QuantRx Biomedical has submitted 510(K) application to the FDA for Q-Reader thyroid testing system, following the completion of clinical testing studies showing that the system is capable of providing healthcare practitioners with laboratory level quantitative results within minutes.
The QN Diagnostics (QND) Q-Reader is a stand-alone instrument with a liquid crystal display (LCD) touch screen located on the top of the unit, and an integrated software analysis capability.
Using QND’s analysis software, the unit uses stored calibration data provided with each QND Assay Kit and an analyte concentration based upon the analyte-specific calibration curve to display a quantifiable reading to the healthcare practitioner on the LCD screen.
QuantRx Biomedical said that the QND Assays are housed within a plastic cassette, which contains a QND-lateral flow Assay Strip. The test system is intended for use at the point of care and to eliminate the need for samples to be taken from the patient and shipped with related documentation to an external laboratory, saving the time needed to return the test results to the health care practitioner.
Walter Witoshkin, chief executive officer of QuantRx, said: “With the successful completion of our studies we believe we have made a significant step forward for the first of many planned diagnostic tests which are intended to provide rapid, low cost, quantitative results.
“The ability to introduce our proprietary technology, which will allow the healthcare professional to run in-clinic assays that had only been available from a commercial laboratory before, will be the basis of our market growth in both human and veterinary diagnostics.”