FDA authorized the first diagnostic test with a home collection option for COVID-19.
The agency re-issued its emergency use authorization (EUA) for LabCorp’s COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.
“Throughout this pandemic, we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” says FDA Commissioner Stephen M. Hahn, MD, in a press release. “With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
The agency worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, a hospital, or other testing sites, Hahn says.
LabCorp plans to make the test available to consumers in most states — with a doctor’s order — in the coming weeks.
In other important COVID-19 news:
- Hospitals could receive billions of dollars in funding, if the third coronavirus relief package is passed by the U.S. Congress this week. The package includes $75 billion for hospitals, $25 billion for COVID-19 testing, and $310 billion for the Paycheck Protection Program, Bloomberg reported.
- A new COVID-19 test that uses saliva samples instead of nasal and throat swabs has received emergency approval from the FDA. The saliva tests, coupled with a genetic testing service — also developed at Rutgers University — could offer a route to large-scale testing, Rutgers told NJ.com.
- The use of chloroquine and hydroxychloroquine to treat COVID-19 remains highly controversial. There are 16 clinical trials on the treatment planned or in progress. “These trials will inform the question of whether the treatment is of meaningful value to patients, and, if it is, at what point in the illness and at what dosage. In the meantime, the push for broad treatment in the absence of these data is ill-advised….” CSPI president Dr. Peter Lurie and Dr. Joshua M. Sharfstein of the Johns Hopkins Bloomberg School of Public Health wrote in a “Rapid Response” article in the BMJ.