Calypte Biomedical (Lake Oswego, Oregon) reported that it has received approval from the U.S. Agency for International Development (USAID), the U.S. government agency responsible for worldwide humanitarian and development assistance, for its Aware HIV-1/2 OMT oral fluid rapid test, with that agency placing the test on its waiver list.

The inclusion on this list by USAID gives the company “access to the largest source of bilateral funding available for HIV testing,” CEO/Chairman Roger Gale said in a conference call regarding the news.

Gale was referring to President George W. Bush’s Emergency Plan for AIDS Relief (PEPFAR).

“We believe this approval, in which the U.S. [Centers for Disease Control and Prevention] coordinated the evaluation, is both a major achievement and milestone for the company,” he said. “The approval reassures and reaffirms the global market for HIV tests, [and] that the Aware test is a quality product whose effectiveness in the global battle against HIV/AIDS is confirmed.”

Calypte said it believes that there is a “significant need for rapid detection” of sexually transmitted infectious diseases like HIV to control proliferation of disease. Particularly in developing countries, a rapid test using saliva could benefit such countries, as its Aware HIV-1/2 OMT test can be used both at the point-of-care and at home, according to the company.

The USAID inclusion now permits countries such as South Africa, Kenya and Uganda, where Calypte’s oral fluid HIV test is approved, to purchase AWARE using funding from PEPFAR, Gale told investors and others on the call. PEPFAR was first reported in 2003. Earlier this year, Gale said it was reaffirmed, when “President George W. Bush asked Congress to commit $15 billion over the next five years, including nearly $10 billion in new money to combat AIDS.”

Gale called access to the funds a “primary enabler of sales.” In addition to the three African countries where the test is now registered, Calypte, through its distributor, is also focused on getting approval for its test in some of the other 15 PEPFAR-focused countries.

Gale said the company is “well along” towards its goal of securing product registration in Tanzania, and it has begun activities along these lines in both Mozambique and Zambia, as well.

When the CDC evaluated the company’s oral fluid test, it found the Calypte test “holds its own against what are considered to be some of the best rapid blood tests in the world,” including the Inverness Medical Innovations’ (IMI; Waltham, Massachusetts) Determine HIV-1/2 test, which Calypte described as the most widely used HIV test in the world, and Trinity Biotech’s (Dublin, Ireland) Uni-Gold HIV, a test that is approved by the FDA.

IMI reported the acquisition of the Determine/DainaScreen assets technology from Abbott Diagnostics (Abbott Park, Illinois) in 2005. Uni-Gold is owned by Trinity Biotech (Dublin, Ireland), which received FDA approval in 2004.

The company said the USAID approval is expected to be lucrative for Calytpe.

For example, Gale said that in one year, about 23% of PEPFAR funds were spent on prevention, including testing for the disease. Broadly estimating, he said that funds at that level would support testing programs of about 1.5 million to 2.5 million tests per country per year.

Gale also reported that the company has just received registration for the Aware HIV-1/2 OMT test in India and is considering manufacturing the product in that country. Gale also said the company recently opened an office in Dubai of the United Arab Emirates, which will serve as its base for sales efforts in the Middle East and North Africa.

In October 2006, Calypte reported receiving approval for its Aware Oral Fluid HIV-1/2 rapid test for both PRO and over-the-counter markets in the Russian Federation. At that time, the company said that the Russian Federation was the second market, following the United Arab Emirates, to approve use of its HIV-1/2 test.