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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
What the Federal COVID-19 Fraud Crackdown Means for Labs
If your lab received federal relief funds from the US government during the COVID-19 pandemic, you could be at risk of FCA lawsuits.
Revised VALID Act Proposes Risk-Based FDA Regulation of LDTs
The most recent congressional effort to pass LDT legislation may prove to be the one that finally comes to fruition.
BioMérieux and Sema4 Complete Strategic Acquisitions
Two of the biggest merger and acquisition-related deals that came down in May involved BioMérieux and Sema4
New VALID Act Would Establish Risk-Based System for LDTs Regulation
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.
Collaboration Explores Humanoid Robot for Sequencing Sample Prep
Companies will explore LabDroid’s capacity to automate sample preparation workflows for long-read sequencing systems.
Who Got the Early Jump on the Monkeypox Lab Tests Market?
Companies are using the lessons learned from COVID-19 to get out of the box quickly in developing test kits for monkeypox.
FY 2022 Q1 Could Be the Last Hurrah for the COVID Earnings Surge
Most diagnostics companies experienced modest, flat, or negative top-line revenue growth rates in the first quarter of 2022.
HIPAA vs OSHA: What to Do When Laws Collide
What happens when lab personnel’s OSHA rights to access illness and injury records seemingly clash with HIPAA privacy laws?
OIG Gives the OK to Free Genetic Testing & Counseling Arrangement
New OIG Advisory Opinion offers valuable insight into where the agency draws the line on free genetic tests.
Recent Kickback Cases Range from $300 Million Scheme to a Free Service
Of this month’s four Labs in Court cases, three involved kickbacks resulting in widely varying penalties.
