DX Deals

Hologic Leverages Google Cloud Machine Learning to Boost Cervical Cancer Screening

Hologic has its head in a cloud. And that’s a good thing. On Feb. 1, the Massachusetts-based medical technology firm announced that it has entered into a strategic collaboration with Google Cloud to develop an advanced platform for screening of cervical cancer. The strategy is to combine Hologic’s Genius Digital Diagnostics System with Google Cloud’s machine learning (ML) capabilities to create a digital cytology platform “to transform screening and accelerate the eradication of cervical cancer across the globe.” Here’s the lowdown:

Product Strategy: Hologic AI + Google Cloud ML = Digital Cytology Powerhouse

Hologic claims that its Genius Digital Diagnostics System is the first digital cytology platform to combine artificial intelligence (AI) with advanced digital imaging to help identify pre-cancerous lesions and cancer cells in women. The collaboration enables the company to leverage Google Cloud’s state of the art ML technology to enhance the system’s deep learning component so that it will provide “more actionable insights from cytology slides for cytotechnologists and pathologists.” Hologic will also use be able to use Google Cloud’s reliable and secure cloud data architecture to further improve the system.

Business Strategy

It’s hard to know what the business strategy is because the firms didn’t disclose the financial details of their collaboration, other than the fact that it’s a multi-year arrangement. What we do know is that the Genius Digital Diagnostics System is CE marked in Europe but isn’t yet available in the U.S. Getting FDA approval may be tricky given the current uncertainties surrounding the agency’s regulation of ML-based software for medical device applications.

These have been active times for Hologic. At the end of February, the firm announced that it has completed its $230 million strategic acquisition of Biotheranostics, a San Diego-based, privately held producer of genetics diagnostics products for breast and metastatic cancers, including the PCR-based Breast Cancer Index and CancerType ID tests. Just two days before revealing the Biotheranostics play, Hologic announced that it had expanded its presence in Europe by acquiring Berlin, Germany-based women’s health provider Somatex Medical, for $64 million.
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Here’s a summary of key strategic diagnostic deals announced in February 2021:

STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS

Partner 1 Partner(s) 2+ Deal Summary
Qiagen Inovio Pharmaceuticals
  • Objective: Develop next-generation sequencing-based liquid biopsy companion diagnostic tests for use with Inovio therapies
  • Dynamic: Expanded collaboration initially targeting diagnostic test to identify women most likely to benefit from Inovio’s VGX-3100 immunotherapy for advanced cervical dysplasia associated with HPV infection
Adaptive Biotechnologies Laboratory Corporation of America
  • Objective: Provide access to Adaptive’s immune-driven clinical diagnostic and research products
  • Dynamic: Expand current collaboration and servicing agreement covering ClonoSeq and ImmunoSeq assays to Adaptive’s T-Detect COVID test
Becton Dickinson Scanwell Health
  • Objective: Develop an at-home rapid test for SARS-CoV-2
  • Dynamic: BD to create a lateral flow antigen test and pair it with Scanwell Health mobile app
Thermo Fisher Scientific Mindray
  • Objective: Offer drug screening technology to clinical and drug court labs in US and Canada
  • Dynamic: Exclusive agreement to offer Mindray’s BS-480 and BA-800M analyzers together with Thermo Fisher’s DRI and CEDIA drugs of abuse immunoassay reagents for drug screening of urine samples
Hologic Google Cloud
  • Objective: Bolster Hologic’s digital cytology platform
  • Dynamic: Multi-year collaboration to integrate Google Cloud’s machine learning technologies into Hologic’s Genius Digital Diagnostics digital cytology platform, which combines artificial intelligence and advanced digital imaging to help identify pre-cancerous lesions and cancer cells in women
AmoyDx AstraZeneca
  • Objective: Develop companion diagnostic for treating ovarian cancer patients with homologous recombination deficiency (HRD)
  • Dynamic: Deal comes after firms agreed to collaborate on molecular diagnostics development for gynecological indications including those characterized by HRD
Kroger Health Gauss
  • Objective: Offer Gauss’ smartphone-enabled, at-home COVID-19 Rapid Antigen Test Kit at Kroger retail locations
  • Dynamic: Kroger Health to offer kit online and at counters of its 2,200 pharmacies across U.S. once it gets EUA from the FDA
Stella Diagnostics Mayo Clinic
  • Objective: Evaluate Stella’s test for predicting disease progression in Barrett’s esophagus
  • Dynamic: Use targeted mass spectrometry to assess potential of multiple protein markers for progression of Barrett’s esophagus, including the proteins that compose Stella’s STLA101 panel
Twist Bioscience Berry Genomics
  • Objective: Develop next generation sequencing target enrichment and library preparation tools for inherited diseases
  • Dynamic: Berry Genomics to also offer Twist’s NGS panels for cancer diagnosis
Twist Bioscience Victorian Clinical Genetic Services (VCGS) of Australia
  • Objective: Develop whole-exome capture assay for VCGS to use as a clinical diagnostic test
  • Dynamic: Assay combines Twist’s Human Comprehensive Exome with VCGS’ customized content for rare and inherited diseases to minimize gaps in clinically relevant genes and transcripts
GBS (iQ Group subsidiary) Johns Hopkins Bloomberg School of Public Health
  • Objective: Accelerate development of saliva-based diagnostic tests for coronavirus
  • Dynamic: Sponsored research agreement to support GBS’ research into saliva testing for use in commercializing two of its rapid point-of-care tests, the SARS-CoV-2 Antibody Biosensor and Saliva Glucose Biosensor
LifeLabs Multiplex Genomics
  • Objective: Perform SARS-CoV-2 testing and track virus variants in Canada
  • Dynamic: LifeLabs to provide Multiplex Genomics SARS-CoV-2 samples for testing and the latter will then sequence positive samples to assign them to SARS-CoV-2 variants
Natera Personalis
  • Objective: Develop cancer treatment monitoring and molecular residual disease (MRD) testing
  • Dynamic: Natera to use matched tumor and normal exome sequencing data generated by Personalis to validate design of its Signatera personalized circulating tumor DNA assays
  • Natera to commercialize assays
Fulgent Genetics BioIQ
  • Objective: Use next-generation sequencing to identify SARS-CoV-2 variants
  • Dynamic: BioIQ to offer Fulgent’s coronavirus genome sequencing assay on its diagnostics software platform to inform testing regimens, clinical treatment protocols and vaccination strategies
Avricore Health Avrok Laboratories
  • Objective: Provide rapid SARS-CoV-2 antigen testing for international travelers
  • Dynamic: Avrok, which operates a CLIA-certified lab in California, to oversee testing of travelers in Canada, U.S., Mexico and the Caribbean, with test results reported directly via Avricore’s HealthTab point-of-care screening platform
Kantaro Biosciences Atrys Health
  • Objective: Distribute Kantaro’s SARS-CoV-2 antibody tests
  • Dynamic: Atrys to offer Kantaro’s COVID-SeroKlir and COVID-SeroIndex tests in parts of Europe and South America, including Spain, Portugal, Colombia, Brazil, Peru, and Chile
  • Deal also includes Bio-Techne, which is Kantaro’s manufacturing partner
Avacta Mologic
  • Objective: Develop, manufacture and distribute Avacta’s SARS-CoV-2 tests
  • Dynamic: Mologic to manage CE marking of Avacta’s AffiDx SARS-CoV-2 lateral flow rapid antigen test under its existing ISO13485 quality system and transfer the CE mark once it’s issued
  • Mologic to also distribute Avacta’s SARS-CoV-2 spike antigen test in undisclosed low- and middle-income countries
NeoGenomics Parexel
  • Objective: Advance application of precision medicine in clinical trials
  • Dynamic: Use real-world genomics data to accelerate patient matching and optimize trial design, site selection, clinical development and translational research
Tecan UgenTec
  • Objective: Offer labs integrated sample-to-answer PCR workflows
  • Dynamic: Market Tecan’s liquid handling and automation workstations in combination with UgenTec’s FastFinder PCR analysis software
Congenica Gabriel Precision Oncology
  • Objective: Develop clinical interpretation software platform for somatic cancer
  • Dynamic: Combine technologies to build automated system enabling next-generation sequencing-based cancer molecular diagnostics from multiple genomic assays

DISTRIBUTION, SALES & MARKETING AGREEMENTS

Product Owner Distributor Deal Summary
Binx Health McKesson
  • Products: Binx io molecular diagnostic testing platform
  • Territory: U.S.
Fluidigm Zhejiang PuLuoTing Health Technology
  • Products: Fluidigm CyTOF technology, panels and reagents
  • Territory: China
Genedrive Beckman Coulter Life Sciences
  • Products: Genedrive’s 96 SARS-CoV-2 test
  • Territory: U.S. and Europe
Epimune Tanner Pharma (via its TannerLAC unit)
  • Products: Epimune’s I.Mune TBNK lymphocyte quantification test
  • Territory: Latin America
Sysmex Siemens Healthineers
  • Products: Sysmex’s CN-Series line of automated blood coagulation analyzers
  • Territory: Global
  • Parties also extended the scope and duration of their existing hemostasis testing systems and reagents global distribution agreement
PixCell Medical Aidian
  • Products: PixCell’s HemoScreen point-of-care hematology analyzer
  • Territory: Finland, Norway, Denmark, Latvia, Estonia
  • Exclusive

LICENSES

Licensor Licensee Deal Summary
Baseclick DNA Script Exclusive license to Baseclick’s Click chemistry for printing modified DNA
ERS Genomics G+FLAS Life Sciences of South Korea Non-exclusive license to ERS’ CRISPR-Cas9 patent portfolio
ERS Genomics ZeClinics Non-exclusive license to ERS’ CRISPR-Cas9 patent portfolio

SUPPLY, SERVICE, TESTING & MANUFACTURING AGREEMENTS

Supplier/Servicer Client/User Deal Summary
Quest Diagnostics Emblem Health Quest to serve as sole national lab for all Emblem Health Insurance Plan of New York products in 2021
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