Tag: proficiency testing

Proposed Bill in Congress Would Regulate LDTs

CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for

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Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests

CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acceptable evidence that their genetic test is accurate and that it produces information

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FDA Official Outlines Need for Federal Regulation of LDTs

AT A CONGRESSIONAL BRIEFING LAST WEEK, a federal official charged with regulating laboratory-developed tests made the case that LDTs are inconsistently reliable and thus put patients at risk, according to MedPage Today.

“If you take the same patient sample and you send it to different labs, you can get different results,” stated Jeff Shuren, MD. He is

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Medi-Cal to Cut Lab Pay on July 1 by 25% to 30%

CEO SUMMARY: Since 2011, state officials in California have aggressively cut laboratory testing fees for Medi-Cal, the state’s Medicaid program. Now state officials say they will implement a new methodology next month for determining lab testing fees. The new methodology is based on lab pricing data produced as a result of whistleblower lawsuits against labs that were settled in 2011. Should prices fall below the costs of performing these tests, the Medi-Cal program may see legal challenges from the lab industry.

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March 30, 2015 Intelligence: Late Breaking Lab News

Intelligence Late & Latent News

Last Friday, at Geisinger Medical Center in Danville, Pennsylvania, members of the health systems’s authority board were given tours of the new $63.4 million clinical laboratory facility. It is scheduled to open on May 4 and will feature the latest state-of-the art analyzers and lab automation systems. Located in a new building of 162,378 square feet, it will be home to more than 350 lab employees.

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