Scout DS® is cleared for sale as a screen for pre-diabetes and type 2 diabetes in Canada, Mexico, has been CE-Marked for the EU, with pre-submission documentation for a de novo classification in process with the FDA (1Q2015).
Miraculins holds a strong patent portfolio with multiple patents issued in the U.S., multiple pending patent applications, and patents issued/pending in Europe, Canada, India, Japan, China and Korea.
The company has proprietary encrypted algorithms and instrument standardization methods and materials.
In addition, there has been about $40-$50 million invested in the researching and developing the technology.
