Discussion
tumor, allergy, lung cancer, early-stage lung cancer, TAA
VIRUS, TUMOR, DISEASE, ALLERGY, SENSITIVITY, LUNG CANCER, DISEASES
We describe an improved immunometabolism blood test that measures the function of the immune cells in response to LC antigenic stimuli based on enhancement of the glycolysis metabolic pathway of immune cells. Glycolysis enhancement is a marker for the rapid activation of most immune cells [This research article compares results from two clinical trials; in the earlier clinical trial an earlier MA-LC protocol was used and in the later clinical trial an improved protocol was used. Since the clinical benefits for early detection have been demonstrated, this current research focuses on early-stage lung cancer (stages I, II). Our results indicate that the MA-LC in its final version improves the test’s specificity from 81.7% (Table Sensitivity and specificity of MA-LC of the earlier clinical trialSensitivity and specificity of MA-LC of the later clinical trialThe sensitivity and specificity obtained by MA-LC in detecting early-stage lung cancer is much higher than the results reported for stages I, II in the literature by using only one method [Other biomarkers noninvasive tests focus on detecting circulating biomarkers, including tumor DNA, tumor antigens, tumor cells, exosomes, and extracellular vesicles. These biomarkers are released to peripheral blood primarily when the tumor reaches a certain size at a later stage of the disease.We have previously shown [The broad potential of this immunometabolism-based platform may also extend to other types of diseases, as well as to treatment monitoring and therapy selection. It could provide the cellular immune status of vaccinated people to SARS-COV-2 by using virus spike peptides, measure other cellular immune statuses to diseases such as allergy, autoimmune, immunodeficiency, antimicrobial immunity, follow up the effect of immunotherapy treatments, and measure drug efficacy.Liquid ImmunoBiopsy™ is a new, promising, and non-invasive platform that measures the metabolic state of the immune system as a direct indicator of cellular immune responses (primarily T and B cells) to antigenic stimuli. The MA-LC provides results within five hours of receiving the blood sample for MA-LC. The analytical sensitivity of the test is high with a lower limit of quantification (LLOQ) of 0.000119 (d/minute) in change of acidity over time. It specifically quantifies glycolysis which is a biomarker for the activation level of immune cells that are re-exposed in vitro to lung TAA stimulants.The present study has limitations. Not all control subjects received LDCT screening, nor were they followed-up after the blood draw, therefore, it is unknown whether lung cancer cases were already present and missed. Separately, cross validation is a widely used approach for assessment of classification performance and can address known individual confounders. However, cross-validation procedures do not control simultaneously for all confounders, and the use of an independent test set is needed to evaluate the generalizability of these results. Prospective studies are planned to validate classifier performance in an independent cohort and verify the generalization predictions from confounder-controlled CV.The MA-LC is, 