New England Journal of Medicine Publishes Study Results Suggesting Veracyte's Percepta™ Bronchial Genomic Classifier Can Reduce Unnecessary Invasive Procedures in Lung Cancer Diagnosis
The AEGIS trials involved 639 patients (298 in AEGIS I and 341 in AEGIS II) at 28 sites in
"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
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
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
An estimated 250,000 patients currently undergo a bronchoscopy for suspected lung cancer each year in
The paper describing the AEGIS I and II study results, "A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer," appears in the
Full data from the AEGIS II study will also be presented this week 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)
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A second ATS mini-symposium, "We Can Work It Out: Diagnosing and Differentiating Interstitial Lung Disease" will highlight data from a study of
Abstract Title: Diagnosis of Idiopathic Pulmonary Fibrosis on Transbronchial Biopsies Using Machine Learning and High Dimensional Transcriptional Data (67185)
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Conference Call on
The live webcast and subsequent replay may be accessed by visiting Veracyte's website at http://investor.veracyte.com. Alternatively, please call (855) 541-0980 (U.S.) or (970) 315-0440 (international) to listen to the live conference call. The conference ID number is 45232876. The webcast replay will be available on the company's website approximately two hours following completion of the call.
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
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