A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...

Medical laboratory scientists collect samples and perform lab tests, calibrate and maintain equipment, and perform statistical analysis. Their work is crucial for clinicians to diagnose diseases.

Diagnostic test developers, including clinical laboratories, responded to the COVID-19 pandemic with inspiring creativity to meet patient testing needs. These developers found unique ways to enable ...

In addition to the cost, the excessive overuse of laboratory testing causes patient discomfort and can lead to hospital-acquired anemia, which results in additional testing, prolonged hospitalizations ...

Platinum-Free Systemic Therapy in First-Line Metastatic Urothelial Carcinoma: Mirage or Oasis in the Platinum Desert? Cancer predictive or diagnostic assays, offered as Laboratory-Developed Tests ...