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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Courts Dismiss Two Whistleblower Lawsuits
In this month’s Labs in Court roundup, a medical device company and genetic testing company each win key victories.
Eleven Things Labs Must Know to Comply with PAMA
An overview of PAMA and key aspects lab compliance officers should be aware of to help ensure compliance.
CMS to Crack Down on Unnecessary COVID-19 Add-on Tests
Recent OIG report suggests some labs might have gamed Medicare coverage rules in 2020 by billing for unusually high numbers of such tests.
An AI Invasion: Improving Breast Cancer Biopsies
Researchers report the first-ever routine clinical use of an AI-based tool for breast cancer biopsies in a pathology lab.
How to Resolve Three Common Types of Preanalytical Interference
Experts share new strategies for dealing with hemolysis, icterus, and lipemia interference.
ACMG Strongly Recommends NIPS for Common Fetal Trisomies
In a new practice guideline, the group also “strongly recommends” that NIPS be offered to patients to screen for fetal SCA.
Easier, Noninvasive Diagnosis of Neurological Disorders
More companies have begun offering neurofilament light chain blood tests as a cost-effective alternative to conventional methods.
Roche Scores First European IVDR Approval for Diagnostic Tests
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
Early in Pandemic, HIV Testing Dropped Sharply, but Quickly Rebounded
A recent CDC report concludes that disruptions to HIV testing due to the COVID-19 pandemic compromised America’s ability to prevent the disease.
Weekly Enforcement Report: Medical Equipment & Kickbacks
While labs were absent from recent enforcement actions, last week saw kickback schemes involving DME companies and a medical device company.