A recent article in Fortune suggested that, despite the bumps in the road for Theranos, Elizabeth Holmes' vision was probably correct in terms of the need for reform in the clinical lab industry (see: Despite Clamor Surrounding Theranos, The Entrepreneur's Vision Of Transforming Diagnostics Is Near). Below is an excerpt from an article:
Despite the recent controversy with Theranos, transformative changes in health care diagnostics are here to stay. The entrepreneur’s vision for radically improved solutions is out of the genie’s lamp, and consumerized, affordable, and convenient diagnostics will soon be an ongoing part of millions of people’s health and wellness lifestyle. Over the past few weeks, Theranos founder Elizabeth Holmes has been criticized for missteps and misrepresentations about blood diagnostic technology produced by her company. Whether or not these allegations turn out to be true, the Theranos story should not distract investors and the industry from the real prize: consumer-friendly blood diagnostics, anyone can afford and get access to, so people can better monitor and improve their health.....[T]he field of blood diagnostics is in the midst a revolution. As blood diagnostic technology rapidly advances, one of the biggest innovations is with user experience – bringing minimally invasive diagnostics to your pharmacy, your home, your office and your smart phone. In five years time, frequent...diagnostic blood tests will be an integral part of managing one’s health. Without ever stepping foot into a clinic, people will be able to safely and accurately monitor lipid parameters and track for certain biomarkers of disease, all from the comfort of home. Even more exciting is what happens when these tests become truly affordable, accessible anywhere, and analyzed by intelligent monitors. Some obvious opportunities: early detection of disease, incremental behavior change, and hopefully longer healthier lives.
I agree with the need for transformative changes in the clinical lab industry and diagnostics articulated in this article. Hence and to kick off this discussion, I thought that it would be useful to generate a simple list of what I think might be key descriptors that could characterize the reform process:
- Understandable/analyzable reports.
- Useful in terms of health improvement and disease avoidance.
- Risk minimization; no inaccurate data and avoidance of iatrogenic injury
As I developed this list, I was striving to come up with terms that the lay public would understand and relate to. After all, they will be major drivers of the reform effort. After I completed the list and understanding that it will be subject to subsequent revisions, it occurred to me that my idealized diagnostic system was far removed from our current one. In other words, our healthcare system that has evolved over many decades has been designed largely by and for physicians and healthcare executives. It's far from being consumer-friendly. The reform of diagnostics will obviously move in this direction, largely fueled by the profits that can be achieved by entrepreneurs who develop companies and apps that support greater consumer engagement in diagnostics and healthcare delivery.
I want to make one more brief point in terms of the affordability of diagnostics. Most lab tests are quite inexpensive to perform because they are highly automated. The price for tests that may be seen by self-pay consumers is relatively high because of the markup of these prices by hospitals, often to compensate for other services that are run at a loss. As lab testing becomes unmoored from hospital spread sheets as is the case with direct access testing (DAT), the prices will move closer to their true, and lower, cost.