European Commission clears TrueDX platform and TSH assay

27 May 2012 (Last Updated May 27th, 2012 18:30)

True Diagnostics has received CE-mark approval to distribute its TrueDX platform and quantitative thyroid-stimulating hormone (TSH) test in Europe.

True Diagnostics has received CE-mark approval to distribute its TrueDX platform and quantitative thyroid-stimulating hormone (TSH) test in Europe.

Using the TrueDX platform, physicians can immediately determine whether a patient suffers from a hypoactive thyroid and the TSH test enables doctors and patients to gain access to diagnosis in minutes, create the right treatment plan and save physicians' time and patients' cost.

The portable TrueDX platform can measure the severity of any medical condition using only a finger prick of blood, small urine or saliva sample, toxins or surface bacteria, while providing results in minutes.

True Diagnostics president and CEO Jerry Lee said that with the regulatory clearance, the company has laid the foundation to begin standardising 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," Lee added.

The company intends to conduct short clinical studies in the US and submit for CLIA-waive and Food and Drug Administration 510(k) clearance to market the TrueDX platform with quantitative TrueDX-TSH tests throughout the US.

The portable TrueDX platform is expected to allow for new biomarker discoveries against cancer, autism, Alzheimer's, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury and viral and bacterial infections.

Hypothyroidism symptoms range from weight gain to depression, forgetfulness, hair loss, thinning and drying of skin, fatigue, loss of libido, feeling cold, constipation and a pronounced goitre.