Diagnostic Assay Global Launch
Worldwide commercialization of an HIV diagnostic assay.
Situation
- Health Advances’ client, a diagnostic company, developed a cell-based assay to predict a patient’s response to a drug company’s novel HIV therapy.
- The two companies signed a collaboration agreement for making the assay available worldwide.
- All patient samples must be frozen and shipped to the US for processing – a challenging requirement in the developing world.
- Health Advances was engaged to develop country-specific recommendations for making the assay available.
Critical Questions to Address
- Who are the key physician decision makers in each country?
- How is HIV treated today in each country? What types of facilities? What diagnostic and monitoring tests are conducted?
- Which laboratories process test samples? How do samples move between facilities today?
What temperature is used for sample transport? Is cold chain reliable?
- Which laboratories in the country or region have the capability to consolidate samples for our client?
Health Advances Approach
- Determine the current HIV/AIDS diagnostic and treatment patterns for each country through primary and secondary research.
- Assess the existing laboratory and transportation infrastructure of each country.
- Conduct in-country site visits with treatment centers and potential laboratory partners to assess capabilities and interest.
- Evaluate cost of potential logistics solutions.
Results
- Health Advances created customized logistics solutions for each country that maximized access to the biomarker while considering cost, physician and patient effort, as well as the effort to both implement and maintain the solution.
- To date, Health Advances has developed and recommended a launch strategy for the biomarker in nearly 70 countries across six continents.
