Veracyte, Inc. has announced preliminary clinical data showing that the company’s non-invasive nasal swab test – the first of its kind – can enable early lung cancer detection and diagnosis so that more lives can be saved. The new findings specifically show that the novel genomic test can accurately classify lung cancer risk in patients with lung nodules so that these patients can obtain the prompt diagnosis and potential treatment they need or may be monitored noninvasively. The findings were presented on October 22, 2019 at the annual meeting of the American College of Chest Physicians® (CHEST) in New Orleans.
Veracyte is a leading genomic diagnostics company that improves patient care by providing answers to clinical questions that inform diagnosis and treatment decisions without the need for costly, risky surgeries that are often unnecessary. The company’s products uniquely combine RNA whole-transcriptome sequencing and machine learning to deliver results that give patients and physicians a clear path forward. Since its founding in 2008, Veracyte has commercialized seven genomic tests and is transforming the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis. Veracyte is based in South San Francisco, California.
To develop and evaluate the test, Veracyte utilized nasal samples from over 700 patients with lung nodules found on computed tomography (CT) scans who were prospectively recruited and whose cancer status was subsequently determined. The researchers evaluated the test’s performance on an independent blinded subset of 261 patients. The researchers determined the genomic test’s ability to identify patients as high risk and low risk for cancer and then modeled its impact on patient care when the cancer prevalence is 25 percent. This aligns with the anticipated cancer prevalence among the people on whom the test will eventually be used.
Among patients whose nodules were benign, the genomic test classified over 40 percent as low risk for cancer, with a sensitivity of over 95 percent, meaning that these patients could be monitored noninvasively with a very low chance of missing a cancer. Among patients whose nodules were malignant, the test classified over 40 percent as high risk for cancer, with a specificity of over 94 percent, meaning these patients could be directed to more invasive diagnostic procedures and treatment, with a low rate of false positive results. The test’s performance was consistent regardless of lung nodule size or location, as well as cancer subtype or stage.
Currently, physicians use clinical factors to calculate the risk of cancer when a lung nodule is found. However, these calculators vary widely in how they measure risk, produce differing results and have in some cases been shown to be less accurate than physician judgment alone. Researchers in the current study determined that the nasal swab test would identify over 70 percent more patients as “low risk” and 18 percent more patients as “high risk,” as compared to one of the most widely used clinical risk calculators.
Veracyte is collaborating with the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration, announced in January 2019, was formed to accelerate two key lung cancer programs for Veracyte: the commercialization of its Percepta® Genomic Sequencing Classifier on the company’s RNA whole-transcriptome sequencing platform, which was achieved in June 2019, and the development of the first noninvasive nasal swab test for early lung cancer detection. Under terms of the agreement, Veracyte and the Lung Cancer Initiative at Johnson & Johnson have combined clinical study cohorts involving more than 5,000 patients with multiple years of clinical outcome data. Veracyte has contributed bronchial and nasal samples from its clinical trials, which are part of the company’s extensive lung cancer-focused biorepository.
Veracyte’s nasal swab test utilizes novel and proven “field of injury” science, which identifies genomic damage associated with lung cancer in current or former smokers using a simple brushing of the person’s nasal passage. The company is developing the test on its RNA whole-transcriptome sequencing and machine learning platform, which leverages highly granular genomic information to answer specific clinical questions.
Veracyte estimates that the market opportunity for its nasal swab test, when used to assess lung cancer risk in patients with lung nodules identified by imaging is approximately $1.9 billion in the United States and $3.9 billion for both the U.S. and European Union. Veracyte also plans to explore opportunities to deploy its “field of injury” technology at other points along the lung cancer care continuum. The company believes the overall global lung cancer diagnostic market is approximately $30 billion.
“Early lung cancer detection is key to saving lives. However, today when a potentially malignant lung nodule is found, physicians lack accurate and reliable tools to determine which patients require more invasive diagnostic evaluation and those who can be managed with noninvasive surveillance.” … “Given the nasal classifier’s ability to more accurately classify cancer risk in patients with lung nodules, the test can help address this diagnostic gap, potentially helping to save more lives while also enabling patients to avoid unnecessary invasive procedures and reducing costs.” – Carla R. Lamb, M.D., interventional pulmonologist at Lahey Hospital & Medical Center, in Burlington, Massachusetts
“Lung cancer is the leading cancer killer worldwide.” … “We are very encouraged by these preliminary data, which suggest that our nasal swab test has the potential to transform how this disease is diagnosed, enabling lung cancer patients to get the treatment they need sooner, while helping patients with benign nodules avoid unnecessary and costly invasive procedures. These data also mark the latest milestone in our long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson. We look forward to finalizing and making our test available to physicians and their patients by early 2021.” – Bonnie H. Anderson, chairman and chief executive officer, Veracyte