A Diagnostics & Imaging Week

Xenomics (New York), a developer of DNA testing systems, reported that it has finalized an R&D agreement with the Lazzaro Spallanzani Institute (Rome), Italy's National Institute for Infectious Diseases.

Previously, Xenomics and Spallanzani created an entity known as SpaXen in a joint venture intended to lead research into the application of Xenomics' proprietary diagnostic technology for the detection of infectious diseases.

"We are pleased that this joint effort between Xenomics and Spallanzani has evolved so effectively and has had so much early success with this new technology platform," said Dr. David Tomei, president of SpaXen and a co-founder of Xenomics.

The new agreement defines the relationship among Xenomics, Spallanzani and SpaXen, including licensing of Xenomics' technology, royalties from sales by the parties and other central scientific and business aspects.

SpaXen is doing research concerning the use of Xenomics' Transrenal-DNA systems in the areas of infectious diseases such as HIV/AIDS, tuberculosis, malaria and Leishmaniasis.

Dr. Randy White, CEO of Xenomics, said the agreement combines Spallanzani's "world-class experience in infectious disease with Xenomics' knowledge and technology in disease diagnostics."

The research at SpaXen has led to the filing of several U.S. and international patents demonstrating the ability of Xenomics' Tr-DNA platform technology to diagnose bacterial, viral and parasite-generated infectious diseases.

Xenomics' technology uses simple urine collection and can be applied to various applications, including prenatal testing, tumor detection and monitoring, tissue transplantation, infectious disease detection, genetic testing for forensic identity determination, drug development, and research to counter bioterrorism.

In 1996, the Italian Ministries of Health and Research named the Spallanzani Institute as the National Institute for Infectious Disease in recognition of its reputation as an international center for excellence in healthcare and medical research.

Calypte in South African distribution pact

Calypte Biomedical (Pleasanton, California) reported signing an agreement with Adcock Ingram Scientific (Johannesburg, South Africa) for the marketing of its Aware rapid HIV antibody tests and HIV Incidence test in that country. With the agreement, Adcock placed an order for both the Incidence test and the Aware OMT rapid test.

"We recently announced the appointment of new distributors for eight countries in sub-Saharan Africa," said Dr. Richard George, Calypte's president and CEO. "Momentum seems to be building, and with the appointment of Adcock in South Africa, we now have qualified representation in 11 sub-Saharan countries."

He said that the oral fluid product has been commercially available from Calypte's Thai manufacturing facility since mid-June. "This represents our second order for Aware products in the sub-Saharan region.

"While it is true that most of the countries in the region are autonomous regarding their approaches to HIV intervention, we believe that the success of Adcock in the South African market will help us drive the adoption of our assays throughout the region."

Adcock Ingram is a division of Adcock Ingram Critical Care, a subsidiary of Tiger Brands (Johannesburg), a diversified company with interests in healthcare, food products and fisheries.

Calypte is developing new diagnostics for the rapid detection of HIV and other sexually transmitted diseases.

MedMira expands in Latin America

MedMira (Halifax, Nova Scotia), a provider of rapid flow-through diagnostic tests, said it has expanded its market presence in Latin America with the completion of product registrations in Argentina, Panama and Peru. The company said registrations in these three Latin American markets enable it to continue with the current tender processes leading to the sale of its MiraWell Rapid HIV Test and HIV/Hepatitis C (HCV) combination test to healthcare facilities as well as government-sponsored treatment and prevention programs.

MedMira said it has been working with its distributors, Genesis and Exportrade, to complete the registration process for its tests in these three countries.

The company said its rapid tests are the fastest flow-through diagnostic tests in the world, providing results in three minutes. It said rapid diagnostic tests present "significant value" in the Latin American market, where the HIV epidemic remains concentrated among high-risk groups, including IV drug users (IDUs) and sex trade workers.

According to MedMira, the World Health Organization (Geneva, Switzerland) estimates that nearly 70% of HIV-positive IDUs also are infected with HCV. It said people in these high-risk categories typically visit mobile testing clinics, with a very low percentage returning for their test results. Using MedMira's tests, these types of clinics will be able to provide immediate test results and appropriate counseling options at the time of testing.

Giles Crouch, vice president of sales and marketing for MedMira, said, "We have established a solid foothold in other regions of Latin America, including the Caribbean and Belize, and the time is right to expand into Argentina, Peru and Panama. Governments in the region have realized that prevention is fundamental in the fight against HIV/AIDS and hepatitis C and are beginning to fund testing and treatment programs and are demanding high-quality tests."

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