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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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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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
Six Lab Sales and Marketing Compliance Problem Areas and How to Address Them
It’s imperative for labs to establish and maintain an active corporate compliance program that augments the actual scientific testing.
Developing an Automated HIV Self-Test for Use in Developing Countries
Principal investigator discusses a new research initiative to create a low-cost, rapid HIV self-test.
AI Combined with DM and ABUS Can Improve Breast Cancer Detection
Researchers found that combining AI with both imaging technologies can improve the detection of cancer in women with dense breasts.
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.