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pgx testing labs
PGx Testing Labs Concerned by FDA’s Statements, Actions
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
PGx Labs Concerned by FDA’s Statements, Actions
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
CURRENT ISSUE
Volume XXVII, No. 14 – October 5, 2020
THE DARK REPORT HAS ANALYSIS showing potential reasons why the Department of Justice has generated its largest lab fraud crackdown in history. $6B in allegedly fraudulent claims and 345 defendants may well be the result of an explosion in molecular test claims in 2019. Also, another competitor has entered the lab marketplace, this time with portable COVID-19 testing labs in trailers.
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