Tag: clinical laboratory industry

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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California Lab Company Closes After Negative Medicare Decision

WITH EACH NEW RULING about coverage for a proprietary diagnostic assay, Medicare officials send a message to the entire clinical laboratory industry that any lab company with a proprietary test needs to submit adequate clinical evidence that demonstrates two positive aspects of the test.

First, that the assay accurately measures the biomarkers that it says it

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Do Community Labs Have a Future in the U.S.?

It may be timely to ask a provocative question that touches everyone in the profession of laboratory medicine. Is there a future for community laboratories and hospital lab outreach programs in the United States, given the different forces acting upon the clinical laboratory industry today?

In this issue, our editorial team describes the multiple disruptive consequences

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UnitedHealth Rumored to Be Excluding Labs from Its Network

IN RECENT DAYS, RUMORS HAVE SURFACED that UnitedHealthcare has begun to terminate the contracts it holds with a number of regional and non-national clinical laboratories.

This news surfaced just as The Dark Report went to press. Given its importance to the clinical laboratory industry, we wanted to alert lab executives and pathologists to this development as

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