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New FDA Approved Test Detects Thyroid Disease in Minutes
Tue, 28 Dec 2004, 17:52:00 EDT
HONEY BROOK, PA /Send2Press Newswire/ -- Thanks to FDA approval of ThyroTest(tm), a new rapid hypothyroid diagnostic screening device from ThyroTec, Inc., detection of a common thyroid disease will now come sooner rather than later for millions of Americans. More Americans suffer from thyroid disease than diabetes and cancer combined.
Currently patients suffering from symptoms of hypothyroidism have to wait days to discover lab results. Because ThyroTest(tm) has also gained CLIA Waiver status; patients can now get test result for hypothyroidism in minutes, right in the doctor's office.
"We are excited about bringing ThyroTest to the marketplace," said Jim Small, president of ThyroTec, a New Jersey based medical products development company. "ThyroTest is the first, and only, product to receive FDA approval and CLIA waiver for identifying above normal levels of thyroid stimulating hormone (TSH) in a rapid format. This simple rapid diagnostic screen test is a qualitative measurement that allows physicians to screen patients for hypothyroidism in ten minutes with a whole blood sample."
Hypothyroidism develops when the thyroid gland does not produce enough thyroid hormone, which regulates body's metabolism. A lack of thyroid hormone affects many body systems.
The incidence of hypothyroidism tends to increase with age, with older people, especially women, at highest risk.
Common symptoms include weight gain, fatigue, mood swings, weakness, dry and coarse skin and hair, hair loss, depression, decreased libido, trouble swallowing, increased cholesterol, heavy or irregular periods or trouble getting pregnant.
An estimated 13 million Americans live undiagnosed and needlessly suffer from hypothyroidism. It is also estimated that three to five percent of the U.S. population has some form of thyroid disease. Approximately one in every eight of American women will develop a thyroid disorder during her lifetime.
ThyroTec has chosen American Health Partners, of Oklahoma City, to develop the ThyroTest(tm) brand identity, final market preparation, selection of national sales partners, training and the management of distribution.
"American Health Partners recognizes the benefit of providing doctors a rapid screen for hypothyroidism. Millions of patients who needlessly suffer from the symptoms of hypothyroidism can be screened in one office visit and further steps for treatment can begin immediately," said Brian Banks, president of American Health Partners.
"American Health Partners brings medical innovations to life through a proprietary market readiness process and proven distribution management network. We look forward to partnering with ThyroTec on this outstanding medical innovation."
ThyroTec, Inc., 1801 Horseshoe Pike, Suite One, Honey Brook, PA 19344. (610) 942-8971. www.thyrotest.com
Contact:
Jim Small, President/CEO, ThyroTec, Inc.,
info@thyrotest.com, +1-610-942-8971
NEWS SOURCE: ThyroTec, Inc.
Send2Press® is the originating wire service for this story.
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REFERENCES: New FDA Approved Test Detects Thyroid Disease in Minutes, FDA Approved Test, ThyroTest, hypothyroidism, CLIA Waiver, doctor office, Thyroid Disease, undiagnosed, American Health Partners, ThyroTec, Inc., Dec 28, 2004.
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