Study results published suggest Veracyte's Percepta Bronchial Genomic Classifier can reduce unnecessary invasive procedures in lung cancer diagnosis

Veracyte, Inc., a molecular diagnostics company pioneering the field of molecular cytology, has announced online publication in the New England Journal of Medicine of results from two large, prospective, multicenter studies that assessed the clinical performance of the company's Percepta Bronchial Genomic Classifier in lung cancer diagnosis. Findings from the AEGIS I and AEGIS II trials demonstrate the ability of the genomic test to help patients safely avoid unnecessary invasive, risky procedures on suspicious lung nodules or lesions that were initially found on computed tomography (CT) scans.

The AEGIS trials involved 639 patients (298 in AEGIS I and 341 in AEGIS II) at 28 sites in the United States, Canada and Ireland who were undergoing bronchoscopy, a common nonsurgical procedure, to assess lung nodules for cancer. Specifically, among patients assessed clinically as having "intermediate" risk of malignancy who then had a non-diagnostic bronchoscopy, the Percepta test had a negative predictive value (NPV) of 91 percent, demonstrating the test's ability to reclassify these patients as "low risk" with a high degree of accuracy. The genomic test and the bronchoscopy had a combined sensitivity of 97 percent, compared to 75 percent for bronchoscopy alone. The genomic test's specificity was 47 percent in both studies. The sensitivity of the Percepta classifier alone and in combination with bronchoscopy was consistently high, regardless of nodule size and location, and cancer stage and type.

"These data suggest that the bronchial genomic classifier enables physicians to confidently identify patients who are at low probability for having lung cancer following an indeterminate bronchoscopy result," said senior author Avrum Spira, M.D., M.Sc., professor of medicine at Boston University School of Medicine and co-inventor of the genomic test. "Many of these patients can then be followed with CT scans, rather than undergoing harmful, invasive - and potentially unnecessary - follow-up procedures. The need for improved lung cancer diagnosis becomes increasingly acute given new screening programs that will expand the number of nodules found." Beginning in early 2015, more than eight million Americans at high risk for lung cancer became eligible for annual screening with low-dose CT (LDCT) through new private-insurer and Medicare coverage requirements. Lung nodules and lesions found on CT scans are often small and located at peripheral sites in the lung, making them hard to diagnose without invasive biopsies. Bronchoscopy is the safer, least-invasive diagnostic option, but often produces inconclusive results, leaving physicians with the dilemma of whether to subject patients to risky, invasive procedures or monitor them with the risk that they may in fact have cancer.

In the AEGIS trials, 43 percent of bronchoscopies were non-diagnostic for lung cancer, with 64 percent of patients undergoing invasive follow-up procedures, among which 35 percent of patients had benign nodules or lesions.

"These rigorous studies represent the largest evaluation to date of patients undergoing bronchoscopy, and establish the performance and utility of our Percepta Bronchial Genomic Classifier in lung cancer diagnosis," said Bonnie H. Anderson, Veracyte's president and chief executive officer. "By helping to prevent unnecessary invasive diagnostic procedures, the Percepta test should provide very tangible benefits for patients and physicians, while removing costs from the healthcare system."

An estimated 250,000 patients currently undergo a bronchoscopy for suspected lung cancer each year in the United States, with approximately 40 percent producing non-diagnostic results. Such findings can lead to invasive procedures - transthoracic needle biopsy (TTNB) and surgical lung biopsy (SLB) - that are risky and expensive. TTNB, for example, has a 15-25 percent risk of collapsed lung; SLB is estimated to cost more than $20,000.

The paper describing the AEGIS I and II study results, "A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer," appears in the New England Journal of Medicine. Dr. Spira presented key data from the studies in his keynote address at the American Thoracic Society 2015 International Conference, being held in Denver, CO.

Full data from the AEGIS II study will also be presented as part of an ATS mini-symposium, "Genomics and Cancer: Has it Borne Scientific and Clinical Fruit?":
Abstract Title: A Bronchial Airway Gene Expression Test for Lung Cancer Diagnosis is Validated in a Second Prospective Clinical Trial: Results of the AEGIS 2 Study (C99), Presenter: Duncan Whitney, Ph.D., Date: Tuesday, May 19, 2015.

A second ATS mini-symposium, "We Can Work It Out: Diagnosing and Differentiating Interstitial Lung Disease" will highlight data from a study of Veracyte's genomic test, in development, for idiopathic pulmonary fibrosis:
Abstract Title: Diagnosis of Idiopathic Pulmonary Fibrosis on Transbronchial Biopsies Using Machine Learning and High Dimensional Transcriptional Data (67185), Presenter: Giulia C. Kennedy, Ph.D., Date: Wednesday, May 20, 2015.

About the AEGIS Trials

The AEGIS I and AEGIS II studies evaluated 639 current or former smokers undergoing bronchoscopy for suspected lung cancer. In addition to obtaining standard biopsy samples from the lung nodule or lesion, researchers collected samples from the more-accessible mainstem bronchus for evaluation using the Percepta test. Results of the classifier were not reported to physicians or patients. Patients were then followed until a diagnosis was established or 12 months post bronchoscopy. A lung cancer diagnosis was established either through bronchoscopy or invasive procedures; a benign diagnosis was made through these same procedures or following stable imaging studies.

About the Percepta Bronchial Genomic Classifier

The Percepta Bronchial Genomic Classifier is designed to identify patients with lung nodules who are at low risk of cancer following a non-diagnostic bronchoscopy result, to enable these patients to be safely monitored with CT scans in lieu of invasive diagnostic procedures. The 23-gene molecular classifier uses proprietary genomic technology to detect molecular changes that occur in the epithelial cells lining the lung's respiratory tract in current or former smokers with lung cancer. These changes can be detected in cells obtained from standard cytology brushings taken during bronchoscopy from the mainstem bronchus and indicate the presence of malignancy or disease processes from distant sites in the lung. Thus, the test is designed to determine a lung nodule's or lesion's likelihood of cancer, without the need to sample the nodule or lesion directly. The Percepta test is performed at Veracyte's CLIA-certified laboratory in South San Francisco, Calif. The company began making the Percepta classifier available to a limited number of institutions around the United States in April 2015.