Veracyte, a biotech company working in the field of molecular cytology with a focus on genomic solutions that resolve diagnostic ambiguity, recently announced the publication of a study on the journal BMC Medical Genomics. The study focuses on the company’s Percepta Bronchial Genomic Classifier — a technique that is used to help patients avoid the need for invasive lung cancer diagnostic methods — and details the clinical and scientific procedure that was used to develop the genomic method.
The Percepta Bronchial Genomic Classifier classifies 23 genes and its feasibility was assessed in a population of 299 patients that were enrolled in a large multi center prospective trial across 25 medical centers throughout the US. Patients were former and current smokers that underwent bronchoscopy for suspicious cancerous lung nodules and lesions, which may lead to lung cancer.
Results of the study revealed that the method is feasible in the identification of cancer and was found to be in line with the results from a previous study.
“Our goal was to develop a genomic test that could help identify current or former smokers who are at low risk of cancer following an inconclusive bronchoscopy, so that these patients can potentially avoid unnecessary invasive biopsies,” said Duncan H. Whitney, Ph.D., vice president of discovery research at Veracyte in a recent press release. “Based on this preliminary work, we believe we have accomplished that. We look forward to publication of two subsequent clinical validation studies.”
Results from two other large multi center prospective studies called AEGIS I and AEGIS II are not yet available for publication.
Each year in the U.S. approximately 250,000 patients undergo a bronchoscopy, with about 40% of the evaluations leading to questionable results. Due to the new insurance coverage laws that require at-risk patients to undergo an annual CT screening, these numbers should rise.
Last month the company started to make the test available to some institutions in the United States in order to accelerate testing of the technique.