Integrated Diagnostics (“Indi”) announced that it will provide additional results to validate the accuracy of its Xpresys Lung 2® integrated classifier (XL2) at the American Thoracic Society (ATS) International Conference, being held May 18-23, 2018 in San Diego, CA. These results will be showcased during three presentations covering new data from the large prospective PANOPTIC (PulmonAry NOdule Plasma proTeomIc Classifier) clinical trial.

Lung nodules continue to be a diagnostic concern. Every year, health care providers in the United States discover more than 1.6 million lung nodules in patients. These are “incidentally detected,” meaning they are found during testing for an unrelated cause (for example, a chest X-ray after a fall). Although the majority of incidentally detected nodules are benign, when patients present with a low-to-moderate probability of cancer (from 5 to 65 percent), guidelines may include further evaluation with a PET or CT scan, or more invasive procedures such as a bronchoscopy or biopsy.

“Invasive tests such as a lung biopsy carry significant costs and adverse events that increase morbidity or mortality. The results of the PANOPTIC study predict that XL2 will reduce the need for more involved testing and offer providers additional confidence in diagnosis,” said Indi Chief Medical Officer, Steven Springmeyer, M.D.

The PANOPTIC trial evaluated Integrated Diagnostic’s Xpresys Lung 2 (“XL2”), a pulmonary nodule classifier integrating two proteins with clinical risk factors in patients with incidentally detected nodules. The test combines five standard-of-care clinical factors such as patient age and nodule size in combination with the measurement of two proteins into a single risk assessment. In the study, XL2 was 98 percent effective at distinguishing benign from malignant nodules. These data were recently published in the peer-reviewed medical journal CHEST.

The three presentations at ATS will provide additional information beyond the CHEST publication about XL2 and its role in lung nodule diagnosis. Highlights include:

  • Relative performance of protein measures
    Abstract: 13916
    Day/time/location: Monday May 21, 2:15 PM; Session B110
    Summary: Estimating the risk of cancer has largely depended on nodule size; typically, larger nodules have a higher chance of malignancy. However, recent results of the PANOPTIC study show that information from the protein analytes provides information that is equal in importance to nodule size and greater than the other clinical factors of age, smoking history, and nodule location and edge characteristics.
  • Lymph nodes
    Abstract: 13567
    Day/time/location: Wednesday May 23, 9:15 AM; Session D61
    Summary: Enlarged lymph nodes as seen on a CT scan may indicate a nodule is cancer and has spread. Yet in the PANOPTIC study, XL2’s performance did not appear to be affected by the presence of lymph nodes. Therefore, if there are lymph nodes mentioned on the CT scan report, it is not a contraindication to using XL2.
  • Interim conclusions confirmed
    Abstract: 15050
    Day/time/location: Monday May 21, 2:15 PM; Session B110
    Summary: The accepted standard is that a nodule isn’t benign unless it hasn’t shown growth via CT over two years of observation. Nevertheless, the recently released results of the PANOPTIC study in the CHEST paper in March were an interim analysis: They included patients who had not completed the full two years of follow-up. The team chose to analyze the results early, as the chance of the results being different was small. This proved to be a correct assumption.

“This has been – and continues to be – an exciting trial that sheds light on lung nodule management questions that heretofore have had limited clinical information to establish practice norms,” commented Al Luderer, Ph.D., Chief Executive Officer, Integrated Diagnostics. “These additional findings clearly support our two critical objectives of the test: To reduce the number of unnecessary and invasive tests on patients and provide a convenient ‘rule out’ test for providers to help diagnose lung nodules of lower risk. We look forward to making the test available to clinicians first through a registry format with the intention of improving patient treatment decisions, which could reduce or avoid invasive biopsy or surgery procedures and create improved outcomes.”