A little-known healthcare start-up is slowly setting the stage to transform blood tests.
Theranos, a Palo Alto, Calif.-based company that offers about 153 tests for under $10, scored three major coups in the past week. First, they won FDA approval for their patented technology that performs complex medical tests using just a few drops, rather than a few vials, of blood. Its first application, named in the FDA announcement, extends to the company’s herpes simplex 1 test.
While FDA approval isn't necessary to operate, the decision validates the result of Theranos founder, Elizabeth Holmes' decade-long research, which aims to replace the need for intravenous blood draws with a simple, painless finger stick.
In more news, a bill the company co-sponsored in Arizona, where Theranos operates 42 wellness centers, was signed into law. It allows state residents to pay for a lab test without requiring a doctor’s order or insurance company’s participation. Doctors don’t assume any liability for patients who choose to get tested on their own, and insurance companies are off the hook for payments, as the lab tests are paid for out of pocket.
And finally, the company just announced their expansion to Pennsylvania, where they're partnering with the state's largest health insurer to offer their lab services to policy members.
There are two big reasons Americans should care about these new developments, explained Devon Herrick, a health economist with the National Center for Policy Analysis. For one, if Theranos does successfully roll out their finger-stick blood tests in more than 8,000 Walgreens stores throughout the nation (as they plan to), it means that millions of Americans could have easy, convenient access to low-cost blood tests, without having to visit a doctor first.
Practically, this means that a person who is closely monitoring his cholesterol levels could pay just $2.99 -- half the Medicare rate -- to get his numbers without paying a doctor to order them first. It means a woman can know instantly whether she is pregnant, and whether her pregnancy hormone levels are rising as they should -- again, at about half the rate it would cost Medicare.
"Many states have all kinds of medical procedures that patients themselves aren’t allowed to access unless their doctor orders it,” explained Herrick. "A doctor will tell you patients are not equipped to make decisions like this, but I think increasingly patients are deciding that maybe they don’t want to run to the doctor for every single ache and pain."
For instance, Theranos tests for herpes viruses range from $9.07 to $13.30. While you’d still have to see a doctor for treatment, visiting a Walgreens Wellness Center cuts out an initial doctor visit and separate lab visit.
Secondly, Theranos’ clear, simple list of blood tests, as well as how much each one costs, could have the effect of forcing other labs and blood testing services to lower their own costs, or at least become more honest about why they cost so much more.
Like many other medical procedures in the U.S., the cost of blood work can vary hugely from laboratory to laboratory, and having health insurance doesn't seem to make a difference. A 2013 ABC News investigation found that a woman was charged more than $4,000 for blood work at an in-network facility, while the cost for the same battery of tests at an independent lab cost just $260.
“If [Theranos] can bring down the price of blood tests, it could also lower the costs of the entire health care system,” Herrick continued. "The transparency in pricing would have the effect of enticing doctors, clinics and labs to be more transparent and competitive."
“Any way you can give people more avenues to know about their health, I think, is good,” concluded Herrick. "I’m not saying people will do it, and I’m not even saying if people do it they’ll be better stewards of their own health, but for those who want to be proactive, it’ll allow them to more easily assess their health status."
Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons and a physician in Tucson, Ariz. is all for the new law as well.
"I think it would be perfectly fine if my patients could go to Walgreens and get as many tests as they like," said Orient in a phone call with HuffPost. She praised Theranos for moving biochemical testing out of "the dark ages" with their testing technology, and said the convenience and cost of a blood stick test would be a boon to people who would like to closely monitor, say, the effects of a new diet or new exercise regimen on their blood sugar levels.
However, she did caution that, like all medical tests, there are downsides to over-testing, which include increased anxiety and more medical intervention in the case of a false positive result.
"For people at low risk of disease, any positive test that you get is likely to be a false positive, and that patient will be exposed to anxiety and a whole lot more tests trying to pursue the positive result that probably doesn't mean anything," she explained. "This goes for all kinds of tests -- mammograms in particular have a high false positive rate and expose women to all sorts of terrors as they pursue further testing."
Still, Orient praised the fact that divorcing blood tests from the initial doctor's visit and pre-authorization from a health insurance company resulted in lower costs for consumers, which means they are more accessible to people.
"On the whole, it's very good for patients to be able to get frequent, low-cost tests and not have to run for the doctor every time they want a test," she said.
UPDATE: This story was updated to include news about Theranos' Pennsylvania expansion.