According to the international AIDS charity, Avert, more than 40 million people around the world are living with human immunodeficiency virus (HIV); the number is staggering, and continues to grow; many people don’t even realize they’re infected, their ignorance fuels the worldwide epidemic.
Many companies and organizations are dedicated to the movement to educate and test at-risk individuals. Calypte Biomedical Corp. (OTCBB: CBMC) is one company focused on the creation of testing solutions for HIV, STDs and other chronic disease. The company develops, manufacturers, and distributes in vitro diagnostic tests addressing the growing HIV market.
The company has already completed the regulatory approval process for the Aware HIV-1/2 BSP test in South Africa, Uganda, Zimbabwe, and Kenya, and earlier this week, announced it received registration and marketing approval from the Drug Control Authority of India (DCAI) for its Aware HIV-1/2 OMT (oral fluid) rapid test in India.
“As has been highlighted in recent news reports, India is at the forefront in the fight against HIV/AIDS and we have seen strong interest in our oral fluid tests from both the Government and private sectors. A Calypte team has just returned from India where we have begun putting in place the infrastructure to access and build on this important business opportunity. We expect the market for HIV diagnostic testing in India to grow significantly in the next few years,” Roger Gale, Calypte’s chairman and CEO said in a press release.
Gale continued that the company intends to create a distribution network and to establish research and manufacturing operations in India.
“This DCAI approval is a significant milestone in the advancement of our business; a very exciting time for all of us at the Company. Once our non-invasive HIV diagnostic tests gain market acceptance, we anticipate significant growth in market share of such tests,” Gale said.
The near term focus for the Aware product family is to develop a test that can be performed without the need of drawing blood. By succeeding in reaching this goal, the risk of an accidental infection is significantly reduced. Another benefit of a non-blood based test is the circumvention of certain cultural issues regarding the use of blood in certain less developed regions of the world.
Currently, the firm has succeeded in creating rapid tests for the detection of HIV-1 and HIV-2 that require either oral fluid (OMT) or a blood/serum/plasma (BSP) sample. Oral samples are collected by wiping a swab across both the upper and lower gums, and then mixing the collected material into a dropper full of diluent.
For 2007, the company’s focus is to extend the international commercialization of its HIV-1/2 rapid diagnostic tests. In several countries, the firm’s products will be utilized to test for HIV, and either or some combination of tuberculosis, hepatitis B or C, and malaria. Ultimately the objective of the firm is to establish local manufacturing sites in China (entered into a joint venture with Beijing Marr), India, and the Middle East to complement its existing facility in Thailand.
Calypte is currently waiting for final approval by the Chinese State Food and Drug Administration to begin marketing its product. The trial has been completed, and all required information was submitted in early May of this year.
According to the company, of India’s estimated 1.1 billion civilians, roughly 2.5 million people are living with HIV. The concern surrounding the growth of infection has spread to the Government of India. The government has launched a $2.8 billion AIDS campaign to prevent the spread of virus among the country’s population.
“Calypte believes that a simple and cost effective non-invasive rapid test is an ideal solution to safely and quickly identify HIV/AIDS patients for treatment and care in large-scale programs such as this,” said the company.
