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
Lab Owner Convicted for $463 Million Genetic Testing Fraud
Case is a recent example of the trend toward Medicare schemes involving telehealth, cancer genetic testing, and kickbacks.
Five Key Changes Affecting Labs in the New Spending Bill
While the federal spending bill passed at the end of 2022 will have a large impact on clinical labs, it doesn’t include LDTs reform.
Congress Delays Part B Price Cuts but Nixes Long-Term SALSA Solution
Legislation offering permanent relief from both PAMA price cuts and reporting didn’t make it into the federal spending bill passed Dec. 23.
Massive Caseload Overwhelming No Surprises Act Payment Dispute Resolution System
According to a recent CMS report, the sheer volume of out-of-network payment disputes is overwhelming the system.
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.
