A Medical Device Daily

Calypte Biomedical (Lake Oswego, Oregon) reported receiving approval for its Aware Oral Fluid (OMT) HIV-1/2 rapid test for both PRO and over the counter (OTC) markets in the Russian Federation.

The company said that the Russian Federation is now the second market, following the United Arab Emirates, to approve use of an HIV-1/2 test OTC, permitting greater access to HIV testing in these countries. The approval was granted by the Minister of the Federal Service of Health Care and Social Development Control of the Ministry of Health of the Russian Federation.

Roger Gale, Calypte CEO and chairman, said, “We have worked closely with Marr Technologies , our strategic partner and the company’s largest investor, whose introductions and coordination directly facilitated this approval. . . . We plan to utilize their expertise in this region in support of our sales and marketing activities.”

Gale added: “[G]iven the potential size of the Russian market, we expect that it will be one of our most significant markets for sales. It is one of our highest priorities and we believe we can begin to supply the Russian market by year end. We believe strongly that the privacy and non-invasive ease of use provided by our OTC test are attributes that squarely address the needs of the Russian Federation in its plans to contain the HIV/AIDS epidemic.”

According to the 2005 AIDS Epidemic Update jointly published by the Joint United Nations Programme on HIV/AIDS and the World Health Organization , there are 860,000 adults living with AIDS in the Russian Federation (as of the end of 2003). The update notes, “In early 2004, more than 80% of all officially reported HIV cases since the beginning of the epidemic had been among drug injectors. The epidemic, meanwhile, is becoming more mature.”

The Bill and Melinda Gates Foundation considers Russia one of the “Next Wave” countries facing the largest increase in HIV/AIDS this decade. In 2004, Russia established a Country Coordinating Mechanism (CCM) to address the situation. CCM membership includes the government, as well as NGOs, the people living with AIDS network, and UNAIDS donors.

Calypte develops diagnostic products for the detection of sexually transmitted diseases such as the HIV-1 BED Incidence EIA and new diagnostic test products for the rapid detection of HIV and other sexually transmitted diseases, several of which do not require blood samples.

IDSI adds to distribution network

Imaging Diagnostic Systems (IDSI; Fort Lauderdale, Florida), a developer of laser optical breast imaging, said it has three exclusive distributors and has added five countries to its global distribution network for its CT Laser Mammography (CTLM) technology. Able Global will be IDSI’s exclusive distributor.

HAWA Imaging , a medical imaging equipment distributor in Sweden, will become part of IDSI’s European Region and have exclusive coverage in Sweden, Denmark, and Norway. According to the European Network of Cancer Registries, Northern European countries, particularly Denmark and Sweden, have some of the highest incidence rates of breast cancer in Europe.

According to the Malaysian National Cancer Registry, breast cancer is the most common cancer in Malaysian women and the number of breast cancer cases is on the rise. Since the October 2005 passing of Malaysia’s First Lady from breast cancer, there has been an increased emphasis on breast cancer detection and treatment throughout Malaysia.

IDSI’s Latin and South American distributor network will expand into Mexico as Mayerick, one of the first radiological distributors in Mexico, begins exclusive CTLM distribution in Mexico. According to the Mexican Histopathological Registry of Neoplasias, breast cancer is the second most common type of cancer in women and the rates of new cases and deaths are increasing.

Tim Hansen, IDSI CEO, said, “We are pleased to announce additions to three of our global regions. Asia-Pacific, Latin and South America, and greater Europe each hold tremendous opportunities for commercialization of CTLM. Our latest distributors are experienced in the diagnostic imaging capital equipment business and have excellent customer relationships. Malaysia and Mexico add substantially to our global geographic coverage. Historically, there have been many scientific and clinical breast imaging developments from Scandinavia, so we anticipate an excellent reception to our new laser breast imaging technology there.”

IDSI is seeking FDA PMA approval for its CTLM system as an adjunct to mammography. The FDA has determined that the company’s clinical investigation is a non-significant risk investigational device study because it does not meet the definition of a significant risk device under the investigational device exemption rule. The CTLM uses laser technology and patented algorithms to create 3-D images of the breast.

Female Health wins India registration

TheFemale Health Company (Chicago) reported that its second-generation Female Condom FC-2 has received registration by the Indian governmental authorities, permitting the company and its Indian partner Hindustan Latex Limited (HLL) to initiate sales of FC-2 in India.

India is now reported to have the highest number of HIV positive people in the world. Although such cases are less than 1% of its 1 billion population, the Indian government, through its National Aids Control Organization, is implementing prevention programs. Nearly 1 million FC-1 female condoms have been shipped to India in the last year for use in such programs, the company said.

In May, Female Health reported signing a Memorandum of Understanding with HLL to jointly manufacture FC-2 in India. HLL is an Indian government company with an annual male condom manufacturing capacity of 1 billion units. In addition to sales to the Indian government, HLL is launching the female condom (FC-1) to consumers using the trade name Confidom. It is now available in Bangalore, Chennai, and Kolcutta, as well as on-line, with a series of additional city launches planned.

Female Health owns certain worldwide rights to the FC Female Condom, including patents which have been issued in the U.S., UK, Japan, France, Italy, Germany, Spain, the People’s Republic of China, Canada, New Zealand, South Korea and Australia.