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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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- Business deals in the diagnostics space, and more
Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Hopes for Permanent PAMA Relief Dashed
Though the federal spending bill passed at the end of December offers another year’s reprieve from PAMA price cuts, SALSA was not included.
The 5 Most Significant Lab Company M&A Deals of 2022
Merger and acquisition deal volume and value were down last year, but deal impact was not.
Guardant Health Leads Wave of New Cancer Diagnostics Collaborations
Deals involving the development and commercialization of new cancer diagnostics and treatments were the most common in December.
The Top 10 Most Significant FDA New Lab Test Approvals of 2022
Here are what G2 Intelligence considers to be the 10 most significant FDA lab testing clearances of 2022, in rough chronological order.
How Data Automation Solutions Can Improve Collections & Patient Satisfaction
Here’s an approach to ensure your lab patients have the most positive financial experience possible.
Digital Systems Expected to Drive 5% Annual Growth in PCR Testing Products
The total market for PCR products will likely top $5 billion in 2023, according to a new report.
M&A Report: The Top 15 Diagnostic Deals of 2022
M&A activity in the clinical diagnostics space was significantly down in 2022 in terms of both deal volume and deal value.
PAMA Alert: Hopes for SALSA Relief Die at the Eleventh Hour
Congress fails to include SALSA in the omnibus federal government spending bill passed at the end of 2022, but delays PAMA price cuts once again.
CGx Testing and Kickbacks Remain Key Enforcement Targets
In our latest roundup, schemes involving cancer genetic testing and kickbacks remain the most common, but there were some surprises.
January 2023 Labs in Court: Two Usual Cases, Two Unusual Ones
Key cases over the last month include a CGx testing kickback scheme, false billing, and violations of a non-compete clause and HIPAA.
