CDx Development and Commercialisation
We are uniquely placed to partner with clients throughout the entire process of CDx Development through our Clinical Trial Diagnostic Solutions.
From the fundamental research and discovery phase, through the conduct of clinical trials and the manufacturing of test kits or lab developed tests, to the patient sample testing, Almac Diagnostic Services can further leverage 50 years of manufacturing and distribution experience within the Almac Group. We have the capability to produce CDx Kits for Labs and a strong Global distribution network to support Commercialisation.
We are able to tailor our Customised CDx services to the exact requirements of our clients to ensure that their drug and companion diagnostic is competitive in the marketplace.
As disease and drug response is a complex process, we fundamentally believe that multiplex gene signatures are the key to developing the precision medicines of the future. Our experience in using complex biology can be demonstrated through our own internal R&D pipeline of assays across a range of cancer types as well as our CDx partnerships with existing pharma clients. We have extensive proven experience alongside published and validated results.
Our global, state of the art, CLIA-accredited laboratories operate both research-use-only (RUO) Assays and Clinical Trial Assays. We also have strong strategic partnerships in place with multiple platform providers, offering clients true flexibility for their CDx requirements through our flexible platform options.
We have the key organisational and logistical resources necessary to provide an end-to-end service, which can be scaled up to every major market from our clinical laboratory hubs in the USA and Europe and our partnership laboratory in Asia.
With expert supporting services teams in Project Management, Bioinformatics & Biostatistics and Quality & Regulatory Affairs we ensure that your individual project objectives are met on time, within budget and that deliver customised solutions that add real value.
Almac offer support services to help streamline biomarker programmes for our clients. One such support service is our Sample Management Service which includes sample storage, pathology review and downstream processing.
Almac also offer a broad range of Clinical Trial management services such as Clinical Trial Setup & Testing, as well as a Kit Manufacturing & Logistics Service which can be tailored to support individual client’s CDx programme needs.
Our Diagnostic experience spans:
- Infective diseases
CDx Services Include:
- Design Control & Risk Management
- Sample Sourcing
- Assay Development & Validation
- Assay Software Development
- Manufacturing Capability
- Regulatory Submissions & Registrational Trial Testing
CDx Commercialisation Options Include:
- Full single source laboratory (LDT-PMA) Commercialisation
- IVD kit Commercialisation