INDIANAPOLIS, Aug. 17 /PRNewswire/ -- FDA clearance of Roche Diagnostics' 9-minute Parathyroid Hormone (PTH) test during parathyroid surgery provides faster results for surgeons, which may result in shorter surgeries for patients.
The U.S. Food & Drug Administration gave Roche Diagnostics clearance in late July to market the test for use during surgery. The test is used on Roche's Elecsys(R) 1010 and 2010 systems and cobas e 411 analyzer and has been available for non-operative use since April.
The test provides quantitative results on the amount of parathyroid hormone in human serum and plasma to diagnose hypercalcemia and hypocalcemia, which helps physicians diagnose parathyroid dysfunction.
Surgeons use the test to establish a PTH baseline on patients with parathyroid adenoma that can cause their parathyroids to malfunction. The test can now be used during surgery at different intervals after the gland is removed to determine whether all the adenoma has been removed and the gland is back to normal function.
"This test provides surgeons with immediate intraoperative feedback," said Dr. Herbert Chen, chief of endocrine surgery for the University of Wisconsin. "It helps surgeons find abnormal glands and helps surgeons confirm what they have removed is abnormal."
Dr. Chen's research, published in Surgery in 2005, determined that intraoperative parathyroid hormone measurement improves cure rates in patients undergoing minimally invasive parathyroidectomies because it allows surgeons to recognize and address additional hyperfunctioning parathyroids during surgery that were missed by preoperative imaging. The study was based on a review of 345 patients who underwent minimally invasive parathyroidectomy for primary hyperparathyroidism from January 1990 to June 2004.
Dr. Gerard Doherty, an endocrine surgeon at the University of Michigan, who typically performs five parathyroidectomies on his surgery days, said the test will help him save enough time on surgeries that he will able to perform six parathyroidectomies.
"If we can save enough time in each of those cases to add another surgery, then that's a big benefit," said Doherty.
Doherty estimates the test will help him cut at least five to eight minutes off the length of a typical surgery, and much more time from the surgeries of the patients with more than one impacted gland and the surgeries of the "slow degrader" patients whose PTH levels fall slower after their adenoma is removed.
"This test can help patients, surgeons and hospital administrators," said Andy Thomson, Senior Vice President of Centralized Diagnostics, Roche Diagnostics. "The reduced test time -- in most cases less than half the time of competing tests -- means surgeons spend less time waiting for test results, allowing them to get their patients out of the operating room faster."
About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2006, sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our website http://www.roche-diagnostics.us/.
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For further information please contact:
Lori McLaughlin
Corporate Communications
317.521.3112
lori.mclaughlin@roche.com
Roche Diagnostics
