Veracyte Announces that New NCCN Guidelines Uniquely Recommend Use of Decipher Prostate Genomic Test Score to Guide Specific Treatment for Men Following Radical Prostatectomy

Rhea-AI Summary

Veracyte (Nasdaq: VCYT) announced that its Decipher® Prostate RP genomic classifier is included in the 2022 NCCN Clinical Practice Guidelines for Oncology, advocating its use for treatment decisions in prostate cancer. The guidelines recommend Decipher Prostate RP for patients post-radical prostatectomy, particularly for those with high-risk scores (>0.6) for salvage radiotherapy. This recognition stems from data showing the classifier's predictive value in clinical outcomes, including survival rates and response to hormone therapy.

Positive

• Decipher Prostate RP is now recommended by NCCN for prostate cancer treatment decisions.
• The recommendation is based on extensive clinical validation and high-risk patient data.

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• None.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT) today announced that its Decipher^® Prostate RP genomic classifier is uniquely recommended in the 2022 National Comprehensive Cancer Network^® (NCCN) Clinical Practice Guidelines for Oncology to guide treatment decisions for men with prostate cancer. The new guidelines specifically recommend Decipher Prostate RP after radical prostatectomy and that men with high-risk scores (>0.6) should be strongly considered for salvage radiotherapy with the addition of concurrent hormone therapy, when early radiation therapy is missed.

“We are thrilled that Decipher Prostate RP is now recommended by the NCCN to guide specific treatment decisions,” said Elai Davicioni, Ph.D., Veracyte’s senior vice president, scientific and clinical operations, urologic cancers. “The NCCN’s designation is unique to Decipher Prostate RP and underscores the extensive clinical validation and clinical utility data behind the test. We believe this recommendation will ultimately enable more men to receive the treatment they need, while reducing unnecessary therapy.”

The new NCCN recommendations are based on results of the NRG Oncology Phase 3 randomized controlled trial, RTOG 96-01. This study, which followed patients for a median of 12 years, demonstrated that Decipher risk results were associated with hormone therapy benefit, with Decipher high-risk men receiving greater absolute benefit from hormone therapy compared to Decipher low-risk men. In the subset of patients who received hormone therapy in addition to early salvage radiotherapy, Decipher high-risk men experienced improvements in distant metastasis, prostate cancer-specific mortality and overall survival, while Decipher low-risk men had good oncologic outcomes without hormone therapy.

The Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, Phase 3, prospective, randomized controlled clinical trials; 13 Phase 2/3 prospective trials; and more than 20 retrospective studies of Phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient's risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global 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 leverages 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, colon cancer and idiopathic pulmonary fibrosis are available to patients and its renal cancer and lymphoma subtyping tests are in development, the latter as a companion diagnostic. 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) regarding the Decipher Prostate RP Genomic Classifier’s ability to provide prognostic information that can help guide treatment decisions for prostate cancer patients who are candidates for salvage radiotherapy. 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. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to, 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 . 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.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.

Veracyte, the Veracyte logo, HalioDx, Decipher, Decipher GRID, Afirma, Percepta, Envisia, Prosigna, Lymphmark, “Know by Design” and “More about You” are registered trademarks of Veracyte, Inc. and its affiliates in the U.S. and selected countries. nCounter is the registered trademark of NanoString Technologies, Inc. in the U.S. and selected countries and used by Veracyte under license.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210914006008/en/

Investor and Media Contact:

Tracy Morris

Vice President of Corporate Communications & Investor Relations

tracy.morris@veracyte.com

650-380-4413

Source: Veracyte, Inc.

FAQ

What is the significance of the NCCN recommendation for VCYT's Decipher Prostate RP?

The NCCN recommendation underscores Decipher Prostate RP's clinical utility, guiding treatment for prostate cancer patients post-surgery.

How does Decipher Prostate RP impact prostate cancer treatment decisions?

It helps determine the need for salvage radiotherapy in high-risk patients, potentially improving treatment outcomes.

What trials support the Decipher Prostate RP recommendations?

The recommendations are based on results from the NRG Oncology Phase 3 RTOG 96-01 trial.

What are the expected benefits of using Decipher Prostate RP based on the NCCN guidelines?

It aims to enhance patient outcomes by providing tailored treatment strategies and reducing unnecessary therapies.

What is the Decipher score and its relevance?

The Decipher score predicts the risk of metastasis within five years, aiding clinicians in therapy selection.