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...]
EUA
FDA to Issue Emergency Use Authorization for Multi-Analyte Respiratory Panels During the Pandemic
September 17, 2020
LDTs
FDA Breaks New Ground by Authorizing SARS-CoV-2 Tests for Sample Pooling
September 8, 2020
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
July 20, 2020
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
June 17, 2020
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
March 18, 2020
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
March 8, 2020
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?
March 4, 2020
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
November 15, 2019
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
November 14, 2019
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
November 13, 2019
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...]
