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Labs Express Concern about Testing Access if FDA Regulates LDTs

Posted by Andy Lundin | Mar 5, 2024 | Compliance |

Nearly 85% of respondents to an ARUP Labs survey on the impact of the FDA’s proposed rule to regulate LDTs believe it will hurt their labs.

A new study aimed to develop a non-invasive method for early detection of GDM using cell-free DNA (cfDNA) and deep learning models.

Babson Diagnostics’ highly-automated microsample laboratory has been awarded accreditation by the College of American Pathologists (CAP).

Posted by Chris Wolski | Jan 23, 2024 | Compliance |

CLP Editor Chris Wolski examines the need for LDT regulations, and issues an industry-wide call to action.

Low-code LIMS offer an adaptable, nimble platform, facilitating quick customization to cater to the specific, individualized needs of a lab.