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A Swiss deep-tech spin-off developing a novel malaria diagnostic technology seeks scientific and business collaborations to further develop and commercialise their technology.

Country of Origin: Switzerland
Reference Number: TOCH20200903001
Publication Date: 8 September 2020

Summary

A Swiss university spin-off has developed a novel malaria diagnostic test that is based on a patented and published amplification of a pan-malarial biomarker using a chemical method. It enables faster, more sensitive and less expensive diagnostic tests as it aims at detecting asymptomatic carriers in countries where Plasmodium vivax malaria parasites are dominant. To further develop the technology a company or university is sought for technology and research cooperation or financial agreement.

Description

Malaria is a disease of the most vulnerable: the very young and the poor. There are around 219 million cases and more than 400’000 deaths worldwide annually, with children under 5 years old accounting for 67% of these deaths.

Despite huge progress in the reduction of malaria cases and deaths, many countries with the potential to eliminate the disease are still not on track to meet milestones set by the WHO. The main reason for this is the failure to identify and treat asymptomatic carriers (ACs) with current diagnostic technologies such as Rapid Diagnostic Technology (RDT) and microscopy.
ACs are those who have become infected with malaria parasites but who themselves display no symptoms. They act as reservoirs of malaria parasites and may contribute to continuous transmission of the disease and can ignite devastating epidemics. RDT and microscopy are not sensitive enough to detect ACs. With the current tools, even with the most optimistic scenarios and projections, there will still be 11 million cases of malaria in Africa in 2050.

The patented technology of the Swiss university spin-off is based on the observation that hemozoin – a biocrystal formed in blood due to malarial infection – can be used as a catalyst for polymerisation reactions.
The innovative element of this novel diagnostic technology is the research team’s multidisciplinary approach, which combines polymer science with parasitology and ultimately led to the discovery of a highly sensitive assay for malaria detection.
The assay combines the high sensitivity of signal-amplification by catalytic radical polymerisations with cheap and stable non-biological reagents and a simple read-out that does not require sophisticated instrumentation.

This renders it ideal for diagnostics in the field, especially in harsh environments where malaria-ridden communities often reside. Besides its robustness, there are four other clear advantages:
- High sensitivity: The device can detect down to 10 parasites/μL.
- Affordability: It only costs USD 2.- per test.
- Speed: It takes only 20 minutes from blood to readout.
- User-friendliness: Technical training takes under 1 hour.

The device has two components:
- Reusable: A device with microfluidic cuvette and hole puncher
- Consumables : lancet, reagents, buffers, filter paper

The Swiss spin-off is looking for partnerships to further develop the diagnostic technology (e.g. field tests, cross-comparison with other tests) and to bring it to the market (approval by health ministry, scale-up, production assistance, roll-out).
Biotech, pharmaceutical companies, universities and research centers with expertise in the field of tropical diseases, especially malaria, are sought for technology and research cooperation and/or financial agreement.
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Advantages and Innovations

There are currently three types of malaria diagnostic.

1. Malaria rapid diagnostic tests (MRDTs):
- inexpensive lateral flow strips
- insufficient sensitivity, accuracy and robustness
- insufficient for a screening campaign needed for malaria eradication

2. Microscopy with Giemsa staining
- a widespread diagnostic method
- highly dependent on the skills of macroscopics and highly time-consuming
- not sensitive enough to detect infections to the levels present in asymptomatic carriers

3. Polymerase chain reaction (PCR)
- relies on the amplification of parasite DNA to detect low-level infection
- relies on expensive consumables and equipment
- not used routinely for diagnostics but mainly for research purposes

In comparison, the chemical amplification concept combines the sensitivity and robustness of PCR methods with the low cost and ease-of-use of MRDTs and therefore fills a customer need and technology gap.

Stage Of Development

Prototype available for demonstration

Stage Of Development Comment

The current prototype is the 3rd generation, and three field tests had been conducted.

Requested partner

The specific area of activity of the partner: 
- Company/university with research activities in tropical diseases, particularly malaria; research and development activities in diagnostic technology and equipment.
- Company/university engaged in medical diagnostics with concern for malaria.
- Company/university interested in collaboration to bring the malaria diagnostic device to the market and to assist with production.
- Company/Investor looking to invest in novel malaria diagnostic technology developed for emerging markets.


The tasks to be performed by the partner sought:
Research cooperation:
- Field tests of the diagnostic technology to confirm its effectiveness and added value to the local market’s needs for malaria eradication, which will lead to the use approval by the local Ministry of Health and distribution of the diagnostic kits on the local market.
- Cross-comparison of the diagnostic tool with other tests in local environments.

Technology cooperation:
- Scale-up of the diagnostic kits in development and production assistance.
- Development of routes to health ministry sales and roll-out.

Financial agreement:
- Financial investment in exchange for an equity of 5% to 7% in order to help with the development, manufacturing and eventually scaling of the diagnostic kits.

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