Diagnostic Test

Diagnostic Test

The need

Decreasing the lung cancer mortality rate is a clear unmet medical need today.

Lung cancer is the primary cause of cancer mortality in developed countries. Currently, almost 80% of lung cancers are detected at an advanced stage in which treatments have limited efficacy and survival rates are low (4.3% survival rate at 5-years if cancer has metastasized). However, detection of lung cancer at an early stage has the possibility of significantly reducing mortality with a greater chance of cure (the 5-year survival for localized cancer is 55%) [6]. Therefore, early diagnosis of lung cancer is crucial to reduce its mortality.

A suitable screening test has long been sought to accurately detect lung cancer at earlier stages, when treatments are more effective. First diagnosis only when disease has already reached the metastatic phase is the main reason for failure in treatment. Low dose computed tomography (LDCT) is effective in the early detection of lung cancer, providing higher resectability and long-term survival rates.

While annual screening using imaging tests is expected to save many lives through early detection, it also finds many indeterminate pulmonary nodules (IPNs) lesions that can’t be defined as benign or cancerous. It has raised concerns that many patients will be unnecessarily subjected to invasive, risky and expensive procedures, including fine-needle biopsy and surgery, just to get a diagnosis.

The test

DiagnoLung is a non-invasive signature (plasma-based) that can be used for Non-Small Cell Lung Cancer (NSCLC) diagnosis and as a tool for high-risk screening population. It is an ELISA-three-protein based test, addressing those individuals under low dose computed tomography screening to avoid false positive nodules in the images. The test intends to decrease the high false positive rate in screening; identifying persons with malignant IPN who should undergo more rigorous and invasive diagnostic evaluation and confirm diagnosis of lung cancer.


  • 6. KSEER Cancer Statistics 2006-2012

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