06.05.14
Irvine, Calif.-based diagnostic products company Biomerica Inc. has earned two new approvals from the China Food and Drug Administration (CFDA). The company’s Parathyroid Hormone (PTH) and Calcitonin products will be distributed through a China distribution channel new to the company, reportedly a leading vitamin D test supplier in the country.
Parathyroid hormone (PTH) is a hormone released by the parathyroid glands. These glands are responsible for managing calcium, vitamin D, and phosphorus levels in the blood and bones. PTH helps regulate calcium levels in the blood. In 2013, the number of vitamin D tests performed worldwide is estimated to be greater than 100 million and is expected to reach almost 140 million tests in 2015. Vitamin D testing in China is growing very rapidly but is still considered to be in the beginning stage of testing. The Institute of Medicine guidelines for dietary intake of vitamin D were meant to prevent the seasonal increase in PTH associated with lower vitamin D status. Consistently increased concentrations of PTH are associated with an increase in risk for osteoporosis in later life. Intact PTH is the most frequently ordered parathyroid hormone test. It is used to help diagnose the cause of a low or high calcium level and to help distinguish between parathyroid-related and non-parathyroid-related causes. Calcitonin is primarily used to help diagnose C-cell hyperplasia and medullary thyroid cancer, to evaluate the effectiveness of treatment, and to monitor those affected for recurrence.
“We are pleased to receive CFDA approval and open up a new distribution channel in China. Our PTH and Calcitonin products are a great fit for our new distribution partner’s Vitamin D test,” said Biomerica’s CEO Zackary Irani.
Parathyroid hormone (PTH) is a hormone released by the parathyroid glands. These glands are responsible for managing calcium, vitamin D, and phosphorus levels in the blood and bones. PTH helps regulate calcium levels in the blood. In 2013, the number of vitamin D tests performed worldwide is estimated to be greater than 100 million and is expected to reach almost 140 million tests in 2015. Vitamin D testing in China is growing very rapidly but is still considered to be in the beginning stage of testing. The Institute of Medicine guidelines for dietary intake of vitamin D were meant to prevent the seasonal increase in PTH associated with lower vitamin D status. Consistently increased concentrations of PTH are associated with an increase in risk for osteoporosis in later life. Intact PTH is the most frequently ordered parathyroid hormone test. It is used to help diagnose the cause of a low or high calcium level and to help distinguish between parathyroid-related and non-parathyroid-related causes. Calcitonin is primarily used to help diagnose C-cell hyperplasia and medullary thyroid cancer, to evaluate the effectiveness of treatment, and to monitor those affected for recurrence.
“We are pleased to receive CFDA approval and open up a new distribution channel in China. Our PTH and Calcitonin products are a great fit for our new distribution partner’s Vitamin D test,” said Biomerica’s CEO Zackary Irani.