Calypte begins U.S. initiative

Jul 10 2007

Calypte Biomedical Corporation has announced that it has leased an 11,000+ square foot site located in Portland, Oregon.

The site permits the consolidation of its research laboratory and administrative functions under one roof and will become the Company's new headquarters location. The site also provides manufacturing space which the Company plans to utilize to build pilot lots for clinical trials in the U.S. The Company expects these studies to be a prelude for submitting a formal application for approval with the U.S. Food and Drug Administration ("FDA").

"This facility is our first step in reestablishing our presence in the U.S. diagnostic test market and moving toward approval of our Aware(TM) HIV- 1/2 oral test in the U.S. We plan to start by commencing the process of filing for FDA approval of an oral fluid test for professional use," stated Roger Gale, Calypte's Chairman and Chief Executive Officer. "One of the uses of funds from the recently-completed PIPE is to advance our efforts to market our oral fluid tests in the U.S. market. Calypte has invested over $3 million to acquire technology and equipment to take advantage of this opportunity."

"While multiple outcomes are possible, our objective for beginning the FDA regulatory process is to ultimately receive approval for manufacturing and distribution of an over-the-counter ("OTC") oral fluid HIV diagnostic test in the U.S.", Mr. Gale concluded.

The U.S. is the largest market for HIV diagnostic tests in the world, with 2005 revenues for screening tests estimated at $165 million. An FDA advisory panel has recently announced its support for having an OTC test available in the U.S. In September 2006, the CDC updated its HIV testing guidelines, specifically recognizing the benefits of rapid tests in timely communicating HIV status to patients. The CDC's revised recommendations include routine HIV testing for patients in all health-care settings after the patient is notified that testing will be performed unless the patient declines (opt-out screening); at least annual testing for persons at high risk for HIV infections; and routine opt-out screening for all pregnant women.