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her2neu test
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…
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 …
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…
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 …
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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