LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims

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  Lab and Pathology Insider Logo  
September 17, 2019  
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LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
From National Intelligence Report
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict…
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placeholder INDUSTRY TRENDS
Adoption Quickening for Genomic Cancer Testing in Community Settings
From Diagnostic Testing & Emerging Technologies
Clinicians are increasingly using genomic cancer testing in community health care settings, although there are…
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Enforcement Trends: New Emphasis on MD Practices Puts Labs at Growing Risk of Antitrust Enforcement
From Lab Compliance Advisor
In addition to the usual Medicare and Medicaid anti-fraud laws, labs have a new liability risk to contend with…
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Are Erratic Scheduling Practices Causing Financial Instability for Your Hourly Lab Employees?
From Laboratory Industry Report
A study reveals that for today's hourly workforce, missing a single shift comes at a steep cost…
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Genetic Testing Fraud Prosecutions are on the Rise around the Country. Are Your Genetic Testing Practices Compliant?
From G2 Blog
Over the last year, a number of genetic testing fraud investigations and prosecutions have been initiated by…
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