Veracyte Announces New Data Reinforcing Percepta Nasal Swab Test’s Clinical Performance and Utility in Lung Cancer Risk Assessment

May 16, 2022 at 16:17 PM EDT

Findings Presented at ATS 2022

Veracyte, Inc. (Nasdaq: VCYT) today announced new data showing that its Percepta Nasal Swab test accurately assesses lung cancer risk among current and former smokers with lung nodules, regardless of their smoking history burden and whether they are considered high risk for lung cancer based on U.S. Preventive Services Task Force (USPSTF) screening criteria. The findings were presented today at the American Thoracic Society 2022 International Conference (ATS 2022), being held in San Francisco.

“Our analysis showed that the nasal genomic classifier performed similarly well in patients across the spectrum of tobacco-related risk," said Carla R. Lamb, M.D., a pulmonary and critical care physician and Director of Interventional Pulmonary at Lahey Hospital & Medical Center who presented the study findings. “These findings suggest that the test can be reliably used in ever-smokers whose lung nodules were found incidentally, as well as through screening.”

For the study, researchers evaluated data from a subset of 291 current and former smokers with lung nodules who were part of the original clinical validation study for the Percepta Nasal Swab test. Among these individuals, 213 (73%) met USPSTF screening criteria (pack years ≥20, years since quit <15, age 50-80 years), while 78 (27%) did not. Researchers compared the performance of the classifier in the two patient subsets and found no statistically significant differences in the classifier’s sensitivity and specificity between the two groups.

Specifically, among those who met the USPSTF criteria for lung cancer screening, the test’s sensitivity was 96% when it identified a nodule as low risk for cancer and its specificity was 94% when it identified it as high risk. Among patients who did not meet the USPSTF lung cancer screening eligibility, the test’s sensitivity was 100% when it identified nodules as low risk for cancer and its specificity was 88% when it identified them as high risk.

“The data presented today reinforce the important role that the Percepta Nasal Swab classifier may play in helping to guide next steps for current and former smokers with lung nodules – including those who may be considered low risk based on their smoking history burden,” said Giulia C. Kennedy, Ph.D., Veracyte’s global chief scientific officer and chief medical officer. “More accurate, timely diagnosis of these patients could ultimately lead to fewer unnecessary diagnostic procedures among those without lung cancer, and timelier treatment for those with the disease.”

The Percepta Nasal Swab test’s performance in classifying lung cancer risk has previously been demonstrated, and it is being made available to a limited number of sites as the company develops the clinical utility evidence to support reimbursement.

Also at ATS 2022, Veracyte will host two Learning Theater events during which leading physicians will discuss their experiences incorporating novel genomic testing into the diagnoses of interstitial lung disease (ILD) and lung cancer, respectively:

Title: Integrating novel genomic data to improve ILD diagnostic and prognostic confidence

Presenter: Lisa H. Lancaster, M.D.

Date/Time: May 17, 12:30 p.m. PT

Location: Mini Theater #2

Title: Integrating the Percepta Genomic Sequencing Classifier for lung nodule risk stratification

Presenters: David Feller-Kopman, M.D. and Shaheen Islam, M.D.

Date/Time: May 17, 1:30 p.m. PT

Location: Mini Theater #1

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company that improves patient care by answering important clinical questions to inform diagnosis and treatment decisions. Our growing menu of advanced diagnostic tests help patients avoid risky, costly procedures and interventions, and reduce time to appropriate treatment. Our tests address eight of the 10 most prevalent cancers by incidence in the United States. In addition to making our tests available in the United States through our central laboratories, our exclusive license to a best-in-class diagnostics instrument positions us to deliver our tests to patients worldwide through laboratories that can perform them locally. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, our statements related to our plans, objectives, expectations (financial and otherwise) or intentions with respect to Veracyte’s Percepta Nasal Swab test. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," “suggest,” "may," "will" “prospective” and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. An example of a forward-looking statement includes, among others, that the Percepta Nasal Swab may help patients more accurately, quickly and confidently assess lung cancer risk so that patients may avoid unnecessary invasive procedures. Additional factors that may impact these forward-looking statements can be found under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on February 28, 2022, and our subsequent quarterly reports on Form 10-Q. A copy of these documents can be found at the Investors section of our website at www.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, Veracyte specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.

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