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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
Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service
From - National Intelligence Report
The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect…
Cytokines Could Predict Risk of Side Effects From Immunotherapy
From - Diagnostic Testing & Emerging Technologies
Blood-based cytokine markers may help identify cancer patients at greatest risk of developing side effects from immunotherapy treatment, according to…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Here are some of the more notable launches from the busy October-November period…
New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
LDTs: FDA Announces New Approach to 510(k) Approvals
From - National Intelligence Report
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including…
Earnings Report: Top Payers Announce Q3 Earnings
From - Laboratory Industry Report
The country's five largest commercial payers posted strong results for the third quarter of fiscal year 2018…