News

Posted On: 10/20/2004

Medical Services Shanghai Starts Test Kit Production

Medical Services International Inc. (MSI; Edmonton, Alberta, Canada) recently announced that it has shipped -- to its new production facility in Shanghai -- significant quantities of the components required to assemble its VScan HIV and TB test kits. Medical Services has already received approval to export VScan test kits from China. These components are being shipped in anticipation of pending regulatory approval to sell the VScan test kits in China.

During the meetings in August 2004, MSI was informed by regulatory authorities that all required testing on the VScan test kit had been completed and that final approvals for the kits would be issued in approximately 60 days. Since these meetings, the company has not received any additional requests for information or data that would materially affect the approval process. MSI expects that the final regulatory approvals will be received within or close to the time frames indicated.

The production facilities in Shanghai are "state of the art," according to the company, and have an initial production capability of 6 to 8 million kits per year. The facility has received its Quality Assurance Certificate related to ISO 9001:2000/ ISO 13485:2003, IVDD 98/79/E.C. This certificate allows MSI to export as well as sell the VScan test kits in China.

In addition to its own facility, MSI has agreed to a joint venture with a government-owned pharmaceutical manufacturing firm. This facility is fully GMP-certified and has an excellent Quality Assurance program, an MSI press release says. This manufacturer currently supplies 26 distributors, 3000 direct sales outlets and 100 hospitals with medical supplies. The jointnetwork will give excellent distribution to the VScan products.

MSI has already confirmed orders of in excess of 1.5 million VScan kits in China. The company anticipates that it will generate in excess of $3.4 million U.S. in revenue from kit sales this year, with a profit in excess of $800,000.