Probably because that would accomplish nothing. From the initial refusal to publish details for review, and then the repeated delays, I'm guessing the "Edison Machine" is just snake oil.
It's really pretty simple, and rather clear from the article, that Theranos has been cheating, VW-style. They use regular equipment to get through "proficiency testing", but use the Edison machine for regular patient specimens:
From the article:
> The two types of equipment gave different results when testing for vitamin D, two thyroid hormones and prostate cancer. The gap suggested to some employees that the Edison results were off, according to the internal emails and people familiar with the findings.
> Former employees say Mr. Balwani ordered lab personnel to stop using Edison machines on any of the proficiency-testing samples and report only the results from instruments bought from other companies.
> The former employees say they did what they were told but were concerned that the instructions violated federal rules, which state that a lab must handle “proficiency testing samples…in the same manner as it tests patient specimens” and by “using the laboratory’s routine methods.”
> Portions of the inspection report that CMS had initially redacted included references to the Edisons, Theranos’s family of proprietary blood-testing devices. Those passages, which are no longer redacted in the latest version, show that the devices often failed to meet Theranos’s own accuracy requirements for a range of tests, including one to detect prostate cancer.
There is an accompanying article [1] that gives more background. The part on there internal quality control tests show the tech just isn't there.
> The inspection report showed that 29% of the quality-control checks performed on the company’s proprietary blood-testing devices in October 2014 produced results outside the range considered acceptable by Theranos.
> In February 2015, an Edison-run test to measure a hormone that affects testosterone levels failed 87% of quality-control checks, the report said.
It doesn't look like they are using Edison to run most of their tests, so we can excuse the experimental tests if they aren't being used for actual patients. Chalk that up to work-in-progress.
What is absolutely inexcusable is their treatment of patients, especially when they found out that results were incorrect.
> Inspectors also found that Theranos sometimes released patients’ results even when the Edison devices used to run those tests produced erratic results in quality-control checks.
and
> The inspection report said Theranos didn’t notify doctors treating patients potentially affected by the erroneous results until mid-November, or seven weeks after the inspectors first identified the problems.
Seven weeks to notify customers that you may have fucked up a medical test? We reach out to customers about potential software bugs within an hour.
This is an instance where I am glad to have government slowing down innovation. "Move fast, break things" doesn't work when people's lives are at stake.
Relevant: On 27 October 2015, Holmes announced Theranos would publish data verifying the accuracy of its Edison testing device. They still haven't done so.
Given the intense scrutiny they're under, if they had the data, you'd think they would be eager to release it to prove their critics wrong.
> Theranos does stand for well thought-out and useful therapy and diagnosis and does not represent the harms suggested by another similar Greek word, thanatos (death).
This is gold. Yesterday Theranos just voided its two years of testing results by its Edison.
https://www.businessinsider.com/theranos-problems-blood-test...
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