The U.S. FDA has expanded the emergency use authorization (EUA) for Rutgers University’s saliva-based COVID-19 test to include at-home use of Spectrum Solutions LLC’s SDNA-1000 whole saliva collection device, a development that underscores the need for wider testing as localities across the country emerge from lockdown and restart their economies.
This is the first at-home option for saliva collection; the action comes just two weeks after the FDA authorized Laboratory Corp. of America’s polymerase chain reaction test for SARS-CoV-2, the virus that causes COVID-19, to include the company’s Pixel self-collection kit for nasal samples.
In announcing the decision, FDA Commissioner Stephen Hahn said enabling people to self-collect samples for the Rutgers Clinical Genomics Laboratory’s test “provides an additional option for the easy, safe, and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site.”
Spectrum CEO Stephen Fanning said the move highlights the agency’s recognition that “current methods of obtaining biosamples for COVID-19 testing were limited in scope and scale due to supply shortages[,] and the current testing methods were also constantly putting health care workers at risk of exposure. We’ve developed a better, more innovative solution.”
As of May 10, more than 8.3 million people in the U.S. have been tested for COVID-19, but Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases and a member of the White House Coronavirus Task Force, has said the current rate of 1.5 million to 2 million tests per week needs to double by the end of May.
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