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Siemens Healthcare Laboratory

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Berkeley, California, US

About Siemens Healthcare Laboratory

Siemens Healthcare Laboratory (SHL) based in Berkeley, California, is a part of Siemens Healthineers, a leading global integrated diagnostics company. SHL offers end-to-end diagnostic solutions and services for biopharma therapy-development programs. SHL services include biomarker signature discovery, assay development, reference laboratory services via our CLIA laboratory and global commercialization of assays.

Certifications & Qualifications

BSL-1 BSL-2 CLIA/CAP GCP GLP GMP

Our Services (14)


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Enhanced Liver Fibrosis (ELF™) Test

Price on request

For research use only (RUO)

The Enhanced Liver Fibrosis (ELF™) test is performed as a simple blood test.

The ELF test is an in vitro diagnostic multivariate index assay that provides a single ELF score by combining immunoassay measurement of three serum protein biomarkers that shows good correlation with fibrosis stages in chronic liver disease. The component serum protein biomarkers are:

• Hyaluronic acid (HA): a glycosaminoglycan, a chief component of the extracellular matrix

• Procollagen III amino terminal peptide (PIIINP)

• Tissue inhibitor of metalloproteinase 1 (TIMP-1)

The ELF test is used extensively in a number of clinical trials for metabolic disease and fibrosis therapy development.

Non-Alcoholic Steatohepatitis (NASH) Non-alcoholic fatty liver disease (NAFLD) Liver Disease Non-Viral Liver Disease Immunoassays Serum Primary Sclerosing Cholangitis (PSC) Show 7 more tags Show less

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Bioanalytical Assays

Price on request

Gene Therapy Bioanalytical Testing Services

Quantitative or qualitative PCR-based assays suitable for shedding, bio-distribution, pK, or other applications
Viral vector characterization using DNA sequencing
Testing operations under CLIA/CAP, GCP, GLP, and GMP/QSR compliant-practices as required
Control system design and calibrator/control materials manufacturing
Infectivity, neutralization, and other tests
DNA/RNA extraction from various sample types, including tissue, blood cells, plasma, urine, saliva, stool, and semen
Stably or transiently transfected cell line development
In-house capabilities for working at BSL2

Viruses qPCR RT-qPCR Fresh Tissue PBMC's Plasma Stool Biofluids Oncology Hematology Immunology Immuno-Oncology Viral shedding viral clearance viral tracing viral infectivity Show 16 more tags Show less

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Immunoassays

Price on request

• Siemens Healthineers automated clinical laboratory platforms, including ADVIA Centaur® and Atellica® systems

• Transfer of protocols, addition of automation on our central laboratory platform, and development of new assays

• Custom assay development or analytical validation of existing RUO assays for clinical research use

Our extensive immunoassay test menu includes:

Anemia
Ferritin
Folate
RBC Folate
Vitamin B12

Cardiac
BNP
CKMB
Myoglobin
TnI-Ultra™

Inflammation
IgE, Total

Oncology
AFP
BR 27.29
CA 125II
CA 15-3
CEA
PSA
PSA, Complexed
Serum HER-2/neu

HIV
HIV 1/O/2 Enhanced (EHIV)

ELISA Advia Centaur

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Clinical Chemistry

Price on request

Range of automated clinical chemistry tests, including:

General Chemistry
Alanine Aminotransferase (ALT)
Alanine Aminotransferase (Liquid P5P)
Albumin (BCG)
Albumin (BCP)
Alkaline Phosphatase
Ammonia
Amylase
Aspartate Aminotransferase (AST)
Aspartate Aminotransferase (Liquid P5P)
Bilirubin, Direct
Bilirubin, Total
Calcium (CPC)
Carbon Dioxide
Chloride
Cholesterol
Cholinesterase
Creatine Kinase
Creatinine
Creatinine, Enzymatic
Gamma-Glutamyl Transferase (GGT)
Glucose, Hexokinase
Glucose, Oxidase
HDL Cholesterol
Iron
Lactate
Lactate Dehydrogenase (L-P)
LDL Cholesterol
Lipase
Magnesium
Microalbumin
Pancreatic Amylase
Phosphorus
Potassium
Sodium
Total Iron-binding Capacity (TIBC)
Total Protein
Total Protein, Urine
Triglycerides
Urea Nitrogen (BUN)
Uric Acid

Specific Proteins
α1-Acid Glycoprotein (AAG)
α1-Antitrypsin (AAT)
Antistreptolysin O (ASO)
Apolipoprotein A-1
Apolipoprotein B
β-2 Microglobulin
Complement C3
Complement C4
CRP
CRP, High Sensitivity
Haptoglobin
Immunoglobulin A (IgA)
Immunoglobulin G (IgG)
Immunoglobulin M (IgM)
Lipoprotein(a)
Prealbumin
Rheumatoid Factor (RF)
Transferrin

Serum ADVIA Chemistry Atellica

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Virology Services

Price on request

Ultrasensitive HIV detection (For Research Use Only (RUO)
HCV genotyping (LiPA, NS5B sequencing)

HIV Hepatitis C

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Exome Sequencing Services

Price on request

For Research Use Only (RUO)

• Customized workflow of provider-required read depth coverage

• Increased coverage of particular genomic regions of interest available

• Additional data analysis services, including read mapping, data QC reporting, and variant calling

• Pathologist evaluation of stained tissue, identification of tumor-containing regions, and digital slide scanning

Oncology Illumina NextSeq 500 sequencing system Genomics Next Generation Sequencing Illumina NextSeq Blood FFPE tissue Frozen Tissue PBMC's DNA Show 10 more tags Show less

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Clinical Laboratory Services

Price on request

Clinical laboratory services: Validate assays in our CAP-accredited, CLIA-certified laboratory

• High-complexity services including molecular testing (qPCR, NGS), immunoassays (automated, ELISA), clinical chemistry, mass spectrometry, ELISA, clinical virology (HIV, HCV)

• Highly qualified California-licensed testing personnel

• Clinical trial support services

• Secure facility, secure data handling

• Labware LIMS: 21CFR part 11-compliant installation

• Digital pathology workflow - microtomy, staining, pathology assessment, whole slide imaging (Aperio), microscopy (Zeiss Axio imager 2) fluorescence microscopy


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DNA Extraction and Purification

Price on request

Whole blood or collected PBMC samples; FFPE or frozen tissue

FFPE:

• Histology cutting and staining

• Pathology review

Extraction and DNA quantitation:

• DNA quality check for down stream WES usage

VERSANT Tissue Preparation System Qiagen Qiacube PBMC's FFPE tissue Frozen Tissue

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qPCR

Quantitative PCR
Price on request

Assay design, optimization, and validation for use in biomarker research and development.

ABI 7500

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RNA Extraction and Purification

Price on request
Request a quote for more information about this service.
VERSANT Tissue Preparation System Qiagen Qiacube PBMC's FFPE tissue Frozen Tissue

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qRT-PCR

Quantitative reverse transcription polymerase chain reaction
Price on request

Assay design, optimization, and validation for use in biomarker research and development.


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Mammalian Cell Culture

Price on request

• Viral infectivity, neutralization, and other tests

• Stably or transiently transfected cell line development

• In-house capabilities for working at BSL2

• Facilities for scaling up testing in larger trials


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Tandem Mass Spectrometry Methods

Price on request

UPLC-MS/MS

Numerous applications in bioanalysis, including therapeutic drug monitoring; qualitative and quantitative detection of metabolites, hormones, vitamins, proteins, peptides, glycans, oligonucleotides, antibodies, and antibody drug conjugates; biomarker discovery; proteomics; metabolomics; lipidomics

Mass Spectrometry Waters Acquity UPLC PDA/QDA (MS)

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Bioanalytical Assay Development and Optimization

Price on request

Fit-for-purpose design, optimization, and validation of assays for use in biomarker research and development and clinical trials.


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