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. **** 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