Wednesday, April 15, 2020

FDA Approves Coronavirus Saliva test

View this post on Instagram

Rutgers University has developed a novel coronavirus saliva test that will be available at a number of New Jersey testing sites starting Tuesday. ⁣ ⁣The Food and Drug Administration granted emergency use authorization (EUA) to Rutgers' saliva testing approach, which is the first FDA-approved testing method that does not use invasive cotton swabs to collect samples, the university announced in a Monday press release. ⁣ ⁣"The impact of this approval is significant," Professor Andrew Brooks, chief operating officer and director of technology development at Rutgers’ RUCDR Infinite Biologics, said in a statement. "It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections." ⁣ ⁣He added that the new method will "preserve precious personal protective equipment (PPE) for use in patient care instead of testing" and "significantly increase the number of people tested each and every day" because patients will be able to self-collect saliva. ⁣ ⁣"All of this combined will have a tremendous impact on testing in New Jersey and across the United States," Brooks said. ⁣ ⁣The White House COVID-19 task force called Brooks on Saturday after the FDA approved his department's test method to congratulate him and to ask about any specific hurdles his department had to overcome to expand testing in the community.

A post shared by Fox Business (@foxbusiness) on



View this post on Instagram

The U.S. Food and Drug Administration approved a decontamination process that could clean up to 4 million medical masks for frontline health care workers per day, according to the agency. ⁣ ⁣As doctors and nurses face ongoing shortages for personal protective equipment while treating coronavirus patients, the FDA has provided an emergency use authorization (EUA) for a decontamination process that would allow N95 masks, originally intended for single-use, to be cleaned using vaporized hydrogen peroxide gas. ⁣ ⁣The FDA is allowing the Irvine, Calif.-based company Advanced Sterilization Products to carry out a decontamination process using vaporized hydrogen peroxide gas to clean masks. The company uses sterilization machines called STERRAD, which uses hydrogen peroxide gas plasma sterilization. ⁣ ⁣The machines are already in use in around 6,300 hospitals, according to the FDA, and each can clean 480 respirators per day. ⁣ ⁣The sterilization system will help combat the shortage of vital face masks used by doctors, nurses and health care workers to protect themselves from exposure to COVID-19. ⁣ ⁣"Our nation's health care workers are among the many heroes of this pandemic and we need to do everything we can to increase the availability of the critical medical devices they need, like N95 respirators," FDA Commissioner Dr. Stephen M. Hahn said in a statement.

A post shared by Fox Business (@foxbusiness) on