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Covid-19 salivary rapid and easy molecular test

Country of Origin: France
Reference Number: TOFR20210325001
Publication Date: 25 March 2021

Summary

A French company specialising in critical medical devices has developed a Covid-19 salivary rapid and easy molecular test in collaboration with a recognised research organisation. This saliva screening solution is CE-IVD (In-Vitro Diagnostic Devices Directive) marked and is for professional use only. The company is looking for new international partners through licence agreements or commercial agreements with technical assistance.

Description

The recent pandemic outbreak of coronavirus disease (COVID-19) calls for rapid and accurate viral detection to circumvent the spread of the disease. Nasopharyngeal and oropharyngeal swabs are the most used samples for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS - CoV -2) infection. 

The French company has developed a complete Covid-19 salivary rapid and easy molecular test with a recognised research organisation.

The test includes:
• A kit with the reagents and equipment necessary for its realisation
• A transportable heating device
• A smartphone application allowing the reading and traceability of the result

This solution is a saliva test that can be performed in the field with a colorimetric reading of the results, all in less than an hour.
It consists of taking less than 1 mL of saliva under the patient's tongue. The sample is successively deposited in two tubes heated, thanks to a mobile device. A colorimetric reading allows to diagnose the presence of the virus in the tested patients.

The performances of this test have been validated by a study conducted in a recognised hospital centre, by using Reverse Transcription quantitative-Polymerase Chain Reaction (RT-qPCR) technology. This technology is the main employed diagnosis method.
This saliva test, marketed internationally from June 2020, was approved in France by the HAS - Haute Autorité de Santé in December 2020 and is now reimbursable since January 2021.
This reliable, painless, rapid and easily deployable screening allows mass testing and optimisation of containment and decontainment strategies.

The company is looking for new international partners. Licence agreements are proposed to distributors, who would possibly propose first level maintenance.
Commercial agreements with technical assistance are proposed to care facilities, laboratories or entities wishing to acquire the solution to perform tests on their patients or users. The French company would provide support to implement this saliva test.
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Advantages and Innovations

The test is:
• Comfortable and painless: a simple saliva sample
• Reliable: 86% sensitivity and 99% specificity, including on the variants detected to date: UK, South Africa, Brazil…
• With its ready-to-use consumables and its device, this test can be deployed in places such as airports, train stations, concert halls, sports complexes, companies...
• Results within 40 minutes
• Easy to interpret through colour recognition

Stage Of Development

Already on the market

Requested partner

Licence agreements are proposed to distributors who should distribute the Covid-19 test and possibly propose first level maintenance.
The French company will provide all this solution and necessary support for the marketing of this solution (documentation, sales support, sales training, user training support….)

Commercial agreements with technical assistance are proposed to care facilities or laboratories wishing to acquire the solution to perform tests on their patients. These agreements are also proposed to entities (companies, associations, local authorities, etc.) wishing to propose a testing solution to their users, customers, employees, members.
The French company provides the equipment, the test kits, the application and the support (user manuals, training) needed to implement this saliva test.

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