True Diagnostics, Inc. Completes FDA Pre-Submission For TrueDX(TM)-TSH Test

SAN DIEGO, CA--(Marketwired - February 12, 2015) -

True Diagnostics, Inc., a Point-of-Care diagnostic company located in Carlsbad, California, announced today that the Company has completed its pre-submission filing with the Food and Drug Administration (“FDA”) to request additional feedback for its planned 510(k) filing for the TrueDX™ TSH system. True Diagnostics is developing its TrueDX™ system designed to inform real-time treatment decisions for Point-of-Care clinicians.

The diagnostic industry has been evolving towards the Point-of-Care to meet the growing demands of patient care. Researchers project the global POCT market is expected to grow at a CAGR of around 8.4% over the next five years. Point-of-Care tests provide quicker results to make critical diagnostic and therapeutic decisions for both the provider and the patient. The TrueDX™ Platform Technology leverages a proprietary calibration assay and method that demonstrates improved standards for specificity, accuracy, stability and simplicity over traditional Point-of-Care methods.

“The challenges associated with obtaining CLIA-waived status for a medical diagnostic device are standards that we embrace with our product designs. Our management team’s experience and key partnerships will help us deliver on the potential opportunities growing within the Point-of-Care market,” said Jerry Lee, President and CEO of True Diagnostics. “True Diagnostics previously completed device approvals for its TrueDX-TSH test in Europe and China and we look forward to launching the TrueDX platform in the US,” Lee said.

About True Diagnostics

For the $21 billion point-of-care market, the power of the TrueDX™ Platform lies in its simplicity: tests have a 24-month shelf life; they do not require refrigeration; and laboratory quality results from small samples can now be available to clinicians in minutes. The TrueDX™ Platform’s simplicity, portability and affordability also allow it to be easily adopted into emerging markets. The platform’s flexible design additionally permits it to quickly commercialize a myriad of biomarkers discovered 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 utilizing traditional lab methods, such as an CLEIA, ELISA, or GC/MS can now be ported into a simple, fast, and portable assay which offers quick diagnosis and treatment at the point-of-care, point-of-incidence and remote-of-care settings.