Herouville-saint-Clair, August 7, 2020
LOOP DEE SCIENCE AND CHU DE CAEN NORMANDY ANNOUNCE THE COMMERCIALIZATION OF COVID-19 ANALYSIS KITS
Hérouville-Saint-Clair (Normandy), France – August 7, 2020 – Loop Dee Science and the University Hospital of Caen Normandy have finalized the development of a molecular biology detection system for COVID-19 that provides results in 50 minutes and directly at the patient’s POINT OF CARE. Because of their practicality, these unit tests could be used, for example, in health homes or other places that require rapid testing. The launch of the LoopXplore COVID-19 analysis kit and the analysis device automated analysis system represents a major step forward to overcome some of the limitations of the currently used diagnostic tests.
A test that will be soon be CE marked
Loop Dee Science and the Caen Normandy University Hospital will co-publish the results of the validation study of this new screening method in a scientific journal. The results obtained show that this new device is particularly reliable: it has a sensitivity of 96% and a specificity of 96% on a total of 348 samples tested.
Based on these excellent results, a technical file was submitted to the ANSM (Agence Nationale de la Sécurité du Médicament et des Produits de Santé) in order to obtain the CE marking, which is necessary to put on the market and sell this device.
A test whose production has been anticipated to meet demand
In order to meet the high demand, Loop Dee Science has moved into new premises equipped with a clean room and has invested in the purchase of an industrial freeze-dryer and production machines, thanks in part to the financial support of the Normandy region and the assistance of the Direction Générale de l’Armement. Loop Dee Science can now commit itself to respond to future orders.
A collaboration with the University Hospital that calls for others
At the end of this first fruitful collaboration, Loop Dee Science and the Caen University Hospital are strengthening their scientific partnership and announcing co-development projects for rapid influenza tests, as well as other viruses of national and international interest that are compatible with the analysis device (measles virus in particular).
Normandy’s economic network strongly mobilized to make this new test available
In addition to its scientific partnership with the University Hospital of Caen, Loop Dee Science is determined to promote local development by relying on the economic know-how of Normandy. Loop Dee Science’s kits and analysis equipment bring together many innovations and resources from the region, such as Eldim in Hérouville-Saint-Clair, which manufactures the analysis device, the Lemoine Group in Flers, which provides swabs and PRN in Carpiquet, which provides packaging.