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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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
New Insight into Deaths of US Cancer Patients Due to COVID-19
Recent study provides new details on how COVID-19 impacted cancer deaths in the US early in the pandemic and which groups were most affected.
Qiagen Enters Neurology Space with Parkinson’s CDx Collaboration
The developer of NGS-based companion diagnostics targets the growing neurology biomarker market.
Pharmacogenetic Testing Leads to Better Depression Treatment Decisions
A recent study shows pharmacogenetic testing can help caregivers make better decisions when prescribing antidepressants.
New Guideline for Using Lab Tests to Improve Cancer Treatment
The new CAP guidance addresses use of immune checkpoint inhibitors for evaluating and treating patients with specific cancers.
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.
