Lab Compliance Advisor

Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice

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Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule

By Rachel Muenz | Nov 21, 2024 | 1 min read

Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule

A group of four laboratory professionals, three standing and one sitting, meet in the laboratory. Two of the lab professionals are holding clipboards.

How the LDT Final Rule’s Exemptions Apply to Oncology Labs

By Scott Wallask | Nov 7, 2024 | 1 min read

Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines

A closeup image of a female laboratory assistant in PPE typing on a laptop at the laboratory bench

FDA Watch: FDA Approves Enhanced Cologuard Cancer Test

By Ron Shinkman | Nov 1, 2024 | 1 min read

Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent

An illustration of the human colon with cancerous mass.

Pathway Genomics Denies Wrongdoing, Settles False Claims Allegations for $4 Million

By Glenn S. Demby | Jan 4, 2016 | 1 min read

From - G2 Compliance Advisor
As the year came to a close, the Federal Bureau of Investigation and the U.S. Attorney's Office announced December 30, 2015, a $4 million settlement with Pathway Genomics. The San Diego-based laboratory denied wrongdoing but agreed to pay that sum to resolve…

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CDC Year in Review and Future Plans Include Laboratory Safety

By Glenn S. Demby | Jan 4, 2016 | 1 min read

From - G2 Compliance Advisor
Laboratory safety and diagnosis of infections figure prominently in the Centers for Disease Control and Prevention's (CDC) review of 2015 and its agenda for 2016. The agency's Year in Review highlighted "the most pressing public health challenges of…

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