TAG:

genomics

PGx Testing Labs Concerned by FDA’s Statements, Actions

This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…

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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 ce…

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January 14, 2019 Intelligence: Late Breaking Lab News

Up to 10,000 patients will get free genetic testing at Northwell Health, the nation’s largest urban health network. In a deal announced on Jan. 9, Northwell Health and Color, a genetic testing company, will collaborate on a program to offer geneti…

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U of Florida Health Improves Patient Care with PGx Testing

CEO SUMMARY: Since 2011, the University of Florida Health System has used pharmacogenetic test (PGx) results to guide physicians when they prescribe certain drugs. This initiative has improved patient outcomes, reduced the overall cost per episode of care, and gained partial reimbursemen…

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Sonic Uses Lab Data, Patient-Contact Tools, to Improve Outcomes

CEO SUMMARY: In its work for a federally qualified health center, Sonic Healthcare USA helped physicians use a data-driven approach to population health management that incorporated integrated financial and clinical analytics. Also, Sonic developed technologies that give ordering physicia…

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April 16, 2018 Intelligence: Late Breaking Lab News

Add Estonia to the growing list of nations that will now provide genetic information to its citizens. On March 20, the government rolled out an initiative that, in its first phase, will generate genetic information for 100,000 of its 1.3 million residents. This data will address an individual’s ge…

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Why Pharma, Private Equity Want to Reshape Lab Industry

CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professio…

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March 5, 2018 Intelligence: Late Breaking Lab News

“More people took genetic ancestry tests last year than in all previous years combined,” declared Senior Editor Antonio Regalado in a story published on Feb. 18 by MIT Technology Review. He wrote that, just in 2017, the number of people who had their DNA analyzed with direct-to-consumer genetic g…

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January 22, 2018 Intelligence: Late Breaking Lab News

In a first for Australia, a pathology lab was given authorization to use patient-collected cervical specimens from eligible women for cervical cancer screening purposes. VCS Pathology of Melbourne, Victoria, was given this authorization by Australia’s National Association o…

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January 2, 2018 Intelligence: Late Breaking Lab News

In Arizona, individuals and patients who paid for clinical laboratory tests performed by Theranos, Inc., are finally getting refunds. These payments are a result of a settlement between the Arizona Attorney General and Theranos. News accounts indicate that, over the time in 2013 thr…

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