Caen (Normandy), France – April 6, 2021 – Since January 2020, Loop Dee Science has been developing a COVID-19 testing device.
After 15 months of development and production, here is the latest update.

CE IVD marking

The LoopXplore COVID device was registered with ANSM for CE/IVD marking.
In September 2020, it received the CE IVD certification for in-vitro diagnostic devices.
Consequently, it was included on the list of tests reimbursed by social security.

This CE IVD marking authorizes marketing in the European Union and countries recognizing CE standards.
Additionally, the device is classified as an RDT (Rapid Diagnostic Test) and may be reimbursed by local health insurance funds.

Detection of variants

LoopXplore COVID-19 targets three regions of the RdRp gene, a minimally mutagenic part of SARS-CoV-2.
As a result, it detects all known variants, including British, Brazilian, and South African.
Moreover, Loop Dee Science’s R&D team continuously monitors virus mutations using WHO data to maintain detection accuracy.

Ongoing clinical trials

A publication co-written with Professor Astrid VABRET and Dr Meriadeg AR’ GOUILH validates retrospective sample testing.
Furthermore, a clinical trial at Caen CHU tests nasopharyngeal swabs from patients and compares results with PCR.
This trial refines the sensitivity and specificity of LoopXplore COVID-19.

International marketing

Loop Dee Science currently commercializes LoopXplore COVID-19 kits in France and Belgium.
Through a partnership with Torrelab, the device is distributed in Spain.
ACTG-CRO now distributes it in Tunisia and Libya.
Additionally, subsidiaries Loop Dee Science Europe (Caen) and Loop Dee Science Asia (Shenzhen) support global commercialization.

Software for device control

The LoopXHub software, developed with OSI Santé, will soon be available.
It allows control of up to 10 devices, generates reports, stores results, and more.
A basic version is free, while the full version costs €150.

Innovation strategy

Loop Dee Science also develops solutions for measles with Caen CHU and for food pathogens like Salmonella and Listeria.
Future applications include environmental and veterinary fields.
Thanks to the device’s versatility, many innovative applications can be developed collaboratively.

Would you like to develop new solutions? Contact us!

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