Our Lung Cancer Program

Lung cancer diagnosis – despite highest medical need – suffers from the lack of any in vitro diagnostic tools that, in combination with imaging technologies, would make population wide screening for this most deadly cancer feasible. The current dilemma in lung cancer screening is, that, although screening by spiral CT can identify more cancers early, it has not been proven to provide a mortality benefit and its lack of specificity funnels too many people into a diagnostic follow-up consisting of e.g. bronchoscopy, biopsy or surgery. These procedures may be associated with morbidity and even mortality partly eliminating the potential benefit of spiral CT screening.

In our lung cancer program, we address this challenge with two approaches that could complement existing diagnostics procedures. With both, we have made exceptional progress throughout 2008 and 2009 partly owing to the overwhelming support by clinical opinion leaders and experts in the field. In both approaches we make use of a number of proprietary lung cancer biomarkers we discovered in 2007 and 2008. As a short-term opportunity, we have now decided to develop a follow-up test to consisting diagnostics procedures.

In a first version, this test will aid in the diagnosis of bronchial carcinoma in bronchial lavage samples obtained routinely during bronchoscopy of patients with suspected lung cancer. During the procedure, fluid is aspirated from the suspicious area of the lung after injection of saline solution first. This lavage fluid is then analyzed by the pathologist for tumor cells often resulting in inconclusive results, leaving the final diagnosis to the chest physician. This includes deciding between sending the patient off to biopsy, risky surgery or repeating imaging some weeks later to see whether the suspicious nodule has grown and thereby can be confirmed as a malignant tumor losing valuable time for treatment.

In two consecutive studies we have successfully shown that our biomarkers can detect cancer from a significant portion of bronchial lavage samples, even if the cytological findings are negative or inconclusive. As the biomarkers are very specific, i.e. we only see a very small number of false positive results, a test based on our biomarkers should have a very high positive predictive value, i.e. a positive test result may provide a high degree of certainty that the patient has cancer and requires immediate follow-up. This additional information will thus support the pathologist and the clinician in establishing a diagnosis in particular incases with inconclusive histology and cytology. Based on the clinical data we generated and a thorough assessment of the clinical utility as well as the significant market potential, in spring 2009 we took the decision to develop such a bronchial lavage test, as a CE-marked IVD product that we plan to commercialize ourselves starting from the first half of 2010 in the German domestic market and via distributors in further regions.

As a second, rather long-term opportunity for partnering we pursue the development of a blood- or sputum-based screening test for lung cancer, that would enrich true cancer cases – either alone or as part of a risk model – in the target population for screening by low-dose CT-scanning. Such a screening test has the potential to complement diagnostic imaging resulting in a better balance between medical benefits and risk associated with population-wide screening for lung cancer. In a first sizeable study on clinical blood samples in 2008, we could demonstrate the feasibility of detecting lung cancer in these samples with our proprietary biomarkers. Currently, we are further optimizing the biomarkers for this application. At the same time, we are expanding our network of clinical collaborators in the lung cancer field and are in active discussion with imaging companies on the integration of in vitro diagnostic and imaging information.

The products by Epigenomics or its partners mentioned on this page are not available for sale in the United States. The analytical and performance characteristics of any product to be eventually sold in the U.S. based on this technology have not been established.