Navigation Links
SD Canada Announces CE Mark for ThyroChek(R) Adult and NeoNatal Tests
Date:3/11/2009

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
    info@thyrochek.com

http://www.thyrochek.com

This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com.


'/>"/>
SOURCE Screening Devices Canada, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Pressure BioSciences, Inc. Issued First Patent in Canada
2. Dalton Medicinal Chemistry Partners Achieves Milestone in Collaboration with Boehringer Ingelheim (Canada) Ltd.
3. Dalton Medicinal Chemistry Partners Achieves Another Milestone in Collaboration with Boehringer Ingelheim (Canada) Ltd.
4. Cepheid Receives Health Canada Medical Device License for Xpert MRSA(TM) Test and GeneXpert(R) System
5. Kiwa Bio-Tech Products Group Discusses Cooperative Research With the University of Waterloo, Canada
6. ABR-Affinity BioReagents Finalizes Agreement for Distribution of Osenses Antibodies in the U.S., Canada and Europe
7. Enerkem announces progress on construction of Canadas first cellulosic ethanol plant
8. Canadas Best-Selling Soymilk Now Available with Marteks lifesDHA
9. Seduce with Mousse - Replens Introduces Intimate Options: First Personal Lubricant Mousse in Canada
10. pH Balanced RepHresh Vaginal Gel(R) now Available to Women in Canada Attacking Tough, Embarrassing Feminine Issues
11. Elekta Sees Record Attendance and Record Number of Submitted Abstracts at International Leksell Gamma Knife(R) Society Meeting in Quebec, Canada
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... Ginkgo Bioworks , a leading organism design company ... as one of the World Economic Forum,s Technology ... companies. Ginkgo Bioworks is engineering biology to manufacture ... the nutrition, health and consumer goods sectors. The ... Fortune 500 companies to design microbes for their ...
(Date:6/24/2016)... ... ... While the majority of commercial spectrophotometers and fluorometers use the z-dimension of 8.5 ... end machines that use the more unconventional z-dimension of 20mm. Z-dimension or ... the cuvette holder. , FireflySci has developed several Agilent flow cell product lines ...
(Date:6/23/2016)... ... 23, 2016 , ... UAS LifeSciences, one of the leading ... UP4™ Probiotics, into Target stores nationwide. The company, which has been manufacturing high ... its list of well-respected retailers. This list includes such fine stores as Whole ...
(Date:6/23/2016)... , June 23, 2016 A person commits ... the crime scene to track the criminal down. ... U.S. Food and Drug Administration (FDA) uses DNA evidence to ... Sound far-fetched? It,s not. The FDA has ... to support investigations of foodborne illnesses. Put as simply as ...
Breaking Biology Technology:
(Date:6/9/2016)... attendance control systems is proud to announce the introduction of fingerprint attendance control software, ... employees are actually signing in, and to even control the opening of doors. ... ... ... Photo - http://photos.prnewswire.com/prnh/20160609/377487 ...
(Date:6/3/2016)... , June 3, 2016 ... Management) von Nepal ... und Lieferung hochsicherer geprägter Kennzeichen, einschließlich Personalisierung, ... führend in der Produktion und Implementierung von ... der Ausschreibung im Januar teilgenommen, aber Decatur ...
(Date:6/2/2016)... 2016 Perimeter Surveillance & Detection ... Physical Infrastructure, Support & Other Service  The ... offers comprehensive analysis of the global Border Security ... revenues of $17.98 billion in 2016. Now: ... leader in software and hardware technologies for advanced video ...
Breaking Biology News(10 mins):