Entrepreneurship

Current Situation

Worldwide more than 100 million people suffer from infection with Chlamydia trachomatis¹. In industrial countries this disease is not a serious health problem as it is easy to diagnose and treat. The diagnostic methods of choice are NAAT (nucleic acid amplification tests) technologies, especially PCR tests, because of its high sensitivity and cost effectiveness.² However, in developing countries laboratory diagnostic tests are often spared as the processing time and costs are too high for the performed mass screenings.

“[...] we collect close to 8000 samples a day. That’s why we end up freezing them and store them for many months. But we can’t let the patients wait, so we treat the patients and then a year later we find out it was not chlamydia.”

- Prof. Khumbo Kalua (BICO Malawi)

In Malawi the costs for analysing one patient sample by PCR amount to 1 $³. As the average income is less than 0.75 $⁴ and chlamydial infections of the eyes mainly affect the poorest of the poor, this prize is still too high to be paid by the patient. For these reasons, diagnosis are mainly made by looking at the symptoms of the disease only, making the total elimination of chlamydia trachomatis infections almost impossible.

Our Product

The aim of our project was the development of a point-of-care test system that is affordable for those countries in which it is most urgently needed. Therefore we concentrated on designing a fast and cheap detection system that does neither require special laboratory equipment nor extensive biochemical knowledge. Our device contains genetically modified E. coli bacteria which detect a specific amino acid secreted by chlamydia trachomatis. The cells are encapsulated in alginate spheres and immobilized in a lab-on-a-chip device, ensuring an easy handling and maximal biosafety. Patient samples like swabs can be tested immediately without further processing, as long as they are liquid. The probe is applied to the diagnostic chamber of the device and stimulates, in case of a chlamydial infection, the diagnostic E. coli bacteria to produce a fluorescence signal (for further information. To quantitatively analyse the produced signal we developed a small dark room containing a COMOS detector, which can be attached to the camera of a smartphone. The evaluation will be done through an App that has been written by the iGEM team Sydney, Australia. The lab-on-a-chip devices with the encapsulated bacteria are single-use products, however, they are very cheap in their fabrication. As we already successfully transformed an E. coli strain with our receptor-reporter-construct and E. coli bacteria are easy to culture and fast proliferating, large scale production of the detection system could start immediately. The microfluidic devices consist of a extremely cheap polymer solution called polydimethylsiloxane (PDMS). By using the master template our nanoscientists created the devices could be produced in an industrial scale for less than 0.10 $.

Our Application Scenario

The finished product was designed to be useable even in rural areas without access to laboratories. However, the large scale production of this application, especially of the microfluidic devices, needs to be performed in clean rooms, since even small dust particles can block a capillary tube and render the device useless. In the current design of the device, the diagnostic bacteria are fixed in the reaction chamber before assembly (consisting of fusion of both halves of the microfluidic device). Therefore it would be necessary to distribute the microfluidic devices from a centralized production facility in a ready-to-use condition. We are still testing, whether bacteria and alginate capsules withstand -80° Celcius storage. The frozen devices could be sent to the headquarters of the chlamydia trachomatis elimination programs, which are present in most developing countries. These institutions could be set up to distribute the device throughout the country, with the diagnostic microfluidic device and a manual. To successfully use the diagnostic application, the devices would be thawed at the centralized institution and transported for use to endemic focal points. After thawing, the bacteria survive six to seven days in LB medium before overgrowth and toxic side products negate further use. During the Global Trachoma Mapping Project (GTMP) which took place between December 2012 and January 2016, the usage of smartphones was established to register trachoma cases in 29 different countries.⁵ For our lab-in-phone setup we can take advantage of these existing networks and the knowledge of the field workers in terms of handling digital data. A connection between pre-existing apps for trachoma mapping and our app for diagnosis is easily conceivable and would optimize the documentation of the fight against trachoma.

Financial Support

In most countries, including Malawi, the fight against chlamydial infections of the eye progresses steadily. Although, since the complete elimination of trachoma is coming closer, the need of reliable methods to verify the extinction of chlamydia trachomatis is bigger than ever before. As a result, the Neglected Tropical Diseases Support Center (NTD-SC) of The Task Force for Global Health made, among others, an open call for “Defining alternative endpoint indicators for trachoma programs”.⁶ In the estimation of Prof. Khumba Kalua, who is an expert in the field of fighting chlamydia trachomatis, our product would have the chance to get a grant from one of the NGOs that are part of the GET2020 (The Alliance for the Global Elimination of Blinding Trachoma by the year 2020).

“As long as you have a good idea, you can apply for it. So the money is there [...] for people to investigate markers for the endgame. From mobile health to diagnostics to anything else. You can think of anything, as long as it will help.”

- Prof. Khumbo Kalua (BICO Malawi)

Furthermore, our product might also be an interesting project for (start-up) companies in the aspiring field of synthetic biology. Since the goal of the application is to eliminate global trachoma by enabling early diagnosis of chlamydial infections, the time frame of relevance is estimated to be 15 to 20 years for the application, until the chlamydial disease is eradicated. If the device proves efficient, size of production would progressively decline in this time frame. Combined with the low price of the product, as automated production would drop the estimated production costs below 0.10 $, this makes the market niche somewhat secure, as other biotech companies would not be attracted to compete for a device, of which the price cannot be undercut and that will be soon superfluous.

Furthermore, our product might also be an interesting project for (start-up) companies in the aspiring field of synthetic biology. Since the goal of the application is to eliminate global trachoma by enabling early diagnosis of chlamydial infections, the time frame of relevance is estimated to be 15 to 20 years for the application, until the chlamydial disease is eradicated. If the device proves efficient, size of production would progressively decline in this time frame. Combined with the low price of the product, as automated production would drop the estimated production costs below 0.10 $, this makes the market niche somewhat secure, as other biotech companies would not be attracted to compete for a device, of which the price cannot be undercut and that will be soon superfluous. With a grant of NTD-SC or other sponsors it would be possible to produce a first small batch of our devices which Prof. Kalua and his colleagues at BICO would be happy to test in the field.

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Team:Hamburg/Entrepreneurship

Entrepreneurship

Current Situation

Our Product

Our Application Scenario

Financial Support