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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Articles and Reports
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
July 2023 FDA Watch
Key approvals announced in June represented important steps forward for the lab testing industry.
Special Report: Financial Firms Project Rapid Growth of Genetic Testing Market through 2030
The outlook of the global genetic testing market based on recent reports from five financial consulting firms.
M&A & Strategic Dealmaking: Illumina May Finally Be Ready to Unwind GRAIL Acquisition
After an eventful month in the Illumina-GRAIL saga, the story may soon be over.
Billing & Coding of Infectious Disease Testing
Recent developments pose reimbursement and compliance challenges for billing and coding infectious disease testing—here’s how to manage them.
Dx Deals: Walmart Teams with Simple HealthKit to Provide Accessible At-Home Testing
The national retailer recently signed a deal with Simple HealthKit to provide Walmart customers online access to at-home diagnostic test kits.
July 2023 Enforcement Roundup
Though UDT-related enforcement actions predominate, an uncommon vendor-related case was in the mix this month.
July 2023 Labs in Court
Recent cases involve COVID-19 fraud, UDTs, and the latest HIPAA Right of Access settlement.
Compliance Perspectives: The Risks of Using ChatGPT & How to Manage Them
While ChatGPT has its place, allowing lab staff to use it exposes you to liabilities—here are some ways to manage the risks involved.
Compliance Tool: Model ChatGPT Acceptable Use Policy
As generative AI chatbot use increases, labs may want to implement a written acceptable use policy for staff.
OIG Semi-Annual Report Calls Out Drug, Genetic, and COVID-19 Testing Fraud
These three lab testing areas were the main sources of fraud and abuse revealed in the OIG’s latest Semi-Annual Report to Congress.
