Dive Brief:
- Theranos CEO Elizabeth Holmes told attendees at the America's Health Insurance Plans annual meeting last week that direct-to-consumer lab testing is key to health reform and a way to reduce disease and high health costs.
- The company's technology allows testing for hundreds of conditions with only a fingertip drop of blood versus a vial.
- Although critics doubt the test's accuracy, Holmes said the FDA will be the "ultimate scrutinizer" of the technology.
Dive Insight:
Some are concerned that the technology combined with eased restrictions may enable over-testing. As Charles Ornstein wrote in ProPublica, "More testing leads to more false positives and incidental findings (abnormalities that don't pose a risk to your actual health). That leads to a higher probability of treatment. And treatment carries side effects."
Although currently there are 20 states that either limit or prohibit individuals from getting their own lab tests, state policies do seem to be shifting. A new Arizona law goes into effect this July allowing residents to obtain and pay for any lab test with no written authorization from a provider.
"This simple new law can serve as a model for our nation and is essential to the creation of a modern health care system focused on preventative care," Holmes said. She added that over-the-counter HIV tests have played a role in controlling AIDS and the same could work for the estimated 8 million Americans with undiagnosed diabetes. Furthermore, more direct-to-consumer will allow people to become more familiar with testing costs and "that transparency will drive pricing down, reducing their healthcare costs," Holmes claimed.
Other diagnostic companies are trying to capitalize on the consumer market as well, so Holmes has a vested interest in promoting this kind of policy. In April, the country's largest diagnostic company, LapCorp, announced that it would being allowing customers to order certain clinical tests without a doctor's order. As we wrote at the time, you can expect to hear more about this as consumers start to demand more control over their health—and some providers hesitate.