News: Calypte Announces India Approval
DCAI Regulatory Approval Received for the Aware(TM) HIV-1/2 Oral Fluid Rapid Test
LAKE OSWEGO, Ore., July 11, 2007 /PRNewswire-FirstCall via COMTEX/ -- Calypte
Biomedical Corporation (CBMC), medical diagnostic tests manufacturer for the
rapid detection of antibodies to the human immunodeficiency virus (HIV) announced
today that it has received registration and marketing approval for its Aware(TM)
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."
