AltheaDx provides the translational development capabilities for PCR-based diagnostic design, verification and validation in compliance with US and European guidelines.
UNIQUE TRANSLATIONAL CAPABILITIES
Diagnostic development requires a different set of design and development controls than is needed for standard clinical laboratory testing. AltheaDx’s experienced Development and Quality teams work with both pharmaceutical clinical groups and leading diagnostics manufacturers to provide core translational capabilities.
AltheaDx is a focused developer of PCR-based diagnostics. AltheaDx works with the pharmaceutical and/or clinical partner to define the diagnostic test, often taking it initially through a first-stage development program as a research use test used in our own clinical laboratories.
For application in the clinical lab setting, all assays developed at AltheaDx can be formulated as RUO kit components for transfer to other clinical laboratories. AltheaDx also prepares all standards and reference material for the validation of the tests within other labs, and serves as the gold standard lab for interlab testing.
Beyond RUO, the diagnostic progresses in design and development to become an IUO and then proceeds into the diagnostic submission process. AltheaDx works in concert with the diagnostic sponsor to define the diagnostic development program, mapping out timelines, scope of work and commercialization plan. AltheaDx functions as a translational partner acting to assure that the sponsor’s needs and timelines are met and, with the right diagnostic manufacturing partner, that the diagnostic is deployed broadly for use.
For PCR products planned for diagnostic application, AltheaDx can utilize several different manufacturers of GMP level product. With these manufacturers multiple options for diagnostic product creation exist, running the range from using the manufacturer as an OEM to produce a 3rd party labeled product, to manufacture and use of the companies sales force for product sale, through to licensure of the product to the manufacture for in-house production and sales as part of their own product line.
