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Chris P
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Hey Kaiser, I think the legend labels are flipped on the graph you did. North Dakota should be in the 10-18 range.
Toggle Commented Dec 9, 2013 on The importance of a proper scale at Junk Charts
I have been in the pharma/medical device industry for 20 years now and know some of the stories in the pathology/testing world from colleagues. Technology innovators came up with a cool information-based product and sold it at first as a novelty. FDA was fine with the "for entertainment purposes only" nature of the information provided. Entrepreneurs enhanced their product in the last year to provide data that was truly diagnostic or related to therapeutic guidance (BRCA1, CYP processing) and started pushing this information out. FDA was not pleased with the validation studies that had been done on that information and said it needed to hit 510k qualifications. Management had an experienced Reg Affairs Director (from xDx who faced similar challenges ?) but decided to play tough. Why play tough? My speculation would be that the validation testing would swamp the company or they thought they were too big/popular/cutting edge for the FDA to stop them. Having worked at a company with multiple letters from the FDA that ended with a consent decree stopping sales for 1.5 years, I would say the popularity card does not work. If the FDA perceives the risk to patient safety, it is up to the company to PROVE it is safe rather than for the FDA to show evidence of the harm done. I am curious to see how the next chapter reveals itself. I would agree that they were providing a useful service, but we don't know that it is consistent and at the quality levels necessary. In this, the CEO points out that they were using a non-CLIA lab for the tests initially. I read that as management not reading the regulatory environment well from the beginning.
My partner and I both travel a lot and have been using TSA Pre-check for the last year. Pre-check is the old school security that you were randomized into. It was first offered to US Citizens who had gone through a background checks for immigration fast lanes (Global Entry or Nexus) plus ultra frequent flyers for major US carriers (50k miles or more initially) at select airports (SLC our home was one of the first). It also had randomization involved in that when you got to the line check, your boarding card was scanned and 3 beeps meant Pre-check and 1 beep meant regular screening. From my experience this gave pre-check about 80% of the time and bumped to regular 20% of the time, so you always had to be prepared to switch lines and screening modes. They may be practicing for higher volumes. Ninety percent of the time I go through the precheck line there is no one in the line so they may not know throughput.