Commercialisation of COVID-19 test kits.

Press release

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.

Test that will be soon be CE marked

Loop Dee Science and the Caen Normandy University Hospital will co-publish the validation study results in a scientific journal.

The study confirms that the COVID-19 screening device is highly reliable. In fact, it shows 96% sensitivity.
Additionally, the device demonstrates 96% specificity across 348 samples tested.

Thanks to these excellent results, a technical file was submitted to the ANSM.
This step is crucial to obtain the CE marking, required for marketing and selling the device.

Once approved, the CE marking will allow the device to be distributed safely across the European Union.
Moreover, it ensures compliance with regulatory standards, giving professionals confidence in the test’s performance.

Whose production has been anticipated to meet demand

To meet growing demand, Loop Dee Science has moved into new premises with a clean room.

Furthermore, the company invested in an industrial freeze-dryer and additional production machines.

Thanks to financial support from the Normandy region and assistance from the Direction Générale de l’Armement, production capacity increased.

As a result, Loop Dee Science can now confidently fulfill future orders and respond to rising market needs.

Collaboration with the University Hospital that calls for others

At the end of this first successful collaboration, Loop Dee Science and the Caen University Hospital are strengthening their scientific partnership.

Moreover, they are announcing co-development projects for rapid influenza tests.

In addition, other viruses of national and international interest will be targeted, including the measles virus, compatible with the analysis device.

These initiatives highlight the ongoing commitment to innovative and versatile diagnostic solutions for public health.

A test that will be soon be CE marked

In addition to its scientific partnership with the University Hospital of Caen, Loop Dee Science promotes local development in Normandy.

Furthermore, the kits and analysis equipment integrate numerous regional innovations and expertise.

For example, Eldim in Hérouville-Saint-Clair manufactures the analysis device, the Lemoine Group in Flers provides swabs, and PRN in Carpiquet supplies packaging.

This approach highlights the company’s commitment to regional collaboration and leveraging local economic know-how.

Loop Dee Science
Stefan GALLARD
Co-fondateur – Directeur
Marketing/Communications
s……@loop3.sc3hegu8899.universe.wf
Tél. : +33 07 82 13 11 06

CHU de Caen Normandie
Alexandre DREZET
Directeur de la stratégie
d……@chu-caen.fr
Tél : +33 02 31 06 49 61

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