Pharmabiz

ICMR issues comprehensive guidance on ethical requirements for laboratory validation testing

In a significant move aimed at upholding ethical standards in the realm of medical research, the Indian Council of Medical Research (ICMR) has recently released detailed guidelines on the ethical ...
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 ...
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 ...
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 ...
JD Supra

Senate bill proposes laboratory developed tests to be regulated under CLIA process

U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability ...