ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
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Articles and Reports
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs
Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common
Congress Moves to Permanently Restore Medicare Coverage of Pharmacy Lab Tests
Congress is renewing its previous efforts to make Medicare reimbursement of pharmacy testing permanent—here’s what that could mean for labs.
Compliance Alert: OIG Sounds the Alarm on Medicare Overpayments for Physician Services Provided to Inpatients
According to a recent report, Medicare overpaid for such services over a two-year period between 2019 and 2020.
Special Report: The Current State of Genetic Testing Fraud Enforcement
Current genetic testing enforcement trends and what you can do to minimize the liability risks of your lab.
Reproposed SALSA Offers Real Chance of Long-Term PAMA Relief
After it failed to pass at the end of 2022, lab leaders and other insiders say they’re optimistic SALSA will pass this year.
Expert Q&A: Expanding Beyond COVID-19 Testing
Gather Labs founder and CEO Rachael McCrary discusses how her lab has achieved success beyond COVID-19 testing.
Core Laboratory Worker Compensation Highest at Mass Spectrometry Facilities: Staffing Survey
Recent survey provides insight into how current pressures are impacting laboratory staff wages and compensation.
Inside the Lab Industry: COVID-19 Declines Kill Top Lab Company Earnings but Genetic Firms Rebound
Yet, despite these declines, Q1 was neither as bad as expected nor totally devoid of positive signs for the future.
Three Strategies for Creating a Sustainable Recruiting Model
What should pathology groups and labs do in order to attract and maintain clinical talent in today’s economy?
M&A & Strategic Deals: Dealmaking Shows New Signs of Life but FTC Scrutiny Casts a Dark Shadow
After a significant lull, M&As in the lab diagnostics space heated up in May, with several key deals announced.
June 2023 FDA Watch
So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.
