Veracyte (VCYT) Announces Significant Data from Percepta Bronchial Genomic Classifier in Lung Cancer Screening

October 26, 2016 4:35 PM EDT

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Veracyte, Inc. (Nasdaq: VCYT) announced new data from a prospective, multicenter clinical utility study showing that use of the Percepta Bronchial Genomic Classifier to resolve inconclusive diagnostic results in patients undergoing evaluation for suspected lung cancer led to a significant reduction in surgeries and other costly, invasive procedures. The findings, presented at the CHEST Annual Meeting 2016 being held this week in Los Angeles, demonstrate the genomic classifier's ability to improve the clinical efficacy of lung cancer screening and diagnosis without the need for surgery.

The new study comprised 230 patients with lung nodules or lesions found on CT scans who received an inconclusive result on their bronchoscopy – a minimally invasive procedure used to evaluate lung nodules – and whose nodule samples were then tested with the Percepta classifier. Among patients with a low or intermediate pre-test risk of malignancy (based on clinical factors and smoking history), use of the Percepta classifier resulted in a 33 percent decrease in surgical procedures when the genomic test reclassified them as "very low risk" or "low risk" for cancer. This is compared to how physicians previously reported that they would manage such patients without the genomic test results. Use of the test also led to a 28 percent reduction in the frequency of follow-up CT scans. The interim findings are from an ongoing clinical utility study for the genomic test, which involves over 40 academic, community and U.S. Department of Veterans Affairs sites around the country.

"Diagnosing lung nodules is often challenging, due to their small size or hard-to-reach location," said D. Kyle Hogarth, M.D., pulmonologist and associate professor of medicine at The University of Chicago Medicine, who shared the findings in a poster presentation. "While lung cancer screening offers new opportunities to save lives through early detection, it increases the risk of finding nodules that are not clearly benign or cancerous, even after a bronchoscopy. This can lead to risky and expensive surgery, which often turns out to be unnecessary. Our new findings confirm that use of the Percepta classifier helps reduce surgeries and other costly procedures by giving physicians clearer answers earlier."

The new study results underscored the challenge associated with lung cancer diagnosis. The researchers found that bronchoscopy alone was able to provide an actionable diagnosis in only 31 percent of patients undergoing a work-up for potential lung cancer.

Lung cancer kills nearly 160,000 Americans each year – more than the next three leading cancers combined. In 2015, more than eight million Americans became eligible through Medicare and private insurance for annual lung cancer screening with low-dose computed tomography (LDCT) in an effort to find cancers earlier, when they are more treatable.

Additional clinical utility data presented at the CHEST 2016 meeting by Ryan Van Wert, M.D. of the Stanford School of Medicine suggest that the Percepta classifier would prompt a significant reduction (from 57 percent to 18 percent) in invasive procedure recommendations by physicians, compared to when no genomic test results are available following an inconclusive bronchoscopy. Researchers found that physicians were also likely to reduce their invasive procedure recommendations, regardless of setting (academic vs. community-based), number of bronchoscopies performed, geography or other factors. These data are based on a survey of 202 physicians.

"These two studies provide compelling evidence that use of the Percepta Bronchial Genomic Classifier is changing care for lung nodule patients, enabling them to avoid the operating room in their effort to get a diagnosis," said Bonnie Anderson, Veracyte's president and chief executive officer. "We believe these clinical utility findings will support expanded coverage and reimbursement for the Percepta classifier, making it more widely accessible to lung nodule patients, including the eight million Americans now eligible for lung cancer screening."

Three Medicare Administrative Contractors have recently issued draft local coverage policies that, when finalized, will enable access to the Percepta classifier for more than half of the Medicare beneficiaries across the United States.



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