TrueDX Receives CE Approval for TSH testing On a New Point-of-Care system

TrueDX Receives CE Approval for TSH testing On a New Point-of-Care system

SAN DIEGO, CA – May 24, 2012 – True Diagnostics, Inc.™ (www.TrueDiagnostics.com) has announced it has received a CE Mark to allow it to distribute its TrueDX Platform and quantitative TSH (Thyroid Stimulating Hormone) test in Europe. With the TrueDX Platform, doctors can immediately determine if a patient suffers from a hypoactive thyroid by using only a finger prick of blood. This unique test enables doctors and patients to gain access to diagnosis in minutes, create an effective treatment plan, while saving physicians’ time and patients cost and anxiety. True Diagnostics is actively engaging distribution partners throughout all EU markets, with initial focus in Germany, UK, France, Italy and Spain.

This is the second regulatory clearance for the TrueDX Platform with TSH test, having received sFDA approval for China in September 2011. True Diagnostics expects to run short clinical studies in the U.S. this summer and further submit for CLIA-waive and 510k FDA clearance to market the TrueDX Platform with quantitative TrueDX-TSH™ Tests throughout the U.S.

What will the TrueDX Platform mean for doctors and patients seeking to more easily identify Hypoactive Thyroid? Hypothyroidism affects over 200 million people globally, more than people with diabetes. TSH is the fourth most requested blood test in America. Hypothyroidism is commonly undiagnosed and misdiagnosed with symptoms ranging from weight gain to depression, forgetfulness, hair loss, thinning and drying of skin, fatigue, loss of libido, feeling cold, constipation, and a pronounced goiter.

Jerry Lee, President/CEO of True Diagnostics, notes, “With this latest regulatory clearance, the Company has laid the foundation to begin standardizing a full range of diagnostic and monitoring tests that will provide instant results to doctors and patients and demand little training. With distribution partners already lined up and more coming soon, we expect initial shipments to Europe to begin within 60 days.”

The strength of the TrueDX Platform lies in its simplicity. Tests have a 24-month shelf life. They do not need to be refrigerated. Laboratory quality results from small samples can now be available to doctors to review in minutes. The TrueDX Platform’s simplicity, portability, and affordability allow it to be easily adopted into emerging markets. The platform’s flexible design also permits it to stay ahead of potential competitors and quickly commercialize a myriad of new biomarkers discoveries for cancer, autism, alzheimer’s, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections, and more. In essence, any biomarker discovery utilizing traditional lab methods, such as an ELISA process, can now be developed into a simple, fast, and portable assay which can offer quick diagnosis and treatment right in the physician’s office.

About the Company True Diagnostics, Inc. creates simple diagnostic solutions for the $46 billion medical point-of-care, sterility assurance, animal health, and food processing markets. After 30 years in the global medical diagnostic field, the inventor of the home pregnancy test created the TrueDX Platform which can measure the severity of any medical condition (using only a finger prick of blood, small urine or saliva sample, toxins, surface bacteria, and more), provide results in minutes (not days), and is completely portable. The TrueDX Platform takes point-of-care, point-of-incidence, and remote-of-care applications out of the lab to provide more flexible treatment that can begin immediately. The TrueDX Platform creates unique and powerful opportunities for new diagnostic solutions through its ability to: 1) quickly bring new diagnostic tests to market; and, 2) open new geographic and application opportunities.

For more information, call 760-683-9158 or go to www.TrueDiagnostics.com

True Diagnostics introduces the TrueDX Platform for use with an ever-growing list of tests for medical and environmental conditions. The TrueDX Platform is comprised of six elements: 1) The TrueDX™ Reader; 2) TrueDX™ Tests; 3) Raw scanned data; 4) TrueDX™ Software for analyzing scans; 5) Graphical user interface; and, 6) Network connectivity through computer linkage.

To learn more about the TrueDX Platform contact us.

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TrueDX™ Reader

True Diagnostics introduces the TrueDX Reader, both easy-to-use and portable, and designed to read all TrueDX™ Tests. The Reader requires a USB-port for power and only a few minutes to load and set-up its proprietary analysis software. Initial screening and monitoring of conditions are faster, easier and more portable than ever. The TrueDX Reader is designed for use with the TrueDX™ Platform.

To learn more about the TrueDX Reader contact us.

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TrueDX™ Software

True Diagnostics introduces the TrueDX Software, both easy-to-use and portable, and designed to read all TrueDX™ Tests. The Software only takes a few minutes to load and set-up its proprietary analysis software. Initial screening and monitoring of conditions are faster, easier and more portable than ever. The TrueDX Reader is designed for use with the TrueDX™ Platform.

To learn more about the TrueDX Software contact us.

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TrueDX-TSH™ Test

True Diagnostics introduces the TrueDX-TSH Test using simple and quantitative immunoassay technology for both initial detection and monitoring of TSH in whole blood. Using only finger stick whole blood, health professionals can now make timely medical decisions in the most remote locations around the world. The TrueDX-TSH Test is designed for use with the TrueDX Platform.

For For Export Only

To learn more about the TrueDX-TSH Test contact us.

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TrueDX-T4™ Test

True Diagnostics has also created a TrueDX-T4 Test for the detection and monitoring of free thyroxin in whole blood. With only a finger stick of whole blood, a simple and quantitative test is now available for global health professional. The TrueDX-T4 Test is designed for use with the TrueDX Platform.

For Research Use Only

To learn more about the TrueDX-T4 Test contact us.

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TrueDX-GNeg™ Test

True Diagnostics introduces the TrueDX-Gram Neg Test, the first simple & quantitative immunoassay test for the detection and monitoring of Gram-Negative Microorganisms from multiple surfaces using a small sample size. The TrueDX-GNeg Test is designed for use with the TrueDX Platform.

For Research Use Only

To learn more about the TrueDX-GNeg Test contact us.

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TrueDX-GPos™ Test

True Diagnostics introduces the TrueDX-GPos Test, the first simple & quantitative immunoassay test for the detection and monitoring of Gram-Positive Microorganisms from multiple surfaces using a small sample size. The TrueDX-GPos Test is designed for use with the TrueDX Platform.

For Research Use Only

To learn more about the TrueDX-GPos Test contact us.

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TrueDX-PSA™ Test

True Diagnostics introduces the TrueDX-PSA Test, the first simple & quantitative immunoassay test for initial detection and monitoring of PSA in whole blood. Using only finger stick whole blood, health professionals can now make timely medical decisions in the most remote locations around the world. The TrueDX-PSA Test is designed for use with the TrueDX Platform.

True Diagnostics, Carlsbad, CA, received CE approval for a quantitative TSH (Thyroid Stimulating Hormone) test on the TrueDx platform. This new platform is a completely portable point of care system that can handle multiple tests on a single reader. A finger pin prick of blood, small urine or saliva sample can be analyzed at point-of-care, and a digital signal even allows to extend functionality to Remote-of-Care wireless applications.

The Reader only requires a USB-port for power and a few minutes to load and set-up its proprietary analysis software. The test itself is a quantitative immunoassay offering detection and monitoring of markers in whole blood and it can be stored for 2 years at room temperature.

TrueDX Reader TrueDX Receives CE Approval for TSH testing On a New Point of Care systemThe company claims to have 61 tests in its product pipeline of which 57 have passed through proof of concept. The detection of hypothyroidism by quantitative measurement of TSH in blood is their first approved clinical test available in Europe. Other tests are available for research only, which include: quantitative T4, gram negative bacteria (Gneg), gram positive bacteria (Gpos) and prostate specific antigen (PSA).

Jerry Lee, President/CEO of True Diagnostics is cited in the press release:

“With this latest regulatory clearance, the Company has laid the foundation to begin standardizing a full range of diagnostic and monitoring tests that will provide instant results to doctors and patients and demand little training. With distribution partners already lined up and more coming soon, we expect initial shipments to Europe to begin within 60 days.”

True Diagnostics expects to run short clinical studies in the U.S. this summer and further submit for FDA clearance to market the TrueDX Platform throughout the U.S.

Source : http://www.truediag.com/press52412.html

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