Tag: medical laboratory tests

Official Makes Case in Favor of FDA LDT Guidance

IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed FDA LDT guidance. Among the interesting insights are that FDA officials will not be surprised if some labs file a lawsuit challenging

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Feds Show How Labs Took $500 Million from Medicare

CEO SUMMARY: In this second phase of the whistleblower case against three cardiology testing labs and a sales consulting company, federal prosecutors are requesting a jury trial against the individuals named in the court documents filed August 7. Federal investigators alleged that executives at one lab began a fraud scheme in 1999 and then expanded that scheme to other labs over 15 years. The suit claims that the labs made improper payments to referring physicians.

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Theranos, Capital Blue Sign Lab Test Agreement


CEO SUMMARY: With each passing month, Theranos is looking more like a traditional clinical laboratory company, based on how it is expanding its patient service center network and courier/logistics system into different regions while pursuing managed care contracts with health insurers. Meanwhile, respected laboratory scientists and physicians are using peer-reviewed medical journals to point out that Theranos has yet to publish details about the performance of its diagnostic technology to enable independent validation.

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Our Editor Describes Visit to Theranos Test Center

CEO SUMMARY: Theranos now operates wellness centers in Walgreens in Palo Alto, California, and Phoenix, Arizona. It con- tinues to claim it is transforming the lab testing experience for patients and physicians. It says it can perform hundreds of lab tests, using a finger stick collection and a micro-specimen vial, and return results in four hours. Last month, our editor visited a Theranos wellness center in a Walgreens pharmacy with a test requisition for four lab tests. He reports here on the experience.

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