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molecular diagnostic assays

In Florida, More Tests Added to UHC’s Decision-Support Program

IN THE FIRST BROAD EXPANSION OF ITS pilot decision-support program for clinical lab testing in Florida, UnitedHealthcare (UHC) will add genetic and molecular tests, drug tests, and pathology procedures, among other assays starting in two months. On March 1, UHC will expand its labor…

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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 o…

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Is New Cycle of Fraud Plaguing Lab Industry?

CEO SUMMARY: Taken collectively, the growing number of federal investigations of clinical lab companies and health insurer lawsuits against lab companies alleging fraudulent business practices signals a disturbing new trend for the lab industry. Although these allegations are lev…

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February 17 Intelligence: Late Breaking Lab News

GeneCentric is a new lab testing company in Durham, North Carolina that was started by former executives of Laboratory Corporation of America. It intends to raise $20 million in a Series B capital offering. GeneCentric’s business model is to license molecular diagnostic tests, then develop the…

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Lab Companies’ IPOs Go Two-for-Three in November

CEO SUMMARY: This fall, a parade of molecular and genetic test companies moved forward with initial public offerings (IPOs) of their stock. In September, Foundation Medicine raised $106 million from its IPO. Encouraged by this success, three different companies proceeded with IPOs during …

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Medicare Contractor’s Ruling on MolDx Test Causes Lab to Close

CEO SUMMARY: On May 14, Predictive Biosciences learned that its Medicare contractor had determined that one of its three molecular tests for bladder cancer was a screening test. It also never got a determination on its other two molecular tests. Because Medicare is half of the lab’s pay…

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Health Insurers See Big Increase in Lab Utilization

CEO SUMMARY: In a recent public workshop, managed care executives revealed that the annual cost of outpatient laboratory testing is increasing at twice the rate of all other medical services. One big driver in the increased spending on lab testing is increased utilization…

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Ascend Clinical Acquires PathCentral Lab Business

CEO SUMMARY: Ascend Clinical and PathCentral see an opportunity to provide sophisticated services to community pathology groups. Ascend Clinical will expand the molecular diagnostic and gene sequencing business it is purchasing from PathCentral. PathCentral will concentrate on marketing i…

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November 19, 2012 “Intelligence: Late Breaking Lab News”

Only one clinical lab industry vendor made the inaugural list of the Modern Healthcare’s fastest- growing health companies. It was Sysmex America, of Mundelein, Illinois. Sysmex ranked number 26 on a list of 40 healthcare companies. Modern Healthcare reported that…

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2011’s Top 10 Lab Stories Point to a Busy 2012

CEO SUMMARY: Given the specific news stories that make up THE DARK REPORT’S list of the “Top Ten Lab Stories for 2011,” it might be said that 2011 was a rather quiet year overshadowed by anticipation of the coming reforms mandated by the Accountable Care Act of 2010. For the clinica…

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