A collaborative partnership approach
When it comes to the discovery, development and commercialisation of companion diagnostics (CDx) for future precision medicines, no two pharmaceutical or biotech companies will ever have the same needs.
At Almac Diagnostic Services, we understand these needs: timelines can be challenging, platform flexibility may be required, regulatory approaches may vary & clinical studies often require bespoke methodologies.
Working with companies worldwide, we offer a truly collaborative Rx / Dx approach to create and deliver customised CDx solutions that are unique, helping you to differentiate your drug in the marketplace.
Range of services
- Design Control & Risk Management
- Sample Sourcing
- Assay Development & Validation
- Assay Software Development
- Manufacturing Capability
- Regulatory Submissions
- Clinical Trial Support
Our approach to CDx development has been designed to offer you complete flexibility, with a range of diagnostic platform and chemistry options and specialist supporting services, tailored to your specific drug and companion diagnostic development requirements.
- Multiple Disease Areas (Experience in both Oncology and Non-Oncology Indications)
- Platform Agility & Strategic Commercial Agreements (NGS, qpCR)
- Global Laboratory Facilities (UK/EU, USA and China Partner Laboratory)
- Flexible CDx Development & Commercialisation Models (ssPMA or IVD Kit)
Regulatory expertise & accreditations
- Regulatory Submission Experience: FDA, MHRA and EMEA
- Laboratories: CLIA & CAP certified and ISO17025 & ISO15189 accredited
- Manufacturing Accreditations: ISO13485 for design and development of IVD assays
- Software Development Accreditations: ISO14971 & IEC62304 accredited
CDx Development Pathway
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 CDx solutions that add real value.
We have the 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 & our partnership laboratory in Asia.
Find out more about our CDx commercialisation capabilities.
Almac Diagnostic Services are currently working on multiple CDx development programmes with Global Pharma and Biotech partners:
++ Almac currently working with Turning Point Therapeutics on key CDx Programme. See: NEWS