July 2015 may prove to be the start of it all—at least in the laboratory diagnostics and blood testing industry. Multiple decisions made last month could disrupt the $50 billion blood testing industry as we know it—and put the power back in the hands of people.

The ball has indeed started rolling, and we can thank Elizabeth Holmes and her company Theranos for giving it a good push. 

Holmes, a Stanford University dropout, founded Theranos in 2003 at the ripe old age of 19 after her uncle died from cancer that was not caught early enough. The company’s goal is to facilitate health information to consumers easily, inexpensively and at the time it matters most.

“By the time there are already symptoms, it can often be too late to fundamentally do something about it. We define Theranos as: detecting the onset of disease in time for therapy to be effective. So we can begin to build a world where no one finds out too late that something is wrong. And no one has to say goodbye too soon,” reads the company’s website.

To make this possible, Theranos developed painless finger-prick blood tests. With just a few drops of blood, these lab tests can scan for disease and conditions almost instantaneously. Debuting tests to the public in 2013, Theranos now offers more than 200 variations—153 of them for under $10. And as of July 2, one such test for herpes (which retails at $9.07) has been approved by the FDA. The regulatory body approved the entire Theranos system, including Theranos’ test device, analytical software and patented Nanotainer Tubes.

What’s unusual about this FDA approval is that it was voluntary—Theranos did not need to seek approval as the FDA does not require Laboratory Developed Tests (LDTs) to be submitted for review in order to be sold to the public. However, according to its press release, “Theranos believes that the rigor of FDA review helps to ensure that tests are properly designed and interpreted, consistently manufactured and of the highest quality.”

A second win for Theranos came just days after the FDA approval. On July 5, Arizona passed a bipartisan law allowing residents to access and pay for any lab test themselves, without first being required to get a doctor’s note in response to a health issue or dependent on insurance eligibility. Theranos already has a wellness center in Arizona, so the law opens an even wider door for the company’s blood tests. 

And that was just the first week of July. On July 16, another FDA panel granted approval for Theranos to process the now-approved herpes blood tests outside of a lab—which means they can be analyzed at the company’s wellness centers in Arizona, California and Pennsylvania. 

Despite Holmes and Theranos seeking FDA approval, there has been some backlash from the academic community and others in the medical profession regarding the company’s lack of transparency. Some believe Theranos should release information on exactly how the technology works, including raw data and protocols, and consider it a strike that the technology has never been peer-reviewed. 

But, as we’ve seen in the past, peer-review has its own set of problems. And, one must ask, why should Theranos release its proprietary information?

Pharmaceutical companies don’t release the recipe for their drugs. In fact, those companies are doing everything they can to hold onto their drug patents for just a little bit longer.  
New drugs from pharma are released to the public after extensive trials and subsequent federal approval—which is similar, albeit not as rigorous, to the process Theranos went through with the FDA.

For the herpes test review, Theranos provided study data to the FDA from 818 subjects of varying age and ethnicity, demonstrating that its system could be run accurately using a finger-prick amount of blood compared with commercially available tests that use blood drawn from a vein. Theranos devices and tests were all compared against an FDA-cleared, commercially available reference method.

If we willingly accept the FDA’s stamp of approval on oral drugs, why not for a low-cost blood test that can better reach the masses?