“Wouldn’t it be great if we could come up with a noninvasive diagnostic assay to detect pancreatic cancer at an earlier, more treatable stage?” asked Lori Aro of Myriad Genetics. Her company has been trying to do so for years. So why hasn’t it happened?
Aro, senior director for new product planning at Myriad, outlined the business obstacles at a recent panel hosted by Boston Children’s Hospital’s Technology and Innovation Office (TIDO).
First, who are the target patients for a pancreatic cancer test? Skinny diabetics, patients with chronic pancreatitis, patients with hereditary cancer risk — or all three? “Those three patient types all sit in different doctor’s offices,” said Aro. Simultaneously reaching endocrinologists, gastroenterologists and high-risk patients would be an insurmountable challenge, Myriad concluded.
Second, the assay would likely need to be validated in all three patient populations, with confirmatory imaging. Could the test populations be large enough to make the results statistically significant?
Third, a new test wouldn’t change care, as there is no treatment for pancreatic cancer. In fact, no current data show that earlier diagnosis improves survival. So who would pay for it?
Aro’s story exemplifies just some of the challenges in developing a new diagnostic test. Supreme Court rulings, such as Myriad vs. Association for Molecular Pathology and Mayo vs. Prometheus, have made it hard to patent diagnostic correlations. The Centers for Medicare & Medicaid Services (CMS) and, to some extent, the U.S. Food and Drug Administration (FDA) are requiring long and costly trials to demonstrate clinical utility and better patient outcomes before they will pay for a new test. And Medicare has decreased reimbursement rates for tests in general.
How do scientists interested in developing diagnostics navigate such hurdles? The panel provided six takeaways.
Read the full post on Vector: Getting academic diagnostic discoveries to market: 6 tips from industry
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
The post From discovery to delivery: Moving academic innovations to the market appeared first on MassDevice.
from MassDevice http://ift.tt/2aBYJhl
Cap comentari:
Publica un comentari a l'entrada