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.
The 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.
Press release: True Diagnostics Receives CE Mark for TrueDX(TM) Platform & TSH Test
Link: TrueDX technology page…