The battered diagnostics company Theranos this week tried to pivot from its failed past as a blood testing company to a future developing lab equipment.
But that future looks quite murky.
Theranos CEO Elizabeth Holmes gave an optimistic presentation on Monday about the company’s new technology, dubbed miniLab. It’s a tabletop platform that Theranos said will be able to run more than 150 lab tests using a small amount of blood. But based on the internal data that Holmes shared, the miniLab is nowhere close to that capacity yet. And she offered no timetable for getting it on the market.
“I will be totally wrong if we try and guess that,” Holmes said in an interview with Reuters distributed to the media.
Industry analysts and consultants said it’ll likely be a long haul: Before Theranos can start selling that new invention, the company must convince regulators that, unlike its first product, this one actually works. It’ll also have to distinguish itself from other portable blood testing devices on the market.
And it’ll have to persuade potential customers to forget about the company’s first, failed testing platform, the Edison — even though the miniLab looks almost exactly like the Edison, from the outside at least.
That likely means at least two years of conversations with regulators, validation tests at multiple sites, and review by the Food and Drug Administration, said Zvi Ladin, a consultant at Boston MedTech Advisors. The small chunks of miniLab data Theranos has disclosed so far suggest some promise, he said, “but the devil is in the details.”
And details, to date, have not been kind to Theranos.
The California company once promised to revolutionize the lab testing industry by using a single drop of blood to run hundreds of tests. Those claims slowly came unglued over the past 12 months, as the Centers for Medicare and Medicaid Services found that Theranos’s practices in its California lab resulted in “immediate jeopardy to patient health and safety” and summarily banned Holmes from owning or running a lab for two years.
Those sanctions don’t take effect until September, or even later if the company appeals.
Theranos has signaled Holmes will stay in her position as CEO, regardless, though she did recently resign from an honorary post as one of the Obama administration’s Presidential Ambassadors for Global Entrepreneurship, Fortune reported on Tuesday.
Since she wouldn’t be allowed to run a lab during the two-year sanction period, Theranos has said it would shut down the company’s lab in Arizona, at least temporarily, if the ban takes effect. Theranos has already shut down its California lab to address concerns raised by federal regulators. Holmes said in the interview that “we’re rebuilding it from scratch” — but offered no timetable for doing so.
(To get around the sanctions against owning clinical labs, Holmes could potentially transfer her voting shares in the company into an independently controlled trust, according to Michael Greeley, a senior investor at Flare Capital Partners who has been watching the case closely.)
If Theranos is able to bring the miniLab to market, that could represent a path to redemption. The company wouldn’t need to run its own labs to bring in revenue; it could instead sell miniLabs to hospitals and doctor’s offices.
The question is: Would anyone buy them?
Competitors and industry insiders aren’t so sure.
“Just being smaller isn’t a technological solution,” said Brian Blaser, executive vice president of Abbott Diagnostics, a large laboratory equipment vendor. “It needs to be smaller, competitively priced, have a fast turnaround time — and be reliable.”
And reliability is one of Theranos’s most serious stumbling blocks, he said.
Abbott Diagnostics used to have “a healthy paranoia” about the diagnostics Theranos was developing, Blaser said. But these days, it’s not so worried, given that Theranos has been working on blood testing equipment for the 13 years it has been in business — and still seems far from being able to sell a commercially viable diagnostic. After seeing Holmes’ presentation, “we’re less concerned,” Blaser said.
Holmes has committed to having external companies review and validate miniLab test results. The company has also said it’s in the process of submitting data for peer review and publication. But none of that has happened yet, and the timetable is uncertain.
Other big challenges for Holmes: raising money and recruiting executives.
The company was once valued at $9 billion but is now nearly worthless, at least according to an estimate by Forbes magazine. Asked directly if Theranos has a current revenue stream, Holmes answered “yes, yes” but gave no details, saying only that she’s “committed to building the company.”
It’s unclear how much cash the company has on hand. “We’re a private company. We don’t disclose that,” she said.
All this has left analysts wondering what type of future Theranos can have. “I can’t think of another case that looked like this,” Greeley said.
Meghana Keshavan and Rebecca Robbins contributed to this report.