Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.and by: Roche Molecular Systems,: A proud sponsor of today's podcast. Guests:
Mark Trusheim, Founder, Co-Bio Consulting Bio and Contact Info
Listen (11:54) Science blossoming, but still a long ways to go
Listen (6:41) The economics of diagnostics
Listen (3:41) Why the indignation over Myriad gene patents?
Listen (5:11) Finding IP protection for innovative diagnostics
Listen (7:54) ACA a new opportunity for payers to improve misaligned incentives
Listen (7:10) From one-off tests to whole genome, proteome testing
Continuing our series Commercializing Diagnostics, we’re joined by an economist who has been the CEO for a diagnostics company and now consults. Mark Trusheim is the founder and president of Co-Bio Consulting and Executive in Residence and Visiting Scientist at the MIT Sloan School of Management. He’s also a Special Government Employee for the FDA’s Office of the Commissioner.
The world of diagnostics is in great flux. The science is blossoming and technology is evolving at lightning speed. Whole genome sequencing threatens to overtake "one-off" tests. Gene patents are up in the air and regulation is uneven between IVDs and LDTs. Furthermore, a new healthcare law, the ACA, offers payers new opportunities to address misaligned incentives in the practice of medicine. How does a diagnostic company create value with a test and then protect that value in such a changing landscape? Running longer than our typical 30 minutes, Mark's interview will put you on the front row of the diagnostics show.
Note: Today's show was recorded before the recent Supreme Court decision on gene patents.