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Veracyte to Unveil Practice-Changing Genomic Diagnostics Data Across Multiple Oncology Indications at 2021 ASCO

- Pivotal clinical validation data for Percepta Nasal Swab test in early lung cancer detection -

- New data demonstrating ability of Decipher Prostate test to identify high metastasis risk in African American men -

Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company with a presence in seven of the top ten cancers in the United States, announced today that six abstracts for its genomic tests in lung, prostate and thyroid cancers will be presented at the 2021 ASCO Annual Meeting, which will be held virtually June 4-8, 2021.

The accepted abstracts include pivotal clinical validation data for Veracyte’s Percepta Nasal Swab. This first-of-its-kind, non-invasive test will help physicians determine which patients with lung nodules found on CT scans are at low risk for cancer and can be safely directed to routine monitoring without fear of missing a cancer and which patients should undergo further, including potentially more-aggressive, clinical work-up. Veracyte plans to introduce the nasal swab-based genomic test in the second half of 2021, as part of the company’s comprehensive lung cancer portfolio.

“We are thrilled with the compelling data that will be presented at ASCO, which reflect our tests’ ability to positively impact patient care in a range of major cancers,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “We are particularly excited about the opportunity in lung cancer, where early detection can save lives, but where distinguishing between cancerous and benign lung nodules is often challenging and can lead to missed cancers or unnecessary procedures. We believe our Percepta Nasal Swab test is going to be a game-changer for patients being evaluated for lung cancer.”

Among other Veracyte highlights, researchers will share prospective validation data for the Decipher Prostate test, demonstrating the genomic test’s ability to predict aggressive prostate cancers among African American men as compared to the use of clinical factors alone.

Below are details of the Veracyte abstracts accepted for presentation at ASCO. All posters will be available to meeting registrants on demand beginning June 4, 2021, at 9:00 a.m. EDT.

Title:

Early candidate nasal swab classifiers developed using machine learning and whole transcriptome sequencing may improve early lung cancer detection.

 

(Title of poster to be presented: A validated nasal swab classifier developed using machine learning and whole transcriptome sequencing may improve early lung cancer detection.)

Abstract #:

8551

First Author:

Peter Mazzone, M.D., M.P.H., Cleveland Clinic

 

 

Title:

A prospective Validation of the genomic classifier defines high-metastasis risk in a subset of African American men with early localized prostate cancer: VanDAAM study. (oral presentation)

Abstract #:

5005

First Author:

Kosj Yamoah, M.D., Ph.D., Moffitt Cancer Center

Time:

June 8, 2021, 8:00-11:00 a.m. EDT

 

 

Title:

The impact of Percepta Genomic Sequencing Classifier (GSC) on clinical decision making in patients with a high- risk lung nodule. (poster presentation)

Abstract #:

8549

First Author:

Sonali Sethi, M.D., Cleveland Clinic

 

 

Title:

Validation of the Decipher Genomic Classifier (GC) in SAKK 09/10: A Phase III Randomized Trial of Dose-Escalated Salvage Radiotherapy (SRT) after Radical Prostatectomy (RP). (poster presentation)

Abstract #:

5010

First Author:

Alan Dal Pra, M.D., University of Miami Health System

 

 

Title:

NTRK, RET, BRAF, and ALK Fusions in Thyroid Fine-Needle Aspirates (FNAs). (poster presentation)

Abstract #:

6083

First Author:

Lori J. Wirth, M.D., Massachusetts General Hospital

 

 

Title:

Detection of actionable molecular alterations through combined DNA/RNA molecular profiling of biopsies collected in early stage lung cancer at time of diagnosis. (online abstract)

Abstract #:

e20546

First Author:

Joshua Babiarz, Ph.D., Veracyte

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 Percepta Nasal Swab and our Decipher prostate and Veracyte thyroid tests. 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. Examples of forward-looking statements include, among others, statements regarding Veracyte’s belief that its Percepta Genomic Atlas Nasal Swab and our Envisia Decipher prostate and Veracyte thyroid tests provide clinical value that helps physicians diagnose and treat lung 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 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.

Veracyte, Afirma, Percepta, Envisia, Prosigna, "Know by Design" and the Veracyte, Afirma, Percepta, Envisia and Prosigna logos are registered trademarks of Veracyte in the U.S. and selected countries.

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