End-to-end biopharmaceutical services

Siemens Healthcare Laboratory

End-to-end diagnostic solutions for biopharma partner therapy development programs


Who We Are

Siemens Healthcare Laboratory (SHL), LLC offers services which may begin with biomarker discovery, leading to prototype development, use in clinical trials, and followed by optional development and commercialization of In Vitro Diagnostic (IVD) assays.

Our rigorous, stepwise biomarker-development process supports development of high-quality biomarker assays for early- to late-stage clinical trials testing.

Assay prototypes of these biomarkers can be developed on our proprietary technology clinical laboratory platforms and validated for fit for purpose uses.

Our CAP-accredited, CLIA-licensed laboratory offers high-quality testing services to support your clinical trial needs and beyond.

End-to-End Biopharmaceutical Services

We offer end-to-end diagnostic solutions for our biopharma partners' therapy development programs

A seamless continuum of cutting edge diagnostic test development services from biomarker discovery to commercialization for therapy development programs.
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Biomarker Discovery and Next Gen Proteomics

Our discovery team has expertise in working independently or jointly through a partner to discover the best biomarkers for specific intended uses.

Our strategic partner’s proprietary mass spectrometry technology, enables depths of proteome coverage with reproducible and precise quantification to identify the most promising, actionable biomarkers to support clinical decision making.

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Identification of Biomarker Candidates

Derive more value from diagnostic data obtained from your clinical trials and discover biomarkers for next-generation systems.

SHL can optimize existing organ-specific models to build new multi-analyte/modality algorithms for specific therapies and new disease states.

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Assay Prototype Development

Siemens Healthcare Laboratory specializes in developing molecular shedding, cell-based infectivity, and detection of viral antibodies using immunoassays for gene-therapy development needs.

At the cutting edge of medicine, viruses have been engineered into serving as therapy platforms to infect and deploy genetic material to correct deleterious genetic mutations in specific target tissues.

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Establishment of Clinical Utility via Clinical Testing

Our CAP-accredited, CLIA-licensed laboratory offers high quality, testing services to support your clinical trial needs and beyond, if required.

SHL has extensive testing and regulatory experience with early small or late-stage large clinical trials, including multinational clinical trials. 

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Potential Development of IVD Assay

For global biomarker availability, Siemens Healthineers offers development of IVD assays and digital imaging solutions for deployment on our routine platforms.

We understand the stringent regulatory environments, such as the U.S. FDA, European notified bodies and others, for blood and imaging biomarker commercialization. We will recommend a path forward for your blood test or imaging biomarker commercialization channel.

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Commercialization of IVD Assay

Developed IVD is designed to run on Siemens Healthineers immunoassay platforms for use in hospitals, reference laboratories, and specialty laboratories.

With the availability of the IVD as routine tests on clinical platforms, clinical laboratories will be able to offer these biomarker tests to patients and their providers to optimize their treatment selection and outcome.

Domains of Service Expertise

Our service expertise includes diagnostics for neurological diseases, liver diseases, oncology, and infectious diseases.

Liver Diseases

Liver Diseases

Noninvasive Liver Fibrosis diagnostics to aid patient selection and monitor for liver diseases such as NASH 

  • Enhanced Liver Fibrosis (ELF) Blood Test* 
  • Liver modeling
  • Biomarker Integration 

Learn more about the ELF* testing service

Neurology

Neurology

Biomarkers that aid in monitoring therapeutic effectiveness and diagnosis of neuro-degenerative diseases, including dementia, Alzheimer’s Disease (AD), and Multiple Sclerosis

  • Neurofilament Light (NfL)
  • AD markers: CSF AB42/Tau
  • Clinical Decision Support

Learn more about Neurofilament Light Chain (NfL) Testing Service 

Oncology

Oncology

Diagnostics to aid in stratification, therapy selection, and monitoring in clinical research settings

  • Patient immuno-status

Infectious Diseases

Infectious Diseases

Diagnostic tools to support the use of pathogen and viral detection

  • Sepsis

Viral detection and antibody test development expertise for therapy and vaccine development programs against a range of viruses including HCV, HIV, and SARS-CoV-2

CLIA Laboratory

Services offered by our CLIA-certified lab in Berkeley, CA, meet the needs for your therapy development program

Siemens Healthcare Laboratory includes a CLIA-accredited clinical laboratory service leading the way in innovative, high-complexity testing solutions to service clinical trials testing needs and beyond. 

Quality testing services

Quality Testing Services

  • High quality testing services for your valuable therapy development program
  • CLIA-certified, CAP accredited laboratory
  • Licensed in all required states
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Security

  • Secure facilities (24/7 monitoring) and IT networks

  • Secure cloud networks for data management and distribution

Broad technology transfer experience

Broad Technology Transfer Experience

Over 25 years of experience in CLIA laboratory operations

Extensive clinical trials testing and regulatory expertise

Extensive Clinical Trials Testing and Regulatory Expertise

  • Services early-small or late-stage large clinical trials needs including multinational clinical trials
  • Clinical trials for PMA and 510(k) test submissions to U.S. FDA
Commercial clinical testing solutions beyond clinical trials

Commercial Clinical Testing Solutions Beyond Clinical Trials

  • Biomarker tests development 
  • Development and manufacturing of IVD kits for global distribution