New Data Presented at CHEST 2022 Reinforce Clinical Value of Veracyte’s Genomic Tests in Interstitial Lung Disease and Lung Cancer

SOUTH SAN FRANCISCO, Calif.--()--Veracyte, Inc. (Nasdaq: VCYT) today announced that two abstracts highlighting the clinical value of the company’s Envisia Genomic Classifier and Percepta Nasal Swab tests in interstitial lung disease (ILD) and lung cancer, respectively, were presented as posters today at the American College of Chest Physicians (CHEST) Annual Meeting 2022, taking place in Nashville, Tenn., October 16-19.

The first poster provides further evidence that the Envisia Genomic Classifier can help identify patients with ILD, including idiopathic pulmonary fibrosis (IPF), who are likely to have progressive disease. The Envisia test identifies a genomic pattern of usual interstitial pneumonia (UIP) in lung tissue samples obtained by transbronchial biopsy.

In a study of 135 patients with undiagnosed ILD, researchers found that those who had an Envisia-positive result for UIP had a lower baseline lung function, as measured by forced vital capacity (FVC) testing, compared to patients with an Envisia-negative result for UIP (66.9% vs. 73.4%; p=0.034). They also had a significantly lower FVC when measured approximately one year later (63.2% vs. 73.3%; p=0.002). Further, Envisia-positive patients had a significantly greater absolute decline in FVC compared to Envisia-negative patients (-3.7% vs. 0.1%; p=0.03) and findings were similar independent of pathology results.

Our findings suggest that a positive Envisia test result may serve as a biomarker for FVC decline by identifying the genomic signature of UIP in patients whose CT scans do not reveal definitive UIP.” said Lisa Lancaster, M.D., professor of Medicine at Vanderbilt University Medical Center, who presented the findings at the CHEST meeting. “Importantly, the Envisia test may help identify patients with progressive pulmonary fibrosis who could potentially benefit from earlier therapy before they might experience significant, irreversible loss of lung function.”

Researchers also presented new preliminary study findings for use of the Percepta Nasal Swab test on potentially cancerous lung nodules found on CT scans. Veracyte developed the novel, noninvasive Percepta Nasal Swab test to help physicians more accurately, quickly and confidently determine which patients with lung nodules are low-risk for cancer and can be safely directed to routine monitoring, and which are high-risk for cancer and should proceed to further diagnostic work-up and treatment as needed.

The new data suggest that the Percepta Nasal Swab test may categorize more lung nodule patients as low-risk or high-risk for cancer, as compared to the standard-of-care (SOC) approach, which consists of a physician’s own assessment of clinical factors along with CT imaging. Previous data have demonstrated that the Percepta Nasal Swab test is highly accurate when it identifies patients as low- or high-risk for cancer.

The data presented at the CHEST 2022 meeting reinforce our commitment to driving innovation that can help physicians make better care decisions for their patients,” said Bill Bulman, M.D., medical director, Pulmonology, at Veracyte. “These findings suggest that, beyond helping to diagnose IPF, our Envisia test may also help to identify progressive disease in patients with other forms of ILD. Additionally, early results suggest that our Percepta Nasal Swab test may be able to change risk stratification so that patients with suspicious lung nodules may receive more-appropriate care.”

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. In addition to making our tests available in the United States through our central laboratories, our exclusive license to our best-in-class diagnostics instrument (nCounter Analysis System) 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 our clinical tests in and outside of the United States. Forward-looking statements can be identified by words such as: “appears,” "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will," “positioned,” “designed” and similar references to future periods. An example of forward-looking statements include, among others, that our Envisia test will be able to improve patient care beyond diagnosing IPF and that the Envisia test may identify patients with progressive pulmonary fibrosis who could potentially benefit from early, aggressive therapy before they might experience significant, irreversible loss of lung function as well the statement that our Percepta Nasal Swab test will be able to significantly improve care for patients with suspicious lung nodules and has the potential to identify more lung nodule patients as low-risk or high-risk for cancer as compared to standard of care. 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 on February 28, 2022, and our Quarterly Report on Form 10-Q to be filed for the three months ended June 30, 2022. Copies of these documents, when available, may be found in the Investors section of our website at www.investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim 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. Veracyte, the Veracyte logo and Decipher are registered trademarks of Veracyte, Inc. and its subsidiaries in the U.S. and selected countries.

Veracyte, the Veracyte logo, Envisia and Percepta are registered trademarks of Veracyte, Inc. and its subsidiaries in the U.S. and selected countries. nCounter is the registered trademark of NanoString Technologies used by Veracyte under license.

Veracyte delivers the Envisia Genomic Classifier and Percepta Nasal Swab test from its CLIA laboratory. Those tests are not CE-IVD marked and have not been cleared or approved by the FDA; their performance characteristics were determined by Veracyte and they might be considered for Research Use Only in some markets. Please contact Veracyte for confirmation. This piece is distributed purely for educational purposes and is not intended to promote or encourage any off-label use of Veracyte products.

Contacts

Investors:
Shayla Gorman
Director, Investor Relations
investors@veracyte.com
619-393-1545

Media:
Tracy Morris
Vice President, Global Corporate Communications
tracy.morris@veracyte.com
650-380-4413

Contacts

Investors:
Shayla Gorman
Director, Investor Relations
investors@veracyte.com
619-393-1545

Media:
Tracy Morris
Vice President, Global Corporate Communications
tracy.morris@veracyte.com
650-380-4413