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.
Keep up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
Know where labs may fall foul of compliance requirements—and discover the actions your lab can take to mitigate the risk of noncompliance
Recently announced collaboration between Viome and Henry Schein allows dentists to offer sample collection for Viome’s assay to patients
Labs that invested heavily in POC molecular tests during COVID-19 are well positioned to leverage this equipment toward GAS diagnostics
Recent enforcement actions and court cases include kickback schemes a-plenty and a reminder to focus on HIPAA compliance
Factors laboratories should consider when evaluating their compliance challenges, needs, and goals to select compliance solutions
New policies aim to better protect data against increasing cyberattacks, but academics say the changes will limit critical research
How widespread is corruption in the lab—and what can be done to combat it?
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
Though IVD and commercial lab Q3 2023 earnings reports held promising signs, Q4 2024 and FY2023 results tell a different story.
Partnership between Mindera and PBM aims to optimize treatment matches for the disorder, as some drugs cost nearly six figures annually