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Selfdiagnostics is Estonian/German medtech company founded in 2008 with the purpose of developing NAAT (nucleic acid amplification technology) based POCT (point of care testing) platform and devices. The platform will be applicable for several human molecular diagnostics and prognostics purposes like testing for infectious diseases, genetic testing, personalized medicine related testing etc.

Selfdiagnostics holds “InTime” trade mark to sell Point of Care (POC) products in Europe

The mission, vision and purpose of the Selfdiagnostics OÜ and its subsidiary SelfD Technologie GmbH have been carried forward by a global paradigm shift in the area of healthcare. Facing an increase of healthcare expenses, an ageing society and the advent of the information society, governments and individuals are looking for ways to concentrate more on personal and preventive diagnostics to avoid potentially risky and expensive consequences. Easily accessible information about health, possible dangers to it and cures have raised people’s awareness, and in consequence the wish to deal with their possible health problems preventively, decisively and in time. Selfdiagnostics sees a challenge here to develop and introduce to the market products to prevent health problems that are economical and innovative in the sense of the population’s health, and effective in that of the economy.

Our mission is to evolve and offer innovative, user-friendly and discreet solutions to prevent health problems thereby building-up Selfdiagnostics as one of the worldwide innovation leaders in preventive medicine solutions.

The main values of the enterprise:

• To be responsible towards society
• To be customer-focused
• To be innovative and economical
• To be result-oriented
• To develop partnerships

Founders

The founders of the company are building the key people steering all corporate activities:

Marko Lehes MBA - CEO. Degree in physics, MBA in Entrepreneurship and Technology Development, experienced in leading large complex organization, investment management and tech transfer;

Indrek Tulp PhD - CSO. PhD in molecular technology, experienced in molecular design (Europe and USA);

Prof. Ülo Langel - Chairman of dept. of Neurochemistry, University of Stockholm; Adjunct Professor, The Scripps Research Institute; Adjunct Professor, Tartu University. Experienced in also biotech business development (exit in related field).

Partners and Advisors

The technology development and business development is strongly supported by:

• Fraunhofer IZI, (Germany) - Fraunhofer is Europe’s largest application-oriented research organization. There are significant synergies with the Institute's other projects, which might work in favor to development cost and timelines<
• Institute of Technology at University of Tartu (UT Institute of Technology), which is instrumental for the development of the isothermal DNA detection method, a core invention enabling the POC device. The institute has different groups led by highly recognized scientists experienced in the cooperation with other institutes and universities internationally, which published more than 30 papers in 2011/12 and owns 28 patents and patent applications. In the Institute there are all necessary contemporary biomedical facilities and a local network of clinics is providing samples and support if required.
• Helmut Kamlah PhD - advisor and consultant to Selfdiagnostics OÜ, having worked for 22 years in the diagnostic industry, finally as head of the POC division of Boehringer Mannheim/Hoffmann-La Roche
• Estonian Development Fund - an independent legal entity established by the Estonian Parliament which the statutory objective to invest state funds into early-stage knowledge and technology intensive start-ups

Technology and products

Selfdiagnostics OÜ is developing NAAT (Nucleic Acid Amplification Technology) based molecular diagnostics platform for POC devices.

Current platform is less complex, more rapid and discrete than other NAAT based platforms (including PCR), and significantly more sensitive, specific and user friendly than other serological platforms.

First device we plan to introduce to market is a rapid test for home-use (OTC) that is able to detect Chlamydia Trachomatis (CT) and Mycoplasma Genitalium (MG) from urine samples.

Business case

First product of Selfdiagnostics will be a NAAT based home-use quick test to detect sexually transmitted diseases (infections by Chlamydia Trachomatis (CT) and Mycoplasma Genitalium (MG)).

Similar rapid tests for home-use available on the market today are not convenient because they require invasive sample collection with swab sticks and many operations with several buffers and tubes.

NAAT based detection methods available on the market are lab-oriented and require complex instrumentation for detection and they still need professionals to operate them.

Selfdiagnostics is developing a platform and rapid tests for home-use to detect Chlamydia Trachomatis (CT) and Mycoplasma Genitalium (MG) with significant advantages:

• The test detects pathogenic DNA from crude urine without inconvenient and painful swab based sample collection
• The use of test does not need any instrumentation and can be performed by untrained individuals
• The accuracy of the new rapid test for home use is better than home use tests available on the market today.

Addressable market

The world market of POC Chlamydia tests sold into all customer segments is judged to be 378 mio Euro, thereof 114 mio Euro in Europe.  The market is growing by approximately 7-8 %. It is expected, that OTC testing will grow significantly stronger than the testing in other market segments. Selfdiagnostics estimates the global accessible market in 2017 of 400 mio Euro, of which 25% can be reached by an innovative DNA detection method.

Competition: no existing products/producers utilize the same or a similar technology which provides the same value for the customer.

Competitive advantage: Unique value proposition, first mover, excellent development team and partners. Technology difficult to copy due to the combination of chemical and technical engineering challenges.

Sales channel and revenue model: sales via own web store and specialized distributors serving the OTC market; partnerships with leading global players in diagnostics.

Achievements

Ongoing activities

Please contact:

Marko Lehes              

CEO/Founder

Marko.lehes@selfdiagnostics.eu

Phone: + 372 52 151 05

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