On October 21, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported data demonstrating the clinical validity of its next-generation Percepta Genomic Sequencing Classifier (GSC) and the clinical utility of its first-generation test in a real-world setting in improving lung cancer diagnosis when bronchoscopy results are inconclusive (Press release, Veracyte, OCT 21, 2019, View Source [SID1234542382]). The findings will be presented on Thursday, October 23, at the annual meeting of the American College of Chest Physicians (CHEST) in New Orleans.
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"These data confirm the performance of our Percepta classifier and its ability to guide care for lung nodule patients when bronchoscopy findings are inconclusive," said Bonnie H. Anderson, Veracyte’s chairman and chief executive officer. "We have been especially pleased by physicians’ positive response to our next-generation Percepta GSC, which we introduced in June of this year and which provides expanded information to physicians."
For the first study, researchers prospectively validated the Percepta GSC on a blinded, independent set of 412 samples from patients with lung nodules that were referred for bronchoscopy evaluation. Among a subset of patients with low or intermediate pre-test risk for whom malignancy was confirmed, the Percepta GSC significantly improved sensitivity for lung cancer detection in combination with bronchoscopy (95.5 percent), compared to bronchoscopy alone (40.9 percent). The genomic classifier demonstrated improved sensitivity compared to bronchoscopy regardless of nodule size or location or cancer subtype.
Among a subset of 188 patients with an intermediate pre-test risk of cancer, which account for the majority of lung nodules, the Percepta GSC demonstrated high accuracy when it down-classified patients to "low risk" for cancer (negative predictive value of 91 percent). The test also had a positive predictive value of 65 percent when it up-classified patients to "high risk" for cancer. The American College of Chest Physicians recommends that patients with a low risk of cancer undergo monitoring with CT imaging and that patients with a cancer risk of 65 percent or greater undergo surgical treatment.
"Bronchoscopy is often used to evaluate potentially cancerous lung nodules because it offers a nonsurgical way to detect lung cancer. However, bronchoscopy results are often inconclusive, which leaves physicians with a dilemma of whether to direct the patient for more invasive procedures or just monitor them with imaging at the risk of missing a cancer," said Giulia C. Kennedy, Ph.D., chief scientific officer and chief medical offer for Veracyte, who was a researcher in the study. "Our findings suggest that use of the Percepta GSC can improve the performance of bronchoscopy, making it a potentially more useful diagnostic tool that can help lung nodule patients at low risk for cancer avoid unnecessary invasive procedures or those at high risk get more timely treatment."
The next-generation Percepta GSC was developed on Veracyte’s RNA whole-transcriptome sequencing and machine learning platform and is based on novel "field of injury" science – which identifies genomic changes associated with lung cancer in current or former smokers using a simple brushing of the person’s airway. The test is performed on a sample from the patient’s main lung airway, which is collected during a bronchoscopy. Veracyte estimates that approximately 360,000 bronchoscopies are currently performed each year to evaluate suspicious lung nodules for cancer and that up to 60 percent of these produce inconclusive results.
A second, independent study is being presented at the CHEST meeting by researchers from LAC+USC Medical Center, a county hospital in Los Angeles, on their experience using the original Percepta classifier.
Lung cancer is the leading cause of cancer deaths worldwide. In the United States, lung cancer causes more than 154,000 deaths each year – more than the next three most prevalent cancers combined. Because lung cancer is difficult to diagnose before it has metastasized, only 16 percent of cases are detected at an early stage, when the disease is more treatable. Lung cancer’s five-year survival rate is only 18 percent, much lower than that of other common cancers. Approximately 80 percent of lung cancer deaths are caused by smoking.