Prosigna Breast Cancer Gene Signature Test Now Reimbursed in Germany

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte, Inc. (Nasdaq: VCYT), a global diagnostics company, today announced that the Prosigna® Breast Cancer Gene Signature Assay is now reimbursed by the statutory health insurances in Germany following a recent decision of the Federal Joint Committee (G-BA). The decision enables eligible patients in Germany with HR+/HER2- early-stage breast cancer to access the test and also underscores the growing importance of genomic testing for individualized treatment of patients.

“Approximately 70,000 women in Germany develop breast cancer each year. This milestone is a victory for those who may potentially benefit from the Prosigna test,” said Morten Frost, general manager of pulmonology and breast cancer for Veracyte. “We applaud the Federal Joint Committee for helping to make advanced genomic testing available to inform breast cancer treatment decisions based on a patient’s individual risk of cancer recurrence. Importantly, by enabling hospitals and laboratories to perform the test locally, the Prosigna test provides high-quality results, faster and without the logistical challenges or quality risks that can occur when patient samples are shipped overseas for testing.”

For women diagnosed with breast cancer, a clear therapy recommendation for or against chemotherapy is often challenging using only clinicopathological criteria. The Federal Joint Committee recommends the use of biomarkers, which now include Prosigna, a second-generation test, to make treatment decisions based on the patient's individual risk profile.

“Increased access to new genomic diagnostic tools will help physicians better care for their patients with breast cancer,” said Albrecht Stenzinger, Professor of Molecular Pathology and Director of Molecular Diagnostics and Biomarkers Institute of the Heidelberg University Clinic. “Further, laboratories’ ability to perform the Prosigna test locally means that physicians can receive the test’s results in a timely manner and can have strong confidence in their accuracy.”

The Prosigna test analyzes the activity of 50 genes known as the PAM50 gene signature. In addition, information such as tumor size, lymph node involvement and tumor proliferation are included in the assessment in order to provide early-stage breast cancer patients and their doctors with reliable prognostic decision-making information. This provides a statement about the likelihood of the cancer recurring within the next 10 years. The Prosigna test is recommended by the European Society of Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO) and the National Institute for Health and Care Excellence (NICE) in the UK.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The company’s growing menu of genomic tests leverage advances in genomic science and technology, enabling patients to avoid risky, costly diagnostic procedures and quicken time to appropriate treatment. The company’s tests in lung cancer, prostate cancer, breast cancer, thyroid cancer, bladder cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping and renal cancer tests are in development. With Veracyte’s exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its tests to patients worldwide. 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 the Prosigna Breast Cancer Gene Signature Assay. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," “suggest,” "may," "will" and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. Examples of forward-looking statements include, among others, statements regarding Veracyte’s belief that the PAM50 gene signature and the Prosigna assay provide clinical value that help clinicians make therapeutic decisions. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to: Veracyte’s ability to achieve and maintain government and private payer coverage for its tests; the benefits of Veracyte’s tests and the applicability of clinical results to actual outcomes. 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 22, 2021 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. The risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty. The extent to which the COVID-19 pandemic impacts Veracyte’s businesses, operations, and financial results, including the duration and magnitude of such effects, will depend on numerous factors, which are unpredictable, including, but not limited to, the duration and spread of the outbreak, its severity, the actions to contain the virus or treat its impact, and how quickly and to what extent normal economic and operating conditions can resume. 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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