Express Pathway -- In Vitro Diagnostic Development and IVD Development, FDA Filing and Diagnostic Commericialization

Clinical Development I-III

From Research Tool to Clinical Diagnostic

Diagnostic Tool

In Vitro Diagnostic Product Development

Biomarkers validated through Althea’s Express Pathway program under GLP conditions are formulated in a format amenable to becoming an in vitro diagnostic (IVD) product. Althea’s Express Pathway enjoys full adoption of Althea’s core proprietary technologies on established instrumentation platforms, such as the Beckman Coulter GeXP capillary electrophoresis system, providing a clear development path for IVD development.

Homebrew Assay

Althea’s development team has extensive experience in formulating biomarkers in assays that can be used in CLIA certified labs. This includes strategic utilization and production of analyte specific reagents (ASRs), or In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) where applicable.

IVD Development

Althea’s position as a leader in the field of bioscience related manufacturing allows for a predictable and reliable source for ASRs. Althea can manufacture and or formulate all ASRs associated with an Express Pathway partner’s IVD product.

FDA Filing

Althea is currently actively engaged in several pre-IDE meetings and filings with the FDA for approval of in vitro diagnostic products (IVDs). We know what it takes for successful filing of an Express Pathway partner’s IVD.

Commericialization

In collaboration with our CLIA-certified central laboratory partners, and instrumentation platform licensees Althea can move an Express Pathway partner’s diagnostic product from a homebrew format to one that is available and used in laboratories worldwide.