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

After a brief summer lull, strategic deal making ramped up in September, especially in alliance making where volume nearly doubled last month’s levels. Here’s an overview of the long-term trends and key deals from late August through the third week of September. Mergers & Acquisitions and Asset Sales The M&A highlight of the month was the closing of Agilent’s acquisition of privately held life science instrumentation manufacturer BioTek for $1.7 billion. The deal, which was announced in July, boosts Agilent’s position in the immune-oncology and immunotherapy markets, albeit at a higher valuation than what the firm had previously pursued. Meanwhile, the other Dx blockbuster announced in July, the $2.8 billion acquisition of Genomic Health by rival genetic cancer testing firm Exact Sciences, remains on track for a late 2019 closing. But perhaps the most noteworthy M&A theme was role reversal, with big lab companies acting as sellers rather than buyers. Thus, two different firms made strategic divestments during the period, including:

• Natera, which sold off its Evercord cord blood and tissue banking business to California Life Sciences Company CBR (Cord Blood Registry) to focus on its core genetic reproductive health, oncology and organ transplant testing operations; and
• OraSure Technologies which sold its cryosurgical systems operations to CryoConcepts so it could give full attention to its core infectious disease and molecular solutions businesses.

In addition to the deals listed below, Illumina announced that it had received an unsolicited “mini-tender offer” from investment firm TRC Capital for up to 500,000 shares of Illumina common stock at a cash price of $268.60 per share. Illumina recommended that shareholders decline the offer, which remains open until midnight Oct. 2. TRC has made similar offers for other companies seeking to acquire just enough of an equity stake to stay below the SEC tender offer disclosure requirement threshold, the Illumina board noted. The other notable M&A deal not listed in the table is the newly announced merger of Cardea Bio and Nanosens Innovations, the companies that teamed up to create a CRISPR-Cas9-based biosensor diagnostic device using a CRISPR-Chip transistor. The plan is for Nanosens to become a Cardea subsidiary with the new firm selling CRISPR-Chip-based products under the Nanosens brand name. Strategic Alliances Volume-wise, September was the year’s most active month of strategic alliance deal making. Among the most intriguing collaborations was the pairing of Quest Diagnostics with data analysis firm hc1 to launch a new service called the Quest Lab Stewardship to help health systems avoid over- and under-ordering of lab tests. By turning the lemons of intense payor scrutiny over test ordering into the lemonade of utilization management based on testing results, this deal highlights the needs of labs to leverage their testing data to evolve their businesses.

---

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

MERGERS, ACQUISITIONS & ASSET SALES
Acquiring Company	Target(s)	Deal Summary
Exact Sciences	Genomic Health	Price: $2.8 billion in cash and stock Status: Expected to close by end of 2019 Genomic Health common shareholders to get per share price of $27.50 in cash and $44.50 in shares of Exact stock, subject to 10% collar based on Exact’s volume-weighted average price for 45 trading days ending July 26 Create cancer DX megafirm that unites Exact’s Cologuard with Genomic Health’s Oncotype DX
OpGen	Curetis GMbH	Price: Curetis to receive 2,662,564 new common shares of OpGen (73% stake) based on $24 million valuation of combined business with current OpGen holders keeping remaining 27% equity share Status: Expected to close in early 2020 Curetis to become wholly owned subsidiary of OpGen to create transatlantic, US-based, Nasdaq-listed company with a commercial-stage molecular diagnostics and bioinformatics franchise and pipeline focusing on infectious diseases and antimicrobial resistance
Agilent Technologies	BioTek Instruments	Price: $1.17 billion Status: Closed Acquisition of privately held life science instrumentation manufacturer expands Agilent’s presence in cell analysis, immuno-oncology and immunotherapy Agilent expects BioTek to contribute $20 million to $25 million to 4Q revenues with no material impact on EPS for quarter
CBR (Cord Blood Registry)	Natera	Price: Undisclosed Status: No closing date announced Natera sells its Evercord cord blood and tissue banking business to focus on core genetic testing business in reproductive health, oncology and organ transplantation
OncoCyte	Razor Genomics	Price: $10 million in cash upfront for 25% of Razor’s outstanding equity + $1 million milestone associated with recent positive CMS coverage decision for Razor test assessing risk in early-stage lung cancer patients after surgery Status: Initial closing expected in Sept. Razor to use $4 million from initial $10 million payment to support supplemental clinical trial of test Razor shareholders eligible for additional $10 million in cash and/or $5 million in OncoCyte common stock upon achievement of clinical trial milestones OncoCyte to use Razor test as predicate in seeking Medicare coverage for its own DetermaVu assay
MyHeritage	River Road Bio	Price: Undisclosed Status: Closed Israeli consumer genomics firm acquires owner of Promethease + SNPedia MyHeritage to offer Promethease free of charge through end of this year + maintain SNPedia as a free resource for academic + non-profit users
CellaVision	RAL Diagnostics	Price: $27.7 million Status: Expected to close in fall 2019 Acquisition of sample preparation firm to bolster CellaVision’s sample prep services for hematology, pathology, cytology + microbiology
ViVitro Labs	ProtomedLabs SASU	Price: Undisclosed Status: Closed Cardiovascular test equipment + medical device testing lab merge operations under ViVitro Labs name
CareDx	XynManagement	Price: Undisclosed Status: Closed CareDx acquires provider of software to simplify transplant quality tracking + waitlist management
PreCheck Health Services	LD Technology + Medical Screening	Price: $5 million in cash upfront + deferred payment of $7 million in cash + $3 million in stock within 12 months Status: No closing date announced Acquisition of medical device firms boosts PreCheck’s point-of-care screening capabilities
CryoConcepts	OraSure Technologies	Price: $12 million cash Status: Closed OraSure sells off its cryosurgical systems business to focus on its core molecular solutions + infectious disease businesses
Inex Innovations and Exchange	Nova Satra Dx	Price: Deal valued at $72 million Status: Closed Merger to form new company, called Inex Innovate, aiming to introduce new tests for ovarian cancer and breast cancer in Asian women by 2020
Progenity	Medimetrics	Price: Undisclosed Status: Closed Progenity acquires Medimetrics’ portfolio of patents for ingestible device technologies
STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS
Partner 1	Partner(s) 2+	Deal Summary
Thermo Fisher Scientific (TF)	Eli Lilly and Company	Objective: Develop companion diagnostic test for Lilly's RET kinase inhibitor, LOXO-292 Dynamic: Use TF’s Oncomine Dx Target test to identify non-small cell lung cancer + thyroid cancer patients with RET alterations who might benefit from LOXO-292 TF to seek FDA supplemental premarket approval broadening clinical claims of Oncomine Dx Target TF to get global commercial rights to new CDx test
Thermo Fisher Scientific	Cedars-Sinai	Objective: Develop liquid chromatography mass spectrometry workflows for clinical research Dynamic: Create data acquisition strategies for global plasma protein profiling + peptide selective reaction monitoring (SRM) assays for analyzing plasma with or without enrichment Use TF’s new triple quadrupole mass spectrometers for large quantitation assays to assess targeted protein workflows in a CLIA environment
Illumina	Adaptive Biotechnologies	Objective: Develop test kits for Adaptive’s ClonoSeq + ImmunoSeq Dx NGS tests to run on Illumina’s NextSeq 550Dx system Dynamic: Under 5-year non-exclusive partnership, Adaptive to seek regulatory approval for + commercialize kits Illumina to develop custom software for using kits on NextSeq instruments + exclusively license software to Adaptive Combine NeuroFlow’s IntegrateHealth platform with Genomind’s Professional PGx Express genetic testing service so that physicians can use former to administer latter + provide test results to patients Adaptive to give Illumina 2 technology access milestone payments for software development + tiered revenue share payments ranging from a low to mid-single digit percentage of kits’ net sales
Foundation Medicine	Natera	Objective: Develop + commercialize personalized circulating tumor DNA monitoring assays for biopharma + clinical customers who order FoundationOne CDx Dynamic: Use FoundationOne CDx test as baseline to define unique variants that codeveloped liquid biopsy assays will monitor Foundation holds option to expand partnership to its FoundationOne Liquid or FoundationOne Heme tests as baseline for monitoring assays Foundation gets exclusive right to commercialize assays Foundation to pay Natera roughly $13 million in upfront licensing fees + prepaid revenues, as well as roughly $32 million in future minimum annual + milestone payments Revenues to be shared
CareDx	NanoString Technologies	Objective: Develop gene expression profiling test called HistoMap to identify allograft rejection in transplant biopsy tissue Dynamic: Combine CareDx’s transplant registries + expertise with NanoString’s nCounter platform + newly launched Human Organ Transplant panel
Quest Diagnostics	hc1	Objective: Provide new Quest Lab Stewardship service to help health systems avoid ordering too many or too few tests Dynamic: Service integrates with electronic medical record to guide doctors as they order tests, creates a systemwide set of tests + analyzes utilization trends
Coriell Life Sciences (CLS)	KPMG	Objective: Provide pharmacogenomics data to clinicians at the point of care Dynamic: Thermo Fisher Scientific to contribute genetic analysis technology + clinical decision support content CLS to offer its Enterprise PGx platform system, backed by TF data + team of pharmacists, to assess genetic risks related to specific patients' prescribed medications + link that information to an institution’s EHR system KPMG’s clinical intelligence platform to analyze information to help clinicians develop treatment plans for patients
Agilent	Mobilion	Objective: Implement Mobilion’s SLIM (structures for lossless ion manipulation) ion mobility system on Agilent’s QTOF mass spectrometers Dynamic: Beta model of system to be available in 2020 with commercial launch slated for 2021
Blueprint Genetics	Archimedlife Medical Laboratory	Objective: Provide biochemical testing for rare diseases in North America Dynamic: Blueprint to license Archimedlife’s technology + tests to offer biochemical testing at its Seattle lab, which also provides NGS genetic testing, with the combined testing services to be available in early 2020
Menarini Silicon Biosystems	BlueBee	Objective: Develop cloud-based platform for processing NGS data from liquid biopsy + formalin-fixed paraffin embedded (FFPE) tissue analysis Dynamic: Platform, called MSBiosuite, automates processing of raw sequencing data generated with Menarini’s Ampli1 kit for single circulating tumor cells + DEPArray kit for FFPE tissue analysis
Celsius Therapeutics	Parker Institute for Cancer Immunotherapy + Institut Gustave Roussy (France) + University Health Network (UHN) (Toronto)	Objective: Discover new molecular mechanisms + targets for drug discovery Dynamic: Use Celsius’ single-cell genomics platform to test tissue samples from cancer patients receiving immune checkpoint inhibitor treatment as part of 3 studies focusing on triple-negative breast cancer (Parker), bladder cancer (Gustave Roussy) + kidney cancer (UHN)
Novigenix	BioLizard	Objective: Develop artificial intelligence-based algorithm to support transition of Novogenix’s Colox immuno-transcriptomic RT-PCR product onto a new LITOseek system Dynamic: BioLizard to create algorithm which Novigenix will also use for other products under development
Adaptive Biotechnologies	Amgen	Objective: Enable Amgen to use Adaptive’s ClonoSeq assay to develop blood cancer therapies Dynamic: Over 4-year agreement, Amgen will pay Adaptive annual development fees + milestones payments in exchange for use of ClonoSeq test
LunaPBC	Medfusion	Objective: Enable users of LunaPBC’s LunaDNA genomic data-sharing platform to access health information in their EHRs Dynamic: Leverage Medfusion’s Patient Data application program interfaces (APIs) to provide users access to lab results, recent diagnoses + other EHR information in the LunaDNA platform
Fulgent Genetics	PWNHealth	Objective: Provide telehealth oversight for Fulgent’s newly launched Picture Genetics line of consumer genetic tests Dynamic: Telehealth firm PWNHealth to provide physician review + genetic counseling for tests
Interpace BioPharma (subsidiary of Interpace Diagnostics)	Genecast Biotechnology	Objective: Develop + commercialize translational studies +clinical trial solutions to biotech + pharma companies Dynamic: Interpace to perform services worldwide except in China, where Beijing-based Genecast will provide services
Sano Genetics	GenePlaza	Objective: Create app for linking users of direct-to-consumer (DTC) genetic tests with clinical trials + other research programs Dynamic: GenePlaza to offer app enabling its customers to review + opt into research projects via Sano’s platform
Arbor Biosciences	Medicinal Genomics (MGC)	Objective: Develop + commercialize new genotyping panel for cannabis Dynamic: Perform genetic testing + create cannabis genome knowledge bank to generate a panel for analyzing unique genetic signatures in cannabis strains
Personalis	Invectys	Objective: Facilitate biomarker discovery in chronic lymphocytic leukemia patients participating in a clinical trial Dynamic: Personalis to analyze samples from patients enrolled in a Phase II trial assessing the efficacy of Invectys' INVAC-1 alone or in combination with tyrosine kinase inhibitor ibrutinib (marketed by Janssen and Imbruvica)
Bioloidics	Agency for Science, Technology and Research’s (A*STAR) Genome Institute of Singapore	Objective: Develop circulating tumor cell assay to assess minimal residual disease + predict relapse in women with surgically-treated breast cancer Dynamic: Biolidics to use its ClearCell FX1 technology in the hopes of creating a liquid biopsy platform for early cancer detection
Genmab	Tempus	Objective: Use artificial intelligence to discover oncology biomarkers + drug targets Dynamic: Expansion of previous collaboration under which Genmab to identify research projects in which Tempus’ sequencing + bioinformatics technology can be used Genmab to develop + commercialize resulting products + pay Tempus milestone + royalty payments
Abionic	Genentech (part of Roche)	Objective: Develop + distribute Abionic’s asthma test panel in US Dynamic: Abionic to lead development process + Genentech to pay the clinical + regulatory costs
Veravas	True Diagnostics	Objective: Commercialize Veravas’ VeraTest Biotin for detecting biotin interference in diagnostic tests Dynamic: New test combines use of True Diagnostics’ screening technology and platform with Veravas’ nanomagnetic particle technology for removing biotin interferences
Fluidigm	Icahn School of Medicine at Mount Sinai	Objective: Develop epigenetic signatures to identify exposure to weapons of mass destruction Dynamic: Under aegis of US DoD’s Defense Advanced Research Projects Agency (DARPA) Epigenetic Characterization + Observation (ECHO) program
Freenome	ADC Therapeutics	Objective: Discover biomarkers for use in new cancer drug development Dynamic: Use Freenome’s multiomics platform for early cancer detection to identify patients likely to respond to treatment with ADC’s antibody drug conjugate loncastuximab tesirine (ADCT-402)
DISTRIBUTION, SALES & MARKETING AGREEMENTS
Property Owner	Distributor	Deal Summary
IsoPlexis	BioStream	Products: IsoPlexis’ IsoCode + IsoLight single-cell protein analysis products Territory: Japan Exclusive
Todos Medical	HWH World	Products: Todos’ TM-B1 + TM-B2 early breast cancer detection blood tests Territory: US, Canada, Singapore, Malaysia, the Philippines, Vietnam, Thailand, Indonesia, South Korea, Hong Kong, China
Todos Medical	Orot[+]	Products: Todos’ TM-B1 + TM-B2 early breast cancer detection blood tests Territory: Japan
Qiagen	ViroGates	Products: Qiagen’s aLF lateral flow test reader Territory: Europe Non-exclusive
LICENSES
Licensor	Licensee	Deal Summary
Cambridge Enterprise	PredictImmune	Expansion of worldwide licensing agreement to give PredictImmune first refusal rights to Cambridge technology to predict disease outcome for systemic lupus erythematosus as a follow-on disease Previous deal covered technology to predict disease outcome in relapsing-remitting autoimmune + inflammatory disease, specifically for inflammatory bowel disease, including Crohn’s disease + ulcerative colitis
Caribou Biosciences	Oxford Nanopore Technologies	ONT licenses Caribou’s foundational CRISPR-Cas9 patents for targeted nanopore sequencing which it plans to use for mediated enrichment of DNA targets for nanopore sequencing
Co-Diagnostics	LGC Biosearch Technologies	Expansion of current licensing agreement allowing LGC to use CoPrimer PCR technology for additional undisclosed research applications not covered in previous deal
SUPPLY, SERVICE & TESTING AGREEMENTS
Supplier/Servicer	Client/User	Deal Summary
Uman Diagnostics (Quanterix subsidiary)	Bio-Techne	Supply antibodies to Bio-Techne for use on its Ella immunoassay platform for quantification of neurofilament light (Nf-L)
NEW CLINICAL STUDIES
DX Partner	Other Partner(s)	Description of Study
Exosome Sciences	Hoag Memorial Hospital Presbyterian	Study to identify + characterize early disease biomarkers for cancer diagnostics, progression + treatment resistance
Biovica	SWOG Cancer Research Network	Evaluate clinical benefit of Biovica’s DiviTum immunoassay using blood samples from women with metastatic hormone receptor-positive breast cancer
Myriad Genetics	University of Leeds Center for Personalized Medicine and Health	Evaluate clinical utility of Myriad’s Prolaris prostate cancer test
Mologic	University College London Hospitals	Clinical trial evaluating value of Mologic’s point-of-care diagnostic test for early detection of sepsis