Abstract
Lung cancer is the second leading cause of death in the United States of America and is responsible for more deaths than any other cancer. Lung cancer has the lowest survival rate of 18.6% compared to 98.28% for prostate cancer, 89.6% for breast cancer, and 64% for colorectal cancer. About 60% of lung cancer patients are diagnosed after their cancer has metastasized, leaving them with less than a 10% 5-year survival rate. Lung cancers detected at Stage 1 have a 5-year survival rate of 70%. Lung cancer patients often do not display symptoms until they have reached an advanced stage where the cancer is uncurable. Therefore, it is crucial to detect lung cancer at its earliest stage to improve prognosis by providing clinical assays to help aid in early detection. Current detection methods include low-dose CAT (LDCT) or CT scans, where baseline LDCT scans have false-positive rates ranging from 7.9% to 49.3%, as well as radiation risks to the patient. Lung nodules found on CT scans or X-rays may lead to further analysis such as positron emission tomography (PET) scan, bronchoscopy, or tissue biopsy. With lung biopsies, the lung nodule may or may not be malignant and the complications from the procedures include pneumothorax, hemoptysis, air embolism, and death. Thus, there is a need for noninvasive screening tests to reduce invasive procedures. However, there are few companies which offer lung cancer screening tests for patient testing either molecular based or proteomic based tests. And to provide such tests there needs to be rigorous testing studies to provide data on whether the test can provide results that can help detect disease and whether these results can be reproduced under the same conditions. There are paths companies can take to provide human testing through regulatory agencies, obtaining United States Food and Drug Administration (FDA) or Clinical Laboratory Improvement Amendments (CLIA) approval. To get either approval, companies need to validate clinical utility as well as perform analytical validation of the test system. Two noninvasive Laboratory Developed Tests (LDTs) have been developed by MagArray for lung cancer screening on its proprietary platform using a combination of the patient’s clinical factors combined with measured biomarkers concentrations in algorithms that yields risk scores for those with lung nodules.