Sommersemester 2010

Executive Summary

The diagnostic assay is a fast and highly sensitive protein chip, which allows the early, pre-symptomatic detection of head, neck and lung cancer. Its superior performance and cost-efficiency address the needs of all stakeholder groups in the cancer diagnosis process. It is the founder team’s vision that the diagnostic assay will become the new industry standard in head, neck and lung cancer diagnosis.

Background

Every year more than one million new cases of lung cancer and head and neck cancer (HNC) are diagnosed worldwide and approximately half of those people die. However, 1/3 of them could be saved if the disease had been diagnosed at an earlier stage. Currently used diagnostic methods like CT or bronchoscopy are expensive, painful and inaccurate to diagnose HNC and lung cancer at an early stage. The annual costs of treatment for a lung cancer and HNC patient are between €17.000 and €22.000. Through early detection those costs can be significantly reduced. Thus, there is an acute need for an early, accurate, painless and cost-saving diagnostic method.

Product

Our  Diagnostic Assay is a fast and highly sensitive protein chip for high throughput clinical diagnostics and research. It will be sold as a diagnostic kit containing the protein chip along with all necessary reagents. By the time of market entry it will be applicable to detect HNc and lung cancer. However, as research activities proceed, further disease areas will be covered. Furthermore, as the underlying technology of light amplification – which comprises the major innovation of the product – is platform independent, it can be applied to and improve almost all existing diagnostic methods.

In contrast to similar products for cancer diagnosis, our Diagnostic Assay allows the detection of biomarkers at an unprecedented level of sensitivity in the atto to femto gram level. Thus, it significantly enables an earlier diagnosis at a still pre-symptomatic stage and consequently increases healing success as well as life expectancy of patients. In addition, it is able to relief the burden of health insurers by lowering treatment costs. Finally, only a sample of body fluids from the patient will be required for testing with our product in contrast to above-mentioned more invasive procedures. Therefore, our Diagnostic Assay is much more comfortable.

Status Quo

At present a prototype of our protein chip has been developed and successfully tested. The patent for the new technology has been filed and is expected to be accepted by the end of 2010. Moreover, potential partners for production, distribution and R&D have been identified and initial commitments have been declared. Further steps will be the transition of the protein chip for serial production and the completion of the approval process.

Market Potential

The European cancer In Vitro Diagnostics (IVD) market is our target market and grows with a Compound Annual Growth Rate (CAGR) of 7%.

The market can be divided into paying customers (diagnostic laboratories, private and public health insurance companies) and receiving customers (patients) and this division is considered in our business model.

Business model

Revenues will be generated in the first stage through an upfront payment in 2010 by our production partner and a milestone payment in 2013 when the product development phase has been completed. Further income will be generated through royalties, which amount to 5–8% of sales revenues.

Company

The Diagnostics GmbH will be founded at the end of 2010 in Vienna. This company will have a wide partner network as production, marketing activities and distribution will be sourced out. Furthermore, the Diagnostics GmbH will establish a “christian Doppler laboratory” for R&D activities in cooperation with our partners. Each partner will contribute knowledge, IP, infrastructure or aid money to this joint project. Therefore, the main purpose of the Diagnostics GmbH will be the protection and the exploitation of IP rights as well as the management of the cooperation network. The three founders have been working together for 14 years and combine an excellent expertise in the biotech, diagnostic and research sector.

Marketing

In 2014 we will start to supply European diagnostic laboratories with our product for research activities. As soon as the accreditation for the European market is completed, expansion into the diagnostic market will take place in 2017.
Marketing activities will be carried out by the Diagnostics GmbH and by our distribution partners. This includes direct sales through an established network of sales representatives, the participation in trade fairs and the publication of scientific articles in specialized journals. As two founders are members of the European Predictive Medicine Association (EPMA), lobbying will be another way to persuade opinion leaders.

Financials

The table below shows the sales trend in three scenarios. These sales will be split between the Diagnostics GmbH, the producer and the distribution partners. 

Sales Forecast (million €):

The accumulated funding requirements of the Diagnostics GmbH will amount to € 1,2 m by 2014. These funding requirements should be covered by an upfront and milestone payment. Furthermore, the annual funding requirements of the CD-lab project will amount to ca. € 500.000, which will be borne by the production partner and the cD-Research Association. Our production partner will most likely reach the Break-Even Point 3 years after market entry (2016).

Cooperation Partner

• Kurt Krapfenbauer, Ph.D.
  Michael Hoffmann, MA
  Prof. Dr. Dietmar Thurnher
  Prof. Dr. Dritan Turhani

• Ansprechpartner

  
  

  Kurt Krapfenbauer, Ph.D.

Student Team

• Christina Ausweger

  
  

  Eva Burgschwaiger

  
  

  Andrea Kugler

  
  

  Reinhard Schmidbauer

  
  

  Isabell Steinek

  
  

  Yordan Todorov