EUA

FDA to Issue Emergency Use Authorization for Multi-Analyte Respiratory Panels During the Pandemic

The convergence of flu season with the global COVID-19 pandemic will create the need for new multi-analyte respiratory panel tests that are capable of not only detection of but also differentiation … [Read more...]

LDTs

FDA Breaks New Ground by Authorizing SARS-CoV-2 Tests for Sample Pooling

It’s not uncommon for the FDA to revise the Emergency Use Authorization (EUA) for a particular diagnostics test to permit a new clinical use. In most cases, these expansions don’t even get an official … [Read more...]

LDTs

FDA Provides New Guidance on Validation of Sample Pooling for SARS-CoV-2 Test Development   

On June 16, the FDA issued new guidance to help labs and commercial manufacturers use test sample pooling to develop, validate and acquire Emergency Use Authorization (EUA) of qPCR-based SARS-CoV-2 … [Read more...]

New Products

First SARS-CoV-2 Antigen Test Gets EUA Clearance from the FDA

First came the molecular and then the serologic assays. And last month, the FDA granted emergency use authorization (EUA) for a COVID-19 assay based on a third kind of testing methodology: antigen … [Read more...]

LDTs

Laboratory Developed Tests: The VALID Act is Back

With all the attention commanded by the coronavirus crisis, a potentially huge development affecting the future of the lab industry has flown under the radar. What’s at stake is the issue that has … [Read more...]

Coronavirus

Two commercial labs testing now for COVID-19

Two commercial lab companies have announced they are moving into testing for COVID-19. LabCorp. said Thursday it was immediately offering testing for COVID-19 and Quest Diagnostics has announced it … [Read more...]

Technology

Point of Care: Is the Blood-Drawing Robot the Phlebotomist of the Future?

Question: Is the human phlebotomist an endangered species? Answer: Not exactly. But a new study suggests that at least one robot may be able to collect blood samples just as well, if not better, than … [Read more...]

NEW PRODUCT DEVELOPMENT

New Product Development: FDA Issues Final Guidance on IVD Oncology Trials

On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic (IVD) in an oncology clinical trial is … [Read more...]

Global News: EU Delays Launch of Eudamed Database

The European Commission (EC) is delaying the launch of the European database on Medical devices (aka Eudamed) until May 2022.  Originally, manufacturers were supposed to be compliant by May 2020 with … [Read more...]

Industry News

Kellison and G2 Intelligence Honor Dr. Sidney Goldblatt

Dr. Sidney Goldblatt, MD, is the 2019 recipient of the Kellison Public Service Award. Dr. Goldblatt has been founder, medical director and CEO of Molecular Dx; founder and CEO of Goldblatt Systems; … [Read more...]


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