Study shows Xpresys Lung helps identify benign lung nodules

Integrated Diagnostics recently announced that the Journal of Thoracic Oncology has published positive results from a landmark clinical validation study, which shows Xpresys Lung, a clinical laboratory-based molecular blood test service, helps identify benign lung nodules with high probability—potentially helping avoid unnecessary invasive testing for lung cancer. The findings show when the test indicates a nodule is likely benign, the result is correct between 84 and 98 percent of the time—with each nodule receiving an individual score based on its molecular signature.

The current study is a retrospective, multi-center analysis of 141 blood samples from patients 40 years or older with lung-nodules ranging from eight to 30 mm in diameter. Researchers used the classifier, Xpresys Lung, which comprises five diagnostic proteins from multiple pathways associated with lung cancer and six normalization proteins, in a blind analysis of these independent plasma samples. The test measures the relative abundance of these proteins using a highly sensitive analytic technique called multiple reaction monitoring mass spectroscopy (MRM-mass spec).

All study samples came from patients with either benign nodules or early-stage non-small cell lung cancer (NSCLC), matched for nodule size, age, gender and clinical site. The sample matching strategy yielded a classifier whose results are independent of a patient's age, smoking history, chronic obstructive pulmonary disease (COPD) diagnosis, or nodule size. Therefore the resulting classifier has the potential to complement each of these risk factors that are currently used in the clinical assessment of lung nodules.