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Elizabeth Holmes Finally Releases Theranos Data, Including A 'miniLab' (cnbc.com)
An anonymous reader quotes a report from CNBC: Theranos CEO Elizabeth Holmes Monday outlined the steps she will take to increase transparency regarding the efficacy of the company's testing methods. Speaking at the conference of the American Association for Clinical Chemistry, Holmes said that Theranos will partner with other institutions "to validate and publish our results." And Holmes' planned presentation includes research conducted under Institutional Review Board-approved protocols. The company also said it intends to submit its results to a publication for peer-review. Holmes' presentation includes a slate of new products such as its miniLab, a robot that can process samples that normally require manual processing in traditional protocols. Theranos seems to be going back to the research and development drawing board, focusing on these new products instead of its much-debated small-volume blood collection technology. Theranos' miniLab is a self-contained laboratory that allows a robot to run a number of tests on samples. The miniLab contains different modules that allow it to conduct a series of tasks that traditionally would require multiple, separate machines. Theranos used its miniLab to run its Zika nucleic acid-amplification-based assay using finger-prick samples the company collected, some in the Dominican Republic. The samples were shipped back to Palo Alto, California, for analysis. Holmes said the results "demonstrate the miniLab's ability to perform automated, integrated molecular testing comparable to methods that require highly-trained personnel."
No, there was no data released. Just a promise to release it, along with a new product announcement.
Yes, the company did say that it would release data at the conference, but this did not happen.
The real "Libtards" are the Libertarians!
Its called "silicon valley". Failure is considered something good there. If you fail, you learn how to build a bigger and better unicorn.
Every successful person has had some big failures before they succeeded, and for every successful company there are multiple failed ones. It's neither good nor bad, it's just life.
As for Theranos...Well, let's just say that I work for one of their competitors, and what I know about this business is that there are routine audits by the FDA to send your lab a test sample, and you have to report back what you found in it given the test parameters that they gave to you. When given one of these samples, you can't speak to other labs about them or do anything that might give you any kind of hint of what the lab result should be, and you report back the findings just like you would with a regular patient lab specimen. If it doesn't fall within a specified range the FDA will notify you and you'll probably have to re-calibrate your equipment, and if it's way out of range then you'll probably get fined somewhere in the hundreds of millions of dollars.
Or something to that effect. I work in the lab's IT department so I don't know the exact process.
My question is: Did the FDA properly audit Theranos, and if not, why? From what I understand, this wasn't found out until some doctor saw his patient's results and questioned it, and then it got blown wide open from there. It shouldn't have even made it to that point really.
My question is: Did the FDA properly audit Theranos, and if not, why? From what I understand, this wasn't found out until some doctor saw his patient's results and questioned it, and then it got blown wide open from there. It shouldn't have even made it to that point really.
As I understand it, the FDA *did* audit Theranos on a single test (HSV-1 IgG aka herpes test). That only tests for the presence (or absence) of antibodies, not a test that requires determining a reasonably accurate concentration of certain chemicals in blood so in a sense it was a somewhat easy test.
Unfortunately, Theranos used the aura of this single approval to build their lab business which they apparently used their proprietary "nanotainer" collection tube. Regardless of the ultimate accuracy of their "Edison" machine used to gain their singular test approval (nobody knows outside the company how many samples were tested on Edison vs diluted and tested on standard lab equipment in production which is another FDA complaint that they didn't track this), the collection procedure also has to be FDA approved to assure audit-able quality and repeatably. This is where Theranos failed big time.
Not only was the "nanotainer" not approved to be listed as collection device, but FDA audits revealed all sorts of problems with its quality control, including no supplier auditing, no validation procedures, nobody in the company approved the final design specifications before manufacturing commenced, no clear customer and lab complaint logging and handling procedure, etc, etc...As the FDA audited the complaint handling procedures it discovered complaint that involved the failure or accuracy of the device that were received and not logged as required (to establish a validation history of a procedure) which brings in to question the reliability of the tests results in actual field conditions.
Uh, the reason why the competitive tests like Quest and LH cost more is because they actually work. Theranos is an outright fraud that was designed from the start to bilk clueless biotech generalist funds out of their cash.
Moron.