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A few weeks ago, 2 companies were listed as being able to perform prostate health index (phi) tests.It is a blood test developed by beckman coulter.The (b)(6) with its headquarters at (b)(6) is one of the few labs that perform these tests.It has a patient service center located in (b)(6).On (b)(6) 2016 patient took a 2 hour drive to the said center.His blood was drawn, frozen and mailed through ups to the (b)(6) headquarters in (b)(6).It arrived safely the following day.They were supposed to immediately do the phi test and provide the reporter's doctor with the results.Unfortunately, they didn't.He inquired.It turned out they were having accuracy issues with the test.The company is now investigating.Reporter contacted the clinical laboratory improvement amendments (clia).However, based on the conversation he had with the medical director, (b)(6) had decided that the problems were so serious that they will discontinue the phi testing, which meant that he wouldn't be getting his results.The frozen samples were then sent to another lab, called (b)(6).But the catch here is, (b)(6) is not licensed in (b)(6).The only other lab that could perform the test is called (b)(6), situated in (b)(6).Coincidentally, they too have discontinued the phi testing.The person who had originally setup the reporter's appointment with (b)(6) suddenly quit her job.The reporter contacted beckman coulter the manufacturer of both the device and the reagent.He says beckman coulter knew about the problems at (b)(6) when the inaccuracies occurred, but they didn't send anyone to investigate and determine the cause of the problem.Reporter called beckman coulter and spoke with (b)(6)-director of corporate communications who reiterated that there wasn't any problem with both the device and reagent.He then called the medical director at (b)(6)- mr.James (b)(6), who said the only problem they were facing, was the accuracy of the results and that the protocol was to try samples from other companies.The results proved to them their tests were all inaccurate, reason why they stopped performing the testing altogether.At this point in time, reporter says no one in california who needs a phi-testing can get it.Reporter finds all this important because the traditional psa testing has been issuing many false positives resulting in many unwanted biopsies.Meanwhile the phi testing eliminates about half of the unnecessary biopsies.Reporter says he's now in a dilemma because he doesn't know, and would be unable to know whether he needs a biopsy or not.On the other hand, he says there is another test called the 4k score.But this test has not yet been approved by the fda so he can't use it and (b)(6) can't pay for it.This test costs (b)(6) compared to (b)(6) charged for phi.Reporter believes beckman coulter is stonewalling and not determining the actual cause of the inaccuracies in its tests at (b)(6).He says he's reporting this to the fda for a proper follow-up and investigation.He's hoping that some immediate action would be taken to help resolve the issue.See fda approval letter of the device: (b)(4).
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