DX Deals

Siemens, California Health Network and Biopharm Research Company Partner for Enhanced Liver Fibrosis Testing

Although COVID-19 remains the driving force, non-pandemic-related strategic deal making continues. Among the most impactful deals announced in December is the partnership among Renown Institute for Health (IHI), Siemens Healthineers and Gilead Sciences to offer the Enhanced Liver Fibrosis (ELF) Test to individuals at risk for nonalcoholic steatohepatitis (NASH).

The ELF Test Project

Siemens’ ELF Test, which is available in the U.S. via the Erlangen, Germany-based company’s CLIA-certified Siemens Healthcare Laboratory, is a non-invasive blood test capable of quickly identifying patients who are at an elevated risk for developing cirrhosis and other liver-related clinical events. Unlike standard liver enzyme tests that detect liver damage after it has already occurred, the ELF Test make algorithm measurements of three serum-based biomarkers of active fibrosis to create a score assessing the risk for future disease progression and evaluation of whether a patient requires increased medical care and monitoring, according to IHI.

The plan is to offer the ELF Test to individuals at risk of NASH participating in a large genetic population health study called the Healthy Nevada Project. The expectation is that testing will be done on more than 30,000 participants over the next two years. The partners didn’t disclose the financial and other terms of the collaboration.

The new collaboration to make the ELF Test available for the Healthy Nevada Projects builds on an existing partnership between Renown IHI, an integrated health network serving Nevada and northeast California, and Gilead, a research-based biopharmaceutical company based in California, that began in July 2019. According to IHI, the organizations have been working together to collect and analyze de-identified genetic and electronic health data from 60,000 qualifying study participants to enhance the understanding of nonalcoholic fatty liver disease and NASH with the hopes of informing the development of treatment options for these diseases.

Here’s a summary of other key strategic diagnostic deals announced in December 2020:

STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS

Partner 1 Partner(s) 2+ Deal Summary
Illumina Emedgene
  • Objective: Develop software for diagnosing NGS-based rare diseases
  • Dynamic: Non-exclusive deal to integrate Emedgene’s clinical rare disease application into Illumina’s TruSight software suite
Illumina Harvard Pilgrim Health Care
  • Objective: Make whole-genome sequencing (WGS) available to certain Harvard Pilgrim pediatric patients
  • Dynamic: Risk-sharing agreement with Harvard Pilgrim to cover WGS via its lab providers network and both sides sharing genetic testing costs risk
Illumina PierianDx
  • Objective: Develop products for NGS-based cancer panel reporting
  • Dynamic: Expand existing partnership with PierianDx’s genomic reporting products, including the Clinical Genomics Workspace and Clinical Genomics Knowledgebase, tobe enabled for use with AmpliSeq for Illumina Focus panel, AmpliSeq for Illumina Myeloid panel, and Illumina TruSight Hereditary Cancer Panel
Amoy Diagnostics Merck KGaA
  • Objective: Develop companion diagnostic test in China for Merck KGaA’s novel MET inhibitor tepotinib (Tepmetko)
  • Dynamic: Amoy to develop and register AmoyDx Lung Cancer PCR Panel (11-in-1 Panel) for lung cancer and seek regulatory approval for use as a MET exon14 skipping companion diagnostic for tepotinib
Celsius Therapeutics Servier
  • Objective: Identify new drug targets for colorectal cancer
  • Dynamic: Celsius to use its single-cell genomics platform to analyze samples from colorectal cancer patients
  • Celsius gets undisclosed upfront payment and up to $700 million in milestone payments
  • Servier gets exclusive option to research, develop and commercialize products directed to up to three of the targets
Genosity Gemini Therapeutics
  • Objective: Develop molecular diagnostic for use in selecting patients for Gemini clinical trial of a dry age-related macular degeneration (AMD) drug candidate
  • Dynamic: Genosity to use samples from prospective study participants to create custom NGS panel to identify individuals with complement factor H (CFH) loss-of-function gene variants
Concert Genetics Trapelo Health
  • Objective: Provide comprehensive evidence-based molecular decision support for oncology
  • Dynamic: Integrate Trapelo Health’s clinical decision support system linking providers, test labs and payors, with Concert’s network of network of health plans and genomics labs
Bluejay Diagnostics Toray Industries
  • Objective: Develop point-of-care test to assess progression of COVID-19
  • Dynamic: Toray to exclusively license its liquid biopsies technology to Bluejay who will perform clinical trials and seek regulatory approval outside Japan, including EUA from FDA
Centogene Alnylam Pharmaceuticals
  • Objective: Perform clinical biomarker study of hereditary transthyretin-related amyloidosis (ATTRv)
  • Dynamic: TRAMmoniTTR study to longitudinally monitor status of symptomatic and asymptomatic participants with variants in TTR gene
  • Centogene to use its metabolomics profiling platform to discover and characterize novel biomarkers for ATTRv in TTR-positive participants
GeneMe Biolyph
  • Objective: Support scaling up of GeneMe’s rapid isothermal molecular point-of-care COVID-19 assay
  • Dynamic: GeneMe to leverage Biolyph’s lyophilization production, expertise, and capacity to expand lifecycle of its FRANKD test
TNG Dx Premier Medical Laboratories
  • Objective: Develop rapid RNA extraction protocol for use in SARS-CoV-2 diagnostics
  • Dynamic: Premier Medical to perform clinical and analytical validation studies on paired saliva samples collected by TNG Dx using anterior nasal sampling to develop extraction protocol, which will be submitted to FDA for EUA by year’s end
Bio-Techne Regulus Therapeutics
  • Objective: Develop rapid RNA extraction protocol for use in SARS-CoV-2 diagnostics
  • Dynamic: Premier Medical to perform clinical and analytical validation studies on paired saliva samples collected by TNG Dx using anterior nasal sampling to develop extraction protocol, which will be submitted to FDA for EUA by year’s end
Canary Health Technologies Divoc Laboratories
  • Objective: Develop rapid, handheld breath test for detecting COVID-19
  • Dynamic: Perform clinical trial on breath samples from 750 people who are either COVID-19 positive or don’t have the virus with product launch in early 2021 if trial is successful

DISTRIBUTION, SALES & MARKETING AGREEMENTS

Product Owner Distributor Deal Summary
UgenTec DMark Biosciences
  • Products: UgenTec’s FastFinder PCR analysis software products
  • Territory: Canada
NanoView Biosciences Quantum Design
  • Products: NanoView’s ExoView platform
  • Territory: China
  • Exclusive
Cell Microsystems Bucher Biotec
  • Products: Cell’s image-based single-cell CellRaft AIR System
  • Territory: Switzerland
  • Exclusive
HalioDx Diagnosticos da America (DASA)
  • Products: HalioDx’s Immunoscore colon cancer risk-assessment test
  • Territory: Brazil
  • Exclusive
Sight Diagnostics Phoenix Capital
  • Products: Sight OLO blood analyzers
  • Territory: Middle East, starting with UAE and expanding to rest of Gulf Cooperation Council region
Cellex Everlywell
  • Products: Cellex’s point-of-care SARS-CoV-2 antigen test
  • Territory: U.S.
Oxford Immunotec Riken Genesis
  • Products: T-Spot Discovery SARS-CoV-2 kit
  • Territory: Japan
  • Exclusive

LICENSES

Licensor Licensee Deal Summary
Arbor Biotechnologies Lonza Lonza gets right to use Arbor’s CRISPR-based gene editing technology in its bioproduction products and services
Oncocyte Burning Rock Biotech Burning Rock gets exclusive right to use Oncocyte’s DetermaRx test in China in exchange for upfront cash payments
Sherlock Biosciences Tolo Biotech Sherlock Biosciences licenses exclusive U.S. rights to CRISPR-Cas12 diagnostic technology; in return, Sherlock grants Tolo exclusive rights to CRISPR-Cas13 SHERLOCK diagnostic platform in Greater China
Horizon Discovery Sanyou Biopharmaceuticals Horizon grants Sanyou two commercial licenses for its CHOSource platform for development of preclinical antibody drug projects and to support the clinical development and commercialization of its customers’ human biotherapeutic products

SUPPLY, SERVICE, TESTING & MANUFACTURING AGREEMENTS

Supplier/Servicer Client/User Deal Summary
Nexus Dx Osang Healthcare Nexus Dx to manufacture Osang’s GeneFinder COVID-19 Plus RealAmp Kit kit at its San Diego facility
Oncimmune NHS Norfolk & Waveney Clinical Commissioning Group Oncimmune to supply its EarlyCDT Lung blood test to the UK’s NHS Norfolk & Waveney Clinical Commissioning Group
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