Profound Discrepancies Seen Between DTC Genetic Results, Confirmatory Testing

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May 1, 2018  
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Profound Discrepancies Seen Between DTC Genetic Results, Confirmatory Testing
From - Diagnostic Testing & Emerging Technologies
Raw data from direct-to-consumer (DTC) genetic tests have an "alarmingly high" false-positive rate, according to a study published…
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FDA Watch: Agency Issues New Guidance to Ease Approval of NGS Tests & IVD Devices
From - Laboratory Industry Report
April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing…
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placeholder  COMPLIANCE PERSPECTIVES
PAMA Reimbursement: CMS Tells Labs How to Secure ADLT Status for New Tests
From - G2 Compliance Advisor
Although the 2018 market-based Clinical Laboratory Fee Schedule (CLFS) is officially in effect, implementation of the new…
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Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer
From - National Intelligence Report
In the PAMA era, there are two salient trends in Medicare Part B lab reimbursements…
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