Elizabeth HolmesAnyone with a stake in the laboratory industry is buzzing about a California company that, after working under the radar for more than a decade, aims to reinvent the way lab testing works in this country. Founded by Elizabeth Holmes, Theranos launched its testing service inside a Palo Alto, California Walgreens in September 2013 with national media coverage.

A lot of the publicity around the company has focused on its proprietary phlebotomy process that uses a painless micro-needle to draw a sample not much bigger than a few drops of blood—still enough, though, to perform more than 70 assays per sample, according to the company. However, Theranos is promising much more than just a patient-friendly experience. Holmes told CLN that the company reinvented the concept of a reference lab infrastructure to provide improved accuracy using these tiny samples, the capability to provide turnaround times of hours, not days, and a pledge to charge less than half of what Medicare pays for its entire test menu.

Now, with hundreds of millions in venture capital, Theranos is creating shockwaves in the lab community. So far, its patient care centers include 41 Walgreens stores in Palo Alto and Phoenix. The company also announced this year that it will provide laboratory services to several health systems, including UCSF Medical Center in San Francisco, Intermountain Healthcare’s hospital system in Utah and Idaho, and Dignity Health’s 21-state system.

How will your technology be used in hospitals?
As a reference laboratory for hospitals, the areas that we’ve focused on immediately are areas where our cost, turnaround time, and the small sample volume can make an impact. But we have also talked about the fact that one of the primary drivers of infection inside a hospital is the central line, and the central line is so often kept in patients longer because of the need to get blood. So there is some real improvement on quality of care that we have the opportunity to help realize in the context of phlebotomy.

Can you describe your technology?
The methods themselves for these tests are not different from the traditional methods. For example, when we measure a viral load, we perform nucleic acid amplification. If we’re measuring a protein, we would use ELISA. So we didn’t invent a new alternative to ELISA or other methods, but built our systems around them, and optimized the tests to be able to use the same methods as in a traditional lab.

We’ve also focused on automation of pre-analytic and post-analytic processing where so much of the error in testing occurs. When someone comes into one of our centers, everything in the sample collection process is tracked, measured, and sent back to the laboratory to help in the interpretation of that result.

How do you respond to the skepticism about your actually being able to achieve all that you are promising?
We’ve started the process and we’re taking one step at a time to benefit the individual. It’s certainly not easy, but we’re taking the long term approach. We are a CLIA certified lab, and have robust clinical data. When someone decides to work with us, the first thing that we do is brief them in detail on that data and get hands-on experience with the performance of our tests. We think that’s absolutely critical.

We have also been proceeding on obtaining clearance of our entire test menu from the Food and Drug Administration. Our obsession here has been to be able to hit the kind of performance standards that are required to make an impact on patient care, for earlier insight into the progression of certain conditions, so these regulatory filings are really important to us.