Home Molecular Dx Laboratory Developed Tests (LDTs)

Laboratory Developed Tests (LDTs)

Most popular
Laboratory Developed Tests (LDTs)

ACMG Launches Evidence-Based Guidelines for Genetic, Genomic Testing

Memorial Sloan Kettering Cancer Center has won FDA authorization for MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) assay
Laboratory Developed Tests (LDTs)

MSK’s Approved NGS-Based Tumor Panel Leads to FDA Assay Review Pathway

Scientist pipetting a DNA sample with the results on a computer sceeen in a laboratory
Laboratory Developed Tests (LDTs)

Bionano Genomics Acquires Lineagen to Expand Genetic Testing

Scientists Loading Centrifuge
Laboratory Developed Tests (LDTs)

Testing Conundrum

Advocacy groups have alleged that the FDA lacks statutory authority to regulate LDTs
Laboratory Developed Tests (LDTs)

Snapshot: LDT Labs Prepare for the Eventuality of FDA Oversight

Edico Genome has launched the DRAGEN Clinical Genomics Information System (CGIS) platform
Laboratory Developed Tests (LDTs)

Edico Genome Launches LDT Development Platform With All Clinical Labs in...

Source: andresr / Getty Images
Laboratory Developed Tests (LDTs)

Lost in LDTs

Source: ©.shock—Fotolia.com
Laboratory Developed Tests (LDTs)

FDA to Require Premarketing Approval for “High-Risk” LDTs

Source: © Alexander Raths/Fotolia
Laboratory Developed Tests (LDTs)

FDA Regulation of LDTs Gets Contentious

Source: © inkaone - Fotolia.com
Laboratory Developed Tests (LDTs)

FDA Issues Draft Guidance on LDTs

12Page 1 of 2

New Products

View More
Load more
Copyright © 2020 Genetic Engineering & Biotechnology News. All Rights Reserved.
Scroll Up