Labroots

Analytical Validation of a Next Generation Sequencing Laboratory-Developed Test

Next-generation sequencing (NGS) has become the go-to tool for testing laboratories looking for increased efficiencies and profitability. NGS allows labs to use smaller tissue samples and reduced time ...
Labroots

Analytical and Clinical Validation Requirements for Next Generation Sequencing Laboratory-Developed Tests

Next generation sequencing (NGS) has revolutionized molecular diagnostic testing. It is important to note that, as with many molecular diagnostic tests currently in clinical use, there are very few ...
Yahoo Finance

Bionano Laboratories Announces Publication of the Analytical Validation of its OGM-Based Laboratory Developed Test for Hematological Malignancies and Additional Multi-Site ...

SAN DIEGO, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Bionano Laboratories today announced the publication of a study covering the analytical validation of its laboratory developed test (LDT), marketed as ...
ascopubs.org

Multi-clinical laboratory validation of a gene expression-based tissue of origin test applied to poorly differentiated and undifferentiated cancers

Outcome of patients with locally advanced breast cancer (LABC) followed at the University of Cincinnati (UC) No significant financial relationships to disclose. This is an ASCO Meeting Abstract from ...
Nature

Preclinical validation of fluorescence in situ hybridization assays for clinical practice

Purpose: Validation of fluorescence in situ hybridization assays is required before using them in clinical practice. Yet, there are few published examples that describe the validation process, leading ...
Royal Society of Chemistry

Analytical Test Methods Validation for GxP Laboratory Compliance: FDA, ICH and USP Requirements - Webinar By GlobalCompliancePanel

This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method ...