The fungus aspergillus causes a spectrum of diseases in humans including life-threatening lung infection in immunocompromised patients. Azole drugs are the mainstay for the treatment of aspergillus diseases, but their use is threatened by the emergence of azole resistance. Resistance in aspergillus is driven by the use of azole fungicides for crop protection and material preservation. If resistance develops the medical azoles also become inactive due to molecule similarity. Azole resistance is now a global problem potentially affecting over 6 million sufferers of aspergillus diseases each year.
There is a urgent need to detect azole resistance as early as possible in order to guide treatment choices, but rapid tests are not available and the current practice of sending aspergillus cultures to reference laboratories causes an unacceptable delay of 8 days or more before results are available.
We have developed an easy-to-use assay (VIPcheckTM) that enables rapid and reliable detection of all types of azole resistance in aspergillus. Extensive validation shows excellent test characteristics (sensitivity 98%, specificity 94%), even when performed by technicians not trained in mycology. Test results are available 5 days earlier compared with a reference laboratory, allowing early treatment changes. The leading European infectious disease organisation will publish guidelines in 2015 that strongly recommends susceptibility testing of aspergillus.
We expect to have VIPcheck™ on the market by mid-2015 and aim to gain a 50% market share by 2021, since VIPcheck™ will be the first and only validated commercial aspergillus resistance test that complies with the new guidelines. Revenues from teaching and consulting will support our brand of high quality and excellence. In 2018 we aim to market our next product, a molecular-based resistance test to complement the VIPcheck™, which we will finance with revenues from VIPcheckTM sales and k€250 additional funding from investors. FungDx expects to break even in 2017 fuelled by VIPcheck™ sales and to establish a net cash position of m€6 by 2021.