Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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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
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.
CMS to Crack Down on False Billing of COVID-19 Add-on Tests
Some labs took advantage of COVID coverage rules to bill Medicare for medically unnecessary RPPs, allergy, and genetic tests.
New Cancer Diagnostic Tests Stand Out
Key Dx announcements last week involved companion diagnostics, liquid biopsy assays, and an RUO leukemia test.
Clinical Laboratory Enforcement Update
Get an overview of trending areas of enforcement and steps labs and pathology practices can consider to protect their businesses.