TAG:
her2 test
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 …
Eastern Canada’s Latest Lab Errors Get Attention
CEO SUMMARY: Authorities for Eastern Health in Newfoundland and Labrador province in Canada are conducting a root cause analysis after finding discrepancies in breast cancer testing that affected nine patients. Health officials said these cases were discovered as a result of an improved q…
Momentum Continues for Digital Pathology
CEO SUMMARY: Last month, digital imaging in pathology gained additional momentum with the latest FDA clearance. Aperio Technologies, Inc., now has FDA clearance to market its slide scanning system for reading digital progesterone receptor (PR) slides on a computer monitor. Aperio plans to…
Growing NeoGenomics Offers FISH Test TC/PC
CEO SUMMARY: This specialty lab testing company now has laboratories in Fort Meyers, Florida; Nashville, Tennessee; and Irvine, California. It recently beefed up its executive ranks and is adding to its menu of genetic and molecular assays. In December, 2006, NeoGenomics …
New Technologies Bring New Issues for Pathologists
TECHNOLOGICAL IMPROVEMENTS ARE MOVING through the lab industry like a buzz saw through balsa. Three briefings in this issue provide examples. In two briefings, we address the topic of false positive results generated in part because of innovations in molecular testing. In the third briefing, we expla…
New Rules to Boost Cancer Test Accuracy
CEO SUMMARY: Recent developments in breast cancer testing are leading to changes in pathology. Oncologists and pathologists have issued new guidelines regarding HER2 testing and new research suggests changes may be coming for estrogen-receptor testing as well. For the first time, the new …
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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