Genomic Test for Suspicious Lung Nodules Available Through J&J Initiative

Veracyte, Inc, announced last week that its Percepta test, the first product under a partnership with Johnson & Johnson Innovation, is now available for physicians to offer additional information for patients with suspicious lung nodules.

Company officials said the test, called a genomic sequencing classifier (GSC), improves upon the original Percepta. In a statement, they said the RNA whole-transcriptome sequencing—based test allows for more information to be gathered with fewer invasive procedures or treatment delays.

“Lung nodules are often challenging to diagnose using traditional tools,” Giulia Kennedy, PhD, Veracyte’s chief scientific and medical officer, said in the statement. “The ability to use genomic testing—such as the Percepta GSC —to determine which patients need intervention and those who may be safely monitored with routine imaging can help improve patient outcomes.”

The product launch follows the May 2019 presentation of data at the American Thoracic Society International Conference, which showed that the new test can identify patients with a low risk of cancer with a negative predictive value of 91%. The findings also show that the test up-classifies patients with high risk with a positive predictive value of 65%, which can guide physicians to take additional steps to confirm whether patients have lung cancer.

Low-risk patients with lung nodules can be monitored with computerized tomography imaging, while patients of 65% or higher should have surgery to determine their diagnosis, according to guidelines from the American College of Chest Physicians.

According to the company’s statement, Percepta GSC identifies genomic changes through “field of injury” science, using a brushing of the person’s airway that is collected during a bronchoscopy. Determinations are based on machine learning, and the Percepta GSC advance can help resolve the 60% of bronchoscopy results for nodules that turn up inconclusive results.

The test is the first of 2 lung cancer programs under the Lung Cancer Initiative at Johnson & Johnson to detect lung cancer at its earliest stages, when it is easiest to treat. The collaboration will involve studies of 5000 patients, with Veracyte providing bronchial and nasal samples.

Lung cancer is the leading cause of cancer death in the world. It causes 154,000 deaths in the United States each year, with 80% of cases caused by smoking.