Qualitative detection of epigenetic markers associated with lung cancer in pulmonary nodule patients

• Lung cancer is the leading cause of cancer mortality worldwide. Majority of lung cancer patients are diagnosed at advanced stages due to no effective diagnostic tools exist. When lung cancer is detected at earlier stages, the survival rates could be potentially increased 10 to 50-fold.
• Low-dose computed tomography (LDCT) allows detection of early stage lung cancer with high sensitivity that reduces mortality of lung cancer. However, the diagnostic accuracy of LDCT is limited due to its high false positive rate, and it is unclear whether early stage lung cancers detected by LDCT would ultimately progress and led to death. Lung cancer screening by chest x-ray and sputum cytology also have far failed to overcome limitations in early detection and risk assessment, and thus not been proven effective at improving overall survival.
• Thus noninvasive diagnostic tests using biomarkers are needed for assessing malignancy in indeterminate pulmonary nodules detected by LDCT.

• Blood-based epigenetic biomarker PCDHGA12 test with proven clinical sensitivity and specificity for lung cancer.
• It has been proven to be able to diagnose lung cancer with 77.8% sensitivity and specificity of 92.3% in a pivotal study on 522 subjects.
• It utilizes the general real time PCR Instrument Systems to measure epigenetic marker in 2 ml of serum samples.
• This easy to use and fast solution requires less than 8 h of hands-on time, providing actionable results in real-time.

Qualitative detection of epigenetic marker for adjunctive test to bronchoscopy for diagnosis of lung cancer

• Bronchoscopy is one of the most important diagnostic procedures in patients with a suspicion of lung cancer; however, the diagnostic performance of bronchoscopy is unsatisfactory, with detection sensitivity for peripherally located lesions being as low as 34%.
• Bronchial washing cytology, a routine adjunctive test, does not significantly improve the performance of bronchoscopy owing to its low sensitivity for peripheral lesions (28?32%).
• For clinicians, it is difficult to select between imaging surveillance and invasive procedures when bronchoscopy results are negative.
• Therefore, a novel diagnostic test with higher sensitivity than bronchial washing cytology that may enhance the diagnostic performance of bronchoscopy is required.

• The pilot study showed that EarlyTect® L test had a sensitivity of 75.0%, a specificity of 78.9%, whereas cytological assessment had a sensitivity of 45.0%, a specificity of 92.1%
• The combination of the two tests exhibited an increased sensitivity (83.3%), a specificity of 71.1%.
• Furthermore, considering the non?diagnostic bronchoscopy group alone, the test demonstrated a sensitivity of 61.9% and a specificity of 78.9%.
• This test may help for detecting lung cancer adjunctive to bronchoscopy.

1. 1. Jeong IB et al. PCDHGA12 methylation biomarker in bronchial washing specimens as an adjunctive diagnostic tool to bronchoscopy in lung cancer. Oncology Letters, 2018;16:1039-1045.