On Thursday January 24th Calypte Biomedical Corporation announced that the Chinese State Food and Drug Administration informed the company’s subsidiary, Beijing Marr Bio-pharmaceutical, that it had completed the technical review of its Aware HIV-1/2 OMT rapid oral test product. Pending the State Food and Drug Administration’s review of conformity to product standard documents and labeling to applicable regulations, the application will move forward to the concluding administrative approval.
The Aware HIV-1/2 OMT test is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes with an accuracy comparable to that of U.S. FDA approved blood based laboratory HIV EIA tests. Calypte believes there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in developing countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.
Calypte also announced this week that it has entered into an $8 million common stock purchase agreement with Fusion Capital Fund II, LLC. Under the agreement Calypte may sell up to $8 million of its common stock to Fusion Capital at any time over the next 24 months in increments ranging from $100,000 to $1,000,000. The agreement has been authorized by the SEC and the proceeds will be used by Calypte to further commercialize the company’s Aware HIV-1/2 OMT rapid oral test product, which has been receiving a lot of attention recently.
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