Theranos’ recent troubles on their blood testing (Walgreens halting expansion, FDA halting nanotainers as ‘uncleared medical devices’ and last week chain grocery/drugstore Safeway dropping their $350 million deal for 800 locations) have been well covered in media both here and elsewhere. But what if their Unique Selling Proposition–that people should have the ‘basic human right’ to order up their own inexpensive blood tests and then be responsible for their own interpretation–is counter-productive for many patients? After all, it’s what Theranos has been organized and raised $400 million+ on. Dr Robert Wachter of UCSF, who is no top-down Ezekiel-esque ‘nanny stater’,... Continue Reading
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Theranos/FDA update: nanotainers are ‘uncleared medical devices’
...an investigator says of the validation phase of an unspecified Theranos device. Neither did it “ensure the device conforms to defined user needs and intended uses.” Theranos claims that the company addressed and corrected all the complaints within a week or less, and have documented same. The controversy over the nanotainers strike at the heart of Theranos’ Unique Selling Proposition (all the posed photos with CEO Elizabeth Holmes striking a Steve Jobs-like pose in the ash can?). Without it, they are just another lab testing company that is perhaps cheaper. Also FierceHealthIT and The Wall Street Journal (may be paywalled).... Continue Reading
Blood is drawn: Theranos responds vigorously to TTA re WSJ
From his very first interactions with Theranos, the reporter made abundantly clear that he considered Theranos to be a target to be taken down, and not simply the subject of an objective news story. The articles that appeared last week are the inevitable product of that approach.–Theranos Facts, 22 Oct Breaking news. Blood is drawn. A spokesperson for Theranos (from FTI Consulting), Ms Shea Maney, has responded directly to this Editor regarding the content of the Wall Street Journal article, previously covered here (The $9 billion question mark) along with followup in primarily Fortune but also commentary in the Health... Continue Reading
The Theranos Kerfuffle: a setback, but is it for the best? (updated)
...and press hype are bonkers and Stark Raving Mad, mit out a relationship to reality. There’s a buried but tasty piece of speculation on Theranos’ real market. Because of the makeup of the corporate board, heavy on government, retired military and defense types, Theranos’ real market may not be retail and consumer-driven, but governmental entities such as the Department of Defense. You do have to slog through the usual extraneous cracks about old, white male Republicans and Rupert Murdoch to get to it, though. Not that Theranos is the first company that’s ever played this game. Your Editor will go... Continue Reading
Is Theranos a $9 billion question mark?
Breaking News. According to an exposé published yesterday in The Wall Street Journal*, low-cost and fast growing small sample blood testing company Theranos [TTA 28 Aug] is not ‘doing what it says it does’. Four former employees allege that Theranos’ testing system, dubbed the Edison, which processes small finger-pricked blood samples collected in ‘nanotainers’, only handles a fraction of the tests claimed–19 out of 205. In a complaint to regulators, one Theranos employee accused the company of failing to report test results that raised questions about the precision of their proprietary Edison system–and that most of the tests were being... Continue Reading
Integrating inexpensive lab testing, imaging to EHR–and vice versa
In the Dr Eric Topol patient-driven world, personal lab testing would be walk in, keep retail hours and not even need a doctor’s order. That is the model for Theranos, a well-funded low cost blood testing company operating 43 centers in California, Arizona (no doctor order needed) and one Pennsylvania Walgreens. Their latest alliance is with EHR physician practice giant Practice Fusion, which claims about 112,000 doctors actively using its cloud-based, ad supported platform, claims to be the fastest growing US EHR with at present 100 million patient records. The Theranos reporting app, which also connects patients with doctors who... Continue Reading
Apps and wearables – developments over the summer
...wearables definition past breaking point, it would seem churlish not just to pop in the video of the first ever FAA-approved medicine delivery by a Flirtey drone. About as tenuous as the last link comes news too of the hugely impressive Theranos securing FDA waiver to take its blood tests out of the lab, so promoting point-of-care-testing (POCT) further. And finally, this mobihealthnews item entitled Class action lawsuit alleges Fitbit misled buyers with inaccurate sleep tracking, and this Iowa State university study on activity tracker accuracy reminds me that my Jawbone UP3 stopped tracking my sleep completely after just eight... Continue Reading
NYeC Digital Health: two diverging visions of a connected future (Part 1)
...tests are increasingly DIY, with smartphones capable of doing assays and Theranos’ inexpensive tests from a few drops of blood using microfluidics technology, available direct to consumer at a drugstore. Imaging devices are again smartphone based–CellScope‘s otoscope, Peek (eye) and GE’s VScan ultrasound (yes, it is still around) lead to less expensive home or retail-based physical exams. And the results would be owned by the patient. The PHR doesn’t go far enough for him–the patient would own their data, all of it, from day one. Medications are also expensive (in the US, the top ten drugs account for $62 bn... Continue Reading
The smartphone as great healthcare leveler: Eric Topol
...at HealthLeaders’ CFO Exchange conference. A promoter of the ‘creative destruction of medicine’ (the title of his most recent book, WSJ article), he believes that everything from the office visit (virtualized) to lab tests (future add ons will essentially be labs-on-a chip able to analyze tiny blood samples) to ER visits to the tsunami of sensor-generated vital data will be democratized, using the smartphone as its nexus. Yet even he admits that ‘intermediate” technology such as Theranos‘ micro-sample lab analysis units and Better’s nurse-practitioner healthcare guidance (we’ve dubbed ‘concierge medicine for the masses’) on multiple platforms will be in the... Continue Reading
Turning an iPhone into an endoscope
...evaluated the image quality compared to the Storz HD camera standard, and concluded that they were equivalent for flexible ureteroscopy and somewhat inferior, but still acceptable for flexible cystoscopy. Savings? $46,469–$154 compared with $46,623 for the Storz HD. The device is yet to go to human trials. FierceMobileHealthcare. iMedicalApps (abstract) The Endockscope was also commented on by Dr. Eric Topol in his Medscape article on genomic medicine, decision support tools such as IBM Watson possibly replacing doctors, a robot administering anesthesia, the Theranos fast blood testing system possibly disrupting lab testing…Topol on ‘Taboo Genetics,’ a Frugal App, and Magic Supplements... Continue Reading
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