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:7/20/2017)... BC, Canada (PRWEB) , ... July 20, 2017 , ... ... today announced the winning recipients of the 2017 IAC Awards at the 22nd World ... awards, the committee also named four faculty to receive the Distinguished Fellowship Awards. , ...
(Date:7/20/2017)... ... July 20, 2017 , ... ... on digital pathology and artificial intelligence Tuesday, July 25, during the Association of ... from Johns Hopkins Medicine. , Baras, Associate Director of Pathology Informatics, will ...
(Date:7/20/2017)... ... July 20, 2017 , ... Crucial Data Solutions (CDS) ... study participants truly unified. TrialKit, a native mobile app, empowers investigators and clinicians ... studies entirely on mobile devices. With TrialKit, clinical researchers can utilize Core Motion ...
(Date:7/18/2017)... Switzerland (PRWEB) , ... July 18, 2017 , ... ... R&D, today announced that Merck, a leading science and technology company, has implemented ... innovative therapeutics for the therapeutic areas of Oncology, Immunology, and Neurodegenerative Diseases. , ...
Breaking Biology Technology:
(Date:4/5/2017)... -- The Allen Institute for Cell Science today announces the ... and dynamic digital window into the human cell. The ... of deep learning to create predictive models of cell ... growing suite of powerful tools. The Allen Cell Explorer ... available resources created and shared by the Allen Institute ...
(Date:4/3/2017)... , April 3, 2017  Data captured ... engineering platform, detected a statistically significant association ... prior to treatment and objective response of ... potential to predict whether cancer patients will ... treatment, as well as to improve both pre-infusion ...
(Date:3/29/2017)...  higi, the health IT company that operates the ... , today announced a Series B investment from ... The new investment and acquisition accelerates higi,s strategy to ... population health activities through the collection and workflow integration ... collects and secures data today on behalf of over ...
Breaking Biology News(10 mins):