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SD Canada Announces CE Mark for ThyroChek(R) Adult and NeoNatal Tests

Rapidly growing thyroid test market expands to EU, LATAM and Africa

SAINT JOHN, New Brunswick, March 11 /PRNewswire/ -- Screening Devices Canada, Inc. announces the immediate availability of ThyroChek, the rapid test for elevated TSH, the first clinical indicator of hypothyroidism to countries in the European Union. Until now, it has only been offered in the U.S. as an FDA-regulated, CLIA-waived test for adults to the 200,000 physician office labs. With the CE mark indicating conformity to European standards for medical devices, both adult and neonatal ThyroChek tests are available for sale worldwide.

SD Canada is moving ThyroChek to overseas markets as healthcare institutions there recognize that FDA-approved tests perform as advertised and the CE mark provides credibility to further open doors. The move will also build the thyroid health market, according to Sharon Cunningham, president of SD Canada: "Europeans know their thyroid gland. Food, such as bread in Russia, is marked indicating that the nutrients contained in the loaf support thyroid health. ThyroChek may also be available as a home test there, so that consumers can assess their own thyroid health. This is important especially to women planning pregnancies, to seniors concerned about vagaries of aging and to residents that have environmental concerns such as nuclear waste storage that may reflect in thyroid health."

ThyroChek NeoNatal has never been available in the U.S. as testing newborns for TSH elevation; an indication of congenital hypothyroidism is performed routinely in every hospital. This is not the case in some countries of the EU. Most countries of South America, Africa and Asia do not have a testing program. The CE mark will enhance neonatal testing opportunities for this disease in iodine-deprived areas of the world.

The market for thyroid health testing in the U.S. is $1.2 billion, according to medical diagnostic leader Inverness Medical Innovations, Inc. The TSH test accounts for at least 4% of all lab testing in North America. The American Association of Clinical Endocrinologists indicates that nearly 30 million Americans have some form of thyroid dysfunction, most likely hypothyroidism, with only half of that number diagnosed.

Doctors can write very few scripts without a thyroid test. TSH or thyroid stimulating hormone is, through a biofeedback mechanism, responsible for oxygen regulation in every human cell. With ThyroChek, there is no wait for a lab report as a meaningful qualitative result is available from a single drop of blood within 10 minutes. With a CLIA-waived license, the U.S. physician can keep revenue that would otherwise go to a lab, without sacrificing accuracy.

"Ordering a TSH test alone initially, followed by T4 in only those cases of abnormal TSH, will significantly decrease unnecessary testing and expense," according to Dr. Anthony J. Viera, based on his study at the family medicine clinic at the Naval Hospital in Jacksonville, FL.

    For more information:

    Sharon Wyman, 647-477-5672

This release was issued through eReleases(TM). For more information, visit

SOURCE Screening Devices Canada, Inc.
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