Advisory Panel Shows Support for OTC HIV Test, Highlights Community Need
This article was originally published in The Tan Sheet
Executive Summary
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
You may also be interested in...
OraSure Plans To File Over-The-Counter HIV Test Application By Year End
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.
Sales & Earnings In Brief
Inverness JV results: The first product from Inverness Medical Innovations' consumer diagnostic joint-venture with Procter & Gamble is expected to launch in the U.S. late this year following an international launch, Inverness announces during its fiscal 2007 fourth-quarter earnings call Feb. 20. In May 2007 the firms completed a joint venture to create SPD Swiss Precision Diagnostics, a business that develops, manufactures and markets diagnostic products including pregnancy tests and fertility/ovulation monitoring products (1"The Tan Sheet" Jan. 1, 2007, p. 10). During the October-December period, responsibility for U.S. sales and distribution of SPD's products was transitioned from Inverness to P&G. Inverness' consumer diagnostics business achieved sales of $29.7 million in the quarter, compared to $42.2 million in the prior-year quarter as the firm incurred $16.1 million in costs linked to the joint venture...
OraQuick Advance test marketing
A consumer counseling system with 24-hour phone and online assistance will be developed for use with the OraQuick Advance Rapid HIV-1/2 Antibody Test in the OTC market, according to an agreement OraQuick marketer OraSure and health services provider Constella Group announce April 12. In addition to helping customers use OraQuick, the system will provide medical referrals when needed, according to a release. It also will be a "critical component" of product development as OraSure prepares to apply to FDA for OTC approval of OraQuick, the company said. OraSure, which expects to continue conducting clinical work on the product into 2008, received support for nonprescription marketing of the product from an FDA advisory committee in 2005 (1"The Tan Sheet" Nov. 7, 2005, p. 7)...