Updated AUA/ASTRO Guideline Includes Supportive Statement for Use of Genomic Tests, Including Decipher Prostate, for Men With Localized Prostate Cancer

Rhea-AI Summary

Veracyte has received favorable recognition in a new clinical guideline from the American Urological Association and the American Society for Radiation Oncology for its Decipher Prostate genomic classifier. This updated guideline emphasizes the significance of genomic testing in guiding treatment for localized prostate cancer, citing comprehensive evidence from phase 3 randomized clinical trials. The Decipher Prostate test helps predict cancer outcomes and assists physicians in making informed treatment decisions, ultimately improving patient care.

Positive

• Updated clinical guideline acknowledges the Decipher Prostate test's role in treatment strategies.
• Clinical trials demonstrate a strong correlation between Decipher Prostate scores and patient outcomes.
• Potential to improve patient care by providing clarity in treatment approaches.

Negative

• None.

Decipher Prostate test specifically cited for its extensive clinical evidence, including from multiple phase 3 randomized trials in high-risk prostate cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT) announced today that an updated clinical guideline from the American Urological Association (AUA) and the American Society for Radiation Oncology (ASTRO) includes a new statement that is favorable for genomic testing, including the Decipher Prostate genomic classifier, to help guide care for men with localized prostate cancer. The guideline authors specifically cite extensive evidence, including from multiple phase 3 randomized clinical trials, which have previously demonstrated that the Decipher Prostate genomic risk score is strongly associated with important prostate cancer-specific and oncologic outcomes.

The updated guideline, which appears on the AUA website and online in The Journal of Urology, states that clinicians may selectively use tissue-based genomic biomarkers when added risk-stratification may alter clinical decision-making. The guideline specifically says, “Of note, accumulating evidence has indicated that GC [genomic classifier] scores, specifically Decipher, derived from biopsy specimens do correlate with cancer outcomes.”

“We are extremely pleased that this updated guideline recognizes the important role that genomic testing can play in determining treatment approaches for men with localized prostate cancer,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “Notably, the guideline authors point to extensive data from multicenter, prospectively collected, phase 3 randomized trials that demonstrate association of Decipher Prostate test results with risk of distant metastasis and prostate-cancer-specific mortality. These include studies of patients on active surveillance to men with high-risk prostate cancer. We believe our test can give physicians and patients the clarity and confidence they need to select appropriate treatment approaches.”

Veracyte will be sharing information about the Decipher Prostate genomic test at Booth #1563 of the 2022 AUA Annual Meeting, which is taking place May 13-16 in New Orleans.

About Decipher Prostate

The Decipher Prostate genomic classifier is a 22-gene, whole-transcriptome-developed genomic test designed 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 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 our Decipher Prostate genomic classifier. 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 Decipher Prostate genomic classifier can help guide treatment among men with localized prostate 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 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.

Veracyte, the Veracyte logo, HalioDx, Decipher, Decipher GRID, Afirma, Percepta, Envisia, Prosigna, Lymphmark, Immunoscore, TMExplore, Brightplex, Immunosign, “Know by Design” and “More about You” are registered trademarks of Veracyte, Inc. and its subsidiaries 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.

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Investors:

Shayla Gorman

Director, Investor Relations

investors@veracyte.com

619-393-1545

Media:

Tracy Morris

Vice President of Global Corporate Communications

tracy.morris@veracyte.com

650-380-4413

Source: Veracyte, Inc.

FAQ

What does the updated clinical guideline say about Veracyte's Decipher Prostate test?

The updated clinical guideline emphasizes the importance of genomic testing, particularly the Decipher Prostate test, in guiding treatment for localized prostate cancer.

When will Veracyte showcase information about the Decipher Prostate test?

Veracyte will present information about the Decipher Prostate test at Booth #1563 during the AUA Annual Meeting from May 13-16, 2022.

What is the Decipher Prostate genomic classifier used for?

The Decipher Prostate genomic classifier is designed to help inform treatment decisions for men with localized prostate cancer, predicting the risk of metastasis and cancer-specific outcomes.

What evidence supports the efficacy of the Decipher Prostate test?

The guideline specifically cites extensive evidence from multiple phase 3 randomized clinical trials demonstrating that Decipher Prostate scores correlate strongly with important oncologic outcomes.