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

The swirl of autumn leaves has brought a swirl of diagnostic deals. Here’s a recap of the key activity from mid-September through the third week of October.

M&A and Asset Sales
Quest Diagnostics announced an agreement to sell its India medical diagnostics business to Bangalore-based specialized diagnostics company Strand Life Sciences. The acquisition is expected to be an important addition to Strand’s 24 diagnostic labs across India, particularly as the company expands its work in oncology, genomics, and precision medicine. Terms of the deal, which is expected to close by the end of the first quarter of 2019, were not disclosed.

It’s been a busy month for Quest, which has also acquired several companies. Details are provided in the chart below.

A deal not included in the chart but worth mentioning involves BioMérieux. The global in vitro diagnostic company announced it may eventually increase its previously announced minority stake in Suzhou Hybiome Biomedical Engineering, a Chinese firm that develops and manufactures a range of automated immunoassay analyzers that have been cleared by the China Food and Drug Administration.

A key trend appears to be driving M&A deals. Now that the American Clinical Laboratory Association (ACLA) lawsuit against CMS has been dismissed, there is greater clarity with regard to PAMA reimbursement rates; cuts to Medicare Part B prices will stand. In order to offset the reduction in revenues, diagnostic companies are looking to other sources, namely acquisitions. Of course, ACLA may appeal or there may be regulatory compromises. In the meantime, however, expect heavy M&A activity.

Strategic Alliances
Many new alliances were announced this past month, including expansion of a collaboration between LabCorp and Walgreens that was initially piloted at 17 Walgreens stores in 2017. Customers at an additional 600 Walgreens stores throughout the U.S. will now have access to LabCorp specimen collection and testing services.

LabCorp also has two other new alliances. Details are provided in the chart below.

In addition to the alliances included the chart, there is another of note. It again has to do with Quest Diagnostics.

Quest has announced the formation of the Global Diagnostics Network (GDN), a partnership with other large labs across the globe aimed at sharing diagnostic innovation, information, and services in order to generate diagnostic insights and enhance global health care. GDN will initially focus on collaboration on companion diagnostics, and the creation of an emerging pathogen preparedness network to expedite infectious disease research and response. Network founding members are Al Borg Medical Laboratories, based in Saudi Arabia with labs across the Middle East and Africa; Dasa, based in Brazil; GC Labs, based in South Korea; KingMed Diagnostics, based in Hong Kong with labs across Southeast Asia; Primary Health Care, based in Australia; and SynLab, based in Germany with labs across Europe and on four continents. The GDN has a presence on every continent and collectively is present in countries with over half of the world’s population.

Here’s a summary of key diagnostic deals from mid-September through the third week in October:

Acquiring Company Target(s) Deal Summary
Agilent Technologies ACEA Biosciences
  • Price: $250 million cash
  • Status: Agreement to acquire with no closing date announced
  • Purchase of developer of xCELLigence real-time cell analysis instruments and NovoCyte and NovoCyte Quanteon high-performance benchtop flow cytometry systems most recent in string of 2018 acquisitions for Agilent
Quest Diagnostics Oxford Immunotec Global
  • Price: $170 million cash
  • Status: Definitive agreement with no closing date announced
  • Acquisition of Oxford Immunotec’s US lab business including T-Spot.TB tuberculosis and Accutix tick-borne disease testing services
  • Oxford Immunotec to sell T-Spot.TB test kits and accessories to Quest under long-term supply agreement
  • Sides also expect to enter strategic agreement to grow T-Spot.TB testing in US
Quest Diagnostics ReproSource
  • Price: Undisclosed
  • Status: Closed
  • Quest to add Mass.-based firm’s fertility diagnostics services to its women’s health and reproductive line
Quest Diagnostics Hurley Medical Center
  • Price: Undisclosed
  • Status: Closed
  • Quest acquires unspecified assets of Hurley’s outreach lab services operation
Summit Health
(Quest Diagnostics wellness sub)
Hooper Holmes, dba, Provant Health
  • Price: $27 million
  • Status: Closed
  • Acquired company had filed for Chapter 11 after 2017 merger of Hooper Holmes and Provant Health left combined company with a working capital shortfall and over-leveraged balance sheet
Quest Diagnostics PhenoPath
  • Price: Undisclosed
  • Status: Closed
  • PhenoPath’s Anatomic Pathology, molecular oncology and other services to operate as part of Quest’s AmeriPath business
Strand Life Sciences Quest Diagnostics
  • Price: Undisclosed
  • Status: To close in Q1 2019
  • Bangalore-based specialty DX firm to acquire Quest’s medical diagnostics business in India
Exact Sciences Biomatrica
  • Price: Undisclosed
  • Status: Closed
  • Producer of sample preservation technology, including blood and saliva sample collection tubes to operate as wholly owned subsidiary of Exact
Precision for Medicine ApoCell
  • Price: Undisclosed
  • Status: Closed
  • Precision acquires biomarker identification and analysis firm
Predictive Technology Group Taueret Laboratories
  • Price: Undisclosed
  • Status: Closed
  • Predictive acquires DNA and ancestry assets including 1,000 degenerative disc disease-related DNA samples, related family and clinical records, relevant clinical records and 800 ancestry matched control samples
LGC Berry and Associates
  • Price: Undisclosed
  • Status: Closed
  • Acquisition of Berry’s olio reagents bolsters LGC’s nucleic acid chemistry product line
Brooks Automation GeneWiz
  • Price: Undisclosed
  • Status: Expected to close by end of 2018
  • NJ-based GeneWiz provides genomic services, including Sanger sequencing, gene synthesis, cloning and mutagenesis, oligo synthesis and NGS
Partner 1 Partner 2 Deal Summary
LabCorp Walgreens
  • Objective: Offer LabCorp testing services to Walgreens customers at store sites
  • Dynamic: Expand current 4-year collaboration to 600 new Walgreens stores in addition to existing 17 LabCorp at Walgreens locations already open in Florida, Colorado, North Carolina and Deerfield, Illinois
  • Co-branded patient service centers located near pharmacy area inside Walgreens stores where specimens are collected and sent to LabCorp’s labs for testing
Covance (part of LabCorp) Definiens
  • Objective: Accelerate development of biomarkers, oncology drugs and companion diagnostics
  • Dynamic: Combine Definiens uses machine learning and deep learning-based technology for profiling tumor microenvironments with Covance’s biomarker identification and companion diagnostics development expertise
LabCorp Baptist Health (BH)
  • Objective: Provide technical services and enhanced data analytics to BH’s eight hospital-based labs
  • Dynamic: Expansion of existing reference lab services relationship under which LabCorp will help create core lab at BH Louisville
  • BH to own core lab and keep ownership of the eight hospital labs
DiaSorin Inc. Meridian Bioscience
  • Objective: Sell DiaSorin’s H pylori stool antigen test for use on Meridian Bio’s Liaison platform
  • Dynamic: Test to be sold under Meridian name worldwide with focus on US market
  • Meridian Bio to receive royalties on US and UK sales
Myriad Genetics Pfizer
  • Objective: Promote use of Myriad’s BRACAnalysis CDx test for identifying patients suitable for treatment with Pfizer’s talazoparib
  • Dynamic: Commercialization plan under existing companion diagnostic agreement, in which Myriad is seeking FDA approval for its BRACAnalysis CDx® as a companion diagnostic with talazoparib, Pfizer’s investigational PARP inhibitor
Celmatix Teva Pharmaceutical (via Oncotest-Teva subsidiary)
  • Objective: Make Celmatix’s Fertilome genetic test for reproductive health and fertility available in Israel
  • Dynamic: First international expansion of Fertilome test
ArcherDx Merck KGaA
  • Objective: Commercialize NGS-based companion test for unnamed Merck drug candidate
  • Dynamic: Archer to use its ArcherDx platform to develop and seek regulatory approval for CDx to identify patients potentially benefiting from Merck drug
Atomo Diagnostics Mylan Pharmaceuticals
  • Objective: Commercialize Atomo’s HIV self-tests, already CE marked in Europe, in low- and middle-income nations
  • Dynamic: Mylan gets exclusive rights to commercialize the tests in over countries in Africa, Asia, Middle East, Commonwealth of Independent States and Latin America
Roche Diagnostics Genialis
  • Objective: Develop streamlined NGS workflow for drug discovery
  • Dynamic: Integrates Roche’s KAPA RNA HyperPrep Kits with Genialis’ software platform
Foundation Medicine Novartis
  • Objective: Develop companion diagnostic tests for Novartis targeted oncology and immuno-oncology drugs
  • Dynamic: Use FoundationOne CDx genetic profiling assay to develop, gain regulatory approval and commercialize CDx includes development, regulatory support and commercialization of companion diagnostic tests
  • Agreement allows for global expansion in non-US markets including Japan
BGI Americas Gencove
  • Objective: Merge respective technologies to create single low-pass sequencing service signatures for therapeutic response
  • Dynamic: Combine join BGI’s DNBseq NGS technology with Gencove’s ImputeSeq low-pass sequencing analysis pipeline
GeneWiz Nashville Biosciences
  • Objective: Develop extensive research support product
  • Dynamic: Combine Nashville Bio’s BioVU biobank with GeneWiz’s NGS services
Celcuity Puma Biotechnology
  • Objective: Use Celcuity’s CELx HER2 Signaling Function test to evaluate efficacy and safety of Puma Bio’s Nerlynx (neratinib) and chemotherapy on patients with early-stage triple-negative breast cancer
  • Dynamic: Phase II clinical trial sponsored by West Cancer Center
Diagnomics Translational Software
  • Objective: Offer comprehensive and customized pharmacogenetic test reports
  • Dynamic: Analysis to be performed on Illumina’s Global Screening Array with report evaluating patient’s likely drug response, metabolism, and treatment efficacy generated using Translational Software’s platform
Bio-Techne Micropoint Bioscience
  • Objective: Develop point-of-care diagnostic tools for Chinese market
  • Dynamic: Integrate Bio-Techne’s ProteinSimple Ella microfluidic multianalyte immunoassay with Micropoint’s microfluidic chip for point-of-care testing in China
OrigiMed Members include nearly 40 local hospitals led by Beijing Xisike Clinical Oncology Research Foundation and East Clinical Center of Ontology
  • Objective: New initiative to create cancer genetics database specific to Chinese population
  • Dynamic: Project, called Special Chinese Big Data Platform for Cancer Genomics Informatics, to gather data on roughly 5,000 Chinese patients to help identify genetic drivers of cancer and factors for metastasis, disease relapse, drug efficacy and toxicity
Fulgent Genetics StemCyte
  • Objective: StemCyte to offer Fulgent’s genetic testing services
  • Dynamic: Strategic partnership to include Fulgent’s Beacon Expanded Carrier Screening and Newborn Genetic Analysis
Genexosome Technologies (US subsidiary of Avalon GloboCare) Weill Cornell Medicine
  • Objective: Standardize processing of cGMP-grade exosomes for clinical studies using Genexosome’s exosome isolation platform from human endothelial cells
  • Dynamic: Codevelopment program also seeks to identify and isolate tissue-specific exosomes for liquid biopsy and clinical use
  • Includes material transfer agreement letting Weill Cornell use Genexosome’s isolation system
Cancer Genetics Cellaria
  • Objective: Develop precision medicine tools and platform technologies to support oncology therapeutics development
  • Dynamic: Cancer Genetics’ Genomics Center of Excellence to characterize Cellaria’s biopharma products line and use its biomarker and genomics testing capabilities to study patient diversity focusing on solid tumors in primary and metastatic disease
Geneseq Biosciences Australian Clinical Labs (ACL)
  • Objective: Commercialize Melaseq, Geneseq’s blood-based melanoma detection test
  • Dynamic: Geneseq gains access to agreement gives us access to ACL’s clinical and biospecimen network
Genomics England Iqvia
  • Objective: Develop platform for bringing together clinical and genomic data in support of evidence-based precision medicine and drug discovery
  • Dynamic: Iqvia, formerly known as Quintiles IMS, to offer its E360 analytics technology to authorized users of Genomics England’s database of de-identified genomic and phenotypic records
Centogene Denali Therapeutics
  • Objective: Conduct targeted global patient identification and recruitment campaign for Centogene’s Parkinson’s disease LRRK2 inhibitor program
  • Dynamic: Centogene to use its CentoCard dried blood spot collection kit to collect samples for identifying Parkinson’s patients with mutations in LRRK2 gene
IDbyDNA The Rady Children’s Institute for Genomic Medicine
  • Objective: Study diagnostic capabilities of sequencing technologies in pediatric central nervous system infections
  • Dynamic: Multi-site trial to evaluate clinical utility of IDbyDNA’s NGS system for directly identifying pathogens in pediatric patients with suspected CNS infections
Evonetix LioniX International
  • Objective: Create prototype microelectromechanical systems (MEMs) for DNA synthesis
  • Dynamic: LioniX to use semiconductor microfabrication techniques and materials to manufacture the silicon array to be used by Evonetix to synthesize de novo DNA
BGI Maxwell Plus
  • Objective: Develop model for predicting risks of prostate cancer patients’ developing advanced or metastatic disease
  • Dynamic: Use Maxwell’s artificial intelligence technology to analyze data from patient samples sequenced on BGI’s MGISEQ-2000 instrument with sequencing to be done at BGI’s Australia lab
Protagen National Center for Tumor Diseases
NEC Laboratories Europe
  • Objective: Improve approaches for in silico prediction of immunotherapy response in malignant melanoma patients
  • Dynamic: Use machine learning to develop biomarker models for immunotherapy endpoints, including adverse effects, clinical response and survival
DCN Dx E25Bio (MIT spinout)
  • Objective: Develop single infectious disease testing device for detecting dengue, Chikungunya and Zika viruses
  • Dynamic: Leverage E25Bio rapid, low-cost, highly-specific and sensitive fingerstick blood test technology developed at MIT lab for onsite detection and global epidemiological analysis
Cytox Australian Imaging, Biomarker, and Lifestyle Flagship Study of Ageing (AIBL)
  • Objective: Test new algorithms for identifying individuals at risk for developing Alzheimer’s disease
  • Dynamic: Expansion of existing alliance leveraging Cytox’s variaTECT SNP array and SNPfitR interpretive software to assess genetic risk for accelerated development of Alzheimer’s among pre-symptomatic and mild cognitively impaired people using its currently available technologies on biobanked samples provided by AIBL
Property Owner Distributor Deal Summary
Cancer Genetics (CGI) GeneCast Biotechnology
  • Products: CGI’s microarray gene expression Tissue of Origin test
  • Territory: China
  • Exclusive
Curetis Beijing Clear Biotech
  • Products: Curetis Unyvero A50 platform and assay
  • Territory: China
  • Expansion of exclusive distribution deal from five to eight years following first Chinese regulatory approval
CopyCount-CNV Fluidigm
  • Product: CopyCount-CNV’s DNA Software for use with Fluidigm’s Biomark HD system
  • Territory: Not specified
  • Non-exclusive
Licensor Licensee Deal Summary
Arcis Biotechnology Teleflex
  • Property: Arcis’ nucleic acid sample preparation chemistry
  • Technology access agreement allowing Teleflex to use technology to develop a rapid diagnostic assay using RNA detection
Avacta New England Biolabs (NEB)
  • Property: Avacta’s affimer technology
  • NEB gets right to commercialize assay using Actava’s affimers that it’s developing
BioAffinity Technologies Precision Pathology Services
  • Property: BioAffinity’s CyPath Lung laboratory-developed test for early-stage lung cancer diagnosis
  • Deal provides for continued development and commercial sale of assay which Precision Pathology will market
ERS Genomics GenAhead Bio
  • Property: ERS’ CRISPR-Cas9 genome editing patents
  • GenAhead to offer CRISPR-Cas9 services to pharmaceutical companies and researchers to produce cells with precise genetic modifications utilizing high knock-in efficiency in mammalian cell lines
  • Non-exclusive
ERS Genomics Axcelead Drug Discovery Partners
  • Property: ERS’ CRISPR-Cas9 genome editing patents
  • Axcelead said it plans to use CRISPR-Cas9 property to enhance its drug discovery service offerings
  • Non-exclusive
Thermo Fisher Scientific Siemens Healthineers
  • Property: Thermo Fisher’s BRAHMS PCT procalcitonin biomarker assay
  • Sixth licensing agreement of assay
University of North Carolina at Chapel Hill GeneCentric
  • Property: UNC’s NGS-based PurIST pancreatic cancer subtyping technology
  • Exclusive
Supplier/Servicer Client/User Deal Summary
Quest Diagnostics Regional Medical Center Health System
  • Quest to provide lab reference testing and supply chain support to regional health care provider for 5-county service area in northeast Alabama
Expedeon Reszon Diagnostics International (Malaysia)
  • 3-year agreement to supply Reszon colloidal gold
Agilent Technologies Cancer Genetics
  • Non-exclusive supply agreement under which Agilent will produce and provide CGI probe reagents for its FISH-based HPV-Associated Cancer Test assessing genomic changes associated with cervical cancers to identify patients at high risk for disease progression

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