New noninvasive diagnostic solutions for lung cancer being developed function as a complement to LDCT imaging.

By Andy Lundin

Diagnostic imaging is a critical tool in identifying early lung cancer. Studies have shown that noninvasive low-dose computed tomography (LDCT) screening drastically improves the survival rate of cancer patients and can help healthcare providers spot potentially cancerous lung nodules or other abnormalities1.

However, physicians can only determine if a lung nodule is malignant via invasive biopsies. Worse still, most lung nodules are benign2, further complicating successful disease diagnoses. To help avoid these potentially unnecessary, invasive biopsies, researchers are developing new noninvasive diagnostic solutions for lung cancer.

Noninvasive Lung Nodule Testing

Veracyte’s Percepta Nasal Swab test is one example of a new noninvasive diagnostic alternative. The solution works as a complement, and not a replacement for, LDCT imaging, says John Leite, PhD, Veracyte’s chief commercial officer, CLIA.

“The test is based on pioneering work out of Boston University, which demonstrated that there are alterations to the expression of specific genes from cells in the nasal passageway that are strongly associated with lung cancer amongst current or former smokers,” says Leite. “We developed the Percepta Nasal Swab test using whole-transcriptome analysis and machine learning technology and we recently published data from our clinical validation study in the journal CHEST demonstrating that our test improves lung cancer risk assessment.”

How the Nasal Swab Test Works

“Our Percepta Nasal Swab test is based on novel ‘field of injury’ technology, which shows that genomic changes associated with lung cancer in current or former smokers can be found in the respiratory tract,” says Leite.

Leite says the test can report whether a patient has a high-, moderate- or low-risk for lung cancer, providing insights to help physicians objectively determine which patients with lung nodules to further work up for lung cancer and which patients to simply monitor with imaging.

The clinical validation study found the Veracyte test to be highly accurate in identifying patients with nodules that are low-risk for cancer (97% sensitivity, with 40% specificity), as well as patients with high-risk nodules (92% specificity, with 57% sensitivity).

What’s Next?

To further validate the effectiveness of the nasal test for patients, Veracyte is conducting a prospective, multicenter clinical utility study.

The company hopes to use findings from the study—called NIGHTINGALE—to help make the test reimbursable. Leite says the company has grander plans to provide broader access to the noninvasive test.

“In addition to making the Percepta Nasal Swab test available to physicians and their patients in the U.S. through our centralized CLIA lab, we plan to offer it outside of the U.S. as an IVD test that labs can perform locally,” says Leite. “We are developing it as a next-generation sequencing-based test—enabled through our recently announced partnership with Illumina—and expect to launch it OUS in 2026. This dual approach will enable us to serve patients globally, where lung cancer is the leading cause of cancer death worldwide.”

Further reading: Veracyte’s Nasal Swab Test Gets Clinical Validation for Lung Cancer Risk Assessment

Photo: Veracyte


  1. “Screening Sharply Improves Lung Cancer Long-term Survival.” RSNA. Press Release. November 7, 2023.
  2. “Pulmonary Nodules.” Cleveland Clinic. 2024.