Product cylce

The product cycle can be classified into the 4 following phases:

Phase 1 - Proof of concept: (Duration: 12 months)

New assays are developed that can reliably measure CD4+ counts in blood and meet major specifications outlined under the 'Specifications' section of this site.

Phase 2 - Prototype development, scale-up and validation: (Duration: 12 months)

Prototype development, scale-up and validation: New assays meet most, if not all, of the pre-determined specifications and offer reliable and reproducible results in medium-scale production. 

Phase 3 - Clinical trials & cost effectiveness analysis: (Duration: 8-12 months)

Assays are tested in resource-poor settings to ensure that assay specifications are achievable in field conditions. Assays are then evaluated at five to ten clinical sites for effectiveness in managing ART, while the manufacturing needs and cost structure of the selected products are further examined.

Phase 4 - Technology transfer & large-scale production: (Duration: 8-12 months)

In partnership with and through technology transfer to a company, ideally in the developing world, large scale production and distribution of CD4+ assays will take place.