Support for Diagnostic Development Partners
Support for Diagnostic Development Partners
Almac Diagnostic Services’ global ISO15189 compliant, CLIA and CAP certified laboratories can support Diagnostic Development Partners, (such as platform providers, reagent manufacturers and other diagnostic companies), to help develop & execute your global product development plans.
Our Experience & Way of Working
- A flexible business model where you can contract with us on a ‘fee for service’ based model for a specific service or a combination of services.
- Experience of product development, both in-house and on behalf of partners
- Scientific teams with over 20 years of diagnostic development experience
- Responsive project management teams
- A reputation for generating high quality lab data to help with your studies & submissions
- Provide a diverse range of services through our comprehensive portfolio of instruments and chemistries (NGS, qPCR, ddPCR, ELISA and IHC)
How we can help
We can facilitate third party product development in several ways, including:
Support For Product Development
- Almac can support your product development needs by acting as a reference site for your analytical validation studies. We can also help as part of ‘intra-lab’ studies if required.
Support For Orthogonal Testing
- Almac can support your orthogonal testing needs from our range of platforms across a number of technologies, including NGS, qPCR, ddPCR, ELISA and IHC.
Support For Clinical Testing
- Almac can act as your clinical testing site from our Global ISO15189 compliant, CLIA / CAP certified labs covering UK, EU and USA and from our partnership labs in China.
Support For Regulatory Needs
- Almac can provide regulatory consultancy with up-to-date guidance and support for your development programmes around IVDR compliance with the regulations for Europe.
Example of Diagnostic Development Partner support – Illumina, Bayer & Almac
Press Release – “Illumina Introduces New Pan-Cancer Companion Diagnostic to Match Patients with Rare Genetic Mutations to Targeted Therapy”.
“We were delighted to be the clinical study partner for Illumina in this significant achievement of the first CDx claim for the Illumina TSO Comprehensive (EU) panel. TSO Comprehensive (EU) represents a powerful and versatile platform with a broad range of cancer-relevant content, and we recognize its value to our biopharma partners, for the development and delivery of companion diagnostics to further precision medicines.”
Richard Kennedy, Medical Director, Almac Diagnostic Services
Contact Us
Looking for a diagnostic provider to partner with for your product development needs?
Simply fill in the form below and we will get in touch with you to discuss your requirements.