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
Compliance Tool: Model Policy on Use of HIPAA-Protected Health Information for Marketing Purposes
This template helps lab leaders implement a written policy limiting and establishing procedures governing use of PHI for marketing.
Compliance Tool: HIPAA Compliance Fact Sheet for Lab Marketing Staff
This template helps labs create a fact sheet that highlights the key HIPAA-related do’s and don’ts for marketing staff.
Inside the Lab Industry: Q2 Earnings Decline Despite Rebound in Core Business
Though COVID-19 testing declines continue to negatively affect lab industry profits, the latest figures suggest the worst may be over.
October 2023 Labs in Court
Recent cases involve charges and judgments related to COVID-19 add-on tests, genetic testing fraud, and kickbacks.
Compliance Perspectives: How to Comply with the CMS 60-Day Overpayment Repayment Rule
While overpayments may not be your fault, they expose your lab to the risk of liability under the Affordable Care Act.
How to Ensure Proper Documentation for Billing Laboratory Services
What do lab professionals need to do to ensure sufficient documentation for billing clinical laboratory and pathology services?
A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
September 2023 Labs in Court
In last month’s key cases, Illumina and Guardant seek to dismiss lawsuit related to trade secrets and breach of contract.
DX Deals: Teaming with Google Leads to WGS Success for PacBio
A strategic partnership with Google enables more accurate whole genome sequencing with machine learning.
September 2023 FDA Watch
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
