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Direct Access Test Laboratories Targeted by NY State Attorney General

CEO SUMMARY: Following an investigation of two lab companies providing direct access testing in New York State, the New York Attorney General entered into agreements with each lab company. Direct Laboratories, LLC, of Mandeville, Louisiana, agreed to cease offering DAT services in New Yor…

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New Company Tracks Details and Prices For 60,000 Molecular and Genetic Tests

CEO SUMMARY: Advances in the speed, accuracy, and cost of next-generation gene sequencing making it possible for clinical labs to create thousands of new tests. How many new tests? NextGxDx, an information technology company, says the nation’s clinical laboratories are introducing new m…

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After Theranos-Safeway Split, Grocer Picks Sonora Quest Laboratories

IT’S RARE TO FIND ONE COMPANY STEP IN after another fails to execute a business strategy successfully. But that happened when Sonora Quest Laboratories in Scottsdale, Arizona, moved to fill the void created when Theranos Inc. did not fulfill an agreement to open pa…

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Direct Access Testing Wars Are Heating Up

CEO SUMMARY: In Phoenix, where Theranos already operates patient service centers in about 40 Walgreens pharmacies, Sonora Quest Diagnostics has an agreement with Safeway to provide clinical laboratory testing service…

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Doctors’ resistance to BeaconLBS comes to Florida legislature

CEO SUMMARY: THE DARK REPORT IS THE ONLY LAB INDUSTRY NEWS SOURCE to report on this important development. A hearing took place recently on a healthcare bill in the Florida senate.  Physicians in Florida are working to get language inserted into a state law that would restrict the …

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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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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 Heal…

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New Pricing Formula for Advanced Diagnostic Tests

CEO SUMMARY: One section of the federal H.R. 4302: Protecting Access to Medicare Act of 2014 is getting positive reviews from many lab experts. The law defines advanced diag…

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New BlueCard Policies Affect Laboratory Test Claims

CEO SUMMARY: This new policy from the Blue Cross and Blue Shield Association (BCBSA) becomes effective on October 14, 2012. No longer can a local lab provide service to a member under the BlueCard program a…

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Coming Next Year for Labs: PAMA, FDA, LDTs, and More

CEO SUMMARY: As 2016 approaches, nearly every lab organization is watching and waiting to learn how federal regulators at CMS and the FDA will move forward with plans to implement PAMA market reporting and regulation of laboratory-developed tests, respectively. Most knowledgeable observer…

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