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FDA Announces Final Rule on LDT Regulation

Posted by Andy Lundin | Apr 29, 2024 | Compliance |

The U.S. FDA finalized a rule regarding its oversight of LDTs to make explicit that IVDs are considered devices under the FD&C Act.

Posted by Andy Lundin | Apr 19, 2024 | Covid 19 |

The lab-developed test will help diagnose Long COVID and is aimed to provide accurate insights into personalized treatment approaches.

Posted by Andy Lundin | Apr 15, 2024 | Womens Health |

Agilent Technologies announced that its GenetiSure Dx Postnatal Assay received European IVDR Class C Certification.

The facility has been designed to manufacture the company’s Co-Dx Pro instrument and test cups for the new platform.

There is a potential to use T-cell diagnostics to diagnose underlying post-viral syndromes by measuring the bodies adaptive immune resistance.