Blood testing company Theranos was once valued at $10 billion, but false claims over its testing abilities led to one of the greatest collapses in the history of the health care industry — and landed its wunderkind CEO, Elizabeth Holmes, in prison for over 11 years. Now, nearly a decade on from that scandal, companies are trying to revitalize the finger-prick blood testing technology that led to the downfall of the Silicon Valley startup.
Theranos claimed that with just a single drop of blood from a finger prick, its tests could provide myriad results about a patient's health. While Theranos wasn't able to accomplish this, other companies are now working to develop a finger-prick blood test that can do what Theranos originally claimed — and possibly more.
One of the most notable companies working toward this goal is Babson Diagnostics; the Austin, Texas, based company has started a finger-prick blood test, BetterWay, that is "designed to need one-tenth the volume of blood — an amount as small as a pea — collected from the fingertip," according to its website. Will these types of companies be able to shed the stigma of Theranos' rocky past?
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Theranos' rise and fall "cast a pall over the idea that critical medical tests could be run on mere drops of blood," but "demand for alternatives to standard blood draws never went away," said Peter Loftus at The Wall Street Journal. Now, several companies, including the aforementioned Babson Diagnostics as well as Becton Dickinson, have "been working out technological kinks that foiled Theranos."
Theranos has "always been a two-edged sword in that it put a stain on the integrity of the industry that I don't think will ever go away," Eric Olson, the founder and chairman of Babson, said to the Journal. But "at the same time, it awoke the idea that things can be different." Theranos had "tapped heavy interest in something faster and less painful than standard blood draws, which can take 6 to 12 milliliters or more," said Loftus.
While the "tech is itself noteworthy for its convenience, its broader ramifications lay in the democratizing access to the critical medical information that resides in patients' veins," Sy Mukherjee said at Fast Company. One of the most notable innovations is that these tests "could allow a pharmacist to conduct regular blood draws locally, rather than having to see a specially trained nurse or professional phlebotomist at a lab or hospital."
For now, Babson "runs only the sorts of tests you'd expect as part of a typical annual physical exam, such as those that measure blood cell counts, hormone levels, and lipids," said Sophie Novack at Texas Monthly. The company "plans to conduct a broader array of tests in the future, but screening for some conditions simply requires much more blood — a fact that Theranos failed to acknowledge," and which ultimately led to its downfall.
However, for "doctors to gain confidence in the new method, it will be crucial for Becton and Babson to publish the clinical data demonstrating its accuracy across a range of patient populations," Dr. Charlene Bierl, a professor of clinical pathology and laboratory medicine at the University of Pennsylvania, said to the Journal.
What next?
Earlier this year, the U.S. Food and Drug Administration (FDA) announced they would begin implementing oversight of these blood tests, which had previously flown under the radar due to a regulatory loophole. But these companies now "have about four years to show that their new offerings deliver accurate results, under a government rule vigorously opposed by the testing industry," The Associated Press said.
The regulation will "gradually phase in oversight of new tests developed by laboratories, a multibillion-dollar industry that regulators say poses growing risks to Americans." However, some are concerned that these regulations will stifle the now-growing blood test market. The "substantial costs associated with FDA approval may dissuade companies from proposing laboratory developed tests unless they are likely to be profitable," J. Wesley Boyd said at Scientific American. It could also "break the medical ethics principles of beneficence (promoting patient well-being) and nonmaleficence, or preventing harms to patients." Any "delays in test availability could deprive patients of important diagnostic information, potentially compromising treatment decisions and prognoses."
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