DIAGNOSTIC DEALS

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

The end of April through mid-May was another busy period for deal making. Here’s a quick overview of activity and key deals.

Mergers & Acquisitions and Asset Sales

Thermo Fisher Scientific’s $1.7 billion acquisition of Brammer Bio, a leader in viral vector manufacturing for gene and cell therapies, recently closed. The deal, one of the largest of the year, strengthens Thermo Fisher’s presence in the pharma and biotech markets.

Other M&As involve smaller transactions. Activity continues to be global in scope, with ongoing focus in Asia as well as Europe. Italian oncology genetics company Impact Lab Group’s acquisition of Toma Advanced Biomedical Assays Services Lab for an undisclosed amount is one such transaction. The deal will create the largest research and genetics laboratory in Italy.

Strategic Alliances

In addition to the 18 new partnerships detailed in the chart below, is the new alliance between U.S.-based diagnostics giant LabCorp and Qiagen, a provider of sample and assay technologies for molecular diagnostics, applied testing, academic, and pharmaceutical research, based in Germany.

LabCorp is now selling Qiagen’s new companion diagnostic for bladder cancer, the therascreen fibroblast growth factor receptor (FGFR) mutation analysis, at its specialty cancer labs. The test is designed to assess whether patients with urothelial cancer are eligible for treatment with Johnson & Johnson’s newly approved FGFR kinases inhibitor Balversa (erdafitinib).

The therascreen FGFR mutation analysis assay is the first test to be sold through LabCorp’s collaboration with Qiagen’s lab readiness program, designed to speed patient access to companion diagnostics soon after FDA has approved a new treatment and its associated test.

The arrangement seems like a lucrative move for LabCorp. Qiagen has an exclusive license from Columbia University​ to the therascreen FGFR technology, while LabCorp and its Covance drug development unit have been developing and selling companion diagnostic tests for the past two decades, and efforts in this area of precision medicine have accelerated recently. Bladder cancer is the sixth most common type of cancer in the United States, and urothelial cancer, or transitional cell carcinoma, is the most prevalent form of bladder cancer. There is a high unmet need among patients looking for new treatment options with advanced metastatic bladder cancer, a disease with dire outcomes: The relative five-year survival rate is only 5%.

Here’s a summary of key diagnostic deals from late April through the third week of May:

MERGERS, ACQUISITIONS & ASSET SALES
Acquiring Company Target(s) Deal Summary
Thermo Fisher Scientific Brammer Bio
  • Price: $1.7 billion cash
  • Status: Closed
  • Contract development and manufacturing organization for viral vectors used in gene and cell therapies to become part of TF’s pharma services business within lab products and services segment
PathGroup Pathologists Bio-Medical Laboratories
  • Price: Undisclosed
  • Status: Closed
  • Acquisition of pathology services firm enables PathGroup to expand its testing menu for all pathology sub-specialties
Beckman Coulter Life Sciences Labcyte
  • Price: $308 million
  • Status: Closed
  • Danaher subsidiary acquires privately held liquid handling firm with $61 million in annual sales
Caris Life Sciences Pharmatech
  • Price: Undisclosed
  • Status: Closed
  • Caris to combine Pharmatech’s “Just-In-Time” clinical trial enrollment system + oncology network with its own Molecular Intelligence service for assessing DNA, RNA and proteins to detect molecular profiles
Meridian Bioscience GenePOC
  • Price: Up to $120 million, $50 million at closing + up to $20 million in Meridian FY 2021 contingent on technical development milestones + final payment up to $50 million in FY 2023 based on sales of certain molecular assays + achievement of minimum profit margin thresholds
  • Status: No closing date announced
  • Acquisition of developer of Revogene molecular diagnostics platform part of Meridian’s strategy to update its molecular offering
 Caprion Biosciences  Serametrix
  • Price: Undisclosed
  • Status: Closed
  • Caprion acquires expertise in immunology + analysis of myeloid-derived suppressor cells (MDSC) + access to US, UK, Australia and China markets
Yourgene Elucigene Diagnostics
  • Price: £9.2 million ($12.0 million), including £6.3 million in cash + £2.9 million in equity in stock (24.6 million new shares issued at 11.7 pence per)
  • Status: Closed
  • Yourgene to fund acquisition boosting its presence in bolster its presence in noninvasive prenatal testing (NIPT) market by selling roughly 97.5 million new shares at 10.25 pence apiece to raise £10 million (which Yourgene board may increase to £11.8 million)
Canopy Biosciences Zellkraftwerk
  • Price: Undisclosed
  • Status: Closed
  • Acquisition of German cytometry startup part of Canopy’s strategy to build a "unique multi-omics" company
PerkinElmer Cisbio Bioassays
  • Price: Undisclosed
  • Status: Closed
  • PerkinElmer acquires life sciences + DX kits and reagents manufacturer with $50 million in 2018 revenues
CareDx OTTR Complete Transplant Management
  • Price: $16 million cash (no financing)
  • Status: Expected to close in May
  • Acquiring provider of organ transplant patient tracking software furthers CareDx’s position in transplant artificial intelligence
Impact Lab Group Toma Advanced Biomedical Assays Services Lab
  • Price: Undisclosed
  • Status: Closed
  • Merger designed to create largest research and genetics lab in Italy
Prescient Medicine Holdings AutoGenomics
  • Price: Undisclosed
  • Status: Closed
  • Acquisition of privately held molecular DX firm and former collaborator helps Prescient develop and commercialize its Infiniti Neural Response Panel
STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS
Partner 1 Partner(s) 2+ Deal Summary
Biotech Support Group (BSG) Leiden University Medical Center (LUMC)
  • Objective: Correlating BSG’s Stroma Liquid Biopsy panel of blood-based protein biomarkers to LUMC’s tissue-derived tumor-stroma scoring methods
  • Dynamic: Under research collaboration agreement, BSG will define + quantify Stroma Liquid Biopsy biomarkers in LUMC-collected sera to correlate LUMC tumor-stroma ratio (TSR) scoring methods
Personalis FLX Bio
  • Objective: Use Personalis universal cancer immunogenomics ImmunoID Next test to evaluate therapy-related changes in tumors of advanced cancer patients treated with FLX Bio’s FLX475 drug
  • Dynamic: FLX Bio to apply Personalis assay in patient cohort for a Phase I/II clinical trial evaluating FLX475, a CCR4 antagonist, as monotherapy or in combination with pembrolizumab
Owlstone Medical Actelion Pharmaceuticals
  • Objective: Develop breath-based test for early diagnosis of pulmonary hypertension (PH)
  • Dynamic: Owlstone to identify volatile organic compounds associated with PH to develop biomarker signature(s) that can be used for early detection of PH
Qiagen Inovio Pharmaceuticals
  • Objective: Develop companion diagnostic for Inovio’s DNA-based immunotherapy for cervical dysplasia caused by HPV
  • Dynamic: Test under investigation for treatment of infection with HPV 16 and HPV 18 and precancerous lesions of the cervix (Phase 3), and vulva and anus (Phase 2)
Eurofins Scientific Adial Pharmaceuticals
  • Objective: Validate companion diagnostic for Adial’s alcohol use disorder drug AD04 and identify patients for a Phase III trial
  • Dynamic: Eurofins to perform lab validation of test at its facilities using qPCR and test potential study participants before enrollment to determine if they have the genetic markers indicating they’d respond to treatment
Indivumed Gnosis Data Analysis
  • Objective: Add artificial intelligence to Indivumed’s IndivuType multi-omics cancer research platform
  • Dynamic: Deal comes a month after Indivumed announced partnership with Evotec to discover and develop new precision therapeutics for colorectal cancer
Arcis Biotechnology Andrew Alliance
  • Objective: Comarket firms’ respective technologies for automated nucleic acid stabilization and preparation
  • Dynamic: Partners to promote use of Arcis’ reagents for DNA + RNA preparation with Andrew Alliance’s Andrew+ pipetting robot and OneLab lab protocol design and execution software
BGI Genomics Pryzm Health
  • Objective: Promote “precision public health” for Australian market
  • Dynamic: Technology sharing pairing BGI’s genomics testing with Pryzm’s data genotype-phenotype matching and analytics technology to provide greater access to precision health services, faster diagnoses, better patient outcomes and lower costs
Roche Diagnostics Bio-Techne
  • Objective: Offer Roche chromogenic detection kits for automated in situ hybridization (ISH) tissue analysis for drug discovery research in US
  • Dynamic: Expansion of existing partnership to include Roche’s Discovery mRNA Purple HRP detection kit and Discovery mRNA Teal HRP detection kit which use feature translucent dyes for co-localization studies for mRNA ISH and enable protein-RNA co-detection on same slide
Biocartis Covance
  • Objective: Offer Biocartis’ Idylla platform and oncology assay menu to Covance’s global customer base
  • Dynamic: Alliance provides for placement of Idylla molecular testing instruments at Covance sites to support customer needs for clinical trials and validate companion diagnostic applications
Verogen Cellmark Forensic Services
  • Objective: Validate Verogen’s NGS-based MiSeq FGx technology
  • Dynamic: Verogen installed platform at Cellmark’s Abingdon, UK lab in Feb.
Enpicom DDL
  • Objective: Jointly develop an immune repertoire sequencing and analysis service
  • Dynamic: Partners to market service to organizations researching immune system-related diseases or developing drugs for immune disorders
PrediLife Institut Curie
  • Objective: Validate PrediLife’s MammoRisk breast cancer risk assay
  • Dynamic: Institut Curie to perform genetic analysis focusing on roughly 100 polymorphisms associated with increased breast cancer risk
Amgen Syapse
  • Objective: Develop observational research analytics tools to assess treatment outcomes for precision oncology
  • Dynamic: Use the Syapse Learning Health Network data-sharing network for precision oncology to identify candidates for Amgen-sponsored clinical trials
  • Partners to also develop evidence standards to help accelerate process of bringing new therapies to market
CareDx Cibiltech
  • Objective: Commercialize Predigraft, a data analysis tool for early prediction of an individual’s risk of allograft rejection and transplant loss
  • Dynamic: CareDx to get exclusive US commercialization rights to Predigraft and become a minority equity owner of Cibiltech
Oxford Nanopore Technologies GrandOmics Biosciences
  • Objective: Achieve better understanding of genetic variation associated with human health and disease and use knowledge to develop clinical applications for future diagnostic use
  • Dynamic: Launch dbSV100k, a population genomics structural variation project using nanopore sequencing technology to analyze 100,000 human genomes by 2021
Macrogen Exosome Plus
  • Objective: Develop exosome-based diagnostics, therapeutics and cosmetics
  • Dynamic: Firms to firms to also collaborate on drug-development education and training, and share infrastructure, equipment and facilities
  • Deal also includes Macrogen’s commitment to be exclusive buyer of Exosome Plus’ Exo2D exosome isolation kits for one year
RxGenomix Coriell Life Sciences (CLS)
  • Objective: Offer package of pharmacogenomics training, implementation, and management services to healthcare providers
  • Dynamic: Combine RxGenomix’s pharmacogenomics training and implementation program with CLS’ bioinformatic services for risk analysis, reporting and population-level healthcare analytics
DISTRIBUTION, SALES & MARKETING AGREEMENTS
Property Owner Distributor Deal Summary
 Agendia Imegen
  • Products: Agendia’s MammaPrint and BluePrint breast cancer genomic tests
  • Territory: Spain + Portugal
  • Exclusive
SensID TATAA Biocenter
  • Products: SensID’s Mdx reference standard products
  • Territory: Sweden, Denmark, Norway, Finland, Czech Republic, Slovakia
NanoCellect Biomedical Daon Biosciences
  • Products: NanoCellect’s Wolf Cell Sorter and N1 single-cell plate dispenser
  • Territory: South Korea
NanoView Biosciences Quantum Design International (via its Quantum Design Japan subsidiary)
  • Products: NaonView’s ExoView exosome characterization platform
  • Territory: Japan
  • Exclusive
OmniSeq LabCorp
  • Products: OmniSeq’s immune profiling and pan-cancer NGS tests
  • Extension of existing exclusive distribution agreement which originally covered only covered OmniSeq’s Comprehensive and Immune Report Card clinical assays
HalioDx Genecast
  • Products: HalioDx’s Immunoscore colon-cancer assay
  • Territory: China
  • Exclusive
LICENSES
Licensor Licensee Deal Summary
Grail Take2
  • Property: Patented technology for early detection of nasopharyngeal carcinoma
  • Exclusive
SUPPLY, SERVICE & TESTING AGREEMENTS
Supplier/Servicer Client/User Deal Summary
Baylor Genetics Saudi Diagnostic Limited (SDL)
  • Baylor to be SDL’s exclusive lab partner for all genetic testing and precision medicine applications
  • Baylor to also provide SDL technical support, technology transfer, and training services
Agilent Technologies SomaLogic
  • Multi-year supply agreement for Agilent to provide customized high-fidelity oligo microarrays for the nucleic acid detection step in SomaLogic’s Somascan assay
NEW CLINICAL STUDIES
DX Partner Other Partner(s) Description of Study
RenalytixAI University Medical Center Groningen
  • 3,500-patient clinical study to evaluate RenalytixAI’s KidneyIntelX kidney disease test
Abbott US Department of Defense + National Institutes of Health
  • Clinical study to evaluate Abbott’s point-of-care blood test for traumatic brain injury
Helix Helix
  • 10,000-patient genetic screening study for familial hypercholesterolemia (the WholeMe study)
Illumina Children’s Hospital of Fudan University (China)
  • Study to evaluate whether whole-genome sequencing can be used as a diagnostic for critically ill infants
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