How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Taking Job at Genetic Lab Doesn’t Violate Oncologist’s Non-Compete with Health Data Firm
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Feds Arrest Ring Leaders of Alleged COVID-19 False Testing Scheme
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Model COVID-19 Exposure Control Plan
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Can Lab Lease Space for COVID-19 Testing to Referring Physician at Below-Market Rent?
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A roundup of recent cases and enforcement actions involving the diagnostics industry
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CMS Waivers Expand COVID-19 Testing Coverage Rules
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Lab to Pay Up to $43 Million After Disregarding Employee’s False Billing Concerns
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How to Create a COVID-19 Exposure Control Plan
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The 18 Things You Can Do for COVID-19 that You Can’t Do for Other Testing
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Colorado MDs Pay $55K for Taking Specimen Processing Fee Kickbacks from HDL and Singulex
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