Veracyte Announces that New Data Show Use of the Prosigna Test Significantly Changed Treatment Decisions for Patients with Early-Stage Breast Cancer

Findings from prospective, population-based study presented at ESMO Breast Cancer Congress 2023

SOUTH SAN FRANCISCO, Calif., May 12, 2023--(BUSINESS WIRE)--Veracyte, Inc. (Nasdaq: VCYT) announced that new data show the use of the Prosigna Breast Cancer Assay altered treatment decisions for patients with early-stage breast cancer, including significantly reducing the use of chemotherapy among those with clinically high-risk disease. The findings are from EMIT, a prospective, multi-year, population-based study in Norway that is investigating the impact of molecular testing – specifically, the Prosigna test – on breast cancer care and outcomes. These initial data focused on treatment decisions and were shared in a poster (#103P) today at ESMO Breast Cancer Congress 2023, taking place May 11-13 in Berlin.

"Our findings demonstrate the important role that gene expression testing, and in particular the Prosigna assay, can play in offering physicians better prognostic information to help guide next steps for their patients with breast cancer," said Bjørn Naume, M.D., Professor at the Department of Oncology, Rikshospitalet Oslo University Hospital. "Specifically, Prosigna test results changed physicians’ treatment decisions in all patient clinical-risk groups with early breast cancer, regardless of whether they were low-, intermediate-, or high-risk, and reduced treatment discrepancies across hospitals."

For the study, researchers evaluated data for 2,164 women in Norway with early-stage (node-negative) breast cancer, recording physicians’ treatment decisions for these patients before and after a Prosigna test result. Prior to Prosigna results, physicians directed 27% to no systemic treatment (low-risk patients), 38% to endocrine therapy only (intermediate-risk patients) and 35% to chemotherapy followed by endocrine therapy (high-risk patients). After Prosigna test results, these treatment decisions changed to 25%, 51% and 24%, respectively. The researchers found that use of Prosigna changed adjuvant therapy decisions for almost one-third (29%) of patients. Notably, for patients assigned to chemotherapy prior to Prosigna results, 45% were de-escalated to endocrine therapy following Prosigna results.

The Prosigna assay analyzes the activity of the PAM50 gene signature, along with clinical-pathological features, to provide a hormone-receptor positive early breast cancer patient and her physician with a prognostic score indicating the probability of cancer recurrence during the next 10 years if treated with endocrine therapy alone. The Prosigna test is performed on the nCounter Analysis System and is available to laboratories in Europe and elsewhere to enable local testing for physicians and their patients.

"We are honored that the Prosigna test was selected to be part of EMIT, which we believe is among the most rigorous studies to evaluate the impact of gene expression testing on clinical decision-making and patient outcomes in breast cancer," said Kelly Marcom, M.D., Veracyte’s medical director for Breast Cancer. "The findings presented at the ESMO Breast conference add to the growing body of evidence demonstrating the clinical utility of Veracyte’s Prosigna assay. We look forward to additional data that will come out of the EMIT trial as researchers continue to follow these patients over multiple years."

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our high-performing tests enable clinicians to make more confident diagnostic, prognostic, and treatment decisions for some of the most challenging diseases such as thyroid, prostate, breast, bladder and lung cancers, as well as interstitial lung diseases. We help patients avoid unnecessary procedures and speed time to diagnosis and appropriate treatment. In addition to making our tests available in the U.S. through our central laboratories, we also aim to deliver our tests to patients worldwide through a distributed model to laboratories that can perform them locally. 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. Examples of forward-looking statements include, among others, that use of the Prosigna Breast Cancer Assay can play a role in offering physicians better prognostic information to help guide next steps for their patients with breast cancer. 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 22, 2023, and our Quarterly Report on Form 10-Q filed for the three months ended December 31, 2022. Copies of these documents, when available, may be found in the Investors section of our website at 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.

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