The U.S. Food and Drug Administration needs more information before it will allow Bethlehem-based OraSure Technologies to release a first-of-its-kind oral COVID-19 antibody test, according to a news release from OraSure.
The FDA guidance on COVID-19 anitbody tests focuses on blood tests since they’re the only kind of test available, according to OraSure President and CEO Stephen S. Tang.
“To date, there are no oral fluid antibody tests for COVID-19 authorized for sale in the U.S.,” Tang said. “The agency did not outline specific requirements for an oral fluid test.”
Stephen S. Tang, president and CEO of OraSure Technologies Inc., discusses the company's saliva DNA test used by 23andMe during a talk hosted by the Lehigh Valley Economic Development Corp. on Wednesday, Oct. 23, 2019, at the ArtsQuest Center at SteelStacks in Bethlehem. The device and its stabilization fluid preserves DNA for years at room temperature, he said.Kurt Bresswein | For lehighvalleylive.com
At the FDA’s request, OraSure will resubmit two separate Emergency Use Authorization applications for its oral specimen collection device, according to the OraSure news release. In addition, the FDA has requested additional analytical studies on sample collection and stability, the release says.
Oral antibody tests are more convenient than blood tests, according to OraSure.
“Oral sample collection is quick, painless, non-invasive and requires less human contact than a blood draw, minimizing the need for personal protective equipment and reducing exposure to potentially infected patients,” the release says.
OraSure got a $600,000 federal grant over the summer to develop the oral antibody test.
The release doesn’t say when OraSure hopes to release its oral COVID-19 antibody test.
In October OraSure released the first-ever at-home COVID-19 test kit to determine whether individuals have the virus. The at-home tests were developed by OraSure subsidiary DNA Genotek.
Test subject provide oral samples at home using the test, then send the samples to a lab for analysis. The company is still working on a product that will allow residents to collect samples and test them at home for COVID-19.
OraSure specializes in at home medical diagnostic test kits. It’s released kits to test for HIV and Ebola.
Our journalism needs your support. Please subscribe today to Lehighvalleylive.com.
Rudy Miller may be reached at rmiller@lehighvalleylive.com. Follow him on Twitter @RudyMillerLV. Find Easton area news on Facebook.
The Link LonkDecember 23, 2020 at 07:21PM
https://www.lehighvalleylive.com/news/2020/12/bethlehem-based-orasure-to-send-information-to-fda-on-1st-oral-covid-19-antibody-test.html
Bethlehem-based OraSure to send information to FDA on 1st oral COVID-19 antibody test - lehighvalleylive.com
https://news.google.com/search?q=Send&hl=en-US&gl=US&ceid=US:en
No comments:
Post a Comment