NEWS

Diagnostic Deals: A Roundup of January’s Mergers, Acquisitions, Alliances, Licenses and Other Major Transactions

January 2017 has already seen an unusually high volume of diagnostic deal making. Here is a quick overview of the key deals and what they portend.

M&A
While Abbott Laboratories made the biggest deal by completing its $25 billion purchase of St. Jude Medical, Bio-Rad Laboratories may have been the month’s most active company. On Jan. 9, Bio-Rad unveiled the new next-generation sequencing (NGS) tool it developed in collaboration with Illumina. A first of its kind, the Illumina Bio-Rad Single-Cell Sequencing Solution enables researchers to study how single cells affect tissue function, disease and therapeutic response.

Less than a week later, Bio-Rad announced that it had reached agreement to acquire droplet-based PCR systems manufacturer RainDance Technologies for an undisclosed amount. The purchase, which is expected to close in the first quarter, dramatically expands Bio-Rad’s capacity to research liquid biopsy via absorption of RainDance’s systems for partitioning samples into one million droplets. The solutions "will extend our reach into next-generation sequencing applications and strengthen our position in the area of Droplet Digital PCR," noted Bio-Rad CEO Norman Schwartz in a statement. But Bio-Rad’s busy month took an unwelcome turn a few days later when the US Patent and Trademark Office’s Patent Trial and Appeal Board handed down a ruling in RainDance’s ongoing patent dispute with 10x Genomics that invalidates a number of the former’s droplet size manipulation systems patent claims. It is unclear how the ruling will affect Bio-Rad’s acquisition of RainDance.

LabCorp, PerkinElmer and QIAGEN were among the major diagnostics companies to announce new acquisition deals during the month. Meanwhile, M&A deals to close during the month included Invitae’s purchase of patient-provider data connectivity platform AltaVoice, and Bruker’s acquisitions of two companies in Germany, including—SCiLS, an informatics firm known for its MALDI imaging products, and InVivo, a biotech firm specializing in antibody and immunoassay development.

Strategic Alliances
It was also a very busy month for Illumina, which, in addition to launching the Illumina Bio-Rad Single-Cell Sequencing Solution product described above, unveiled a pair of important new strategic deals on Jan. 9: a partnership to integrate its BaseSpace® Sequence Hub with IBM’s Watson for Genomics; and a collaboration to integrate its genetic variation analysis sequencing systems with Royal Philllips’s IntelliSpace Genomics informatics platform.

In fact, pooling of data integration and analysis technology was the principle theme behind many of the month’s key strategic alliances, including deals combining:

  • 10x Genomics Chromium system with PerkinElmer’s automated technologies to create jointly offered NGS solutions;
  • Edico Genome’s Dragen bioinformatics processor with Dell EMC’s IU Dell 4130 server for genome analysis to develop bundled NGS computing and storage solutions; and
  • LifeNome’s bioinformatics platform with testing products developed by Imagene Labs to expand the existing partnership’s range of "wellness genomics" products.

Meanwhile, less than a month after acquiring Belgian genomics firm Multiplicom, Agilent Technologies teamed with Centre for Human Genetics of the University of Leuven and University Hospital of Leuven for joint research of reimplantation genetic testing with an eye to developing systems enabling labs to use single sequencing workflow for preimplantation genetic analysis for single gene disorders and translocation carriers. Here is a run down on recent deals of note:

MERGERS & ACQUISITIONS
Acquiring Company Target Deal Summary
Abbott Laboratories St. Jude Medical
  • Closing of $25 billion merger expands Abbott access to $30 billion cardiovascular device market
  • Combined $9.8 billion in CV and neuromodulation platform sales
  • To gain antitrust approval:
    • Abbott had to sell off Vado steerable sheath for percutaneous procedures
    • SJ had to sell off Angio-Seal and Femoseal vascular closure assets
  • Terumo acquires divested assets for $1 billion
Bio-Rad Laboratories RainDance Technologies
  • Price: undisclosed
  • Expected closing date: 1Q 2017
  • RD specializes in droplet-based genomic tools used to research liquid biopsy
  • RD assets acquired, including RainDrop Digital PCR, ThunderStorm and ThunderBolts systems reportedly 500 x greater than Bio-Rad’s internal capacity to partition samples into droplets
Laboratory Corp. of America Mount Sinai Health System outpatient lab centers
  • Price: Undisclosed
  • Expected closing date: Undisclosed
  • LabCorp to acquire 7 Mt. Sinai outreach labs in NYC area—adding to its existing network of 120 lab centers in the region
  • LabCorp will provide clinical pathology, cytology and cytology-related molecular testing
PerkinElmer Tulip Diagnostics Private
  • Price: Undisclosed
  • Expected closing date: 1Q 2017
  • Tulip, which is based in India, produces in vitro diagnostic reagents, kits and instruments
  • Products include screening tests for malaria, HIV, hepatitis and other infectious diseases
  • Latest instance of PE’s strategy of expanding in developing markets
QIAGEN OmicSoft Corp.
  • Price: Undisclosed
  • Expected closing date: Undisclosed
  • Adding O’s genomics software expands Q’s bioinformatics capacity and portfolio
Invitae Corp. AltaVoice (formerly PatientCrossroads)
  • Price: Undisclosed
  • Status: Closed
  • Privately-held AV is a data company with a platform for connecting patients with clinicians
  • Companies will integrate efforts to develop networks combining genetic and clinical data for medical treatment and research
Bruker SCiLS
  • Price: Undisclosed
  • Status: Closed
  • Germany-based SCiLS is an informatics firm specializing in products for matrix-assisted laser desorption/ionization (MALDI) imaging
  • SCiLS assets complement B’s own MALDI systems
Bruker InVivo Biotech Services
  • Price: $276 million
  • Status: Closed
  • Germany-based InVivo is a biotech firm specializing in antibody and immunoassay development
  • InVivo had $5 million in 2016 sales revenue
CareDx Pty (CareDx subsidiary) Illumina subsidiary Conexio Genomics
  • CareDx Pty acquires Conexio’s sequencing-based HLA typing assets
  • Price: Up to $735,000 in total (including up to $232,792 for finished goods, $156,159 for unfinished inventory and quarterly payments equal to 20 percent of the gross revenue from sale of products using assets purchased)
  • Illumina to provide CareDx Pty with access to the services of one of its employees for 12 months to help with transfer of manufacturing operations and expertise associated with assets purchased
Hospital Corporation of America Genospace
  • Price: Undisclosed
  • Expected Closing Date: 1Q 2017
  • Genospace, which develops software for personalized medicine, to merge with HCA’s Sarah Cannon Cancer institute as a wholly-owned subsidiary
Takara Bio USA Holdings Rubicon Genomics
  • Price: $75 million
  • Status: Closed
  • Takara fortifies position in pre-analytical genetic sample preparation and expands into in vitro fertilization
Digipath, Inc. Two family-owned independent labs in New Jersey (one of which also serves the Pennsylvania market)
  • Price: Undisclosed
  • Status: Non-binding Letter of Intent with undetermined/undisclosed closing date
  • Digipath is an independent cannabis lab testing and media firm
  • D’s diagnostic branch, Digipath Labs, aspires to be the market leader known for establishing best practices for cannabis testing
STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS
Partner 1 Partner 2 Deal Summary
Illumina IBM Watson Health
  • Partnership integrating Watson for Genomics with Illumina’s BaseSpace® Sequence Hub
  • Objective: Standardize and simplify interpretation of genomic data
  • Dynamic: Watson to interpret data generated by Illumina’s TruSight® Tumor 170 solid tumor profile— so named because it detects variants for cancers across 170 genes
Illumina Royal Phillips
  • Partnership integrating Illumina’s sequencing systems for genetic variation analysis with RP’s IntelliSpace Genomics clinical informatics platform
  • Deal also provides for coordinated sales/marketing of the resulting solutions
  • Partners will also participate with US health system doing clinical research to develop precision medicine oncology programs
  • Dynamic: Watson to interpret data generated by Illumina’s TruSight® Tumor 170 solid tumor profile— so named because it detects variants for cancers across 170 genes
PerkinElmer 10x Genomics
  • Combine 10x’s Chromium system with PE’s automated technologies to create jointly offered automated next generation sequencing solution
Agilent Technologies Centre for Human Genetics of the University of Leuven and University Hospital of Leuven (Belgium)
  • Joint research of reimplantation genetic testing
  • Objective: Allow labs to use single sequencing workflow for preimplantation genetic analysis for single gene disorders and translocation carriers
  • Follows Agilent’s acquisition of Belgian genomics firm Multiplicom last month
Northwell Health Individumed (Germany-based personalized cancer services provider)
  • Objective: Create cancer research biobank to support precision medicine and drug development
  • 3-year agreement
  • Dynamic: NH to collect lung, breast, pancreatic and other cancer tissue at 3 of its hospitals
  • Individumed to focus on tissue tracking, handling, recovery and storage
Northwell Health Avizia (telehealth systems vendor)
  • NH to use A’s technology to align its telehealth infrastructure encompassing network of hospitals, labs, MD offices and other outpatient providers across the NY metro area
  • A technology will also be used to improve communication among network providers
Teladoc, Inc. Analyte Health, Inc.
  • Partnership to use T’s telehealth platform to connect patients, telehealth providers and labs
  • Objective: Quick, easy and efficient test ordering, specimen collection and lab results reporting
Ohio University Hospitals Seidman Cancer Center Tempus (genomic analysis firm)
  • Objective: Provide genomic data analysis and decision making support to Seidman Cancer Center oncologists
  • Since Oct., Tempus has made similar deals with Mayo Clinic, Rush Univ. Med. Center and Univ. of Pennsylvania’s Abramson Cancer Center
German National Center for Tumor Disease (NCT) Heidelberg Protagen
  • NCT to use Protagen’s SeroTag platform to identify biomarkers for predicting response of melanoma patients to immunotherapy
Lantern Pharma Cancer Genetics
  • Collaboration to develop biomarker panels for grouping cancer patients based on their responses to treatment for use in drug development
  • Will also develop liquid-biopsy tests for patient selection and monitoring
Pfizer The Scripps Research Institute
  • Pfizer to pay undisclosed fee to gain access to TSRI’s chemical synthesis technology
  • Objective: Develop technology for creating next-generation DNA-encoded libraries for use in drug development
KeyGene Genalice
  • 3-year extension of existing partnership for development of plant DNA analysis software
  • KeyGene also announced a pair of new licensing deals this month (see below)
SpeeDx (Australian diagnostics firm) UgenTec (Belgian software developer)
  • UT to use its software to interpret results of SD’s diagnostic tests for sexually-transmitted and other infectious diseases
Helomics MDNA
  • Collaborate to develop new liquid biopsy tests using MDNA’s Mitomic Technology platform
  • H to promote MDNA’s Prostate Core Mitomic Test and liquid biopsy Prostate Mitomic Test in select US markets
Good Start Genetics Genome Medical
  • GM to provide genetic counseling support for GSG’s recently launched VeriYou, a saliva test that uses next-generation sequencing to screen for gene mutations associated with cystic fibrosis and spinal muscular atrophy
Amgen Adaptive Biotechnologies
  • Collaboration to develop and commercialize ClonoSeq, Adaptive’s next generation sequencing- based immune profiling assay to assess minimal residual disease in patients with acute lymphoblastic leukemia
  • Adaptive to seek FDA approval for ClonoSeq
Biodesix Bioyong Technology (Chinese life sciences company)
  • Objective: Develop Biodesix’s Veristrat test for China and develop new MALDI mass spec tests for oncology
  • Potential to extend to other Asia-Pacific countries
Parkinson’s Institute and Clinical Center Centogene
  • Partnership to provide panel-based genetic screening for genetic variants associated with Parkinson’s disease
  • Screening provided for a US patient cohort
  • Centogene to perform genetic characterization at its CLIA-certified labs in Germany
University of California, San Francisco Two Pore Guys
  • UCSF oncologists to use TPG’s handheld nanopore circulating tumor DNA detection platform to develop liquid biopsy assay
Bristol-Myers Squibb GeneCentric Diagnostics
  • Collaboration to use GCD’s Cancer Subtype Platform to identify translational biomarkers for BMS’s cancer immunotherapy Opdivo (nivolumab)
Guardant Health Separate deals with:

  • AstraZeneca
  • Merck
  • Merck KGaA
  • Pfizer
  • Objective: Develop 500-plus-gene liquid biopsy panel that drug companies can use to speed up clinical trials and development of targeted cancer drugs and immunotherapies
Metabolon InnVentis (Israeli precision medicine firm)
  • Partnership to study metabolomics in individuals with arthritis and other chronic inflammatory diseases for diagnostic and treatment purposes
Edico Genome Dell EMC
  • Objective: Develop a bundled compute and storage solution for rapid and effective analysis of next generation sequencing data
  • Amazon recently began selling EG’s Dragen bioinformatics platform on new cloud-based instances
Imagene Labs (Singapore) LifeNome
  • Expansion of existing "wellness genomics" partnership in Southeast Asia to include China & Hong Kong
  • Partnership under which Imagene incorporates LN’s bioinformatics platform into Imagene’s consumer genomics testing products
DISTRIBUTION AGREEMENTS
Property Owner Distributor Deal Summary
Interpace Diagnostics Best Med Opinion
  • Products: Interpace’s cancer molecular diagnostics
  • Territories: Israel
  • Exclusive
Trovagene Alliance Global
  • Product: Trovagene’s Trovera liquid biopsy test
  • Territories: Middle East, Africa, Central and South Asia
  • Provides for early access to research-only liquid biopsy kits Trovagene is co-developing with Boreal Genomics
Trovagene Instituto Diagnostico and Sorgente Genetica Varelli
  • Product: Trovagene’s Trovera liquid biopsy test
  • Territory: Italy
  • Provides for early access to research-only liquid biopsy kits Trovagene is co-developing with Boreal Genomics
Trovagene Progenetics
  • Product: Trovagene’s Trovera liquid biopsy test
  • Territory: Israel
  • Provides for early access to research-only liquid biopsy kits Trovagene is co-developing with Boreal Genomics
Trovagene Amplitech
  • Product: Trovagene’s Trovera liquid biopsy test
  • Territories: France, Belgium and Switzerland
  • Provides for early access to research-only liquid biopsy kits Trovagene is co-developing with Boreal Genomics
Trovagene NM Genomix
  • Product: Trovagene’s Trovera liquid biopsy test
  • Territories: Bulgaria and Eastern Europe
  • Provides for early access to research-only liquid biopsy kits Trovagene is co-developing with Boreal Genomics
Trovagene Diagnostica Longwood
  • Product: Trovagene’s Trovera liquid biopsy test
  • Territories: Spain and Portugal
  • Provides for early access to research-only liquid biopsy kits Trovagene is co-developing with Boreal Genomics
Mobidiag (Finnish IV diagnostics firm) Wallac Oy (subsidiary of PerkinElmer)
  • Products: Amplidiag real-time, PCR-based IVD gastro-intestinal tests including Amplidiag H.pylori+ ClariR, Stool Parasites, CarbaR+VRE, C.difficile+027, Bacterial GE and Amplidiag Easy System
  • Territory: South Africa
Sera Prognostics Laboratory Corp. of America
  • Product: Sera’s PreTRM test for preterm birth
  • Territory: US
  • Exclusive
  • LabCorp also to lead a $40 million Series C funding round to finance Sera’s collection of clinical data to support reimbursement of PreTRM
FactBio Filgren
  • Products: Knowledge Sharing Platform (Kusp) and other FactBio products
  • Territory: Japan
  • Term: 2 years
  • Exclusive
Contextual Genomics Sonic Healthcare
  • Products: Contextual’s Find-It next generation sequencing solid tumor test
  • Territories: Across Sonic’s (which is Australian-based) international labs network
Natera Bio-Reference Laboratories
  • Natera ends 2013 distribution agreement with Bio-References
  • Products: Panorama (noninvasive prenatal test) and Horizon (carrier screening test)—Natera will now market these tests itself
  • Natera also sues Bio-Reference for breach of contract claiming that Bio-Reference used technology it licensed from Natera to develop and launch a competing prenatal assay called ClariTest
LICENSES
Licensor Licensee Deal Summary
Transgenomic LifeLabs
  • Property: Transgenomics’s ICE-COLD-PCR technology for LifeLabs’s use in its mutation enrichment platform for cancer testing
  • Term: 3 years with option to renew
  • Non-exclusive
  • In August, Transgenomic granted non-exclusive distribution rights for ICE-COLD-PCR to VWR International
KeyGene University of Minnesota
  • Property: KeyGene’s Sequence-Based Genotyping technology
  • UMN gets right to incorporate technology into its own genotyping platforms that it offers for use by academic community and industry
CareDx Pty (subsidiary of CareDx) Illumina subsidiary Conexio Genomics
  • Properties: Sequencing-based HLA typing software, technology and trademarks owned by Conexio
  • Side deal to CareDx Pty’s acquisition of Conexio’s HLA assets (listed above in ACQUISITIONS)
NEW PRODUCTS
Company(ies) Product(s)
Quest Diagnostics
  • Test service for physicians to evaluate response of patients with hepatitis B virus to drug therapies
Bio-Rad Laboratories + Illumina
  • Illumina Bio-Rad Single-Cell Sequencing Solution for studying impact of single cells on tissue function, disease and therapeutic response
Abbott Laboratories
  • EnSite Precision cardiac mapping system
  • Advisor FL circular mapping catheter
CloudHealth Genomics
  • HealthySeq NGS based liquid biopsy test for detecting genetic alterations in healthy individuals
Celmatix
  • Fertilome genetic screen for evaluating impact of a female’s DNA on her reproductive health
Bioline (subsidiary of Meridian Biosciences)
  • Range of EPIK miRNA Select assays to complement existing assays
QIAGEN
  • New gene panels for oncology to enhance existing GeneReader NGS System
Baylor Genetics
  • PreSeek, a non-invasive prenatal multi-gene sequencing screen

Takeaway: The turn of the calendar year has brought a significant number of diagnostic deals.

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