<story><title>U.S. Probes Theranos Complaints</title><url>http://www.wsj.com/articles/u-s-probes-theranos-complaints-1450663103</url></story><parent_chain></parent_chain><comment><author>seehafer</author><text>What&amp;#x27;s notable about the meat of the complaint sent to the FDA is that it&amp;#x27;s less &amp;quot;this technology actually doesn&amp;#x27;t work&amp;quot; and more &amp;quot;this company has no culture of experimental integrity&amp;quot;.&lt;p&gt;From the article:&lt;p&gt;&amp;quot;hadn’t fully assembled the proprietary machines used for the herpes study when the experiments began&amp;quot; ... &amp;quot;company underreported the rate at which the machines broke down during the study&amp;quot; ... &amp;quot;employee also alleged that some crucial parts of the devices ... were modified to improve their accuracy&amp;quot;&lt;p&gt;FDA is generally skeptical of validation data not generated from &amp;quot;production equivalent&amp;quot; technology, but they get even more skeptical if you tell them something is X and it turns out to be Y down the road. That (rightly) sends them on a fishing expedition.</text></comment>
<story><title>U.S. Probes Theranos Complaints</title><url>http://www.wsj.com/articles/u-s-probes-theranos-complaints-1450663103</url></story><parent_chain></parent_chain><comment><author>Jerry2</author><text>&amp;gt;&lt;i&gt;Edison machines would sometimes produce “radically different results” for the same patients, the former employee alleged. Referring to a thyroid test known as thyroid-stimulating hormone, the employee wrote that “a patient would swing between” hypothyroidism and hyperthyroidism, or too little of the hormone and too much, when the test was repeated the same day.&lt;/i&gt;&lt;p&gt;This sounds really bad. When you have this huge amount of uncertainty in results, it calls into question their whole finger prick blood sampling methodology. I&amp;#x27;m starting to think that it&amp;#x27;s impossible to get an accurate blood work from a finger prick only.</text></comment>