Biomerica Gets Chinese Approval to Market Two Tests
Biomerica, an Irvine, Calif.-based provider of advanced diagnostic products, said Tuesday that the China Food and Drug Administration has approved its parathyroid hormone and calcitonin enzyme-linked immunosorbent assays.
The PTH and calcitonin products will be distributed through a Chinese provider of vitamin D tests and complement the distributor’s sales, Biomerica said. The company will continue to distribute other products through another Chinese distributor, it added.
PTH, a hormone released by the parathyroid glands, is responsible for managing calcium, vitamin D, and phosphorus levels in the blood and bones. The number of vitamin D tests performed worldwide is estimated at more than 100 million and could reach 140 million tests by 2015, Biomerica says. The market for Vitamin D testing in China is small but growing rapidly, according to the company.
Both the PTH ELISA and Calcitonin ELISA are FDA cleared and available throughout the U.S. — Kellen Owings
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