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Special Report: The 2024 Lab Enforcement Landscape

By Scott Wallask | Aug 29, 2024 | 1 min read

Lab leaders should be wary of telemedicine arrangements, certain marketing firms, and unnecessary PGx and CGx testing

A female laboratory professional looks at a tablet while standing in a darkened laboratory, illustrating the review of laboratory enforcement actions.

Getting Started with the FDA’s New LDT Rule

By Michael Schubert, PhD | Jun 26, 2024 | 1 min read

Experts explain what the phase-in process will look like—and how labs can get ahead of the game.

A laboratory professional uses a tablet while sitting in front of a computer with various health-related icons coming out of it to illustrate the concept of healthcare regulations

LDTs Around the World

By Michael Schubert, PhD | Jun 4, 2024 | 1 min read

Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions

Labs Safe, but Marketing Company and Referring Physician Get In Trouble for Kickbacks

By Glenn S. Demby | Feb 22, 2016 | 1 min read

From - G2 Compliance Advisor
Once again, payments to physicians to induce referrals of lab tests has led to government enforcement efforts—but this time…

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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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