DIAGNOSTICS DEVELOPMENT

IS ON THE FRONTIER OF SCIENCE

In a few years we have moved from the painstaking identification of single gene mutations to rapidly sequencing the entire genome. Laboratories around the globe add to this expanding knowledge while we sleep.  How much like space explorers we are: limited only by our imaginations.

BUT BACK ON EARTH

THERE IS WORK TO BE DONE

To clear a rapid path to market, we must meet these challenges:

• Define the unmet clinical need
• Build the business case
• Identify the regulatory path
• Establish the reimbursement strategy
• Develop a cross-functional, milestone-based product lifecycle plan – and stick to it
• Bring in studies that achieve analytic and clinical validation and clinical utility – on time and within budget
• Select a recognized gold standard
• Ensure the clinical data supports the planned test use and population
• Launch strategic partnerships with key opinion leaders and clinical experts
• Create a data-driven publication strategy – and meet it