Introduction

Lung cancer is the leading cause of cancer death in the world, with 2.2 million new cases and nearly 1.8 million deaths expected in 2020. The risk of developing lung cancer is largely determined by age and smoking status, with smoking estimated to account for nearly 90% of all lung cancers. Other risk factors for lung cancer include environmental exposures, radiation therapy, other (non-cancer) lung diseases, race/ethnicity, and family history.

Despite advances in treatment, the most promising strategy for improving long-term survival is to promote early detection and diagnosis. Screening with low-dose computed tomography allows early disease to be diagnosed, allowing patients to be treated with curative purposes. However, better strategies are required to identify lung cancer in very early stages, to attain the most benefits from the screening, and to help physicians make better decisions. 

Methods

The diagnostic kit developed by SignaL-inc® is a cell-free DNA (cfDNA) based technology using patients' minimum invasive liquid biopsy, such as blood or saliva, that combined with a specific selection of biomarkers, probes to detect oncogenes, for lung cancer will read the biomarkers and identify genes and epigenetic alterations. Lung cancer diagnostic kit SignalOne is as a screening tool technique, adapted to a portable PCR device, that can help the patients even in difficult to reach areas. The use of minimum invasive liquid biopsy helps in reducing anxiety during testing times, making it safe and confortable. The kit could help and assist physicians in the clinical diagnosis, and provide a rapid, accurate and reliable method to diagnose lung cancer. The diagnostic kit can be used for lung cancer screening by detecting abnormalities of ctDNA. It can predict the development of cancer and monitor the treatment.

This research presents the experimental results obtained during the analytical validation of the lung cancer detection and diagnosis kit that quantifies the number of gene copies of 16 cellular oncogenes, which will support the clinical diagnosis of patients and will allow therapy to be directed depending on the molecular profile obtained. 

Results

After the validation and comparation of the data in blood samples and tumoral tissue of more than 300 patients, it is interesting to highlight that most of the selectec biomarkers, including AKT2, are identified in plasma in 90% of cancer patients, and in SignalOne presented sensitivity values ​​of 91% and specificity of 100%, being statistically significant (p= 0.0001), suggesting it is a possible application as a biomarker in a less invasive sample for patients with lung cancer. 

Conclusion

The experimental results obtained in the SignalOne qualitative polymerase chain reaction (PCR) Device,  shows that the device can detect genes in DNA associated with lung cancer; however, positive results should be correlated with tomography, clinical history and risk factors. In case-control studies, SignalOne discriminated between lung cancer patients and healthy controls with high clinical sensitivity (91%) and specificity (100%). The sensitivity of the test did not appear to be affected by the tumor location or by patient age or gender. Nevertheless, currently available data suggests that SignalOne has the potential to be a sensitive and convenient screening option for patients with or at risk for lung cancer. Further research needs to be performed to validate in a big scale clinical trial the SignalOne device - Kit.