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
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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
A New ctDNA Test for MRD Surveillance in Colorectal Cancer Patients
The personalized test is designed to help inform post-surgery adjuvant therapies in CRC patients.
Weekly Enforcement Report: UDTs & Diagnostic Imaging
This week’s cases involved false billing allegations related to urine drug testing, as well as diagnostic imaging false claims and fraud.
New Guidance Released for Cervical Cancer Detection
Recently released AACC document covers newly updated screening guidelines as well as information on surveillance and diagnosis.
Lab Business: It’s Back to Basics for LabCorp & Enzo Biochem
Enzo recently announced that it is selling its lab division to LabCorp for $146 million in cash.
Clinical Lab Services Market to Be Worth More than $125.6 Billion by 2030
A recently released report estimates that the US market will grow at a CAGR of 4.2 percent over the next seven years.
Weekly Enforcement Report: Lab Owners Charged in 2 Fraud Schemes
The owners face fraud charges in two different schemes, one involving urine drug testing and one involving COVID-19 testing.
OIG Greenlights Pharma Patient Assistance Arrangement
New Advisory Opinion 23-01 is similar to other arrangements the OIG has approved in the past.
The End of COVID-19 PHE: Practical Implications for Clinical Labs
In this webinar, our expert speakers will share what the end of the COVID-19 PHE will mean for clinical labs and how they can best prepare.
FDA Says It’s Prepared to Impose LDT Regulations
If Congress won’t do it, we will, the FDA says of laboratory developed test reform.
No Surprises Act Controversy Takes Surprising Twist
Resolution process put on hold after federal court again strikes down parts of the regulation as being unfairly weighted in favor of insurers.