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:12/7/2016)... , Dec. 7, 2016  Genprex, Inc. a ... immunogene therapy treatments, today announced that it has ... a leading strategic communications and advisory firm, to ... The program will combine investor relations, public relations ... raising the profile of Genprex and its lead ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... today a new service to enable rapid migration of large pathology data sets ... one of the factors limiting adoption of digital pathology. Proscia’s free massive dataset ...
(Date:12/6/2016)... Dec. 6, 2016 /PRNewswire/ - SQI Diagnostics Inc. ("SQI" or the "Company") ... the fourth quarter and fiscal year ended September 30, 2016. ... , , ... life sciences and diagnostics company that develops and commercializes proprietary technologies ... Achieved revenues of $1.4 million more than tripling ...
(Date:12/6/2016)... ... December 06, 2016 , ... Symbios Technologies, Inc. , ... company has engaged in a collaborative research partnership with Colorado State University (CSU) ... of the Vice President for Research. This agreement is designed to further the ...
Breaking Biology Technology:
(Date:11/24/2016)... 23, 2016 Cercacor today introduced Ember TM ... trainers non-invasively measure hemoglobin, Oxygen Content, Oxygen ... Respiration Rate in approximately 30 seconds. Smaller than a ... immediate access to key data about their bodies to ... regimen. Hemoglobin carries oxygen to muscles. ...
(Date:11/22/2016)... Minn. , Nov. 22, 2016   MedNet ... supports the entire spectrum of clinical research, is pleased ... Medical LiveWire Healthcare and Life Sciences Awards ... award caps off an unprecedented year of recognition and ... trials for over 15 years. iMedNet ...
(Date:11/19/2016)... 18, 2016 Securus Technologies, a leading provider ... safety, investigation, corrections and monitoring, announced today that it ... to have an independent technology judge determine who has ... high tech/sophisticated telephone calling platform, and the best customer ... do most of what we do – which clearly ...
Breaking Biology News(10 mins):