True Diagnostics Receives sFDA Clearance for its TrueDX™ Platform With TSH
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True Diagnostics, Inc.™ has announced the Company has received sFDA clearance for its TrueDX™ Platform with its first test for TSH and expects shipments to China to begin before the end of the year.
The TrueDX Platform produces quantitative results using LFIA (Lateral Flow Immunoassay) technology and measures the severity of conditions, produces results in minutes from a finger prick of blood (or small urine or saliva sample), and is portable.
This allows point-of-care professionals to begin patient treatment immediately. With the TrueDX Platform, the Company can effectively take any biomarker, quickly commercialize it to produce quantitative results, and bring it to market.
Jerry Lee, President/CEO, stated, "After years of development, we broke the code on producing quantitative results in minutes on an LFIA platform which can handle boundless applications. We also expect to make an announcement soon concerning a significant distribution partnership which clarifies how we are entering the China market with our new TrueDX Platform with TSH tests."