Veracyte announced it has begun rolling out its long-awaited nasal swab test for lung cancer to a limited number of clinical sites, as it continues to build up data to back its full future commercial launch.
The company also delivered recent findings that showed the Percepta genomic test’s ability to more accurately separate groups of patients based on their risk of developing tumors from suspicious lung nodules.
With about 1.6 million nodules being discovered annually through CT screenings, Veracyte’s noninvasive test aims to determine early which people may be able to skip follow-up procedures such as a surgical biopsy and who should be fast-tracked for additional diagnostics and treatment.
The test evaluates genomic changes in the cells lining the respiratory tract for evidence that could be connected to cancer and pairs it with a machine learning model that factors in the patient’s age, gender and smoking history.
The latest results build on data that was presented earlier this year at the annual meeting of the American Society of Clinical Oncology, which examined nearly 250 current or former smokers who had a lung nodule detected by a CT scan.
The new dataset—delivered at this year’s meeting of the American College of Chest Physicians—adds on 63 patients as part of the study’s planned secondary endpoint, with people who had been previously diagnosed with separate cancers outside of the lung.
When combined, the Percepta nasal swab test delivered a false-negative rate of about 3% when categorizing patients as having a low risk for lung cancer, making it largely accurate in helping physicians avoid unnecessary invasive procedures. Among patients labeled as high risk, the test showed a false-positive rate of about 8%.
The test’s results also tracked with the size of the lesion, with 100% of malignant nodules 8 mm and larger being labeled as high or moderate risk and 67% of smaller ones being dubbed moderate risk.
“These findings suggest that the Percepta Nasal Swab test will provide significant clinical utility across a range of lung nodule sizes and lung cancer stages,” Veracyte’s chief scientific officer and chief medical officer, Giulia Kennedy, said in a statement, adding that the latest shipment of tests to sites will help further underpin the company’s clinical utility studies.
Earlier this year, Veracyte picked up a new CEO in Marc Stapley, who previously served as a senior finance vice president at Pfizer and chief financial and administrative officer at Illumina. Former chief Bonnie Anderson now serves as executive chairwoman.
And on Stapley’s first day this past June, the company announced a $300 million deal to pick up HalioDx, the French test maker that will now serve as Veracyte’s European base of operations.
That acquisition follows a $600 million deal from February for Decipher Biosciences, which broadened the company’s diagnostic reach to seven of the 10 most common tumor types, with tests for prostate, kidney and bladder cancer.