Newsfeed : OraSure’s Over-the-Counter HIV Test One Step Closer to FDA Approval

POZ - Health, Life and HIV
Subscribe to:
POZ magazine
Newsletters
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr MySpace
POZ Personals
Sign In / Join
Username:
Password:

Back to home » Newsfeed » November 2009

Most Popular Links
Most Popular Lessons

The HIV Life Cycle

Shingles

Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV

20 Years Ago In POZ


More News

Click here for more news

Have news about HIV? Send press releases, news tips and other announcements to news@poz.com.


emailprint

November 18, 2009

OraSure’s Over-the-Counter HIV Test One Step Closer to FDA Approval

On November 18, OraSure Technologies Inc. announced that it took part in a Blood Products Advisory Committee (BPAC) meeting—held the previous day—to discuss, among other topics, the public need and performance characteristics for over-the-counter (OTC) home use HIV test kits. The BPAC gives advice to the U.S. Food and Drug Administration (FDA) on issues pertaining to the safety and effectiveness of biological products and medical devices.

During the meeting, OraSure participated in a closed session with the BPAC to review results of continuing clinical studies on its OraQuick HIV OTC test, in addition to the necessary clinical work required for FDA approval of the assay. Based on feedback from the BPAC, OraSure will continue seeking FDA approval for the test.

“We are very pleased to have had the opportunity to discuss our ongoing clinical efforts for at-home HIV tests with the Blood Products Advisory Committee,” OraSure Technologies president and CEO Douglas A. Michels said in a statement. “We are gaining greater clarity as to the additional steps for this clinical program and intend to work closely with the FDA to define and execute the remaining studies required for approval.”

Search: OraQuick, OraSure, BPAC, Blood Products Advisory Committee, FDA


Scroll down to comment on this story.



Name:

(will display; 2-50 characters)

Email:

(will NOT display)

City:

(will display; optional)

Comment (500 characters left):

(Note: The POZ team reviews all comments before they are posted. Please do not include either ":" or "@" in your comment. The opinions expressed by people providing comments are theirs alone. They do not necessarily reflect the opinions of Smart + Strong, which is not responsible for the accuracy of any of the information supplied by people providing comments.)

Comments require captcha.
Please enter this number for verification:

| Posting Rules



Show comments (1 total)

 
[Go to top]

Facebook Twitter Google+ MySpace YouTube Tumblr Flickr Instagram
Quick Links
Current Issue

HIV Testing
Safer Sex
Find a Date
Newly Diagnosed
HIV 101
Disclosing Your Status
Starting Treatment
Help Paying for Meds
Search for the Cure
POZ Stories
POZ Opinion
POZ Exclusives
Read the Blogs
Visit the Forums
Job Listings
Events Calendar
POZ on Twitter

Ask POZ Pharmacist

Talk to Us
Poll
Are you buying holiday gifts that raise HIV/AIDS awareness?
Yes
No

Survey
Smoke Signals

more surveys
Contact Us
We welcome your comments!
[ about Smart + Strong | about POZ | POZ advisory board | partner links | advertising policy | advertise/contact us | site map]
© 2014 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.