How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Dx Deals: New Deal Expands Reach of Oral Cancer Test to Dental Practices
Recently announced collaboration between Viome and Henry Schein allows dentists to offer sample collection for Viome’s assay to patients
The Benefits of Group A Streptococcus NAAT
Labs that invested heavily in POC molecular tests during COVID-19 are well positioned to leverage this equipment toward GAS diagnostics
May 2024 Labs in Court
Recent enforcement actions and court cases include kickback schemes a-plenty and a reminder to focus on HIPAA compliance
Choosing and Using the Right Compliance Solution
Factors laboratories should consider when evaluating their compliance challenges, needs, and goals to select compliance solutions
Increasing Fees, Decreasing Access to Data in New CMS Proposal
New policies aim to better protect data against increasing cyberattacks, but academics say the changes will limit critical research
The Landscape of Laboratory Corruption
How widespread is corruption in the lab—and what can be done to combat it?
Dx Deals: Collaboration Takes Psoriasis Testing to New Level
Partnership between Mindera and PBM aims to optimize treatment matches for the disorder, as some drugs cost nearly six figures annually
FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
A Primer on PAMA
The impending legislation that may determine Medicare lab fees from 2025 onward
April 2024 Labs in Court
Recent enforcement actions include convictions and guilty pleas for false claims-related allegations involving toxicology labs.
