Medical diagnostic company Miraculins has filed pre-submission documentation with the US Food and Drug Administration (FDA) for the US marketing approval of its Scout DS system, a non-invasive and highly sensitive test designed to measure diabetes related biomarkers in the skin.
According to Miraculins, the Scout DS system generates results within 80 seconds and it does not require blood draw, fasting or waiting for a lab result.
Using visible light, the non-invasive diabetes testing system measures the optical signature of fluorescent biomarkers in the skin, with accumulation 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 said: "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."
Scout DS is indicated for use for the non-invasive screening of individuals 18 years or older who are at risk for prediabetes and/or type 2 diabetes to determine whether diagnostic testing is necessary.
In April, Miraculins has signed a non-binding term sheet with medical device company VeraLight, to acquire all assets related to the SCOUT DS technology.
Scout DS has also received approval from Health Canada for commercial distribution and it has been granted a CE Mark in the EU, and is also cleared for sale in Mexico.
Image: Miraculins’ Scout DS system for non-invasive diabetes screening. Image: courtesy of Miraculins Inc.