Home 5 Articles 5 Illumina Partners for Development of Next-Gen Sequencing Tests

Illumina Partners for Development of Next-Gen Sequencing Tests

by | Jan 31, 2022 | Articles, Deals-lir, Essential, Laboratory Industry Report

The one thing you can say for Illumina is that its corporate leaders have chutzpah. For those of you who didn’t grow up with grandparents from Eastern Europe, “chutzpah” is the Yiddish word for guts and nerve. Proceeding with the $8.1 billion Grail acquisition without regulatory approval from the European Community (EC) last August took chutzpah. Nor is Illumina sitting back while it awaits word on whether it will have to unwind the deal. This month, the San Diego-based genetic testing giant made a pair of new strategic deals to develop new next-generation sequencing-based (NGS) diagnostics for decentralized testing. Illumina & Agendia Collaborate to Create MammaPrint NGS Test On Jan. 11, Illumina announced it has forged an alliance with Agendia to develop new NGS tests in the oncology space. Under the multi-year collaboration, the firms will use the Illumina MiSeqDx sequencing platform and Agendia’s current MammaPrint test technology to create a decentralized assay aimed at improving breast cancer care. The hope is that the assay, aka, the Agendia MammaPrint NGS test, will become the first decentralized NGS-based breast cancer recurrence risk test to get FDA clearance. “We believe our current FDA-cleared, broadly reimbursed MammaPrint test provides the perfect foundation for […]

The one thing you can say for Illumina is that its corporate leaders have chutzpah. For those of you who didn’t grow up with grandparents from Eastern Europe, “chutzpah” is the Yiddish word for guts and nerve. Proceeding with the $8.1 billion Grail acquisition without regulatory approval from the European Community (EC) last August took chutzpah. Nor is Illumina sitting back while it awaits word on whether it will have to unwind the deal. This month, the San Diego-based genetic testing giant made a pair of new strategic deals to develop new next-generation sequencing-based (NGS) diagnostics for decentralized testing.

Illumina & Agendia Collaborate to Create MammaPrint NGS Test

On Jan. 11, Illumina announced it has forged an alliance with Agendia to develop new NGS tests in the oncology space. Under the multi-year collaboration, the firms will use the Illumina MiSeqDx sequencing platform and Agendia’s current MammaPrint test technology to create a decentralized assay aimed at improving breast cancer care. The hope is that the assay, aka, the Agendia MammaPrint NGS test, will become the first decentralized NGS-based breast cancer recurrence risk test to get FDA clearance. “We believe our current FDA-cleared, broadly reimbursed MammaPrint test provides the perfect foundation for incorporation with Illumina’s MiSeqDx platform,” noted Agendia CEO Mark Straley in a statement. Agendia thus becomes the latest addition to Illumina’s list of more than 30 IVD partners that develop sequencing-based solutions for the prognosis of cancer, therapeutic selection, and various other applications.

Illumina Provides NGS Readout Capability to SomaLogic

A week before the Agendia deal became public, Illumina unveiled a new co-development agreement with protein biomarker discovery firm SomaLogic to create and market multiplexed, high-throughput proteomics assays with NGS-based readout. The tests will be based on SomaLogic’s SomaScan platform and will run on Illumina’s NovaSeq and other high-throughput NGS platforms. More broadly, Illumina will seek to integrate SomaLogic's aptamer-based protein counting technology with its own NGS and bioinformatics platforms. This isn’t the first time Illumina has offered its NGS platforms as a readout for assays developed by other companies. Illumina made a similar deal with Olink in 2020, enabling the proteomics firm to add NGS-based readout for its proximity extension assays. That same year, Illumina cut a deal allowing NanoString Technologies to analyze GeoMx Digital Spatial Profiler data on Illumina's Dragen Bio-IT platform. Here’s a summary of some of other key strategic diagnostic deals announced in January 2022:

STRATEGIC ALLIANCES, PARTNERSHIPS, & COLLABORATIONS

Partner 1 Partner(s) 2+ Deal Summary
Single Cell Discoveries BioTuring
  • Objective: Integrate firms’ respective single-cell sequencing products
  • Dynamic: Single Cell Discoveries to offer BioTuring’s BBrowser single-cell multiomics analysis platform as part of its single-cell sequencing services
Thermo Fisher Scientific Oncocyte
  • Objective: Clinically validate Thermo Fisher's Oncomine Comprehensive Assay Plus and develop Oncocyte’s DetermaIO assay on Ion Torrent Genexus system 
  • Dynamic: Under comarketing agreement running through 2035, Thermo subsidiary Life Technologies to retain exclusive right to partner with pharma companies to develop its Oncomine test as a companion diagnostic, HealthPulse@home into lab systems using LumiraDx’s SARS-CoV-2 RNA Star Complete test
  • Oncocyte keeps exclusive right to partner with therapeutics companies to develop DetermaIO as a companion diagnostic
  • Thermo Fisher to pay Oncocyte a low- to mid-20s percentage of revenue it receives on worldwide sales of a resulting Oncomine IVD test and on sales of DetermaIO IVD outside US
Illumina Agendia
  • Objective: Develop IVD tests for oncology testing
  • Dynamic: Multi-year collaboration to leverage the Illumina MiSeqDx sequencing platform to create new diagnostics to improve breast patient cancer care and management
Illumina SomaLogic
  • Objective: Create multiplexed, high-throughput proteomics assays with NGS-based readout
  • Dynamic: Codevelopment agreement with Illumina to develop and market protein detection assays based on SomaLogic's SomaScan platform that run on Illumina's high-throughput NGS platforms, including NovaSeq 
Illumina Syapse
  • Objective: Assess uptake and actionability of comprehensive genomic profiling in community oncology health system setting
  • Dynamic: Do study using data from Syapse Learning Health Network data aggregation platform to identify trends in testing approaches over time and actionability of results
Scienion Institute for Prevention and Occupational Medicine of the German Social Accident Insurance (IPA)
  • Objective: Develop multiplexed, lateral-flow diagnostic platform for bladder cancer
  • Dynamic: Leverage IPA’s knowledge of biomarkers and biobank 500 urine samples to create test and Scienon’s automated precision dispensing technology to print biomarkers on the lateral flow immunoassay
Yourgene EKF Diagnostics
  • Objective: Offer noninvasive prenatal and other genomic testing services in US
  • Dynamic: 5-year deal with Yourgene to provide EKF subsidiary and CLIA lab Advanced Diagnostics Laboratory with proprietary reagents and NGS analysis software for use in creating noninvasive prenatal testing service providing results within 48 hours
  • ADL to also offer Yourgene's PCR tests for cystic fibrosis, aneuploidy, and DPYD deficiency in chemotherapy toxicity
Veranome Cold Spring Harbor Laboratories (CSHL)
  • Objective: Develop new applications using CSHL's BARseq platform 
  • Dynamic: Collaboration and licensing agreement bringing CSHL’s in situ sequencing and data analytics technologies into Veranome's spatial omics portfolio
Cardea Bio Siemens Healthineers Center for Innovation in Diagnostics
  • Objective: Assess feasibility of developing biosensor testing applications for Cardea's BPU Platform
  • Dynamic: Optimize and test a next-generation SARS-CoV-2 immunoassay
  • Hardware, software, wetware, and know-how to be transferred to Siemens Healthineers' facilities to enable use of and experimentation with BPU Platform 
Becton Dickinson Pfizer + Wellcome (charitable foundation)
  • Objective: Study the role of diagnostics in supporting antimicrobial stewardship practices
  • Dynamic: Survey existing diagnostic practices to understand the benefits and gaps in diagnostic testing in antimicrobial resistance stewardships
Caris Life Sciences HotSpot Therapeutics
  • Objective: Develop HotSpot's precision medicine products and potential companion diagnostic tests
  • Dynamic: Strategic collaboration to initially focus on therapeutic programs using HotSpot's E3 ubiquitin ligase immunotherapy program from pre-first-in-human trials to potential CDx tests and product launch
  • Caris has negotiation rights for CDx tests resulting from partnership 
NeoGenomics Biomarker Collaborative
  • Objective: Expand cancer patient access to biomarkers testing
  • Dynamic: Biomarker to prepare resource page to be provided to patients whose lung cancer biomarker is identified with NeoGenomics' tests 
Grail  PINC AI
  • Objective: Identify patients who may benefit from early cancer detection using Galleri, Grail's multi-cancer early detection blood test
  • Dynamic: PINC AI plans to augment its artificial intelligence-enabled clinical decision support platform to alert doctors to patients with higher risks of cancer who may benefit from early testing using Galleri
C2i Genomics OncoDNA
  • Objective: Pair C2i's AI-based whole-genome sequencing and minimal residual disease cancer monitoring platform with OncoDNA's European network of cancer clinician-researchers
  • Dynamic: Support interventional clinical trial led by Paris' Gustave Roussy Institute to test the clinical utility of escalating metastatic treatments in over 750 patients with high risk of cancer recurrence 
Exagen Queen Mary University of London
  • Objective: Develop patented molecular signatures for rheumatoid arthritis therapy selection
  • Dynamic: Exagen gets exclusive global license from Queen Mary University to patent-pending tests that use RNA expression patterns to predict patient response to commonly prescribed therapeutics for rheumatoid arthritis
Acon Laboratories AusDiagnostics
  • Objective: Launch Acon’s over-the-counter Flowflex COVID-19 Home Test in Australia
  • Dynamic: Acon's Flowflex test is a lateral flow assay to detect SARS-CoV-2 nucleocapsid protein antigen in self-collected anterior nasal swab specimens
Qiagen Actome
  • Objective: Develop protein analysis applications for the QIAcuity digital PCR system 
  • Dynamic: Comarketing agreement giving Qiagen a co-exclusive license for digital PCR applications to use Actome's patented protein-interaction-coupling (PICO)-technology on QIAcuity
  • Qiagen also makes undisclosed investment in German startup
Singular Genomics Systems Broad Institute
  • Objective: Connect Singular’s G4 next-generation sequencing platform to the Terra data platform
  • Dynamic: Partnership giving researchers who use the Singular G4 access to cloud-based data storage and analytical tools optimized for genomic data
Twist Bioscience  Artisan Development Labs (Artisan Bio)
  • Objective: Discover new antibodies against 5 undisclosed targets
  • Dynamic: Apply Twist’s Library of Libraries to discover novel antibodies directed against Artisan Bio's immunotherapy targets, and leverage Artisan’s Immune Cell Engineering Foundry and STAR Guides to develop custom cell therapeutics 
  • Twist to receive upfront technology access and project fees for each program, milestone payments and royalties on product sales
Bio-Techne Akoya Biosciences 
  • Objective: Develop a single-cell, spatial multiomics workflow for analysis of tissue samples
  • Dynamic: Combine Akoya’s PhenoCycler-Fusion workflow with Bio-Techne’s RNAScope HiPlex v2 assay
Pacific Biosciences Care4Rare Canada Consortium
  • Objective: Study complex cases of rare disease with whole-genome sequencing
  • Dynamic: Use PacBio's HiFi long-read sequencing technology to study rare disease samples that have been sequenced with short-read technology, but for which no causative genetic variants were identified
Alamar Biosciences Abcam
  • Objective: Further proteomics research 
  • Dynamic: Combine Alamar's NUcleic acid-Linked Immuno-Sandwich Assay (NULISA) proteomics platform and Abcam's antibody portfolio
Mission Bio SequMed
  • Objective: Create new single-cell assays for early cancer detection
  • Dynamic: Combine Mission Bio's Tapestri platform with SequMed's clinical assay development and data analysis capabilities

DISTRIBUTION, SALES, & MARKETING AGREEMENTS

Product Owner  Distributor  Deal Summary 
SDI Labs  Medi-Wheels Diagnostics
  • Products: SDI’s over-the counter rapid antigen test kits
  • Territory: Global
  • Kits to be sold under Medi-Wheels Diagnostics brand name in packs of two
Purigen Institute of Applied Biotechnologies 
  • Products: Purigen’s Ionic Purification System benchtop instrument for extracting, purifying, and concentrating genomic RNA and DNA from cells and formalin-fixed, paraffin-embedded tissues
  • Territory: Czech Republic, Hungary, Poland, Romania, Slovakia
  • Exclusive
Parse Biosciences  Research Instruments 
  • Products: Parse's Evercode Whole Transcriptome, Cell Fixation, and Nuclei Fixation kits 
  • Territory: Singapore, Thailand, Malaysia, Vietnam
XPhyto Therapeutics  TechUnit 
  • Products: XPhyto's COVID-ID Lab test 
  • Territory: Czech Republic
  • Non-exclusive
OraSure Technologies  Eurobio Scientific 
  • Products: OraSure Technologies' OraQuick saliva-based HIV self-test
  • Territory: France
  • Exclusive

LICENSES

Licensor Licensee Deal Summary
OncXerna Exact Sciences Exclusive license allows Exact to offer OncXerna's Xerna tumor microenvironment panel to identify patients likely to respond to anti-angiogenic and immunotherapies to CUT&RUN and CUT&Tag chromatin profiling technologies as part of its own GEM ExTra test
Socpra Sciences Santé Et Humaines Mainz Biomed Mainz gets exclusive option to globally license portfolio of 5 novel mRNA biomarkers

GOVERNMENT CONTRACTS

Contractor Govt. Agency Contract Summary
Abbott Rapid Dx North America US Department of Defense $306 million firm-fixed-price contract for COVID-19 rapid antigen test kits

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