Bench to Bedside: Formulating Winning Strategies in Molecular Diagnostics

On Wednesday morning at the BIO Convention, I attended the session “Bench to Bedside: Formulating Winning Strategies in Molecular Diagnostics.” The session addressed a growing trend of companies in the research tools market entering the growing molecular diagnostics market. Session chair, Irwin Goverman of Deloitte & Touche, LLP outlined some of the challenges faced by research tools companies expanding into the molecular diagnostics market. These companies must expand their existing capabilities, as well as develop strategies to deal with the regulatory and reimbursement environments for molecular diagnostics. Companies will have to make tradeoffs between what is expedient and what will work best in the long-term.


Panelists Amy Butler from Life Technologies, Inc., and Joel McComb from Illumina, Inc., shared their companies’ experiences making this transition. Both agreed that the primary motivation for moving into this market is the growth of their companies. One of the ways both companies are moving into the molecular diagnostics market is through partnering because they are already making the needed instruments and assays for diagnostics, which makes them an attractive partner for companies that are not building those tools.


Panelist Alicia Loffler, a professor at the Kellogg School for Biotechnology, brought an academic point of view to the discussion. I found it interesting that she kept going back to how fragmented the molecular diagnostics market is and the need for a more educated population—including a better educated physician population, in order for these tests to enter the clinical care setting. She recommended that diagnostic companies learn from strategies employed by device companies. Device companies involved physicians in the creation of their devices, which help facilitate their implementation in clinical care.


At the end of the panel, the panelists touched on an emerging issue that I believe will become even more important as molecular diagnostics move into the standard of care. The issue was whether a patient would pay to have genes mapped one at a time (like an a la carte cafeteria) or pay a one-time fee to have their genome scanned (like an all-you-can-eat buffet). If patients choose the buffet option, they will have their full genetic profiles on hand to consult when needed, while if they choose the a la carte option, they can have genes mapped as needed. Both options have their pros and cons. It will be interesting to see which model emerges as more companies enter the molecular diagnostics market.