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Lab Industry Advisor Subscriptions Include
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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
Does Offering Free Access to Drug Pricing Tool Cross the Kickback Line?
NY federal court ruling sheds light on what constitutes “remuneration” banned by the Anti-Kickback Statute.
Illumina and Precision Health Team Up for Population Study
Partnership will make use of Illumina’s capabilities and expertise in large-scale genomic sequencing and quickly generate high-quality data.
New Senate Bill Targets PBM Consumer Abuses
Lawmakers blame pharmacy benefit managers for high drug prices, introducing a bill to prevent what they term unfair practices.
The Sun Sets on the Controversial SUNSET Rule
HHS pulls the plug on a Trump rule requiring regulations to expire automatically after 10 years.
DOJ Adds 6 Texas Physicians to Improper Lab Test Claims Complaint
In this week’s Labs in Court roundup, six physicians were accused of billing for unnecessary lab tests in connection with an earlier lab fraud complaint.
BioMérieux and Sema4 Complete Strategic Acquisitions
Two of the biggest merger and acquisition-related deals that came down in May involved BioMérieux and Sema4
New VALID Act Would Establish Risk-Based System for LDTs Regulation
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.
Collaboration Explores Humanoid Robot for Sequencing Sample Prep
Companies will explore LabDroid’s capacity to automate sample preparation workflows for long-read sequencing systems.
Who Got the Early Jump on the Monkeypox Lab Tests Market?
Companies are using the lessons learned from COVID-19 to get out of the box quickly in developing test kits for monkeypox.
FY 2022 Q1 Could Be the Last Hurrah for the COVID Earnings Surge
Most diagnostics companies experienced modest, flat, or negative top-line revenue growth rates in the first quarter of 2022.