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FDA Clearance

FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says

This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implic…

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HHS ‘Stands Down’ FDA on Its Oversight of LDTs

CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…

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Expert Sees Pros, Cons In DP and WSI Systems

CEO SUMMARY: Now that the FDA has cleared two digital pathology systems for use in primary diagnosis, a growing number of pathology groups are taking up the question of whether and when they should adopt and use a digital pathology system and whole slide imaging. One pathologist with hand…

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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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FDA Clears Aperio’s Digital Pathology System

CEO SUMMARY: In May, the FDA announced clearance for Leica Biosystems to market its Aperio AT2 DX System for clinical diagnosis in the United States. The Aperio AT2 DX System is intended for in vitro diagnostic use as an aid to pathologists reviewing and interpreting digital images of sur…

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Outside US, Digital Path Moves Ahead Rapidly

CEO SUMMARY: Implementation of digital pathology and whole-slide imaging systems in the United States lags behind that of other countries for two reasons. One is a more acute shortage of pathologists in those countries and the other is a less restrictive regulatory environment. In some lo…

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What’s Coming Next for Anatomic Pathologists?

INTERESTING THINGS ARE UNFOLDING within the profession of anatomic pathology. If the adage of “follow the money” applies to understanding why things happen, then recent events support some surprising conclusions. Take the news reported in this issue of The Dark Report that PathGroup …

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April 29, 2019 Intelligence: Late Breaking Lab News

Investor interest in digital pathology (DP) and the use of artificial intelligence (AI) to analyze digital pathology images seems to be at a fever pitch recently. In the last three weeks, investors poured almost $85 million of capital into just three digital pathology companies, as noted below. This…

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Georgia Micro Lab Slashes TAT by Almost Two Days

CEO SUMMARY: Two projects to boost the performance of the microbiology laboratory at University Health Services in Augusta, Ga., significantly reduced test turnaround times in ways that contributed to improved patient outcomes. The first project was in 2016, when the lab introduced mass s…

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