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:2/10/2016)... , Febr. 10, 2016 /PRNewswire/ - BioAmber Inc. (NYSE: ... to announce that Mitsui & Co. Ltd., its partner ... acid plant, is investing an additional CDN$25 million in ... its stake from 30% to 40%.  Mitsui will also ... acid produced in Sarnia , providing ...
(Date:2/10/2016)... , Feb.10, 2016 ASAE is introducing a ... Management Companies (AMC) the option of joining or renewing ... fee determined by staff size, every employee in any ... ASAE and reap all available member benefits.   ... new organizational membership options will allow organizations of any ...
(Date:2/10/2016)... 2016  Matchbook, Inc., a company specializing in ... companies, announced today the appointment of Jim ... brings nearly 25 years of experience in supply ... nearly two decades in executive level roles as ... Genzyme and, most recently headed global logistics and ...
(Date:2/10/2016)... ... February 10, 2016 , ... SonaCare Medical, LLC reports ... program, Sonalinkā„¢ remote monitoring. The inaugural launch of this new technology occurred over ... Dr. Samuel Peretsman to a HIFU technical expert at SonaCare Medical headquarters. ...
Breaking Biology Technology:
(Date:2/9/2016)... AWRE ), a leading supplier of biometrics software and services, ... December 31, 2015.  --> --> ... an increase of 61% compared to $4.3 million in the same ... was $2.6 million compared to $0.2 million in the fourth quarter ... Higher revenue and operating income in the fourth quarter of this ...
(Date:2/5/2016)... Feb. 5, 2016 ... the "Global Facial Recognition Market 2016-2020" ... http://www.researchandmarkets.com/research/5kvw8m/global_facial ) has announced the addition ... 2016-2020" report to their offering. ... ) has announced the addition of the ...
(Date:2/3/2016)... , February 3, 2016 ... new market research report "Automated Fingerprint Identification System Market ... Latent Search), Application (Banking & Finance, Government, Healthcare, and ... by MarketsandMarkets, the market is expected to be worth ... of 21.0% between 2015 and 2020. The transformation and ...
Breaking Biology News(10 mins):