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New Method to Rule out Early Stage Lung Cancer

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Lung nodules are small masses of tissue in the lung, often referred to as a "shadow" or "spot" on the lung. While the majority of these nodules are benign, a small percentage (approximately fewer than 5%) can be malignant. It is therefore important for clinicians to be able to easily and accurately identify benign nodules to rule out early stage lung cancer. In attempts to overcome the invasive and costly nature of current methods, Integrated Diagnostics have recently developed a new approach which leverages the proteome. 

We spoke to Dr Albert Luderer, CEO of Integrated Diagnostics to learn more about the current challenges of diagnosing lung nodules as benign or malignant, and how the Xpresys Lung 2 liquid biopsy test can help improve this process.

Anna MacDonald (AM): Why has it so far been difficult to diagnose lung nodules as benign or malignant?

Dr Albert Luderer (AL): Predicting whether a nodule is benign or malignant is imprecise because the available clinical and radiologic factors are not specific.  Combine that guess-work with the risks of needle or surgical biopsy in the lung, a vital organ, and it quickly becomes a very difficult situation for the patient and physician.  The best radiologic factor is the size of the nodule with smaller nodules being more often benign.  But cancerous nodules start small and you don’t want to be watching while it becomes too late to cure the cancer with surgical removal.

AM: The Xpresys Lung 2 test can help improve this process. What down stream effect does this have on patient care?

AL: The Xpresys Lung result can have a large downstream effect for patient care.  When the test is “positive” and indicates the nodule is likely benign with high-confidence, then the physician can recommend observation and thus avoid risky invasive biopsy procedures.

AM: Can you tell us about the PANOPTIC study?

AL: The PANOPTIC study is the largest of its kind to observe what care was provided to newly discovered lung nodules and then evaluate what the effect of using Xpresys Lung results would have been.  The study evaluated 685 patients at 33 centers in North America.  The key result is that if the test were used, 40% of invasive procedures on benign nodules would be avoided.  In addition, the proportion of malignant nodules incorrectly sent to observation would be reduced from 45% to 3%.  These results are in the subgroup of patients that have a pre-test probability of a malignant nodule of ≤ 50%.

AM: How does the XL2 test differ from current methods of identifying benign nodules?

AL: There are no other current methods using a blood test that have CMS approval and can provide a result that gives high confidence that a nodule is benign.  The only current methods of showing a nodule is benign is a biopsy or observation of the nodule for a year or more.

AM: How important do you see proteomic approaches becoming in cancer diagnostics?

AL: Advances in proteomic measurement technology have enabled researchers to study hundreds to thousands of proteins and their relationship to disease.  Our work shows the power of the approach and the potential for other similar discoveries to be made not only in oncology but also in other disease states.

Dr Luderer was speaking to Anna MacDonald, Science Writer for Technology Networks.