Miraculins, a medical diagnostic company, has announced the filing of pre-submission documentation with the US Food and Drug Administration (FDA) for the marketing approval of its Scout DS system, a non-invasive and highly-sensitive test designed to measure diabetes related biomarkers in the skin, in the US.
The Scout DS is a non-invasive diabetes screening system that provides a highly sensitive and convenient method for screening for prediabetes and type 2 diabetes based on the presence of diabetes-related biomarkers found in the skin.
It requires no blood drawing and no fasting for a lab result and generates results within 80 seconds.
The non-invasive diabetes testing system uses a visible light to measure the optical signature of fluorescent biomarkers in the skin, the accumulation of which are accelerated by abnormal blood sugar levels and oxidative stress.
Miraculins said that filing of the pre-submission documentation with the FDA is the company’s first formal step to establish a clinical and regulatory plan for the regulatory approval of the Scout DS in the US.
Based on FDA’s feedback for the application, the company will develop appropriate study protocols in support of FDA marketing approval.
Miraculins president and CEO Christopher J Moreau noted this is an important milestone for the company as it begins to implement its plans for the Scout DS globally.
"We look forward to working cooperatively with the FDA as the new owners of the technology and bringing new energy and resources towards establishing a pathway for Scout DS marketing clearance in the important US market, where we believe the measurement of diabetes related biomarkers in the skin can have a considerable impact on the fight against the type 2 diabetes epidemic," Moreau added.