NEW YORK (GenomeWeb News) – Response Biomedical announced on Thursday that China's State Food & Drug Administration has approved its Ramp 200 Reader for marketing in China.
In a statement, Response Biomedical CEO S. Wayne Kay called the approval "a pivotal step forward in increasing our market penetration in this region."
According to the Vancouver, British Columbia-based company, China spent $120 billion last year establishing universal healthcare coverage and is expected to build 400 new hospitals each year during the next decade. The market for in vitro diagnostic products in the country is estimated at $2 billion per year with a growth rate of between 15 percent and 20 percent for the next five years.
China is expected to become the third-largest consumer of IVD products in the world by 2015, it added.
"The market potential for our diagnostic products in China is rapidly expanding and we believe we have the necessary resources and partnerships in place to meet the growing market demand for Ramp 200 and our cardiac diagnostic tests," Kay said.
Response Biomedical's distributor in China, O&D Biotech China, assisted in the approval process, the company said.
The Ramp 200 platform is a diagnostic instrument for clinical and environmental applications. It can run 18 tests per hour on one module and up to 36 tests per hour using three modules, allowing tests to be run on multiple patient samples simultaneously or multiple assays for one patient, Response Biomedical said.