·       Therascreen KRAS for NSCLC
·       Therascreen FGFR for urothelial cancer
·       Therascreen PIK3CA for breast cancer based on tissue or plasma samples
·       Therascreen BRAF for colorectal cancer

*Some approved products come in multiple versions

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.


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

Strategic Alliances, Partnerships, & Collaborations

Partner 1Partner(s) 2+Deal Summary
QiagenNeuron23• Objective: Develop a companion diagnostic test 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
• Dynamic: Qiagen to develop and validate NGS assay to detect a 50 SNP biomarker signature discovered by Neuron23 for use in predicting LRRK2 inhibitor response for Parkinson's disease patients
• Assay to run on Illumina's NextSeq 500 System as part of a collaboration between Qiagen and Illumina
• Collaboration expands Qiagen's NGS testing portfolio for precision medicine beyond oncology into neurology
Thermo Fisher ScientificUgenTec• Objective: Commercialize several new CE-marked respiratory assay plug-ins for UgenTec’s FastFinder analysis software
• Dynamic: Expansion of current collaboration that will allow FastFinder to analyze and interpret results from Thermo Fisher's TaqPath COVID-19 CE-IVD RT-PCR kit and TaqPath COVID-19, Flu A/B, and RSV Combo kit from a single software platform
Foundation Medicine (subsidiary of Roche)Day One Biopharmaceuticals• Objective: Develop FoundationOne CDx as companion diagnostic for Day One's tovorafenib
• Dynamic: Investigational drug currently in a Phase II clinical trial, FIREFLY-1, to treat relapsed pediatric low-grade glioma (pLGG) in pediatric, adolescent, and young adult patients
Foundation Medicine (subsidiary of Roche)Relay Therapeutics• Objective: Develop FoundationOne CDx as companion diagnostic for Relay's RLY-4008 investigational FGFR2 inhibitor
• Dynamic: Test would be used to identify patients with fibroblast growth factor receptor 2 (FGFR2) fusions and select rearrangements in cholangiocarcinoma who may benefit from the drug
RochePhoreMost Ltd.• Objective: Discover new biomarkers for drug development
• Dynamic: PhoreMost to use its SITESEEKER screening platform toward disease-relevant pathways nominated by Roche with novel targets identified to be validated by Roche
• PhoreMost to receive upfront payment and preclinical success-based milestone payments
BioMérieuxBrightInsight• Objective: Develop a clinical decision support tool
• Dynamic: BioMérieux to launch digital diagnostics solution incorporating the BrightInsight Platform and BrightInsight Disease Management Solution
(subsidiary of OpGen)
FIND• Objective: Develop Curetis’ Unyvero A30 RQ platform for use in low- and middle-income countries
• Dynamic: FIND and German KfW bank to provide €700,000 ($697,708) to fund the project
Genome MedicalPierian• Objective: Optimize genomics programs for healthcare organizations and provider groups
• Dynamic: Work together to identify patients who may benefit from genomic testing and interpret the results of that testing
(subsidiary of Eurofins Scientific)
NIMA Partners• Objective: Promote EmpowerDx’s genetic test measuring a patient’s risk for developing celiac disease
• Dynamic: Partnership to raise awareness of celiac disease and improve access to testing
Caris Life Sciences
Flatiron Health• Objective: Integrate Caris’ molecular profiling offerings into Flatiron Health’s cloud-based OncoEMR platform for EHR management
• Dynamic: Molecular DNA and RNA profiling services for cancer detection, diagnosis, monitoring, and therapy selection to be available within OncoEMR
Caris Life SciencesBriaCell Therapeutics• Objective: Support patient identification and enrollment of genetically defined subgroups for a current Phase I/II clinical trial in advanced metastatic breast cancer
• Dynamic: Caris to use its "Right-In-Time" Clinical Trial Network of oncology sites to enroll eligible patients and perform comprehensive tumor profiling for trial patients
MetabolonSwedish Biomarkers For Identifying Neurodegenerative Disorders Early and Reliably (BioFINDER) 2 Study• Objective: Develop new biomarkers for neurological diseases
• Dynamic: Study designed to address the role of tau pathology in a variety of neurological disorders
Broad InstituteDatavant• Objective: Build out a system that combines clinical and genomic patient data across rare and common diseases with unmet medical need
• Dynamic: Broad to get patient consent for sequencing their genome via a direct-to-patient platform that allows scientists to recruit participants for research studies
• Datavant to use its network of clinics, hospitals, and third-party partners to receive complete medical records for patients
• Clinical and genomic data to then be integrated to help researchers identify disease-causing genes and subtypes of established diseases
PaigeOptraScan• Objective: Streamline digital pathology workflows in US, UK, and EU
• Dynamic: Integrate Paige's AI-based digital pathology applications with OptraScan's scanners to provide end-to-end digital pathology workflow solutions
Sophia GeneticsMemorial Sloan Kettering Cancer Center (MSKCC)• Objective: Offer predictive tumor analysis and clinical decision support services
• Dynamic: Sophia to contribute its CarePath multimodal analysis platform and other predictive algorithms to MSKCC's precision oncology databases to deliver actionable insights to MSK clinicians
Dante GenomicsTMA Precision Health• Objective: Offer whole-genome sequencing-based diagnostics to rare disease patients around the world
• Dynamic: TMA will offer its network access to Dante's clinical whole-genome sequencing service, including clinical interpretation and personalized reports
• Dante to use the data to advance internal research related to target identification and drug development with TMA to also include the sequencing data into its own rare disease database
LunaphoreNucleai• Objective: Identify new drug targets, mechanisms of action, and biomarkers, including predictive and prognostic disease markers
• Dynamic: Combine Lunaphore’s COMET multiplex spatial proteomics platform with Nucleai’s ATOM informatics package, which uses machine learning to analyze spatial biology data
IndivumedCellPhenomics• Objective: Discover and validate new cancer drug targets
• Dynamic: CellPhenomics to use Indivumed's nRavel bioinformatics platform to identify, characterize, and prioritize potential drug targets for and build cellular models of different tumor types
QuantuMDxSansure Biotech• Objective: Commercialize QuantuMDx’s Q-POC system and assays in China
• Dynamic: Global R&D, manufacturing, and commercial partnership agreement gives Sansure Biotech exclusive rights to Q-POC in China in return for licensing and royalty payments
• QuantuMDx to also have exclusive rights to sell Sansure-developed assays outside China
• Firms to also develop new assays on the Q-POC
Agilent TechnologiesMettler Toledo• Objective: Launch new sample preparation workflow that improves results and provides a "digital experience for operating chromatographic instruments"
• Dynamic: Solution offers fully automated and digitized liquid chromatography or gas chromatography workflow to eliminate common errors in the weighing process
NanomixMobility Health• Objective: Create point-of-care, laboratory-developed test to measure COVID-19 antibodies that show protection against the disease for use in mobile labs
• Dynamic: Nanomix to supply assay materials and Mobility Health to complete development and validation of test

Distribution, Sales, & Marketing Agreements

Product OwnerDistributorDeal Summary
Virax BiolabsCosmos Holdings• Products: Virax’s Monkeypox Virus Real-Time PCR Detection Kits
• Territory: Europe
• Exclusive for Greece and Cyprus; non-exclusive for rest of Europe
Purigen BiosystemsBucher Biotec• Products: Purigen's Ionic Purification System
• Territory: Switzerland
• Exclusive
Purigen BiosystemsProteigene• Products: Purigen's Ionic Purification System
• Territory: France
• Exclusive
(subsidiary of Athroa)
• Products: NanoSpot.ai's point-of-care SARS-CoV-2 Total Antibody Test
• Territory: Greece
Genes2MeBioVendor• Products: Genes2Me's in vitro diagnostics products
• Territory: Czech Republic and Slovakia
S2 GenomicsTechtum Lab• Products: S2’s Singulator 100 tissue dissociation instrument
• Territories: Norway, Sweden, Denmark, Finland
S2 GenomicsEisenberg Bros.• Products: S2’s Singulator 100 tissue dissociation instrument
• Territories: Israel
Sense BiodetectionTecomedical• Products: Sense Biodetection’s Veros COVID-19 point-of-care test
• Territories: Germany, Austria, Switzerland
C2N DiagnosticsHealius• Products: C2N’s PrecivityAD Alzheimer's disease blood test
• Territories: Australia


LicensorLicenseeDeal Summary
University of BirminghamInnova Medical GroupInnova licenses Reverse Transcription-Free Exponential Amplification Reaction (RTF- EXPAR) nucleic acid amplification technology

Government Contracts

ContractorGovt. AgencyContract Summary
Chembio DiagnosticsUS Centers for Disease Control and Prevention$3.2 million contract to develop a rapid point-of-care test for syphilis
OncocyteUS Department of Veterans Affairs5-year, nearly $3 million Federal Supply Schedule contract for Oncocyte to supply its DetermaRx test, a prognostic assay to aid treatment decisions after lung cancer removal surgery, to be used on VA’s early-stage lung cancer patients

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