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AMP Celebrates Decision to Vacate FDA Rule on LDT Regs

Posted by Chris Wolski | Jun 3, 2025 | Compliance |

A federal court ruled in favor of AMP, striking down the FDA’s attempt to regulate laboratory-developed tests (LDTs) as medical devices.

Posted by Chris Wolski | May 30, 2025 | POC Instruments |

Researchers have developed a new bioluminescence-based diagnostic tool that offers virus detection in complex biological samples.

Rachel Burgoon developed a risk scoring tool to help physicians more effectively identify and treat drug-resistant infections.

Posted by Chris Wolski | May 15, 2025 | Compliance |

The ADLM has urged HHS to reinstate the CLIAC, warning that its elimination endangers test quality and patient care.

A new peer-reviewed study validates Vibrant Sciences’ microarray, enabling fast, accurate, scalable detection of over 17 tickborne pathogens.