CE Mark for True Diagnostics TrueDX Platform and TSH Test

True Diagnostics, Inc.™ has announced that it has received a CE Mark for its TrueDX™ Platform and quantitative TSH (Thyroid Stimulating Hormone) test in Europe. The clearance will enable the company to market the tests in Europe.

Using the TrueDX™ Platform, doctors and point-of-care professionals 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.

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. True Diagnostics is actively engaging distribution partners throughout all EU markets, with initial focus in Germany, UK, France, Italy and Spain.

Hypothyroidism affects over 200 million people globally, more than people with diabetes, cancer or heart disease! TSH is the fourth most requested blood test. 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.