Useful Links
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…
G2 Blog
New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
By Danielle Sloane bio and Chris Climo bio
In a recent piece of federal legislation intended to address the opioid crisis across the United States, Congress enacted a new all-payor kickback law that applies to…
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…
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…