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
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.
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.
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.
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.
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.
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.
Noninvasive Liver Fibrosis diagnostics to aid patient selection and monitor for liver diseases such as NASH
Biomarkers that aid in monitoring therapeutic effectiveness and diagnosis of neuro-degenerative diseases, including dementia, Alzheimer’s Disease (AD), and Multiple Sclerosis
Diagnostics to aid in stratification, therapy selection, and monitoring in clinical research settings
Diagnostic tools to support the use of pathogen and viral detection
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
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.
Secure facilities (24/7 monitoring) and IT networks
Secure cloud networks for data management and distribution
Over 25 years of experience in CLIA laboratory operations
* 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.