Veracyte Announces New Expanded Data at CHEST Underscoring Percepta Nasal Swab Test’s Ability to Improve Early Lung Cancer Assessment - Seite 2

In the expanded cohort of 312 patients, when the Percepta Nasal Swab test identified patients as low risk, its sensitivity was 97%, providing a negative predictive value (NPV) of 98% in a population with the 25% cancer prevalence that would be expected in a broad cohort with suspicious lung nodules. This NPV would assist physicians in avoiding unnecessary invasive procedures in these patients with a very small likelihood of missing a cancer. When the test identified patients as high risk, its specificity was 92%, for a positive predictive value (PPV) of 70% at a malignancy rate of 25%. This PPV would assist physicians in directing these patients to further procedures so they could obtain an accurate diagnosis and speed time to treatment if necessary. Patients in the moderate risk group could be managed according to current clinical guidelines.

In a sub-analysis of the expanded validation set, researchers found that the Percepta Nasal Swab test’s performance is strong across different nodule sizes, with the test identifying 67% of cancers in nodules below 8 mm as moderate risk, while labeling 100% of malignant nodules greater than or equal to 8 mm as high or moderate risk. Performance was also consistent across all stages of non-small cell lung cancer (NSCLC), with 100% of NSCLC Stage II or greater cancers labeled as moderate or high risk.

“These findings suggest that the Percepta Nasal Swab test will provide significant clinical utility across a range of lung nodule sizes and lung cancer stages,” said Giulia C. Kennedy, Ph.D., Veracyte’s chief scientific officer and chief medical officer. “We are excited to begin offering the test to sites as part of our clinical utility study and to transform lung cancer early assessment so that more unnecessary procedures can be avoided and more lives can be saved.”

Also at the CHEST meeting, real-world data will be presented demonstrating that the Percepta Genomic Sequencing Classifier (GSC) can help reduce unnecessary surgeries and guide next steps in lung cancer evaluation for patients with suspicious lung nodules whose bronchoscopy results were inconclusive. In one retrospective clinical utility study, researchers from the Medical College of Wisconsin found that the Percepta GSC reclassified one-third of lung nodules with indeterminate bronchoscopy results as either low risk or high risk. Similarly, researchers from AnMed Health Medical Center in Anderson, South Carolina, found that the Percepta GSC enabled more than half of patients’ indeterminate lung nodules to be reclassified and, among those moved to a low risk category, there was a significant reduction in the rate of invasive follow-up procedures.