[61785487]
The product was an ldt at one company and "transferred" to another company without validation. I worry that medical decisions made on a non-validated test could lead to limb loss, womens health issues, and prostate/urological issues. The company (b)(4) began marketing and reporting results for a series of next generation sequencing tests without a validation starting (b)(4) 2016. They are making claims to the product (it will diagnose prostatitis) without any clinical trial information. This is all headed up by dr (b)(6). They promote the test for infectious disease and it can eliminate the need for amputation in some cases. It claims to identify over 100,000 bacteria but they have not validated these. How can they report it and have doctors act on this information. They also include drug resistance on the report telling the physicians which antibiotics will and will not work. There is no data around any of this information. I was the former (b)(4) of qa and tried to get them to stop this but (b)(6) would not listen (he sees money). I have contacted (b)(4) (false claims for these tests). I urge the agency to investigate this company and this ldt (i know ldt's are not under the fda yet but (b)(4) is piggybacking on (b)(4) - and assuming the vague at best validation (b)(4) did is transferable). This would make (b)(4) a manufacturer and required to submit to the fda. I fear for patient safety. These results belong to someone's father, mother, sister, or child. I would hate for an adverse reaction to happen due to their neglect of regulations and fully validating a test. Tests include - gynecologies (women's health), prosta seq (specimen is urine - they tested 9 samples and thought that was enough), wound seq - swab of the infected area, ura seq (urine specimen to detect 100,000 bacteria). All of these are basically the same test they just call them different names. These tests do not have data that back their report.
Patient Sequence No: 1, Text Type: D, B5