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Biomarkers

CENTOGENE leverages its extensive rare disease expertise, databases, and biobank to develop new diagnostic assays and biomarkers that support our pharmaceutical partners with drug discovery and development – ultimately shortening the diagnostic odyssey and accelerating time-sensitive treatments for rare disease patients.

BIOMARKER BROCHURE

 

  1. Biomarker Discovery

Diagnosis, Prediction, and Therapy Monitoring

Our biomarker portfolio and discovery platform enable you to accelerate and de-risk drug discovery and stratify and monitor patients throughout the drug development process, as well as serve as an efficient companion diagnostic when needed.

  • Realistic reflections of the burden of the disease
  • A strong indicator of drug candidate efficacy in in-vitro disease models
  • A solid basis to establish therapeutic measures
  • Links to clinical manifestation
  • Easy and reliable disease and therapy monitoring

Optimized sample logistics with CentoCard®, our CE-labeled filter card

Value of CENTOGENE’s Biomarker Discovery Platform

CENTOGENE provides solutions for translational research, patient recruitment, clinical drug development, and diagnostic testing to over 35 pharmaceutical partners. We have strong expertise in biomarker discovery with a fast growing pipeline of novel biomarkers.

By leveraging our medical expertise as well as our extensive rare disease data repository CentoMD® and accredited biobank, which both grow rapidly on a continuous basis and provide what we believe reflects the world’s largest diversity of positive tested cases in the field of rare genetic diseases, we can support you in the discovery, development, and deployment of cutting-edge biomarkers across the pharmaceutical value chain.

CENTOGENE’s Biomarkers: A Growing Portfolio

CENTOGENE already has an impressive portfolio of 10 commercialized biomarkers with established biomarkers for AADC deficiency, hereditary angioedema (HAE), Fabry disease, Farber disease, Gaucher disease and Niemann-Pick disease (A/B/C), and a strong pipeline of over 50 in development. Continuously growing this portfolio for pharmaceutical and diagnostic use, we are dedicated to providing complete solutions for internal research as well as for collaborations with our pharmaceutical partners.

Overview of our Biomarker Portfolio


CENTOGENE’s Biomarker Discovery Platform – From the Bench to the Clinic

DRUG DISCOVERY PRE-CLINICAL / CILINICAL DEVELOPMENT COMMERCIALIZATION AND CLINICAL DIAGNOSTICS

SOLUTIONS

  • Target Discovery & Validation
  • Elucidating pathological pathways
  • Screening drug candidates
  • Selection of lead drug candidate
  • Patient identification and recruitment for clinical studies
  • Patient stratification
  • Monitoring response to therapy
  • Potential end-points for regulatory approval
  • Early and accurate diagnosis
  • Screening of high-risk populations
  • Quantification of disease burden
  • Monitoring response to treatment
  • Guiding individualized treatment regimen for improved outcomes

BENEFITS

  • Novel targets and specific drug candidates
  • Accelerated clinical trial recruitment
  • Reducing development risk
  • Lowered cost
  • Optimized trial design and treatment regimen
  • Faster time to market
  • Earlier diagnosis
  • Improved treatment outcomes
  • Increased market traction


Success Story: Lyso-Gb1 as the Most Effective Biomarker for Gaucher Disease

Lyso-Gb1 has been identified as the most precise biomarker for Gaucher disease (GD)1. With a sensitivity and specificity of 100% (see below), it is the optimal biomarker for a sensitive and reliable diagnosis of GD. Evidence of patient data also proves that quantitation of this biomarker can serve as a direct indicator of disease burden and response to treatment for monitoring GD.1

LYSO-GB1 QUANTIFICATION IN GAUCHER PATIENTS AND CARRIERS

100% sensitivity and 100% specificity of Lyso-Gb1 leading to highest accuracy in patient identification for an optimal diagnosis.

LYSO-GB1 LEVELS IN GAUCHER PATIENTS ON THERAPY (N=19, MEAN ΔT BETWEEN T1-T5 = 6 WEEKS)

Lyso-Gb1 levels significantly and rapidly increase at time point t5 after a forced treatment break due to temporary unavailability of enzyme replacement therapy. Lyso-Gb1 thereby proves its superb capabilities for monitoring Gaucher disease.

Scientific Articles

Glucosylsphingosine Is a Reliable Response Biomarker
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Glucosylsphingosine is a Highly Sensitive and Specific Biomarker in Gaucher Disease
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Successful Monitoring of Gaucher Disease
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Footnotes

1 Elstein, Deborah, et al. „Reductions in glucosylsphingosine (lyso-Gb1) in treatment-naïve and previously treated patients receiving velaglucerase alfa for type 1 Gaucher disease: Data from phase 3 clinical trials.“ Molecular genetics and metabolism 122.1-2 (2017): 113-120.

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