OraSure Plans To File Over-The-Counter HIV Test Application By Year End
This article was originally published in The Tan Sheet
Executive Summary
OraSure Technologies says it expects this year to complete a pre-market application for its OraQuick Advance Rapid HIV-1 and -2 over-the-counter saliva test. The product would be the first HIV diagnostic intended for use at home and providing results directly to the user.
You may also be interested in...
The Future Of OTCs: Self-Selection Meets Diagnostics, Genetic Personalization
The next generation of consumer health products, including Rx-to-OTC switch opportunities, may work in concert with cutting-edge diagnostic tools and elements of personalized medicine, says Andrew Fish.
Chembio HIV Tests Could Present OTC Competition For OraSure
Chembio Diagnostics intends to pursue OTC status for its SURE CHECK HIV 1/2 and HIV 1/2 STAT-PAK rapid tests, the company said upon announcing FDA approval of the two products May 30
Advisory Panel Shows Support for OTC HIV Test, Highlights Community Need
Over-the-counter availability of a rapid HIV test would provide a public health benefit, members of FDA's Blood Products Advisory Committee generally agreed at a Nov. 3 meeting in Gaithersburg, Md