Issue: Volume XXII, Number 18 - December 28, 2015

2015’s Top 10 Lab Stories Show Significant Changes

CEO SUMMARY: During 2015, two stories captured the full attention of most pathologists and clinical lab managers. One was how CMS intends to gather lab price market data as mandated by PAMA. The other was the continued efforts by the FDA to move ahead on proposed guidance for regulation of LDTs. However, the full list …

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Letter from Congress to CMS Asks for Delay in PAMA Reporting

CLINICAL LABORATORY ASSOCIATIONS are using a letter-writing campaign to members of Congress as a last-minute Hail Mary attempt to head off the controversial lab price market reporting rule that CMS intends to implement after January 1. Both Democrats and Republicans in the U.S. House of Representatives and the U.S. Senate have signed a letter to …

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FDA Official Makes Case In Favor of LDT Guidance

CEO SUMMARY: Forty years ago, pathologists in hospital and academic labs worked closely with treating physicians to produce laboratory-developed tests for discrete clinical cases. Seeing that, the FDA decided not to regulate those tests, an FDA official said. Over time, however, use of LDTs became a serious concern when labs developing LDTs were no longer involved …

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December 28, 2015 Intelligence: Late Breaking Lab News

To advance the practice of precision medicine through better use of genetic testing, a new limited liability corporation (LLC) was formed. Participating in the LLC are North Shore-LIJ Health System, the nation’s largest urban health system, OPKO Health, Inc., a pharmaceutical company, and GeneDx, a division of Bio-Reference Laboratories (both lab businesses are owned by OPKO). …

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