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

Although not as frantic as the previous month, the pace of deal making remained rapid through the end of May to mid-June. Here's a quick overview of the trends and key deals.

Mergers & Acquisitions

In addition to the mergers, acquisitions, and asset sales detailed in the chart below, Illumina announced that it's pushing back until Q4 the expected close date of its $1.2 billion acquisition of Pacific Biosciences due to ongoing review by UK regulators about competition concerns. After initial review by the UK Competition and Markets Authority (CMA), the investigation has moved to Phase 2, where a group of independent CMA panel members will consider the implications of the acquisition. Despite this obstacle, Illumina remains confident that the deal will move forward.

In other news, Thermo Fisher Scientific and Roper Technologies terminated an agreement under which Thermo Fisher would have acquired Gatan, a wholly-owned subsidiary of Roper and manufacturer of instrumentation and software used to enhance and extend the operation and performance of electron microscopes. The would-be deal was valued at approximately $925 million in cash when it was announced last year.

Although its agreement with Roper turned out to be a bust, Thermo Fisher has been busy. This period, it acquired HighChem, a Slovakia-based developer of mass spectrometry software, for an undisclosed amount. The software company will be integrated into Thermo Fisher's chromatography and mass spectrometry business.

Strategic Alliances

Thermo Fisher was busy during the period announcing entry into four new partnership arrangements, including one with Predictive Laboratories to further female infertility research. Predictive Laboratories will implement several Thermo Fisher reproductive health tests for whole-exome sequencing.

Other notable deals included the partnering of DiaSorin and Qiagen to develop a new ultrasensitive test for Lyme Disease.

Here's a summary of key diagnostic deals announced from late May through the third week of June:

MERGERS, ACQUISITIONS & ASSET SALES
Acquiring Company	Target(s)	Deal Summary
Invitae	Singular Bio	Price: $55 million—approximately 2.5 million shares of Invitae common stock + $5.7 million in cash Status: Expected to close in July or August Singular employees that stay with company to get up to $90 million in Invitae contingent stock awards Acquisition of firm specializing in single-molecule, cell-free DNA analysis for non-invasive prenatal testing advances Invitae's strategy to push into NIPT space
Ascenda Biosciences	Provista Diagnostics	Price: Undisclosed Status: Closed Acquisition of proteomic diagnostic firm which produces Videssa Breast test assessing whether women with indeterminate mammograms need a biopsy
BioMérieux	Suzhou Hybiome Biomedical Engineering	Price: Undisclosed Status: Closed BioMérieux increases its equity holdings in Chinese immunoassay producer in which it acquired majority stake in 2018 from 54% to 67%
Thermo Fisher Scientific	HighChem	Price: Undisclosed Status: Closed Slovakia-based developer of mass spectrometry software to be integrated into Thermo Fisher's chromatography and mass spectrometry business
Covance Drug Development (Lab Corp)	Envigo	Price: $485 million Status: No closing date announced Covance acquires Envigo's nonclinical researcher services while Envigo's Research Models Services business acquires LabCorp's Covance Research Products business
Bio-Techne	B-MoGen Biotechnologies	Price: Purchase of 100% of B-Mogen stock financed with cash on hand for undisclosed price Status: Closed Bio-Techne to include B-MoGen's technology in its own cell and gene therapy products
Meridian Bioscience	GenePOC	Price: $50 million + up to $70 million more in contingent milestone payments Status: Closing of deal announced in April Acquisition of Quebec City-based molecular diagnostics firm
Beckman Coulter Life Sciences	Cytobank	Price: Undisclosed Status: Closed Acquisition of single-cell data analysis and software-as-a-service company enables allows Beckman Coulter to offer a high-end data analytics solution for pharma/biopharma and academic research
Lumos Diagnostics	RPS Diagnostics	Price: Undisclosed Status: Closed Merged company to keep Lumos name and focus on international launch of RPS' FebriDx blood-based POC test for identifying febrile acute respiratory infections (ARI) and differentiating viral and bacterial infections
Schott	Minifab	Price: Undisclosed Status: Expected to close in 2019 German producer of glass substrates for microarrays and microfluidic components made of glass acquires Australian microfluidics company Combined firms to create centers of excellence for polymer in Australia and glass in Germany
PerkinElmer	Cisbio Bioassays	Price: $219.8 million Status: Closed PerkinElmer acquires life sciences + DX kits and reagents manufacturer with $50 million in 2018 revenues
Todos Medical	Amarantus Bioscience Holding	Price: Undisclosed Status: To close when Todos' stock is listed on a national stock exchange Todos exercises option to acquire remaining 80% of its Breakthrough Diagnostics joint venture with Amarantus Parties entered into joint venture in December 2018 to develop LymPro, a blood-based lymphocyte proliferation assay, as diagnostic test for Alzheimer's
Constellation Alpha Capital	DermTech	Price: Undisclosed price paid in Constellation stock shares Status: Closed Under merger terms, skin cancer diagnostics firm to become wholly owned subsidiary of Constellation
Erasmus University Medical Center	GenomeScan	Price: Undisclosed Status: Closed Erasmus MC acquires undisclosed number of shares in genomics service provider Both parties to collaborate with Leiden University Medical Center (LUMC), an existing GenomeScan shareholder, in molecular diagnostics and research
STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS
Partner 1	Partner(s) 2+	Deal Summary
Thermo Fisher Scientific	Predictive Laboratories	Objective: Female infertility research Dynamic: Predictive Labs to implement Thermo Fisher reproductive health tests, including Applied Biosystems CarrierScan assay, Ion ReproSeq PGS assay, CytoScan Dx assay and Ion AmpliSeq Exome RDY for whole-exome sequencing
Thermo Fisher Scientific	Newomics	Objective: Develop new microflow LC-MS workflows for validating disease biomarkers Dynamic: Combine Thermo Fisher's microflow LC-MS systems and Nanospray Flex ion source with Newomics' multi-nozzle emitters
Thermo Fisher Scientific	Evosep	Objective: Develop high-throughput clinical research proteomics workflows for profiling large plasma sample cohorts Dynamic: Combine the Thermo Scientific Q Exactive HF-X mass spectrometer and the Evosep One liquid chromatography solution to develop standardized and high-throughput analytical protocols for proteomics, translational research and pharmaceutical applications
Thermo Fisher Scientific	Biognosys	Objective: Develop data-independent acquisition (DIA) mass spectrometry-based workflows for quantification of target proteins in plasma and other body fluids Dynamic: Extend existing collaboration aimed at developing methods for analyzing plasma and other body fluids
Qiagen	DiaSorin	Objective: Develop ultra-sensitive in vitro test for Lyme disease Dynamic: Test to combine Qiagen's QuantiFeron (interferon-gamma release assay) technology with DiaSorin's Liaison automated analyzers Companies plan to market assay for use alongside DiaSorin's existing Lyme disease tests, Liaison Borrelia IgG and IgM Companies also plan to run multi-site clinical validations during 2020 Lyme disease season and apply for regulatory approval in US and Europe later that year
Resolution Bioscience	Janssen Pharmaceuticals	Objective: Develop Resolution's HRD liquid biopsy test as companion diagnostic for niraparib, a PARP inhibitor being investigated to treat patients with metastatic castration-resistant prostate cancer Dynamic: Resolution HRD is a blood-based, cell-free DNA assay that detects single nucleotide variants, copy number variants, and deletions in genes related to homologous recombination deficiency (HRD) If approved, new CDx assay would be first test to find gene deletions from cfDNA and distinguish between single copy and homozygous gene deletions through a blood draw
Caris Life Sciences	Debiopharm International	Objective: Develop companion diagnostic for new oncology drug being developed by Debiopharm Dynamic: Use Caris' Molecular Intelligence (MI) Transcriptome assay for mRNA analysis to detect rare fibroblast growth factor receptor (FGFR) fusions and identify eligible patients for Debiopharm's FUZE phase II clinical trial of Debio 1347, a selective FGFR inhibitor
Foundation Medicine	Bayer	Objective: Develop NGS companion diagnostics Dynamic: Strategic global collaboration initially focusing on creating a test to identify patients eligible for treatment with larotrectinib (Vitrakvi), a TRK inhibitor approved in the US for patients with NTRK fusions regardless of tumor type or location
Mayo Clinic	Regeneron Pharmaceuticals	Objective: Sequence the exomes and genotype 100,000 patient DNA samples from Mayo's biobank Dynamic: Regeneron to pay for the sequencing and genotyping Both partners to have access to the data for research purposes
University of California	GlaxoSmithKline	Objective: Establish Laboratory for Genomics Research (LGR) to investigate disease-causing gene mutations and develop new technologies using CRISPR to accelerate discovery of new drugs Dynamic: Five-year collaboration in which GSK to provide up to $67 million in funding, facilities for 24 full-time university employees and up to 14 full-time GSK employees Initial focus on immunology, oncology and neuroscience
GeneNews	Oncore Pharma	Objective: Commercialize GeneNews ColonSentry test in all countries outside US and Canada—specifically, deploy 1.75 million ColonSentry tests in next five years Dynamic: Five-year exclusive licensing and services deal under which GeneNews to receive a fixed fee per test, a special royalty payment equal to 10% of Oncore's yearly profits and 1 million shares of Oncore stock All ColonSentry tests to be processed in GeneNews' Virginia laboratory Initial focus on Netherlands, Belgium, Luxembourg, Germany, France, Switzerland, Austria, Spain, Monaco, Italy, Portugal, UK, Ireland, Norway, Sweden, Finland, Denmark, Israel and UAE
LabCorp	Mount Sinai Health System	Objective: Establish the Mount Sinai Digital and Artificial Intelligence-Enabled Pathology Center of Excellence Dynamic: To achieve integration, Mount Sinai to implement Philips' IntelliSite Pathology Solution, which LabCorp is in the process of implementing at its own labs Center of Excellence, to be housed within Mount Sinai's Department of Pathology, Molecular and Cell-Based Medicine, to begin by using new digital pathology tools for interpretation of genitourinary cancers, primarily prostate tumors and head and neck cancers
Sanford Health	Harvard Medical School + Brigham and Women's Hospital	Objective: Determine best practices for using genetic screening to improve population health Dynamic: Four-year collaboration with experts in genomic medicine from Harvard and Brigham and Women's to help guide Sanford researchers use and interpret data collected via Sanford Chip, a new $49 pharmacogenomic laboratory developed test to identify genetic risk factors for medication use and prescription
Decode Genetics	Intermountain Healthcare	Objective: Genetics research Dynamic: Partners to perform whole-genome sequencing on 500,000 patients in Utah and Idaho in a population health initiative called HerediGene
Cartana	Lunaphore Technologies	Objective: Develop hardware for automated sequencing and imaging cycles Dynamic: Integrate Cartana's in situ RNA sequencing (ISS) technology with Lunaphore's microfluidic tissue processor technology
Hamilton	Enable Biosciences	Objective: Fully automate the processing of Enable's ultra-sensitive immunoassay technology in a hands-free workflow with Hamilton's automated workstation Dynamic: Firms to automate the processing of up to 96 liquid biopsy samples at one time using Enable Bio's Antibody Detection by Agglutination PCR (ADAP) technology for immunoassays
NuView Life Sciences	Aperture Bio	Objective: Evaluate NuView's NV-VPAC1 urogenital cancer test Dynamic: Companies to assess use of the test on Aperture's automated RAPID-B platform, which uses robotic flow cytometry to identify and count targeted cellular material in body fluids
Owlstone Medical	International Association of Heat and Frost Insulators and Allied Workers (IAHFIAW)	Objective: Identify and verify breath-based biomarkers for early detection of malignant mesothelioma, an asbestos-caused disorder common in construction and other union workers Dynamic: Use Owlstone's Breath method to measure volatile organic compounds (VOCs) in breath Three-year project with phase 1 to focus on identifying VOCs in breath of people diagnosed with malignant mesothelioma, and phase 2 to launch a blind study to verify the sensitivity, specificity and positive and negative predictive values of selected VOC biomarkers identified in phase 1
Biocartis	Kite (Gilead Sciences)	Objective: Develop molecular-based assays supporting Kite's therapies on Biocartis' Idylla platform Dynamic: Collaboration part of Biocartis' ongoing strategy of expanding its presence in the oncology market via a series of immunotherapy and liquid biopsy assays on the Idylla platform
Biotage	Shandong Yingsheng Biotechnology	Objective: Develop clinical mass spectrometry applications for China market Dynamic: Biotage to provide systems and consumables from its analytical chemistry portfolio to be sold by Yingsheng under its own brand together with Yingsheng's other products
Mobidiag	Autobio Diagnostics	Objective: Develop observational research analytics tools to assess treatment outcomes for precision oncology Dynamic: New Automobi Molecular Diagnostics joint venture to seek Chinese regulatory approval for Novodiag platform and assays and establish local facilities to manufacture system parts and disposables Autobio has invested €8 million and holds a 65% stake in the venture; Mobidiag owns the remaining 35% under a €4.3 million investment Autobio has also made a €10 million equity investment in Mobidiag itself
Bruker	PreOmics	Objective: Commercialize consumables and software for Bruker's 4D Proteomics technology Dynamic: Codevelopment and comarketing agreement covering PreOmics' inStageTip (iST) sample prep technology on Bruker's TimsTOF Pro
Bruker	Genedata	Objective: Develop NGS host cell protein analysis platform Dynamic: Make Genedata's Expressionist software platform support Bruker's TimsTOF Pro 4D omics format
Invitae	Horizon Therapeutics	Objective: Support Invitae's urea cycle disorder genetic (UCD) testing program Dynamic: Invitae to perform genetic testing and Horizon to provide unspecified financial support for program aimed at improving diagnosis of UCD
Luminex	EDP Biotech	Objective: Develop and commercialize blood-based colorectal test using Luminex's xMAP technology Dynamic: Test, called ColoPlex, uses multiplexed immunoassay technology and machine learning to detect early state colorectal cancer and precancerous polyps
DISTRIBUTION, SALES & MARKETING AGREEMENTS
Property Owner	Distributor	Deal Summary
Parallex BioAssays	Bioké	Products: Parallex BioAssays' SnapChip microarray products Territory: Belgium, Netherlands, Luxembourg
Patia	Premier Medical Laboratory Services	Products: Patia's type 2 diabetes risk assay DIABETESpredict which combines genetic risk analysis with behavioral and lifestyle assessments Territory: US Exclusive
Biomerica	Maxhealth	Products: Biomerica's EZ Detect colorectal cancer screening test Territory: China Exclusive Maxhealth agrees to meet annual minimum purchase requirements totalling $17 million over seven years and pay Biomerica $1 million upfront upon meeting certain undisclosed conditions
LICENSES
Licensor	Licensee	Deal Summary
ERS Genomics	Bioneer	Property: CRISPR-Cas9 genome editing technology Bioneer gets right to use technology to develop and commercialize CRISPR-edited cell-based disease models
Integrated DNA Technologies	Editas Medicine	Property: Newly released CRISPR Alt-R Cas12a (Cpf1) enzyme for human therapeutic applications Exclusive
SUPPLY, SERVICE & TESTING AGREEMENTS
Supplier/Servicer	Client/User	Deal Summary
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
BrainBox Solutions	None	HeadSMART (Head injury Serum markers and Multimodalities for Assessing Response to Trauma) to support regulatory filings for marketing approval of the TBI test