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Development and mass-production of diagnostic solutions based on rapid test – Lateral Flow Immunoassays

Country of Origin: Spain
Reference Number: TOES20210811002
Publication Date: 10 September 2021


A Spanish SME leader in the field of biosensor-based analytical devices applied to food safety monitoring and health diagnostics offers the opportunity to collaborate in the development of solutions based on lateral flow immunosensor (LFI)-based rapid tests with the possibility of large-scale production for both health diagnostics and food safety.
This could be held under a manufacturing, research cooperation or technological cooperation agreement.


The Basque SME develops, manufactures and commercializes rapid, portable and user-friendly analytical devices applied to the food industry and to the health sector. This technology is based on enzymatic and immunoassay based biosensing platforms developed combining know-how in electronics, electrochemistry and biotechnology. The Basque SME counts with its own facilities for R&D activities and biosensor manufacturing based on screen printed electrodes, solid electrodes or lateral flow strips.
The company has developed a platform for the development and manufacturing of rapid test based on LFI. Moreover, it has developed accessory items and components of the rapid test that ensure rapid development and no dependence on third parties.
A rapid test based on LFI is a simple to use diagnostic device used to confirm the presence or absence of a target analyte, such as pathogens or biomarkers in humans or animals, or contaminants in water supplies, foodstuffs, or animal feeds. The most commonly known type of lateral flow rapid test strip is the pregnancy test. This test has received wide acceptance because of its ease of use and the ease of interpretation of the results. They are very rapid tests on immunological capture. They provide a fast, reliable and simple way of diagnosis in a format that is easy to use and relatively inexpensive to produce.
This type of device is based on the use of nitrocellulose membranes as a support for immunoassay reactions and is a great alternative to traditional immunoassays, which involve the use of multiwell plates, high cost, complicated washing and sample preparation procedures, long detection times and the difficulty to carry out a correct automation and miniaturization.
Lateral flow tests are widely used in human health for point of care testing. They can be performed by a healthcare professional or by the patient, and in a range of settings including the laboratory, clinic or home. In the medical diagnostic industry, there are strict regulatory requirements which must be adhered to for all products developed and manufactured.
So, the company seeks three different paths for the nearest future. Development of new innovative solutions based on LFI, development of a diagnostic solution based on LFI for a specific application and mass production to a LFI based rapid test. In that order the Basque SME is looking for a research cooperation agreement, a technical cooperation agreement and a manufacturing agreement.
The Basque SME counts with a multidisciplinary team with the necessary capabilities and infrastructure to efficiently integrate new technologies, recognition elements, components or detection methods into LFI-based rapid test. As an example, during the last years the company has been working on different European projects applying paper-based materials to this type of immunoassays.
It has developed a platform that enables the development and manufacturing of rapid test based on LFI integrating different processes by the same company or with local partners, coordinating different processes quickly and efficiently ensuring local and responsible production.
The company is certified according to the ISO 9001:2015 standards and is a critical supplier to companies that commercialize medical devices and healthcare solutions under ISO 13485 standards.


Advantages and Innovations

Currently, in the biomedical sector, the development of immunosensors for biomarker monitoring is a growing area of research and as new biomarkers and their involvement in diseases are defined, this field will continue to grow and become a major player in point of care (PoC) devices. 
In order to achieve a diagnostic PoC immunosensor, all the steps of the immunological reactions together with detection need to be integrated in a single device. For this purpose, several platforms have been developed, including microfluidic chips and lateral flow devices. Advances in microfluidics have enabled the development of devices that allow different stages to be carried out in a cartridge, such as: pre-treatment, reaction, pre-concentration, separation and detection. However, the cost of the materials and the production process, together with the cost of the readers that require a system to control the flow inside the cartridge, in addition to analysing the signal from the strip, has limited their entry into the market. On the other hand, given their advantageous characteristics, paper-based lateral flow immunoassays are dominating the clinical diagnostic market. LFIs based on the use of nitrocellulose membranes to support the immunological reactions are portable, fast and easy to use, allowing the analysis to be performed at the point of care.
In the case of COVID-19, LFI-based tests are being used extensively for both antigen detection for use in the control of the infected population and antibody detection for use in the study of population seroconversion and seroprevalence. One of its main advantages is the rapidity of the test that can provide information in just a few minutes, as well as its high availability for decentralised locations.
The innovation and competitive advantage the company has achieved is to quickly and efficiently develop rapid tests based on lateral flow by integrating different processes without relying on third parties or local suppliers.

Stage Of Development

Available for demonstration

Requested partner

The Basque SME is willing to partner with biotechnology companies that aim to develop new solutions based on the LFI technology. Moreover, the company would also be interested in developing more diagnostic solutions based on LFI for specific applications. In these cases, the company would like a technical cooperation agreement or a research cooperation agreement. 
Nevertheless, the company is also interested in a mass production of those LFI based rapid test. For that so, a pharmaceutical company or a company familiarised with producing biotechnological devices would be appropriate for this partnership, a manufacturing agreement.

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