Calypte Biomedical Corporation has announced that it has received registration and marketing approval for its Aware HIV-1/2 OMT (oral fluid) rapid test in India from the Central Drugs Standard Control Organisation, commonly referred to as the Drug Control Authority of India ("DCAI").
Roger Gale, Calypte's Chairman and Chief Executive Officer, stated, "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."
Mr. Gale continued, "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. In addition to creating a distribution network, we expect to establish both research and manufacturing operations in India. While we will initially enter the Indian market with our HIV-1/2 oral fluid rapid test, we are also considering introducing our Aware(TM) HIV-1/2 rapid tests using both blood and urine samples to complement the current oral fluid test. India is also a logical center for development of Calypte's new products."