• Home
  • Latest
  • Fortune 500
  • Finance
  • Tech
  • Leadership
  • Lifestyle
  • Rankings
  • Multimedia

Trendingnow

1

He worked 100-hour weeks to save a nearly bankrupt boat company. At 83, he’s just turned down $400 million for it—and gave it all to charity instead

2

Costco's $14 million email settlement: Who qualifies for an up-to $500 payment and how to claim before the Aug. 24 deadline

3

Jamie Dimon says his stockbroker father taught him to invest with a 'brutally hard' childhood game

1

He worked 100-hour weeks to save a nearly bankrupt boat company. At 83, he’s just turned down $400 million for it—and gave it all to charity instead

2

Costco's $14 million email settlement: Who qualifies for an up-to $500 payment and how to claim before the Aug. 24 deadline

3

Jamie Dimon says his stockbroker father taught him to invest with a 'brutally hard' childhood game
TechTheranos

Theranos Is Dealt Another Blow, With ‘Abnormal’ Results In New Lab Study

By
Roger Parloff
Roger Parloff
Down Arrow Button Icon
By
Roger Parloff
Roger Parloff
Down Arrow Button Icon
March 28, 2016, 5:20 PM ET
Photograph by Drew Kelly for Fortune
Add Fortune on Google for similar content.

In a peer-reviewed study released on Monday comparing results obtained by different diagnostic labs, scientists at the Icahn School of Medicine at Mt. Sinai found that Palo Alto-based Theranos reported “tests outside of the normal range” 1.6 times more often than did the two leading independent labs, LabCorp and Quest.

Theranos’ “rejection” rates—the number of times results could not be obtained from a sample—were also higher than those of its rivals, the researchers concluded. Finally, the study found that while “its testing services return results that mostly agree with other services,” Theranos’ results measuring lipids—i.e., fatty molecules like cholesterol—were often “not equivalent” to those of other services. The researchers said the variation in lipid tests results between the different services could cause practitioners to “either inappropriately initiate or fail to appropriately initiate statin therapy.” Statins are often used to control cardiovascular disease.

The higher number of abnormal test results, they wrote, “can have negative consequences for medicine in the form of extra testing, additional patient visits to clinics/hospitals, and added doctor services, all of which result in additional costs and burdens to patients or to the healthcare system and are potentially harmful, if the abnormal tests were misdiagnoses.”

At the same time, the researchers acknowledged that they found “surprising” variability among all three services—i.e., even between LabCorp and Quest—and surprising variability even for individual patients who were simply tested at different times of the day by the same service.

A press release summarizing the results of the study is here, while the study itself, published in the Journal of Clinical Investigation, is here. The lead author of the report is Mount Sinai’s Brian A. Kidd, while the senior “corresponding” authors—who designed and oversaw the study—are Eric Schadt and Joel Dudley.

Theranos is the young company led by founder and CEO Elizabeth Holmes. The firm hopes to eventually be able to use fingerstick draws, rather than venipuncture (a needle stuck in the crook of the arm), to perform the complete range of authoritative lab tests. The startup has encountered several roadblocks on its path to this goal, though. The company is currently in talks with federal regulators at the Centers for Medicare and Medicaid Services as it attempts to address “serious deficiencies” the regulators found at its Palo Alto laboratory—one of its two labs.

In an interview with Fortune, the director of Theranos’ lab in Scottsdale, Ariz., Daniel Young, said the company is preparing a formal response to the Mt. Sinai study, which it hopes to publish in the same journal. Meanwhile, Young asserts in the interview that the study’s methodology is afflicted with “major problems,” some of which were summarized in a letter the company sent to the researchers and the Journal on Thursday.

Theranos alleges, for instance, that taking large venipuncture samples from patients before taking a fingerstick sample from the same patient may have caused both elevated rejection rates and skewed outcomes for certain tests.

Theranos also accused two of the scientists of suffering from conflicts of interests because of associations with NuMedii, which Theranos describes as a “bioinformatics” company and a “potential competitor.” In a response to Theranos’ letter, Dudley and Schadt deny that NuMedii is a competitor, asserting that it “is focused on pharmaceutical drug discovery” and “has never had plans, nor has plans now, to participate in the clinical blood business.” They also say that they took venipuncture samples first only half the time, and took fingerstick samples first the other half of the time, in an attempt to control for the issue Theranos has raised.

The study was performed last July, before Theranos largely stopped using its fingerstick methodology (after an FDA inspector opined that its nanotainer collection device—used with fingersticks—was an “uncleared medical device”). Accordingly, the researchers were able to take fingerstick, and only fingerstick, samples at Theranos.

The researchers tested 60 healthy patients, taking 14 samples from each and running 22 different lab tests, resulting in more than 18,000 measurements.

Frederick L. Kiechle, a pathologist and medical director at the Memorial Healthcare System in Hollywood, Fla., said in an interview that he thought the study “was organized in a good a way as one could wish for, given the limitations that Theranos presents,” referring to its black-box nature. (It has not allowed its proprietary methods to be tested by peer review.)

Kiechle did acknowledge, however, that the study would have been even better if it had also tested patients using a gold-standard reference lab like those available at the Centers for Disease Control—a criticism that Theranos also leveled against the researchers.

Based on the study results, says Kiechle, who edits a book on blood drawing published by the College of American Pathologists, “there’s evidence that what’s going on at Theranos does not have the same precision and accuracy that the two other labs have for the tests that were investigated.”

Kiechle says that he has no personal affiliation with LabCorp or Quest, but he acknowledges that his lab does use Quest.

About the Author
By Roger Parloff
See full bioRight Arrow Button Icon
Add Fortune on Google for similar content.

Latest in Tech

Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025

Most Popular

Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Fortune Secondary Logo
Rankings
  • 100 Best Companies
  • Fortune 500
  • Global 500
  • Fortune 500 Europe
  • Most Powerful Women
  • World's Most Admired Companies
  • See All Rankings
  • Lists Calendar
Sections
  • Finance
  • Fortune Crypto
  • Features
  • Leadership
  • Health
  • Commentary
  • Success
  • Retail
  • Mpw
  • Tech
  • Lifestyle
  • CEO Initiative
  • Asia
  • Politics
  • Conferences
  • Europe
  • Newsletters
  • Personal Finance
  • Environment
  • Magazine
  • Education
Customer Support
  • Frequently Asked Questions
  • Customer Service Portal
  • Privacy Policy
  • Terms Of Use
  • Single Issues For Purchase
  • International Print
Commercial Services
  • Advertising
  • Fortune Brand Studio
  • Fortune Analytics
  • Fortune Conferences
  • Business Development
  • Group Subscriptions
About Us
  • About Us
  • Press Center
  • Work At Fortune
  • Terms And Conditions
  • Site Map
  • About Us
  • Press Center
  • Work At Fortune
  • Terms And Conditions
  • Site Map
  • Facebook icon
  • Twitter icon
  • LinkedIn icon
  • Instagram icon
  • TikTok icon
  • YouTube icon

Latest in Tech

Mark Zuckerberg, chief executive officer of Meta Platforms Inc., during the Allen & Co. Media and Technology Conference in Sun Valley, Idaho, US, on Friday, July 10, 2026.
Big TechMeta
Meta stock drops 10% as free cash flow gets crushed—and Zuckerberg hints at launching cloud business with few details
By Eva RoytburgJuly 29, 2026
6 hours ago
Man in glasses gesturing
Big TechMicrosoft
Microsoft’s cloud just hit a new milestone—Azure crosses $100 billion in annual revenue
By Amanda GerutJuly 29, 2026
9 hours ago
Southeast Asia is ‘hungry for innovation’ and eager to leapfrog, says SAP’s new APAC president Verena Siow
AISAP
Southeast Asia is ‘hungry for innovation’ and eager to leapfrog, says SAP’s new APAC president Verena Siow
By Angelica AngJuly 29, 2026
9 hours ago
Inside China’s two-speed economy: Why goods consumption is slumping even as exports and services boom
EconomyAsia Agenda
Inside China’s two-speed economy: Why goods consumption is slumping even as exports and services boom
By Nicholas GordonJuly 29, 2026
10 hours ago
Trump, Sam Altman, and Demis Hassibis at the G7.
AIOpenAI
More than 1,200 AI workers across Anthropic, DeepMind, OpenAI, and Meta are asking for Washington’s help building an AI slowdown plan
By Beatrice NolanJuly 29, 2026
10 hours ago
sam altman looks down while reporters ask questions
CybersecurityOpenAI
Hugging Face drops in-depth hack report, while OpenAI gives us 7 bullets. Here’s what we know now, and what remains a mystery
By Emily ForliniJuly 29, 2026
13 hours ago

Most Popular

He worked 100-hour weeks to save a nearly bankrupt boat company. At 83, he’s just turned down $400 million for it—and gave it all to charity instead
Success
He worked 100-hour weeks to save a nearly bankrupt boat company. At 83, he’s just turned down $400 million for it—and gave it all to charity instead
By Preston ForeJuly 29, 2026
15 hours ago
Costco's $14 million email settlement: Who qualifies for an up-to $500 payment and how to claim before the Aug. 24 deadline
Retail
Costco's $14 million email settlement: Who qualifies for an up-to $500 payment and how to claim before the Aug. 24 deadline
By Sydney LakeJuly 29, 2026
16 hours ago
Jamie Dimon says his stockbroker father taught him to invest with a 'brutally hard' childhood game
C-Suite
Jamie Dimon says his stockbroker father taught him to invest with a 'brutally hard' childhood game
By Sarah GlodekJuly 29, 2026
23 hours ago
Current price of oil as of July 29, 2026
Personal Finance
Current price of oil as of July 29, 2026
By Joseph HostetlerJuly 29, 2026
21 hours ago
eBay will pay nearly $50 million after employees reportedly sent a Massachusetts couple a bloody pig mask, cockroaches and death threats
Law
eBay will pay nearly $50 million after employees reportedly sent a Massachusetts couple a bloody pig mask, cockroaches and death threats
By The Associated Press and Leah WillinghamJuly 28, 2026
1 day ago
The millennial generation is split in 2: an older crowd with boomer-style comfort, a younger set going 'back to the early 1900s'
Real Estate
The millennial generation is split in 2: an older crowd with boomer-style comfort, a younger set going 'back to the early 1900s'
By Nick LichtenbergJuly 25, 2026
5 days ago

© 2026 Fortune Media IP Limited. All Rights Reserved. Use of this site constitutes acceptance of our Terms of Use and Privacy Policy | CA Notice at Collection and Privacy Notice | Do Not Sell/Share My Personal Information
FORTUNE is a trademark of Fortune Media IP Limited, registered in the U.S. and other countries. FORTUNE may receive compensation for some links to products and services on this website. Offers may be subject to change without notice.