Tag: FDA Clearance

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 certain medications. Some pathologists and lab executives have criticized the FDA’s actions

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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 locations outside the United States, pathologists have adopted fully-digital operations,

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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 of Nashville is acquiring Pathologists Bio-Medical Laboratories (PBML) of Dallas. That brings together two regional

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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 spectrometry and MALDI-TOF for bacterial infections, cutting turnaround times from 104 to

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Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry

“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.”

—Ralph Taylor, President, Sysmex America, Inc.

CEO Summary: To bring testing closer to patients, clinical laboratories will need to offer sophisticated point-of-care systems

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Beckman Coulter Sues Quidel for Right to Sell BNP Assay

THERE IS AN INTERESTING COURT FIGHT UNFOLDING between Beckman Coulter Corporation and Quidel over the rights to sell a B-type natriuretic peptide (BNP) assay. The lawsuit is a consequence of Abbott Laboratories’ acquisition of Alere, Inc., last fall.

With that acquisition, Abbott Laboratories became the world’s largest manufacturer of point-of-care (POCT) lab tests. But federal anti-trust

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