A Diagnostics & Imaging Week

S.A. HIFU Ltd., the South African subsidiary of U.S. HIFU (Charlotte, North Carolina), said it has entered into an agreement with STAAR Pty Ltd. to introduce high-intensity focused ultrasound (HIFU) therapy with the Sonablate 500 for prostate diseases in South Africa.

The Sonablate 500 was developed by Focus Surgery (Indianapolis) and is manufactured by Misonix (Farmingdale, New York). U.S. HIFU is the exclusive distributor of the Sonablate 500 in North, Central and South America, as well as South Africa, and is a minority shareholder in Focus Surgery.

HIFU with the Sonablate 500 is a targeted, outpatient procedure that uses focused sound waves to rapidly heat and destroy tissue within the prostate in a matter of seconds. Treatment is delivered through a transrectal probe after the patient receives epidural or spinal anesthesia. The procedure is bloodless, non-invasive and can be repeated if necessary.

The Sonablate 500 is licensed by the South African Department of Health and the first treatments in that country will take place at the Wits University Donald Gordon Medical Center (Johannesburg). S.A HIFU said it hopes to establish HIFU centers of excellence in the major cities in South Africa.

U.S. HIFU also reported that it has partnered with International Hospital Corp. (IHC) and the CIMA hospital chain to make HIFU available in Costa Rica. HIFU with the Sonablate 500 will first be available in Costa Rica at Hospital CIMA San Jose. CIMA operates private hospitals throughout Mexico and Latin America.

The Sonablate 500 received its CE mark for European distribution in 2001 and is being used to treat patients in the UK, Germany, Italy and other European countries. It is not yet approved in the U.S.

Genekam develops avian flu test

Molecular medicine company Genekam Biotechnology AG (Duisburg, Germany) said it has developed a reliable and accurate DNA-based test that is able to detect the avian influenza virus H5N1, along with the H9 virus in a short time under field conditions.

Genekam said that with its “precise and accurate” test, results are available within seven hours. Moreover, it said the test not only is available for special labs, but may also be performed by smaller laboratories for a reasonable price.

The test is based on the polymerase chain reaction (PCR) method and can be used to detect a latent and symptomless infection (e.g., migratory birds) in humans as well as animals, so preventive measures can be ordered immediately, according to the company.

Genekam has developed about 120 DNA-based tests to date, and said it is researching a test for detecting the H7 avian virus.

OraQuick test launched in Mexico

OraSure Technologies (Bethlehem, Pennsylvania) has launched its OraQuick Advance Rapid HIV-1/2 Antibody test in Mexico. The company said the OraQuick Advance is the only FDA-approved and CLIA-waived oral fluid rapid HIV-1/2 test currently available in the U.S., and will be the only oral fluid rapid HIV test available in Mexico.

The OraQuick Advance test will be sold by the company’s exclusive distributor in Mexico, Spite SA de CV, to the National Health Sector, National Council for HIV/AIDS, state HIV programs, non-governmental organizations, hospitals, clinics, physicians and other healthcare providers.

“Mexico is committed to the prevention of HIV/AIDS through increased HIV testing and education,” said Dr. Jorge Saavedra, director-general of the Mexico Center for the Prevention and Control of HIV/AIDS. “Rapid tests such as the OraQuick Advance test will be an integral part of [our] HIV prevention campaign, enabling us to provide the most versatile and comprehensive rapid HIV tests available to our HIV testing agencies across the country.”

OraSure said that according to the Joint United Nations Program on HIV/AIDS, Mexico has 160,000 adults and children living with HIV/AIDS. AIDS caused around 5,000 deaths in 2003.