PURPOSE: Lung cancer is responsible for the greatest number of cancer-related deaths worldwide, primarily due to the lack of a test capable of detecting early stages of this disease. EarlyCDT-LungTM is a commercially-available blood test to aid in early detection of lung cancer for high-risk individuals. Few studies report the quality control (QC) characteristics of a commercial test.
METHODS: EarlyCDT-Lung, a semi-automated indirect enzyme-linked immunosorbant assay (ELISA), utilizes a panel of tumor-associated antigens (TAAs) to measure autoantibody (AAb) levels, which are elevated in patients with lung cancer. Assay quality is monitored daily by tracking calibrated AAb levels for two separate controls per antigen using Levy-Jennings plots. QC procedures are followed to ensure continuity of assay quality between different batches of antigen; new batches are qualified using several levels of evaluation including gel electrophoresis, Western blotting and EarlyCDT-Lung testing of more than 600 patient samples.
RESULTS: EarlyCDT-Lung has a strong quality system responsible for high integrity patient results. Levy-Jennings plots show precision of two control samples for each of the six antigens within acceptance limits of ±3 standard deviations (SD). Reagent verification processes for antigen batch acceptance have been successful in qualifying new batches of antigen for the commercial assay. The calibration system facilitates a robust assay with high precision.
CONCLUSION: The five-year survival rate for lung cancer is approximately 16%. A reliable blood test capable of detecting lung cancer prior to onset of symptoms, such as EarlyCDT-Lung, could have a great impact on how lung cancer is currently being diagnosed. The quality system in place for EarlyCDT-Lung ensures patient results are of highest accuracy, thereby serving as a reliable tool aiding physicians in early detection of lung cancer.
CLINICAL IMPLICATIONS: EarlyCDT-Lung is a reliable blood test based on high quality standards that can assist physicians in detecting lung cancer at its earliest stages for high-risk patients, before a patient becomes symptomatic.
DISCLOSURE: Laura Peek, Shareholder J. Robertson is a shareholder of Oncimmune Ltd.; Employee L. Peek is an employee of Oncimmune USA LLC; G. Healey and A. Murray are employees of Oncimmune Ltd.; No Product/Research Disclosure Information