We have extensive experience in the discovery of clinically relevant and clinically applicable biomarkers, through our own research and development programs and through developing biomarkers for our partners.
We specialise in working with formalin fixed, paraffin embedded (FFPE) samples, particularly in the development of multigene or multiplex signatures. Our research has led to the discovery and development of several complex signatures, which have been out-licensed to diagnostic partners to use for clinical application.
In our commercial partnerships, we have discovered signatures that have been brought forward and developed into research assays, CLIA / clinical trial assays, and full companion diagnostics.
Our Subtyping Approach to Biomarker Discovery
Our subtyping approach involves profiling large retrospective datasets to identify the underlying subgroups that represent fundamental biology. This same approach can be used for the discovery of biomarkers in a wide range of indications. When it is, the biology discovered represents a class effect that can often be seen in multiple disease areas. This approach has benefited a number of clients where clinical trials had previously been run, during which we either used the datasets they already had access to, or we secured access to datasets by means of our retrospective sample collection services.
We have extensive experience carrying out biomarker discovery in a pre-clinical setting, using both cell line models and animal models. We have also brought signatures discovered in this setting into the clinic, for trial enrichment purposes, in early phase trials.
State-of-the-Art Laboratory Technologies and Experienced Scientists
Our biomarker discovery services are supported by our state-of-the-art laboratory technologies, all of which are ideally suited to biomarker discovery, development and delivery in a clinical setting. We also have a team of highly qualified and experienced scientists, bioinformaticians, and biostatisticians with substantial knowledge and experience in molecular and cell biology, drug discovery and development and diagnostic product development.
We recognise that each study is unique and has its own challenges. Our team will work with you throughout to provide a comprehensive service – from initial study design and planning, all the way through to the interpretation of your results.
We offer complete transparency throughout your study, with all methodology, programs and analytical methods clearly explained and available for you for review. We pride ourselves on quality and we work under standard operating procedures. All analytical methods we use are extensively tested and verified and all results are reviewed and supplied to you with complete information, to enable independent confirmation.
For more details on our laboratory infrastructure, please view our Laboratory Services page.
View Almac’s webinar ‘An Integrated Approach to Biomarker Discovery’
Almac: An Integrated Approach to Biomarker Discovery from Almac Group on Vimeo.
Almac Diagnostics is accredited by:
• UKAS to ISO17025 (accreditation number 2740)
• College of American Pathologists (CAP)
• New York State (CLEP Permit)
• Almac also holds individual US State licenses for Florida, California and Pennsylvania
Almac Diagnostics holds ISO13485 certification (SGS) and also complies with GLP, GCP and GCLP.