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news.Screening Devices Canada, a product development, marketing and sales company, has launched ThyroChek, the rapid test for elevated thyroid-stimulating hormone, the first clinical indicator of hypothyroidism in the EU.
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With the CE mark indicating conformity to European standards for medical devices, both adult and neonatal ThyroChek tests are available for sale worldwide.
Screening Devices (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.
ThyroChek neonatal has never been available in the US as testing newborns for thyroid-stimulating hormone elevation; an indication of congenital hypothyroidism is performed routinely in every hospital. The CE mark will enhance neonatal testing opportunities for this disease in iodine-deprived areas of the world, the company said.
Mr Cunningham said: “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.”