On August 5, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported the publication of new data demonstrating that the Percepta classifier significantly reduces invasive procedures in lung cancer diagnosis by classifying nearly 40 percent of patients as "low risk" when bronchoscopy is inconclusive (Press release, Veracyte, AUG 5, 2020, View Source [SID1234562877]). The findings, from a large, prospective clinical study involving 35 centers, also suggest that these results are durable over a one-year follow-up and that the classifier results do not delay time to diagnosis among those patients with lung cancer. The study appears online in CHEST, the journal of the American College of Chest Physicians.
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"Lung nodules are often difficult to diagnose when bronchoscopy results are indeterminate following initial work-up of the patient. As a result, physicians must determine whether to direct patients to further, invasive procedures or just monitor them, at the risk of missing a cancer and delaying necessary treatment," said Giulia C. Kennedy, Ph.D., Veracyte’s chief scientific officer and chief medical officer. "The real-world findings published in CHEST show that use of the Percepta classifier significantly alters physicians’ pre-test clinical plans for an invasive procedure, enabling some patients to safely avoid the potential morbidity, mortality and cost associated with unnecessary, invasive procedures without delaying or shifting the stage of diagnosis among those who have lung cancer."
The real-world registry study prospectively evaluated physicians’ management of lung nodules, as well as resulting clinical outcomes, at 35 academic and community-based U.S. medical centers. Researchers evaluated the impact of Percepta results on clinical decision-making for 213 patients with a low or intermediate pre-test risk of malignancy and a non-diagnostic bronchoscopy.
Comparing physicians’ pre-test to post-test plans for these patients, researchers observed a major shift following the Percepta classifier result. Among 67 patients for whom physicians had initially planned a subsequent invasive procedure, the Percepta test down-classified the risk of malignancy in 34.3 percent. Of these down-classified patients, physicians changed management plans for 73.9 percent – from an invasive procedure to surveillance – and 61 percent avoided a procedure for up to 12 months after initial evaluation.
In addition, researchers observed a larger absolute reduction in procedure rates among down-classified patients (61 percent vs. 52 percent, p<0.01), compared to those patients with unchanged risk.
Lastly, the time to diagnosis was not significantly delayed when comparing Percepta test down-classified patients to patients who were not down-classified (p=0.58), among all patients in the pre-test low and intermediate risk group who had confirmed lung cancers.
"The findings from this real-world multicenter study reinforce the large and growing body of evidence demonstrating that the Percepta classifier can reduce unnecessary invasive procedures for lung nodule patients when bronchoscopy findings are inconclusive," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "These data are particularly important as physicians seek ways to limit their patients’ exposure to invasive procedures. We believe they will help support physician adoption of and payer reimbursement for the Percepta classifier."
About the Percepta Classifier
The Percepta classifier is a novel genomic test that helps physicians determine individual patients’ lung cancer risk when results from bronchoscopy – a non-surgical procedure standardly used to assess lung nodules for cancer – are inconclusive. Veracyte estimates that approximately 545,000 bronchoscopies are performed each year to evaluate suspicious lung nodules and that up to 60 percent of these produce inconclusive results. The Percepta classifier was developed using advanced genomic technology and machine learning, 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 covered by Medicare.