The rapid evolution of COVID-19 testing in response to the need for speed and mobility continues. One notable development on the antigen testing front is Qiagen’s U.S. rollout of a portable digital … [Read more...]
NPR Report
CDC Knowingly Sent Flawed COVID-19 Test Kits to Public Laboratories in Early Days of Crisis
November 24, 2020
Early missteps characterized the federal government’s initial efforts to ensure a supply of reliable COVID-19 diagnostic tests in response to the public health emergency. And now a new National Public … [Read more...]
The Business of Testing
HHS Orders FDA to Resume EUA Review of Laboratory Developed Tests for COVID-19
November 24, 2020
Oh no you don’t! A month after the U.S. Food and Drug Administration (FDA) announced its decision to discontinue review of applications for Emergency Use Authorization (EUA) submitted by test makers … [Read more...]
Genetic Testing
New EMSO Guidelines Address Efficacy of Next Generation Sequencing for Different Cancer Types
November 2, 2020
The European Society for Medical Oncology (ESMO) recently issued guidelines on use of next-generation sequencing (NGS) for various types of cancer as part of routine clinical practice. The … [Read more...]
Testing Strategy
Saliva and Oral Swabs Emerge as Scalable Alternative to Nasopharyngeal SARS-CoV-2 Testing
November 2, 2020
The standard method for detecting upper respiratory viruses is to perform tests on tissue sample from the back of the sinus cavity collected by inserting a long nasopharyngeal swab deep into the … [Read more...]
LDTs
FDA Pulls the Plug on EUA Review of Laboratory Developed Tests for COVID-19
November 2, 2020
On Oct. 9, the U.S. Food and Drug Administration (FDA) dropped a bombshell by announcing that it would no longer review applications for Emergency Use Authorization (EUA) submitted by test makers for … [Read more...]
Emerging Tests
New Initiative Seeks to Standardize SARS-CoV-2 Antibody Tests
September 22, 2020
When the pandemic began, antibody testing was looked to as the kind of ace in the hole that would not only resolve the COVID-19 testing shortage fast and for good but also pave the way for society to … [Read more...]
