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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
New Joint Commission Health Equity Standard Takes Effect Jan. 1
What the equity rule is, who it affects, and how to comply.
FDA Reopens EUA & Immediate EUA-Less Use Pipelines for Monkeypox Tests
Despite lessons learned from COVID-19 testing, HHS and FDA plan for monkeypox testing remains flawed.
Blood-Based Alzheimer’s Tests Are Here, but Not Ready for Widespread Use
While new FDA clearances of blood-based early detection tests for Alzheimer’s represent significant progress, limitations remain.
AI and Digital Pathology: Progress and Potential Pitfalls
Pathologist Rajesh C. Dash, MD, discusses the state of AI and digital pathology, as well as challenges and possible solutions.
How to Meet Diagnostic Lab Staffing Challenges
Two lab staffing experts weigh in on current trends and what labs need to do to attract and retain talent in today’s environment.
M&A Report: Biosynex Looks to Snag Theradiag
A roundup of key mergers, acquisitions, and strategic asset purchases in the healthcare industry in September.
Qiagen Moves into Neurology with Recent Collaboration
The Hilden, Germany-based company is extending its genetic testing profile beyond oncology to neurology biomarkers.
FDA Sets New Limits on EUA Requests for COVID-19 Tests
The agency recently stated that current testing capacity is adequate and established limits on its review of new EUA submissions.
Inadequate Reimbursement Threatens Monkeypox Lab Testing Response
ACLA and public health experts warn that current reimbursement rates will hamper US efforts to contain monkeypox spread.
LDTs: Congress Set to Scuttle VALID Act at the Eleventh Hour
Congress reportedly set to pass a stripped-down version of the FDA user fees bill without the VALID Act component regulating LDTs.