Theranos
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Theranos CEO Elizabeth Holmes banned from owning a lab
Spoiler warning in case you don't want to know how the movie will probably end: the Wall Street Journal reports US regulators have devised to ban the owners and operators of Theranos from running a lab for two years. That includes CEO & founder Elizabeth Holmes, as confirmed by a press release issued tonight. The Centers for Medicare & Medicaid Services (CMS) revoked the lab's Clinical Laboratory Improvement Amendments (CLIA) certificate and imposed a civil money penalty for an unspecified amount.
Walgreens is done with Theranos
After months of screaming at Theranos to clean up its act, Walgreens has formally ended its partnership with the blood testing startup. The pharmacy chain said that the CMS' recent rejection of Theranos' recovery plan and the looming threat of sanctions forced the relationship to end. Walgreens will now close all 40 of its remaining Theranos Wellness Centers in Arizona and "transition" customers to more reliable testing methods. Such as casting bones, consulting the tree spirits or looking at your wrist and then just guessing what's wrong with yourself. Walgreens was Theranos' main source of business, and without those retail locations, it's not clear how the startup is going to survive.
Jennifer Lawrence signs on for big screen Theranos adaptation
The story of blood-testing startup Theranos and its founder Elizabeth Holmes' meteoric rise and fall from grace is already getting the Hollywood treatment. As Deadline Hollywood reports today, Jennifer Lawrence will play the part of Holmes, who at one point seemed to be one of Silicon Valley's biggest success stories, worth about $4.5 billion for her 50% stake in the company. That all came crashing down once the Wall Street Journal started raising concerns that Theranos' main product was unreliable and not actually approved by the FDA.
ICYMI: Man-made meteor showers and live molar video
#fivemin-widget-blogsmith-image-338559{display:none;} .cke_show_borders #fivemin-widget-blogsmith-image-338559, #postcontentcontainer #fivemin-widget-blogsmith-image-338559{width:570px;display:block;} try{document.getElementById("fivemin-widget-blogsmith-image-338559").style.display="none";}catch(e){}Today on In Case You Missed It: Startup Star-ALE wants to create man-made meteor shower tech in time for the Tokyo Olympics in 2020. The Prophix is a video toothbrush tool that can live stream your choppers and save pictures of them to an app in case you're obsessed with the way your teeth look.
WSJ: Theranos is voiding and revising past blood test results
As Theranos faces increased scrutiny from regulators, tonight the Wall Street Journal is reporting the company is taking an extraordinary step by voiding its own blood test results going back two years. According to the Journal, the company is telling the Centers for Medicare and Medicaid Services that it has issued "tens of thousands" of corrected blood test reports, covering results that have been revised or voided altogether.
Theranos loses its COO as it seeks to improve quality
What can Theranos do to restore confidence in its company and the suddenly-in-doubt finger prick blood tests it hoped would revolutionize the industry? It's hard to say, but tonight it's trying to turn things around by announcing some executive reshuffling. COO and president Sunny Balwani (who, along with CEO and founder Elizabeth Holmes is reportedly facing a ban from the blood testing industry) will retire.
Feds begin criminal investigation against Theranos
In a letter addressed to its partners, the once-promising blood test startup Theranos has admitted that it's under criminal investigation. According to multiple sources, the US Securities and Exchange Commission and the US Attorney's Office for the Northern District of California have started looking into whether the firm misled its investors about the state of its technology. The prosecutors even subpoenaed Walgreens, which offers the company's blood tests, and the New York State Department of Health within these past weeks. They asked both organizations for testimony on how Theranos described its tech to them, as well as for any document the company submitted. The Wall Street Journal says the criminal investigation's still in its very early stages, and it doesn't automatically mean the company will be indicted.
Theranos CEO faces ban from operating a blood-testing lab
As more details surface about blood-testing startup Theranos, federal regulators are looking to ban the company's founder. The Wall Street Journal reports the Centers for Medicare and Medicaid Services (CMS) is looking to not only revoke Theranos' federal license, but it also wants to keep its founder and CEO Elizabeth Holmes and president Sunny Balwani from owning or running another lab for a minimum of two years. Theranos currently has testing facilities in California and Arizona, so the ban would impact both locations.
Theranos lab failed to meet its own accuracy standards
Theranos' proprietary blood-testing methods failed to meet the company's own standards as often as 87 percent of the time, according to a new report. Released by the CMS (Centers for Medicare and Medicaid Services) agency and seen in unredacted form by the WSJ, the data confirms that the company knew its finger pin-prick tests were often wrong when it used them in October, 2014. It has since pulled most of the testing done by its key "Edison" machine and can only perform a single herpes test. However, the FDA and CMS received complaints from Theranos employees that even that one was "tainted by breaches in research protocol."
WSJ: Theranos sent faulty test results to patients
News for blood testing startup Theranos just keeps getting worse. After plenty of very public drama and mishaps, the Wall Street Journal is now reporting that federal investigators have found that poor quality control led to inaccurate test results. To make matters worse, the report appears to suggest Theranos was aware the tests were unreliable, but sent the results to 81 patients anyway, putting them in "immediate jeopardy." Theranos disputes this number, telling Engadget the actual number of impacted patients was less than 40, and that it has "no reason to believe that these issues have affected patients' health," according to the new director of the Newark, CA lab at the heart of the investigation, Dr. Kingshuk Das.
Walgreens starts breaking up with Theranos
The Financial Times is reporting that Walgreens is now actively looking to dump troubled blood testing startup Theranos. Sources claim that the pharmacy chain has instructed its lawyers to look at the partnership contract in the hope of finding an easy way out. The paper also says that Theranos is confident that the agreement is watertight and will force Walgreens to stand by it while it fixes its (numerous) problems. It's believed that Walgreens is annoyed at the wealth of negative publicity Theranos has generated and is worried about being tainted by association.
The After Math: Love is in the air
Scientists just confirmed the existence of gravitational waves -- actual ripples in the fabric of spacetime -- but who cares about unravelling the secrets of the universe, Valentine's Day is coming up. To pay respects to the most high holy of made-up bullshit holidays, here are seven of the most heart-string-tugging posts from the last week.
Walgreens has told Theranos to shape up or ship out
The Wall Street Journal is reporting that the relationship between Walgreens and Theranos is becoming fractious. According to the paper's unnamed sources, the drugstore has threatened to end its partnership with the troubled blood-testing startup. It's believed that Walgreens delivered an ultimatum to the firm in late January, saying that it needs to clean up its act within 30 days or be kicked to the curb. If true, then we could see the two part ways as early as the end of February. Walgreens is already doing its best to distance itself from its former BFF after shutting down the Theranos Wellness Center in Palo Alto and re-routing Theranos-branded tests to third-party labs.
Walgreens is beginning to break up with Theranos
The bad news just keeps piling on for Theranos, following yesterday's announcement from the US government that its blood testing technology "jeopardizes" patients' health. Walgreens, the company's main retail partner, said today that it'll be shutting down its Theranos Wellness Center in Palo Alto, California. Additionally, the pharmacy will no longer send blood samples to Theranos' lab in Newark, California. And, to top it all off, Walgreens also says that blood tests from one of the 40 Theranos Wellness Centers it hosts in Arizona must go to a third-party lab, or Theranos' Phoenix lab, not the Newark facility.
US government says Theranos lab jeopardizes patients' health
Federal regulators have sent a letter to troubled Theranos Labs and the news is not promising. The (CMS) Centers for Medicare and Medicaid Services states in a letter that it conducted a CLIA recertification survey of the lab and found it that it was not in compliance. In the letter signed by Karen Fuller, manager of state oversight for CMS, the agency noted that in regard to the hematology portion of the lab "it was determined that that the deficient practices of the laboratory pose immediate jeopardy to patient health and safety."
Theranos could be in trouble with Medicare regulators
Federal regulators have found problems at one of Theranos' labs, according to The Wall Street Journal's sources. The Silicon Valley startup, famous for its blood tests that require just a finger prick's worth of blood, has been under scrutiny recently due to claims its methods are inaccurate. The WSJ says that the Centers for Medicare and Medicaid Services, which regulates clinical labs, has found "serious" and "severe" deficiencies at the site.
Theranos blood test tech supposedly went unchecked for years
The saga of startup lab Theranos continues to get increasingly complicated. The firm, known for its proprietary tests that only need a finger-prick's worth of blood for analysis, has recently faced accusations that its technology was faulty and inaccurate. Now, it seems that its tech was not properly vetted by federal authorities for nearly two years. The Verge has learned that when the Centers for Medicare and Medicaid Services (CMS) inspected Theranos, it made no mention of the Edison machines -- Theranos' blood analyzers -- at all. The reason? Because it never inspected them.
Former employee claims Theranos' FDA-approved test is faulty
Startup medical testing company Theranos came under fire in October as the accuracy of its tests were called into question. The FDA has been investigating since then, and today more fuel was thrown on the fire by some former employees. According to The Wall Street Journal, both the FDA and the Centers for Medicare and Medicaid Services (CMS) each received a complaint from a different former employee. The FDA received notice that the study Theranos submitted to win the agency's approval for its herpes test was "tainted by breaches in research protocol." That's notable because so far that herpes test is the only one of Theranos' tests that has actually been approved by the FDA. Founder Elizabeth Holmes (above) has continued to deny any accusations claiming that Theranos' data is inaccurate.
FDA finds flaws in Theranos' nanotainers and quality control procedures
The latest blow to Theranos' blood testing technology comes from the US Food and Drug Administration, which found flaws in the company's quality control procedures. In one of the two heavily redacted reports the FDA published, the agency says Theranos' "design validation did not ensure the device conforms to defined user needs and intended uses." The agency found out that Theranos describes its nanotainers (tiny containers for blood drawn by pricking a finger) as Class I medical devices, even though they fall under Class II, along with other higher-risk tools.
