Compliance

Docus Showcases AI Platform for Diagnostic Laboratories at ADLM 2026

Docus unveiled an AI platform for diagnostic laboratories at ADLM 2026, offering interpretation, follow-up, and compliance features that integrate with existing LIS via API or HL7.

Compliance

Hair Drug Test Positivity Reaches 19.1% Among US Workers

Hair drug test positivity among US workers rose to 19.1% in 2025, a 46% increase since 2021, with marijuana accounting for over half of positive results, according to the 2026 Quest Diagnostics Drug Testing Index.

Compliance

US Settles Genetic Testing Fraud Case Against Laboratory Owner

The settlement follows a criminal conviction and addresses more than $174 million in fraudulent Medicare claims involving multiple laboratories.

Hawaii Dept of Health Issues Violations to Four Companies Over Illegal Direct-to-Consumer Lab Testing

Jan 8, 2026 | Compliance

State regulators say the companies collected specimens without authorized provider orders, violating Hawaii law.

Proscia Earns SOC 2 Type II Certification for Digital Pathology Platform

Dec 29, 2025 | Compliance

The compliance milestone adds to the company’s existing ISO certifications as enterprise deployments accelerate across pharmaceutical and diagnostic laboratory customers.

AMP Awards Pathologist for Role in Laboratory-Developed Test Litigation

Oct 30, 2025 | Compliance

The pathologist served as joint plaintiff in successful lawsuit challenging FDA regulation of LDTs as medical devices.

FDA Issues Finalized Guidance on Emergency Use of Unapproved Diagnostic Tests

Sep 24, 2025 | Compliance

The guidance establishes a formal framework for how the FDA will exercise enforcement discretion regarding unapproved diagnostic tests in the event of future public health emergencies.

FDA Withdraws Final Rule Regulating Lab-Developed Tests as Medical Devices

Sep 22, 2025 | Compliance

The action follows a federal court order that vacated the 2024 rule, reinstating FDA’s prior policy of enforcement discretion for laboratory-developed tests.

AdvaMed Calls for Diagnostic Tests to Be Included in Breakthrough Coverage Bill

Sep 22, 2025 | Compliance

AdvaMed urges inclusion of diagnostic tests in legislation that would provide four years of coverage for FDA-designated breakthrough technologies.

Lab CEO, Physicians, Marketers Pay $6M to Settle Kickback Allegations

Sep 18, 2025 | Compliance

Settlement resolves False Claims Act litigation alleging illegal payments disguised as management service organization distributions.

Laboratory Organizations Rally Behind RESULTS Act to Reform Medicare Payment Cuts

Sep 11, 2025 | Compliance

Bipartisan legislation aims to overhaul the PAMA rate-setting process that has cut $4 billion in cuts to clinical laboratory services in three years, according to ACLA.

Clinical Labs Navigate What’s Next After FDA’s LDT Rule Reversal

Aug 29, 2025 | Compliance

Greer Massey, PhD, chief scientific officer at Molecular Designs, shares insights on how labs are affected by the rule’s reversal and how they can prepare for future regulatory changes.

FDA Issues Notice to Rescind Laboratory Developed Test Rule

Aug 26, 2025 | Compliance

The agency signals intent to withdraw final rule extending regulatory authority to LDTs following federal court ruling that vacated the regulation.

New Guidance on Modifications to Antimicrobial Susceptibility Testing

Aug 25, 2025 | Compliance

The new document provides framework for drug developers on appropriate use and modification of reference AST methods during antimicrobial development.