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...]
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...]
Inside the Lab Industry
Equity Fund Acquires Controlling Stake in Ancestry.com as Demand for At-Home Genetic Testing Fades
November 2, 2020
Many believe that the boom for direct to consumer genetic testing had passed even before the pandemic began. Still, the sector is abuzz with strategic activity. In August, private equity firm … [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...]
Data
Genomic Testing Utilization Is Low & Geographically Inconsistent but Not Just Due to Payor Coverage
October 8, 2020
Genomic testing is inconsistently utilized in the U.S., even in states with favorable coverage policies. Those are the findings of a report from the Personalized Medicine Coalition (PMC) released in … [Read more...]
FDA Watch
Respiratory Panel Tests Flow from EUA Pipeline Ahead of Flu Season
October 8, 2020
The robust COVID-19 testing EUA pipeline has opened up a new opportunity for companies that produce multi-analyte panels capable of detecting not only the SARS-CoV-2 virus but other respiratory viral … [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...]
