The big question is why the scam wasn’t detected earlier. Theranos promised the moon—or at least a full battery of blood tests from a minim of blood—but it never came close to delivering. And yet, investors and the press alike gave wunderkind founder Elizabeth Holmes pass after pass, perhaps mesmerized by her inspiring backstory and her eerie semblance to a female reincarnation of Steve Jobs, an illusion she cultivated right down to wearing black turtlenecks identical to those favored by the late Apple CEO.
Now that Theranos has collapsed and Holmes faces criminal fraud charges, there are plenty of people claiming they knew the company was bogus all along. But Luke Lee, a Berkeley professor of bioengineering, electrical engineering, and computer sciences and the co-director of the university’s Sensor and Actuator Center, isn’t among them. Lee says it became clear to him that something was amiss at Theranos “after they kept promising and promising, and we never saw any publications, any clear proof they had what they said they had. But in the beginning, I didn’t question it. I’d been doing the same sort of work for 20 years, and I thought maybe they had it all figured out. I thought I’d probably have to give up my own research and go into something else.”
Indeed, Lee has perfected or contributed to two technologies that essentially fulfill the aborted promise of Theranos. The first, a “photonic” ultra-fast polymerase chain reaction (PCR) device, uses light to rapidly amplify DNA. PCR is critical to a wide array of applications, from forensics to agriculture—and most particularly medicine, including blood testing for infectious diseases, tumors, and genetic abnormalities. Lee’s system essentially speeds up DNA amplification from days or hours to minutes.
Lee’s PCR system is preterit to SIMBAS, a “lab on a biochip” developed by a team of researchers from Cal, Dublin City University in Ireland, and Chile’s Universidad de Valparaiso. The Berkeley researchers who contributed to SIMBAS worked out of Lee’s lab, and Lee was a co-author of the peer-reviewed paper that described the process. SIMBAS chips can accommodate up to 200 chambers, each charged with PCR-generated DNA “biomarkers” that can identify specific diseases or disorders. In sum, SIMBAS can be configured for a large number of simultaneous blood tests, quickly yielding accurate results. So why are we talking about Theranos’s failure at this juncture rather than the smashing success of photonic PCR and SIMBAS? There’s a cautionary tale there, observes Lee—and it implicates the entire high tech culture, not just Elizabeth Holmes.
“Holmes was very smart,” says Lee. “She saw the big picture at a time when people were publishing different aspects of the whole, and she figured it all out well enough to line up investors and hire a lot of engineers. She thought if she threw enough money at it, the technology, including mass production, would catch up with her. But it didn’t.”
The Theranos gambit is not an anomaly for Silicon Valley and similar tech centers, says Lee. In fact, Holmes’s approach has become the default path for high tech. Researchers, Lee says, often try to market a device or system before it is ready for prime time. Lee attributes at least a portion of the problem to the impetuosity of youth—and the remainder to simple greed.
“We’re seeing this time and again.” He says. “Younger researchers tend to jump the gun. They have to understand that it’s not just a matter of developing a process. You can’t scamp clinical trials. You have to establish reliability, the results have to be demonstrated as replicable, and you must prove that your process can be mass produced at acceptable price points.”
Visions of riches, Lee says, have vitiated the scientific process, ultimately making it difficult for researchers who have done their due diligence to raise money.
“People are now just chasing money instead of developing and enjoying their talents,” Lee says. “We need to change the old academic directive, ‘Publish or perish,’ to ‘Publish and cherish.’ If you pursue your talents, the money will eventually come. But the goal for too many people is to become billionaires by the time they’re 30. That leads to things like Theranos. For me, people like Edison, and especially the Wright Brothers, are the standard. The Wright Brothers failed so many times, but after many, many trials, they succeeded. They didn’t try to take any shortcuts. They’re my inspiration, especially because I’ve had a lot of challenges of my own after 20 years in this field. Their experiences have convinced me to stick with it.”
The irony, says Lee, is that technologies like photonic PCR and SIMBAS have brought Theranos’s failed promise—rapid, accurate tests from miniscule quantities of blood—tantalizingly close to realization. Once mass production techniques are perfected and verified (something that’s not a trivial obstacle, acknowledges Lee), functional Theranos-like devices might well be deployed. But the Holmes debacle has shaken the entire biotech industry, spooking the venture capitalists who supply the funds that ultimately turn scientific breakthroughs into breakthrough products. Lee is now seeking funding to develop mass production systems for photonic PCR, and he’s finding it a tough go. The same is true, he says, for the team that developed the SIMBAS chip.
“[For the SIMBAS paper] only one biomarker was used because each one is so expensive,” Lee says. “To produce a chip that has biomarkers for all 200 chambers, and then take that through clinical trials to mass production, is going to be require a lot of money. I’m going back to Boston soon to see if I can get funding for clinical trials and mass production research for photonic PCR. I recently returned from Singapore, where I thought I had funding lined up. But it fell through, and Theranos was part of the reason. That’s the real tragedy—this one incident is drying up funding for anything associated with blood tests, or PCR, or biochips—it’s affecting a lot of important research.”