Veracyte presented data from a prospective clinical utility study showing that its genomic lung cancer test reduced the number of invasive procedures by more than 50% in screening and diagnosis of the disease.
The U.S. Preventive Services Task Force recommends annual screening using a CT scan for people at high risk for lung cancer. But studies have shown that many patients whose scans suggest they need further treatment, such as surgery, turn out not to have early-stage lung cancer at all.
The Percepta Bronchial Genomic Classifier is designed to identify patients at low risk of cancer, so they can avoid diagnostic surgery. In February, the company scored coverage for Percepta from a Medicare contractor, the first such test to be covered by Medicare.
Veracyte unveiled the 390-patient study at the annual meeting of the American College of Chest Physicians. It found that doctors who used the test to identify patients at low risk for lung cancer recommended invasive diagnostic procedures half as often as when they did not use the test.
RELATED: FierceMedicalDevices’ 2013 Fierce 15—Veracyte
The study participants either smoke, or used to smoke, and underwent bronchoscopy after a CT scan showed they had a lung lesion. During bronchoscopy, a bronchial brushing was conducted to collect a sample for the Percepta test.
The test uses proprietary “field of injury” technology to catch molecular changes in the lining of the respiratory tract, which can indicate cancer or cancer-related changes in the lung, Veracyte said in a statement.
“Patients with lung nodules that are not clearly benign or malignant present a challenge to physicians and often are recommended to undergo invasive procedures so that a lung cancer isn’t missed,” said Hans J. Lee, M.D., associate professor of medicine at the Johns Hopkins University School of Medicine, who presented the data. “Our findings suggest that patients classified as low risk by the Percepta classifier were monitored with CT imaging rather than being directed to surgery. In broader clinical practice, this can help to reduce surgeries and costs in lung cancer diagnosis and becomes increasingly important as more lung nodules are found through expanded lung cancer screening.”