Home 5 Articles 5 Siemens, California Health Network and Biopharm Research Company Partner for Enhanced Liver Fibrosis Testing

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

by | Jan 10, 2021

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 […]

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 1Partner(s) 2+Deal Summary
IlluminaEmedgene
  • 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
IlluminaHarvard 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
IlluminaPierianDx
  • 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 DiagnosticsMerck 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 TherapeuticsServier
  • 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
GenosityGemini 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 GeneticsTrapelo 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 DiagnosticsToray 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
CentogeneAlnylam 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
GeneMeBiolyph
  • 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 DxPremier 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-TechneRegulus 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 TechnologiesDivoc 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 OwnerDistributorDeal Summary
UgenTecDMark Biosciences
  • Products: UgenTec’s FastFinder PCR analysis software products
  • Territory: Canada
NanoView BiosciencesQuantum Design
  • Products: NanoView’s ExoView platform
  • Territory: China
  • Exclusive
Cell MicrosystemsBucher Biotec
  • Products: Cell’s image-based single-cell CellRaft AIR System
  • Territory: Switzerland
  • Exclusive
HalioDxDiagnosticos da America (DASA)
  • Products: HalioDx’s Immunoscore colon cancer risk-assessment test
  • Territory: Brazil
  • Exclusive
Sight DiagnosticsPhoenix Capital
  • Products: Sight OLO blood analyzers
  • Territory: Middle East, starting with UAE and expanding to rest of Gulf Cooperation Council region
CellexEverlywell
  • Products: Cellex’s point-of-care SARS-CoV-2 antigen test
  • Territory: U.S.
Oxford ImmunotecRiken Genesis
  • Products: T-Spot Discovery SARS-CoV-2 kit
  • Territory: Japan
  • Exclusive

LICENSES

LicensorLicenseeDeal Summary
Arbor BiotechnologiesLonzaLonza gets right to use Arbor’s CRISPR-based gene editing technology in its bioproduction products and services
OncocyteBurning Rock BiotechBurning Rock gets exclusive right to use Oncocyte’s DetermaRx test in China in exchange for upfront cash payments
Sherlock BiosciencesTolo BiotechSherlock 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 DiscoverySanyou BiopharmaceuticalsHorizon 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/ServicerClient/UserDeal Summary
Nexus DxOsang HealthcareNexus Dx to manufacture Osang’s GeneFinder COVID-19 Plus RealAmp Kit kit at its San Diego facility
OncimmuneNHS Norfolk & Waveney Clinical Commissioning GroupOncimmune to supply its EarlyCDT Lung blood test to the UK’s NHS Norfolk & Waveney Clinical Commissioning Group

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