Theranos has a lot to prove.
And on August 1, Theranos CEO Elizabeth Holmes will have a chance at some redemption. She is presenting data on the company’s controversial, “revolutionary” tests that take only a fingerprick’s worth of blood.
That’s happening at the American Association for Clinical Chemistry’s annual conference in Philadelphia.
Theranos has never publicly shared any its data before, saying for a long time that it’d rather go through the FDA approval process. This will be the first time Theranos data has been presented at a medical conference.
Holmes is talking now because Theranos has faced withering criticism — ranging from reports that it tests don’t actually work to a government shutdown of one of its labs — for almost a year.
Even so, it might not be the data that puts the company back in good graces, lab testing experts told Business Insider.
Here’s what’s in store, according to the presentation’s abstract:
- It’s going to be an education session, which means that it’s not pegged to specific study data and conclusions that a study poster presentation would display. This also means that there won’t be independently validated data.
- Theranos will be presenting data that intends to show how the company’s finger-prick blood test, which requires only a small amount of blood, stacks up to a typical blood test that draws a few tubes of blood from a vein.
- Among the tests Theranos will be demonstrating is a test to diagnose the Zika virus.
But that information is essentially “useless,” since it’s still not validated by independent reviewers, Dr. Eleftherios P. Diamandis, head of clinical biochemistry at Mount Sinai Hospital in Toronto told Business Insider. Diamandis who has written critiques of Theranos in the past, said it’s all just speculative. That’s because it won’t be independently validated data from a large amount of test samples. Ideally, Diamandis said, Theranos would need to present millions of tests, with very rare failures. “The quality demands are going to be very high,” he said.
Diamandis, who’s been going to this conference for decades, said he will be attending the presentation, but he’s not going to be taught anything about the technology. He’s mainly just curious to see what Holmes ends up sharing.
A rocky July
A year ago, Theranos was touting its first FDA approval for a herpes test that could be run with just a few drops of blood. This July, the Centres for Medicare and Medicaid, which regulates blood testing labs, barred Holmes from the industry for two years, imposing other sanctions including banning the company from working with the Medicare program.
Theranos is now in the middle of a number of government investigations, including one by a Congressional committee. It’s seen major deals fall apart, and now operates just five testing centres, down from more than 40.
The company has taken steps to make things right, adding scientists to its newly formed Scientific and Medical Advisory Board — among those four former AACC presidents — and hiring compliance and regulatory executives.
Best case scenario
Ideally, if Theranos was able to show independently-reviewed data, that would be the best way to make a comeback. But in the meantime, Howard Forman, Yale diagnostic radiology, economics, and public health professor, told Business Insider that just having them show a willingness to work with the government better would be a step in the right direction.
“I think it would be great if they could show willingness to change whatever management needs to be changed in order to have the relationships they need to be able to rebuild with CMS and CLIA,” he said. But beyond that, they will need to tackle the more serious issue of allowing university researchers to use their technology and run tests without any interference.
Overall, there seems to be an optimism in seeing at least something. If the product works the way Theranos claims it does, it would have a huge impact on healthcare, Forman said.
“In the long run, we’re all better by seeing new entities succeed, not to see them fail,” he said. “But at the same time it has to be on terms that are going to make this country better and not just something that sops up venture money and never returns it to investors in a meaningful way.”
Here’s the full abstract of Monday’s presentation:
Title: Theranos Science & Technology: the miniaturization of lab testing
Abstract: Theranos’ mission is to deliver affordable and easily accessible clinical diagnostic testing. To achieve this objective, the company has developed a family of novel clinical diagnostic methods with the aim to simplify sample collection and reduce sample volume requirements, while performing a wide range of diagnostic tests in both centralised and decentralized settings. This presentation will describe the Theranos lab testing framework, which consists of a finger-stick blood collection and storage device, technologies for processing small volume samples in a centralised setting, and a compact fully-integrated and automated field-deployable diagnostic testing platform. Ms. Holmes will present reproducibility and correlation data for various tests comparing Theranos’ capillary collection and storage device with traditional venipuncture methods. She will also discuss methodology employed for their diagnostic testing platform, and share data to demonstrate the precision and accuracy of these chemistry, immunochemistry, hematology, and molecular assays (traditionally performed on separate instruments) using their analytical testing platform, including a novel molecular test for the Zika virus.
Following the presentation by Ms. Holmes, there will be a moderator-led Q&A session featuring questions submitted in real-time by members of the audience. The moderator panel will include Drs. Patti Jones, PhD; Y.M. Dennis Lo, DM, DPhil, FRCP, FRCPath; and Stephen Master, MD, PhD. This interactive session is not part of the accredited educational program, and as such will not receive Continuing Medical Education or ACCENT credit.
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