Much maligned for keeping its proprietary tech to itself, CEO Elizabeth Holmes said, the secretive company is starting a "new chapter" and will share its data and technology with the scientific community at the start of its product launch.
It's a product Holmes says she believes could radically transform the health care industry.
Her new idea is to miniaturize and centralize the clinical blood testing laboratory. That's what she keeps hidden behind her lab's frosted glass security door, labeled "Edison," the code name for this project that they've been working on for years.
They chose Edison because of his theory "fail 10,000 times and get it right the 10,000 and first," she said. In other words, said, CNN Chief Medical Correspondent Dr. Sanjay Gupta, who interviewed Holmes, "he never failed. He just learned 10,000 ways not to do it" -- and he invented the light bulb.
Holmes hopes this latest invention will be as revolutionary.
"We asked the question, 'Could you create a single system, single platform that would be capable of running any test?' " she said. The idea is to create a mini lab the size of a placemat that could be put in a doctor's office or in some remote location in the field or even potentially in your home. Currently, such technology would take up an entire room.
The idea fits with her theory that lab testing should be accessible to everyone. She started the company after the death of a beloved uncle whose skin cancer spread quickly. She believes that with access to a diagnostic test, it may have been successfully treated. With so much of medicine relying on diagnostic tests, if the technology works, it could be a game changer.
Theranos engineers integrated several detection and processing systems into a single platform and then created this miniature robotics system that could interface with all of them. With all these different testing mechanisms, it could count the number of red blood cells in a particular volume of blood, or it could test for a particular kind of disease. A software system could control the platform and either communicate with licensed professionals elsewhere or direct the machine to execute a particular protocol such as run a test or look for problems in the blood.
Will it work?
Holmes' critics are eager to hear her presentation today at the American Association for Clinical Chemistry conference. David Koch, an Emory University professor of pathology laboratory medicine and past president of the association, said he is "intrigued."
"If it works, great. Today, our laboratories take up a good portion of space," Koch said. "Maybe in the future, that won't be necessary. We can use this space for some other venture in the health care market."
If patients could test their own blood whenever they wanted and get the results whenever they wanted, would that be a threat to the industry or even to users? Koch believes it would.
"For me, honestly, yes," Koch said, "if that happens, if it moves into the home and patients are testing their own blood on a regular basis and making decisions that might be wrong."
However, Holmes believes Theranos' new small lab could be more like a direct-to-consumer HIV test. She said, "a lot of people were really, really concerned about it (at first), but it's played a really important role" in early detection of the disease and helping people get treatment.
The technology is Holmes' Hail Mary pass of sorts. This is a machine that her company has been working on for years, but it could give Theranos a necessary injection of excitement and energy after it got so much bad news this year. Federal regulators issued a forthcoming ban on Holmes to prevent her from running a lab for two years, which she may appeal. Also, the company had to invalidate two years of its results after an inspection found several deficiencies that Theranos failed to fix to regulators' standards.
While the company is continuing to work with federal regulators, even if Holmes is banned from running a lab for two years (which she may appeal), she has no plans to take an extended vacation.
"I have an incredible privilege, which is working to be able to really change the world. That means so much at a personal level," Holmes said. "I also get to experience failure, and those are sometimes the opportunities to turn you into who you really have the potential to be.
"I have been so inspired by a team of people in this company, the hundreds of people who work here who have channeled it toward realizing what Theranos has the potential to be," she said. "We're going to realize that vision, and that vision is that much better and that much harder and that much bigger because of it. I think that's part of the earning the dream."