TAG:

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…

Read More



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…

Read More



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 …

Read More



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…

Read More



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 …

Read More



How Much Laboratory Business Intelligence Have You Missed?

Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!

Sign up for TDR Insider

Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.