Molecular Diagnostics: The Shift to Complexity



The Fourth Annual Workshop on the Regulation & Reimbursement of Molecular Diagnostics

hosted by the Center for Law, Science & Innovation’s Program on Personalized Medicine and the Law

April 17, 2015

Skysong Innovation Center, Scottsdale, AZ


Workshop Objective

Earlier molecular diagnostic tests involved assays for a single analyte, whether it be a gene, a protein or some other biological marker.  This single biomarker-based approach is quickly becoming obsolete as researchers and clinicians move to more complex tests that includes a panel of multiple markers, that can range from a few to hundreds or thousands of individual genes or other biomarkers.  The ultimate example of this multi-marker testing is whole exome and whole genome sequencing, which are rapidly moving into the clinic.  The relatively simple single biomarker tests of the past were relatively simple to evaluate for reimbursement and regulation in that they involved a single biological relationship or pathway, and the components and uses of that test remained static.  So once approved, they rarely if ever changed.  The new complex tests are based on algorithms and knowledge that is constantly being updated with new findings, and thus are dynamic rather than static.  This presents an enormous challenge for both reimbursement and regulation.  Similar issues will be increasingly presented for other medical technologies, such as mobile health apps and imaging.  In this workshop, we will explore these challenges including questions such as:


– How significant is the trend toward multiplex molecular diagnostics?

– How have CMS and FDA responded to this shift towards more complex molecular diagnostics?

– Do current statutory frameworks for reimbursement and regulation provide sufficient flexibility for agencies such as FDA and CMS to adapt to these new types of products?

– How much can a manufacturer modify its current product approved by FDA and/or covered by CMS without seeking a new regulatory approval?

– Will the shift to more complex diagnostics require greater focus on post-market rather than pre-market evaluation?

– Are there lessons to be learned from other technologies that can apply to the context of molecular diagnostics?

– Can and should FDA regulate algorithms?

– How can the data be made accessible for ongoing evaluations of changing algorithms?



 Presented by:

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