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her2neu

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…

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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…

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Local Labs vs. Central Labs Assessed in HER2 Test Study

WHEN IT COMES TO HER2NEU TESTING, a study of accuracy just published by the journal Cancer may raise interesting questions for pathology groups across the nation. “Assessing the discordance rate between local and central HER2 testing in women with locally determined HER2- negative breast …

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2009’s Top Ten Lab Stories Reflect Some Good, Bad

CEO SUMMARY: As the closing year of the first decade of the new century and the new millennium, 2009 brought neither disruption nor upheaval to the majority of laboratories in the United States. Rather, it was marked by at least two themes. One was how public disclosure of problems with l…

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Many Trends in AP Spell Lots of Change Ahead

CEO SUMMARY: Every second year, THE DARK REPORT releases its list of key trends in anatomic pathology. These trends help shape an understanding about the state of the pathology profession. Our current list includes 11 identifiable trends. This is not an auspicious sign for pathologists wh…

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TriPath Imaging and Ventana Sign Major Development Pact

IF THE NEW BUSINESS AGREEMENT between Ventana Medical Systems, Inc. and TriPath Imaging, Inc. is successful, then the anatomic pathology laboratory may have a very different look in future years. Last week, Ventana Medical Systems, Inc. announced a …

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Quest Diagnostics, CVS Pharmacies, Premier, Novation, Luminex, Careside.

QUEST DOES DEAL WITH CVS DRUGSTORES FOR LAB TESTING PATHOLOGISTS CONCERNED about pharmacists moving into the lab testing arena should closely watch the newly-announced relationship between Quest Diagnostics Incorporated and CVS Corporation. Starting this m…

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