OraSure's (OSUR) OraQuick Receives Unanimous Recommendation from FDA Panel

OraSure Technologies, Inc. (Nasdaq: OSUR) today announced that the U.S. FDA Blood Products Advisory Committee (BPAC) provided a unanimous positive recommendation for the Company's OraQuick^® In-Home HIV Test. The BPAC provides advice to the FDA on issues related to the safety and effectiveness of biological products and medical devices seeking FDA approval.

The BPAC voted on two questions posed by FDA:

• Do the projected benefits of the test outweigh the potential risks of false positive and false negative test results? The committee voted 17-0 in the affirmative to that question.
  
• Do the available data provide reasonable assurance that the test is safe and effective for its intended use? The committee voted 17-0 in the affirmative to that question.

In addition to reviewing the Company's clinical data and performance, the BPAC considered data presented by the FDA and testimonies shared during the public comment session. The committee also discussed risk mitigation strategies that should be considered in addition to the current proposed labeling.

---

Serious News for Serious Traders! Try StreetInsider.com Premium Free!

---

You May Also Be Interested In

• FDA authorizes 11 ZYN Ultra nicotine pouches for Philip Morris
• Alzamend Neuro (ALZN) files for 98.4M share offering by selling stockholders
• Boeing names Ryan Shedd as new SVP and controller