Issued in March, the FDA’s Final Rule on laboratory developed tests (LDTs) marks a departure from nearly 50 years of established regulatory standards. This means testing labs will soon face a dramatic shift in how they operate. The Final Rule mandates new qu...
The process to produce the exact concentrations and analytes to suit your testing lab’s specific needs is costly, tedious, and time-consuming. But when nothing less than total control will do to eliminate uncertainty, there’s no substitute for generating the exa...
Troubleshooting QC failures enables your lab to ensure the accuracy and reliability of its test results, which directly impacts regulatory compliance. Prompt identification and resolution of these issues prevents costly delays while maintaining your lab’s efficiency a...
Your reference testing lab relies on its ability to produce consistent, accurate, and reproducible test results. And when it comes to maintaining the highest possible standards for your analysis, there’s no substitute for 100% REAL™ human matrices in your quality co...