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
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.
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.
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.
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.
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.
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
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
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
Diagnostics to aid in stratification, therapy selection, and monitoring in clinical research settings
- Patient immuno-status
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
- High quality testing services for your valuable therapy development program
- CLIA-certified, CAP accredited laboratory
- Licensed in all required states
Security
Secure facilities (24/7 monitoring) and IT networks
Secure cloud networks for data management and distribution
Broad Technology Transfer Experience
Over 25 years of experience in CLIA laboratory operations
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
- Biomarker tests development
- Development and manufacturing of IVD kits for global distribution
Additional Resources
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* Test Information: The ELF score is indicated, in conjunction with other laboratory findings and clinical assessments, as a prognostic marker in patients with chronic liver disease to assess the risk of progression to cirrhosis and liver-related clinical events. This test was developed and its performance characteristics determined by the Siemens Healthcare Laboratory. The Laboratory Developed Test has not been cleared or approved by the US Food and Drug Administration. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.
