Health Affairs

Complex Clinical Laboratory Tests Can Benefit From Design Controls

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 ...
PBS

FDA plans to regulate thousands of lab tests that have long skirted oversight

WASHINGTON (AP) — The Food and Drug Administration on Friday laid out a proposal to begin regulating laboratory medical tests, a multibillion-dollar industry that the agency says poses a growing risk ...
CNN

FDA moves to tighten oversight of laboratory-developed tests to make them safer and more accurate

The US Food and Drug Administration is proposing to step up its oversight of a growing category of medical tests called laboratory-developed tests. The FDA approves and clears many types of lab tests ...
Health Affairs

High-Throughput, Laboratory-Based Antigen Tests Address An Unmet Need In The Global COVID-19 Pandemic

The COVID-19 pandemic continues to rage, with more than five million deaths worldwide. The urgent, global nature of the pandemic has led to great innovation with novel vaccines and diagnostics, ...