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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
Guardant Health Leads Wave of New Cancer Diagnostics Collaborations
Deals involving the development and commercialization of new cancer diagnostics and treatments were the most common in December.
The Top 10 Most Significant FDA New Lab Test Approvals of 2022
Here are what G2 Intelligence considers to be the 10 most significant FDA lab testing clearances of 2022, in rough chronological order.
How Data Automation Solutions Can Improve Collections & Patient Satisfaction
Here’s an approach to ensure your lab patients have the most positive financial experience possible.
Digital Systems Expected to Drive 5% Annual Growth in PCR Testing Products
The total market for PCR products will likely top $5 billion in 2023, according to a new report.
M&A Report: The Top 15 Diagnostic Deals of 2022
M&A activity in the clinical diagnostics space was significantly down in 2022 in terms of both deal volume and deal value.
PAMA Alert: Hopes for SALSA Relief Die at the Eleventh Hour
Congress fails to include SALSA in the omnibus federal government spending bill passed at the end of 2022, but delays PAMA price cuts once again.
CGx Testing and Kickbacks Remain Key Enforcement Targets
In our latest roundup, schemes involving cancer genetic testing and kickbacks remain the most common, but there were some surprises.
January 2023 Labs in Court: Two Usual Cases, Two Unusual Ones
Key cases over the last month include a CGx testing kickback scheme, false billing, and violations of a non-compete clause and HIPAA.
HHS Proposes New Privacy Rules for Substance Abuse Patient Records
Laboratories may have to revise their own medical records disclosure policies to ensure compliance.
How to Comply with New Specimen Collection Fee and Travel Allowance Rules
Here are the changes to Medicare specimen collection fee and travel allowances included in the 2023 PFS and what you’ll need to know to comply.
