Emerging Tests

Qiagen Launches Portable COVID-19 Antigen Digital Testing Hub

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

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...]

Industry Trends

Surging COVID-19 Cases Are Pushing Laboratories to the Breaking Point

Long lines for testing. Shortages of critical testing supplies. Case backlogs and long reporting delays. Laboratories across the country and the patients they serve are reliving the nightmares of … [Read more...]

Inside the Lab Industry

Equity Fund Acquires Controlling Stake in Ancestry.com as Demand for At-Home Genetic Testing Fades

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...]

Point of Care

New Low-Cost Sensor Offers Promising Test for Rapid, At Home COVID-19 Testing

Laboratory companies and scientists are working furiously to produce the rapid, point of care testing technology needed to prevent asymptomatic people from spreading SARS-CoV-2. And in a promising new … [Read more...]

Testing Strategy

Saliva and Oral Swabs Emerge as Scalable Alternative to Nasopharyngeal SARS-CoV-2 Testing

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

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

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

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

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...]


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