True Diagnostics to distribute TrueDX platform, TSH test in Europe

The TrueDX platform helps physicians to determine whether a patient suffers from a hypoactive thyroid and the TSH test enables doctors and patients to gain access to diagnosis, 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 a finger prick of blood, small urine or saliva sample, toxins or surface bacteria, the company said.

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.