With positive early data, Veracyte eyes 2021 launch for nasal-swab lung cancer test

Veracyte’s latest tool for detecting lung cancer accurately divided patients with lung nodules into groups at high or low risk of having lung cancer—using only a nasal swab.

The noninvasive test, along with a different one that Veracyte already markets, could speed up treatment for high-risk patients while helping low-risk patients—who may not have early-stage lung cancer after all—avoid invasive diagnostic procedures such as tissue biopsies. 

The test is based on what Veracyte calls "field of injury" technology, which catches molecular changes in the lining of the respiratory tract to indicate cancer or cancer-related changes in the lung. 

The findings, presented on Tuesday at the annual meeting of the American College of Chest Physicians, come from a 675-patient study. The investigators trained the test on 411 nasal samples from current or former smokers who had lung nodules found on CT scans. They sequenced the RNA from each sample and plugged the data—along with clinical factors such as age, gender and smoking status—into machine-learning models and followed the patients for up to one year until they were diagnosed with lung cancer or benign disease.

They then tested the model on 261 patients, and saw very low rates of false-positive or false-negative results. Of the patients with benign nodules, the nasal swab test classified more than 40% as having a low risk for cancer with 95% sensitivity. In patients with malignant nodules, the test classified more than 40% at a high risk for cancer, with a specificity of 94%. 

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“The test’s performance was consistent regardless of lung nodule size or location, as well as cancer subtype or stage,” Veracyte said in a statement. 

The two-cutoff classifier—the test separates the patients with cancer from those with benign disease, rather just picking out one or the other—gives doctors a tool based on data to guide their patients’ care. 

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 to not have early-stage lung cancer at all.  

Although there is a variety of clinical calculators that doctors can use to determine a patient’s risk for lung cancer, they tend to come up with differing results. 

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“The challenge with those risk calculators is they have never been fully validated and have been developed on various small subsets of patients and tend to not be very generalizable to the total population,” Veracyte CEO Bonnie Anderson told FierceBiotech. 

“[Doctors] take their personal experience and the goal for them is to try to figure out, without any real objective data, which patients they can safely follow and not [do a diagnostic] work up versus those who have a higher risk for cancer they need to get worked up,” she said. 

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Veracyte has been marketing its first-generation Percepta Bronchial Genomic Classifier for years and recently brought to market a second-generation version with Johnson & Johnson.  

“We positioned it to help avoid invasive procedures, but following a bronchoscopy, an outpatient procedure often used if the doctor doesn’t feel the patient is high-risk enough to go straight into surgery, but not comfortable the patient is low-risk enough to not work up,” she said. “But we see a continuing unmet need and that’s where we believe a nasal swab is going to provide a significant advance in patient care.” 

Veracyte plans to launch the nasal swab test in early 2021 but has a lot on its plate between now and then. 

“We have a number of pure development activities that have to be done where we pressure the whole test system from sample collection, the technology, the reproducibility of results... over the course of next year in preparation of an early 2021 commercial launch," Anderson said.