New Data To Be Presented at 2023 ASCO GU Suggest Decipher GRID-Derived Gene Expression Signature Can Help Personalize Prostate Cancer Treatment

Rhea-AI Summary

Veracyte (NASDAQ: VCYT) revealed new insights from the G-MINOR trial at the 2023 ASCO GU Symposium, highlighting the Decipher Prostate Genomic Classifier's clinical utility. The study analyzed data from 1,015 men with prostate cancer, determining that tumor classification by subtype can inform treatment responses. Findings indicated luminal differentiated tumors had the best prognosis post-surgery, while basal immune tumors benefitted most from radiotherapy. Additionally, patients who underwent Decipher testing did not experience significant quality-of-life changes despite increased adjuvant therapy. This reinforces Veracyte's commitment to precision medicine in prostate cancer treatment.

Positive

• The Decipher Prostate Genomic Classifier aids in personalizing treatment for prostate cancer based on tumor molecular subtypes.
• The G-MINOR trial provides evidence that patients with luminal differentiated tumors have the best prognosis post-surgery.
• Patients with basal immune tumors showed the greatest benefit from postoperative radiotherapy.
• Decipher testing does not adversely affect patients' quality of life, supporting its clinical use.

Negative

• None.

Additional findings from G-MINOR trial reinforce clinical utility of Veracyte’s Decipher Prostate Genomic Classifier

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT) announced new data being presented this week at the 2023 American Society of Clinical Oncology Genitourinary (ASCO GU) Symposium which demonstrate that a gene expression signature derived from the company’s proprietary Decipher Genomics Resource for Intelligent Discovery (GRID) database may help physicians further personalize treatment for men with prostate cancer, based on their tumor’s molecular subtype. Additional data being presented at the meeting, taking place in San Francisco and online, February 16-18, reinforce the clinical utility of the company’s Decipher Prostate Genomic Classifier.

In the first study (Abstract #241; Poster #J6), researchers analyzed data from Veracyte’s Decipher GRID database and found that classifying prostate cancer tumors by their molecular subtype could potentially inform their response to treatment. The researchers evaluated 1,015 men with either localized or metastatic hormone-sensitive prostate cancer (mHSPC) using a Decipher GRID-derived, 215-gene expression signature that was previously shown to classify prostate cancer into four molecular subtypes: luminal differentiated, luminal proliferating, basal immune, and basal neuroendocrine-like.

The findings demonstrated that, after radical prostatectomy, men with luminal differentiated tumors had the most favorable prognosis and those with basal immune tumors derived the greatest metastasis-free survival benefit from postoperative radiotherapy, while those with other subtypes did not see the same benefit. Additionally, in men with metastatic disease, those with luminal proliferating tumors derived the greatest survival benefit from the addition of docetaxel to androgen deprivation therapy.

“These findings demonstrate that our Decipher GRID database can provide researchers with new insights that may help physicians further apply a precision medicine approach to treatment of their prostate cancer patients,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “This and the multiple, additional Decipher-focused abstracts being presented at ASCO GU reinforce our commitment to research that aims to help physicians provide their patients with the best care possible and advance our collective understanding of the molecular underpinnings of prostate cancer.”

The Decipher GRID database includes more than 100,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its research partners to help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis to physicians who have ordered the Decipher Prostate Genomic Classifier.

In another study to be shared at ASCO GU (Abstract #345; Poster #M3), researchers evaluated the impact of the Decipher Prostate Genomic Classifier on patient-reported, quality-of-life outcomes. Previously presented data from the same trial show that men who received Decipher Prostate testing were more likely to receive adjuvant radiation therapy following radical prostatectomy than men who did not undergo genomic testing. The new analysis shows that, despite receiving more adjuvant radiation therapy, the men who underwent Decipher Prostate testing experienced no significant difference in quality-of-life reported outcomes related to urinary or sexual function as compared to their untested peers. These findings are from the G-MINOR trial, the first, prospective, randomized trial to evaluate the clinical utility of any prostate cancer genomic classifier. The trial enrolled 356 patients from 12 centers through the Michigan Urological Surgery Improvement Collaborative (MUSIC).

“These new findings suggest that there is no adverse quality-of-life impact for men whose tumors undergo Decipher Prostate testing compared to those whose do not,” said Udit Singhal, M.D., a urologist at University of Michigan Health. “This finding should give physicians even more confidence in using the Decipher Prostate test to help inform treatment decisions for their patients with prostate cancer.”

The Decipher Prostate Genomic Classifier is a 22-gene prognostic biomarker that provides a low, intermediate or high score indicating the aggressiveness of an individual patient’s cancer, to help healthcare professionals more accurately categorize risk and select appropriate treatment.

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. 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. Examples of forward-looking statements include, among others, that the Decipher GRID database can help physicians further personalize treatment for men with prostate cancer; may help physicians with a precision medicine approach to treatment of their prostate cancer patients; and that no adverse quality-of-life impact is seen for men whose tumors undergo Decipher Prostate testing compared to those whose do not. 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 filed for the three months ended September 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. nCounter is the registered trademark of NanoString Technologies used by Veracyte under license.

Veracyte delivers the Decipher Prostate Genomic Classifier from its CLIA laboratories. 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.

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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 were the findings of the G-MINOR trial for Veracyte (VCYT)?

The G-MINOR trial revealed that classifying prostate cancer by molecular subtype can guide treatment responses, with specific subtypes showing different prognostic benefits.

How does the Decipher Prostate Genomic Classifier impact treatment decisions for prostate cancer?

It provides a 22-gene score indicating cancer aggressiveness, helping physicians tailor treatment strategies accordingly.

Did the G-MINOR trial show any negative effects on quality of life for patients undergoing Decipher testing?

No, patients who underwent Decipher testing experienced no significant quality-of-life differences compared to untested peers.

What is the significance of the new data presented by Veracyte at the ASCO GU Symposium?

The new data reinforces the clinical utility of the Decipher Prostate Genomic Classifier in personalizing prostate cancer treatment.

When and where was the 2023 ASCO GU Symposium held?

The symposium took place in San Francisco and online from February 16-18, 2023.