Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

A government shutdown, ongoing tensions with China and concerns about continued economic growth have marked the beginning of 2019. Against this backdrop, diagnostic deals continue to move forward. Here’s a quick overview of the past month’s activity.

The biggest M&A deal for the period involved Luminex, which has completed its previously announced acquisition of MilliporeSigma’s flow cytometry portfolio. Valued at $75 million in stock, assets, and inventory, it gives Luminex access to Amnis imaging flow cytometry products for cell-based analysis, as well as the Guava portfolio of products, which leverage microcapillary technology and are also used for cell-based analysis. These additions complement Luminex’s offerings and enhance its current flow-based systems—and expand the number of the company’s installed systems to more than 5,000.

Other deals that closed this period include two involving OraSure Technologies, and the acquisition of Connective Tissue Gene Tests by Health Network Laboratories. Details for these and other M&As are provided in the chart below.

Strategic Alliances
Among new strategic alliances is a partnership between population genomics technology company Color and NorthShore University HealthSystem. Together, they have launched an initiative called DNA10K, which will provide genetic testing to 10,000 patients as part of their annual exam with their primary care practitioner. The program is aimed at helping patients learn about their genetic makeup, including risk factors for certain disease types such as common hereditary cancers and heart diseases, so that NorthShore may then personalize care for each patient to support improved outcomes, prevention, and overall health. The initiative is the largest known primary-care based genomics program in the United States.

Other U.S. agreements include three involving Personal Genome Diagnostics (PGDx), all of which are detailed in the chart below.

Product integration and deals are likewise hot in Asia this month, especially in China, where, as in the U.S., the focus is often on genomics and/or cancer.

Here’s a summary of key diagnostic deals from late December through January:

Acquiring Company Target(s) Deal Summary
Luminex MilliporeSigma
  • Price: $75 million including $69.9 million under a stock and asset purchase agreement and $5.1 million in inventory purchases
  • Status: Closed
  • Acquisition of MilliporeSigma’s flow cytometry portfolio, including Amnis imaging flow cytometry products for cell-based analysis and Guava portfolio enhances Luminex’s flow-based detection systems line
OraSure Technologies CoreBiome
  • Price: Undisclosed upfront payment + contingent performance-based future payments
  • Status: Closed
  • Acquisition of privately held provider of microbiome research services for customers for pharmaceutical, agricultural and research markets
OraSure Technologies Novosanis
  • Price: Undisclosed upfront payment + contingent performance-based future payments
  • Status: Closed
  • Acquisition of privately held urine sample collection device developer
Health Network Laboratories Connective Tissue Gene Tests
  • Price: Undisclosed
  • Status: Closed
  • Acquisition of molecular diagnostic lab specializing in inherited genetic disorders
Qiagen N-of-One
  • Price: Undisclosed but purchase made with cash reserves
  • Status: Closed
  • Acquisition of molecular oncology decision company boost Qiagen’s offerings in decision support
Chiral Technologies Arbor Biosciences
  • Price: Undisclosed
  • Status: Closed
  • Acquisition of NGS and synthetic biology products provider whose offerings include custom DNA microarrays, oligonucleotide libraries and myBaits line of targeted sequencing panels
Neogen Delta Genomics Centre
  • Price: Undisclosed
  • Status: Closed
  • Acquisition of Canadian animal genomics lab to be renamed Neogen Canada
Partner 1 Partner 2 Deal Summary
Roche Phoenix Molecular Designs
  • Objective: Develop CDx for a kinase inhibitor developed for triple-negative breast cancer
  • Dynamic: Assay to use immunohistochemistry to detect activation of RSK2 kinase in tumors via measuring nuclear RSK2
  • Roche to establish CAP/CLIA-certified protocol for assay for clinical tumor analyses
Luminex AllerGenis
  • Objective: Develop and market precision food allergy diagnostic assay
  • Dynamic: Leverage Luminex xMAP technology to create tests starting with AllerGenis peanut allergies test slated to launch in fall 2019
Illumina PierianDx
  • Objective: Develop cancer sequencing products
  • Dynamic: PierianDx to leverage Clinical Genomics Workspace platform and Clinical Genomics Knowledgebase to provide variant interpretation and reporting for Illumina TruSight Tumor 170 and TruSight Oncology 500 research assays
  • Non-exclusive also covers future products
Veracyte Johnson & Johnson Innovation
  • Objective: Develop Veracyte’s lung cancer tests
  • Dynamic: Veracyte to join J&J’s Lung Cancer Initiative, combine its study cohorts with J&J patient cohorts and collaborate on enrolling new cohorts
Color NorthShore University HealthSystem
  • Objective: Deliver genomic testing as part of routine primary care to population of 10,000+
  • Dynamic: So-called “DNA10K” expands previous collaboration in which patients signed up for Color population health program as a part of their primary care visit
  • Color labs to analyze blood samples provided by NorthShore patients who elect to participate in program
Personal Genome Diagnostics (PGDx) PathGroup
  • Objective: Get US regulatory approval for PGDx Elio tissue complete assay
  • Dynamic: Co-development agreement collaboration integrating PGDx’s scientific, development, and regulatory expertise with PathGroup’s NGS experience
Personal Genome Diagnostics (PGDx) Merck
  • Objective: Use Elio tissue complete assay to assess TMB during enrollment portion of Merck phase II precision oncology KeyImpact study
  • Dynamic: Test to study application of biomarker-based, pembrolizumab-based therapies for advanced non-small-cell lung cancer patients
Personal Genome Diagnostics (PGDx) KingMed Diagnostics
  • Objective: Commercialize PGDx’s Elio tissue complete assay in China and Hong Kong
  • Dynamic: Establish KingMed as qualified clinical trial testing site for assay once assay gets regulatory approval
Sphere Fluidics Peak Analysis and Automation (PAA)
  • Objective: Product integration to help increase throughput in antibody discovery and cell line development
  • Dynamic: PAA to combine its automated microplate handling technology with Sphere Fluidics’ Cyto-Mine single-cell analysis system
BC Platforms MedEngine
  • Objective: Offer “turnkey research solutions”
  • Dynamic: Strategic alliance under which MedEngine to integrate its research and medical knowledge into BC Platforms’ analytics platform and biobank data stores
Adaptive Biotechnologies  Genentech (part of Roche)
  • Objective: Enable Adaptive to develop personalized cancer therapies
  • Dynamic: Adaptive to use Genentech’s TruTCR T-cell receptor screening platform to identify TCRs for targeting individual cancer patients’ neoantigens
  • Genentech to use TCRs to engineer and manufacture personalized therapies and get regulatory approvals
  • Adaptive to get $300 million upfront + up to $2 billion in future development, regulatory and commercial milestones + royalties
Arbor Biotechnologies Vertex Pharmaceuticals
  • Objective: Discover new proteins, including DNA endonucleases, for developing gene editing-based therapies for cystic fibrosis and other diseases
  • Dynamic: Combine Arbor’s protein biodiscovery platform with Vertex’s expertise in developing gene editing-based approaches for treating serious diseases
  • In addition to funding research, Vertex will pay undisclosed up-front cash payment + future milestone payments + royalties on future net sales
  • Vertex to also make investment in Arbor via a convertible note and get an observer seat on Arbor’s board
CellMax Life Medigen Biotech
  • Objective: Clinical trial evaluating patients with stage II and III colorectal cancer
  • Dynamic: Integrate CellMax’s CMx circulating tumor cell platform with Medigen’s liquid biopsy panel to examine patient treatment selection and response
NX Prenatal Milu Labs
  • Objective: Commercialize NX Prenatal’s test for preterm birth risk in Asia
  • Dynamic: Milu to help launch test in China and other countries as part of the new maternal fetal medicine and women’s health business it’s developing in Asia
LifeMap Sciences Novogene
  • Objective: Offer LifeMap Sciences’ TGex clinical genomics platform in China
  • Dynamic: Platform to be offered through Novogene’s Tianjin, China-based clinical lab
Pillar Biosciences China Biotech Services Holdings
  • Objective: Provide Pillar Bio’s precision diagnostic products in Hong Kong, Macau, South Korea and Southeast Asia
  • Dynamic: Parties to create new joint venture
  • China Biotech Services to also participate in Pillar Bio’s Series B financing round
Biocartis Nichirei Bioscience
  • Objective: Commercialize Biocartis’ Idylla MDx oncology tests in Japan
  • Dynamic: Nicherei to seek regulatory approval from Japanese Ministry of Health, Labor and Welfare and serve as local distributor once tests are registered
Property Owner Distributor Deal Summary
Gemelli Biotech Advanced Medical German
  • Products: IBS-smart, Gemelli’s blood test for irritable bowel syndrome
  • Territory: Kuwait, United Arab Emirates, Qatar, Saudi Arabia, Egypt, Turkey
SpeeDx AB Analitica
  • Products: SpeeDx ResistancePlus and PlexPCR tests
  • Territory: Italy
SpeeDx Immuno Diagnostic Oy
  • Products: SpeeDx ResistancePlus and PlexPCR tests
  • Territory: Finland
Sienna Cancer Diagnostics Mirax
  • Products: Sienna’s bladder cancer test
  • Territory: South Korea
  • Exclusive
  • Mirax to also seek regulatory approval for test in South Korea
Omni Life Science Bioké
  • Products: OLS’ CERO benchtop 3D cell incubator and bioreactor + CASY cell counter and analyzer
  • Territory: Belgium, Netherlands, Luxembourg
Roche MilliporeSigma
  • Products: Roche’s biochemical reagents, Kapa Biosystems portfolios and select qPCR and nucleic acid purification products
  • Territory: Global
  • Renewal of existing deal through 2025
Paragon Genomics MGI Tech
  • MGI to distribute Paragon’s CleanPlex NGS panels for use with its own sequencing platforms worldwide except for the US
  • Paragon to distribute MGI’s MGISP-100RS, MGISP-960RS and future automated sample prep systems in US and Canada
  • Neither deal is an exclusive
Licensor Licensee Deal Summary
Salisbury NHS Foundation Trust NimaGen
  • Property: One-step PCR technology using reverse complement probes for use in developing NGS products
  • NimaGen also gets worldwide license to technology for research uses including development and sale of products for sample tracking and authentication within labs, high-throughput screening and diagnostic research
Expedeon Cell Guidance Systems
  • Property: Expedeon’s Lightning-Link Rapid Biotin technology
  • License and supply agreement allows Cell Guidance Systems to use technology to develop its TRIFic (Time Resolved Immunofluorescence Exosome Detection Assay) immunoassays
Genfit Covance (LabCorp drug development business)
  • Property: Genfit’s NIS4, non-alcoholic steatohepatitis liver diagnostic (NASH) assay
  • Agreement allows Covance to deploy NIS4 for clinical research space to further validate its use for better identification and characterization of patients, and to generate new biological insights on NASH disease pathogenesis
Supplier/Servicer Client/User Deal Summary
Abbott Japanese Red Cross Society
  • 8-year deal making Abbott an exclusive supplier of immunoassay-based serological instrumentation, tests and consumables for blood and plasma screening in Japan
LabCorp Texas Association of Community Health Centers (TACHC)
  • Extension of existing making LabCorp exclusive preferred provider of lab services for TACHC
  • Parties to use data analytics to identify population health trends, enabling targeted community and individual outreach about screening, monitoring and treatment options for common health conditions
Primerdesign (molecular testing division of Novacyt) Genesis Diagnostics
  • Exclusive supply agreement with Primerdesign to develop and supply 384-well plate molecular assay panels, including respiratory, women’s health, sexually transmitted diseases, wound and urinary tract infections, to Genesis to use in its Pennsylvania-based clinical service lab

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