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
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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
Federal Court Tosses Consumer Fraud Lawsuit Against Labcorp
Not disclosing list prices of uncovered lab tests on ABN is not consumer fraud, court says.
New Breakthrough Device Designations Fall 37 Percent in 2022
According to the FDA’s recently-released annual report, only 135 devices received the designation last year, versus 213 in 2021.
Bringing Multi-Cancer Tests Closer to Reality
A new method for early detection of 14 cancer types based on glycosaminoglycan profiles shows promise.
USPSTF Again Declines to Recommend Lipid Screening for Asymptomatic Children
The panel recently said there was still not enough evidence to properly assess the harms and benefits of such screening.
Special Report: What Next for COVID-19 Tests?
An overview of what will happen to the COVID-19 tests issued via EUA once the public health emergency ends on May 11.
Weekly Enforcement Update: Inflated Claims Are a Key Theme
Though last week’s cases didn’t involve labs or lab testing, most were FCA-related issues including inflated claims.
Labs Partner with Pharma for New Companion Diagnostics Tests
Specially crafted lab tests speed up adoption of novel drug treatments.
Lab Companies See Mixed Bag of Financial Results in Q4 2022
Q4 2022 financial results released by three key lab companies over the past week mainly included losses, but there were positives as well.
No Routine Lipid Screening for Asymptomatic Children, Says USPSTF
Influential panel cites lack of evidence of tests’ harms and benefits.
FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends
Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.
