Veracyte presents study data on genomic classifier for lung cancer diagnosis
February 26, 2016 – SOUTH SAN FRANCISCO. Veracyte, Inc., a molecular diagnostics company pioneering the field of molecular cytology, announced that data supporting the ability of the company’s Percepta Bronchial Genomic Classifier to help reduce unnecessary, invasive procedures in lung cancer diagnosis were published online in CHEST, the official journal of the American College of Chest Physicians.
Utilizing data from two prospective, multicenter studies,[i],[ii] researchers determined that use of the Percepta classifier could have decreased unnecessary, invasive procedures in 50 percent of the evaluated patient population. The study analyzed patients with lung nodules or lesions whose bronchoscopy results were inconclusive for cancer and who were considered to have an intermediate or low risk of cancer prior to use of the Percepta classifier. The genomic test has previously been shown to have high accuracy when it identified lung nodules or lesions as low risk for cancer among this population.
“As the number of lung nodules and lesions are increasing due to both incidental findings and expanding lung cancer screening programs, providers need clinically proven tools to help them more confidently determine which patients can be followed with CT scans and avoid additional, invasive and potentially risky tests,” said Anil Vachani, M.D., University of Pennsylvania School of Medicine and lead author of the CHEST paper. “Our findings suggest that use of the Percepta classifier may help reduce the frequency and associated morbidity of invasive procedures in lung cancer diagnosis.”
Among the 188 patients evaluated in the study, 77 underwent at least one invasive procedure and 42 of these were ultimately determined to have benign disease. Researchers concluded that, had the Percepta classifier been used to guide decision making, 50 percent of the patients with benign disease could have avoided unnecessary, invasive procedures. The findings are based on the premise that a negative classifier result would have prompted physicians to follow patients with CT scans instead of proceeding to more-invasive diagnostic approaches.
“Unnecessary procedures resulting from diagnostic ambiguity are costly in many ways for patients, medical professionals and our healthcare system,” said Bonnie Anderson, president and chief executive officer of Veracyte. “Given that more than one and a half million incidental nodules are discovered every year and an additional eight million Americans recently became eligible for annual lung cancer screening, we are extremely pleased that the Percepta Bronchial Genomic Classifier is demonstrating the ability to help patients avoid risky, invasive procedures on nodules that are actually likely benign. We believe this also will help reduce costs for the healthcare system.”
An estimated 250,000 patients currently undergo a bronchoscopy, a common nonsurgical procedure, for suspected lung cancer each year in the United States. Approximately 40 percent of bronchoscopies produce inconclusive results, which can lead to risky and expensive invasive procedures such as transthoracic needle biopsy (TTNB) and surgical lung biopsy (SLB). TTNB, for example, has a 15 to 25 percent risk of collapsed lung; SLB is estimated to cost more than $20,000.