As I write this blog, I keep asking myself, what more is there to say about the question of LDT regulation?
It seems to me …
if you’re in favor of more regulation for LDTs then it’s easy to find ways in which the industry has players that need to be reigned in.
if you’re not in favor of more regulations for LDTs then it’s easy to find ways to imply the FDA isn’t up to the task of regulating LDTs or that more regulation will stifle innovation and business.
I guess the only thing anyone has to state at this point is opinion. And like many things, we all have one. So here goes …
We need to have tighter regulations on LDTs.
We can all agree on the medical value of diagnostic products along with the risks that potentially inaccurate results present to patients. If that's the case, then let’s get on with rebuilding the value of these critical decision-making products and our industry as a whole. There has been a race-to-the-bottom for diagnostic products in terms of data generation and monetary value for as long as I’ve been around. The only way to stop this vicious cycle is to embrace the upward spiral of creating trust and value.
Creating trust and value must begin with being transparent with the data and allowing third parties to review and assess that data. Currently, most LDTs live outside of the two main ways we have to be transparent with scientific information – regulation and peer-reviewed papers. Since we can’t mandate publishing, the alternative is regulation. Physicians, patients and insurance companies need to see the data diagnostic tests are based on and be provided the opportunity to make critical health decisions accordingly.
FDA has made all of the accommodations requested over the years from the lab. From a long ramp-up to opportunities for third party review and exceptions for rare disease.
From my viewpoint, the ball is in the lab-industry’s court along with the providers that develop and market laboratory instruments, assays and software. It’s time to step up our game and take our rightful place next to regulated therapies. If we embrace this challenge we may be able to also take our rightful place in terms of how monetary value is placed on our products.
My plea to the industry is: stop fighting regulation and start embracing value.