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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 29, 2024 | Disease States |

The FDA approved Labcorp’s companion diagnostic test designed to determine eligibility for Pfizer’s gene therapy for hemophilia B patients.

GenomOncology announced enhancements to its Pathology Workbench software, which features improved support for germline and somatic testing.

Bruker enhanced diagnostic solutions in microbial identification, antimicrobial susceptibility testing, early sepsis diagnostics, and more.

Posted by Andy Lundin | Apr 24, 2024 | Lab Management |

ELLKAY’s lab enterprise solution facilitates electronic orders, simplifies results delivery, and streamlines reimbursement processes.