A Medical Device Daily

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.”

According to the Regional AIDS Initiative for Latin America and the Caribbean (SIDALAC) and the World Bank, there are 2 million people living with HIV in the region and more than 200,000 new infections a year.

MSI eyes growth in Ukraine, China

Another company seeing growth opportunities for its rapid test kits is Medical Services International (MSI; Edmonton, Alberta), which said it has received regulatory approval of its VScan Hepatitis C, Tuberculosis and Syphilis rapid test kits in Ukraine. The company had previously announced approval of its HIV test kit in that country.

MSI said, “There is a serious tuberculosis problem in this part of the world and the fact that there is a rapid test kit for TB that is as accurate as the VScan TB test kit and gives no false positives will be extremely helpful to medical personnel in treating this disease.”

The company said it is in the process of registering all four test kits in other countries in the region and is working with its distributor for the area to develop a comprehensive marketing program.

MSI also said that it has received a letter of commitment from the Shanghai Police Department that it would begin using the company’s VScan HIV test kit. The test kits will be deployed as part of regular equipment for use in the field as well as in their rehabilitation centers.

The company said that in a recently published article, it was indicated by the National Institute of Infectious Diseases that HIV/AIDS appears to be spreading along drug trafficking routes extending from Yunnan Province to Southeast Asia. Researchers have discovered two strains of HIV and have said they believe the strains found in China have traveled from Laos, Myanmar, Thailand and India.

MSI said the VScan HIV rapid test kits is one of the few kits that has been found to detect both strains.

Sudan buys four Statscan systems

Lodox Systems North America (South Lyon, Michigan), maker of the Statscan Critical Imaging System, said it has signed a $1.2 million contract with Sudan Freezone, a Sudanese government agency. Two Statscans already have been delivered to state hospitals in Khartoum, and two other systems are expected to be delivered and installed in 1Q06.

The Statscan is a flexible-format digital radiography system used for quick diagnoses in hospital trauma units and emergency departments. Its low-dose digital X-ray technology is capable of quickly providing high-resolution, full-body X-rays.

Rodney Sandwith, Lodox product manager, noted that many African countries do not have the resources for medical technology that can only perform single, highly specialized tasks, whereas the Statscan system has multiple uses.

“Statscan is a digital radiography system ideal for trauma, military and pediatric medicine as well as general radiography,” Sandwith said. “Its images can show soft tissue as well as bone simultaneously, which also makes it superb for screening for diseases such as tuberculosis, one of Africa’s most prolific and destructive diseases.”

CEO William Greenway said the contract with the Sudanese government is “a critical step for Lodox, as we continue to embark on our global marketing efforts. We are fast becoming the DR standard for trauma and emergency medicine in some of the leading hospitals in the U.S. and hope to continue that trend abroad.”

Lodox said that Statscan enables high patient throughput, delivering full-body scanning times that are “comparable to the time it takes traditional X-ray systems to produce a single extremity image,” and offers “significant advantages over any competitive technologies in the management of large volume patient scenarios as caused by natural disasters or terrorist-related catastrophes.”

A comprehensive two-view, full-body Statscan procedure can be completed and displayed at a viewing station in less than three minutes, and, depending on the part of the body being scanned, Statscan emits as much as 75% less radiation compared to current X-ray technology.

Lodox Systems North America is a subsidiary of Lodox Systems (Benmore, South Africa).

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