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Veracyte Announces Data Showing Percepta Genomic Atlas Detects Gene Alterations Targeted in Lung Cancer Treatment, Using Diagnostic Biopsy

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Veracyte (Nasdaq: VCYT) announced new data at the ATS 2021 Conference showing that its Percepta® Genomic Atlas can accurately detect lung cancer gene alterations using small biopsy samples. The test employs advanced DNA and RNA sequencing to analyze over 50 genes associated with lung cancer, demonstrating over 95% concordance with reference assays. Set for launch in H2 2021, this test aims to guide targeted therapies for patients. Veracyte's portfolio promotes timely treatment decisions, improving patient care throughout the cancer journey.

Positive
  • The Percepta Genomic Atlas shows over 95% accuracy in detecting lung cancer gene variants.
  • The test is set to launch in the second half of 2021, expanding Veracyte's genomic testing portfolio.
  • It addresses the need for timely genomic profiling, potentially leading to better patient treatment outcomes.
Negative
  • None.

Veracyte, Inc. (Nasdaq: VCYT) announced today new data demonstrating the ability of the Percepta® Genomic Atlas to detect alterations that may inform lung cancer treatment decisions for patients from the same small biopsy that was used for diagnosis. Study findings presented today at the American Thoracic Society (ATS) 2021 International Conference show that the test accurately detects known lung-cancer gene variants using small biopsy samples, which may help guide treatment with targeted therapies.

The in-development Percepta Genomic Atlas will provide comprehensive genomic profiling information on cancerous lung nodules, masses or lymph nodes, utilizing small samples from the same biopsy procedure used for diagnosis (i.e., transbronchial needle aspirate biopsies or TBNA). The test uses targeted DNA and whole-transcriptome RNA sequencing to detect alterations in more than 50 genes known to be present in lung cancer. Veracyte plans to launch the test in the second half of 2021 as part of the company’s comprehensive portfolio of genomic tests in lung cancer.

For the analyses presented at the ATS Conference today, researchers evaluated the feasibility of detecting National Comprehensive Cancer Network (NCCN)-recommended gene alterations with the Percepta Genomic Atlas, using samples from 25 patients obtained during initial bronchoscopy procedures. Results show that the in-development test accurately detected the gene variants in these samples with over 95 percent concordance to a reference next-generation sequencing assay.

“Physicians today are often challenged to obtain genomic profiling information on their lung cancer patients’ tumors, due to inadequate tissue, logistical delays and other factors. As a result, patients often do not receive optimal treatment,” said Giulia C. Kennedy, Ph.D., Veracyte’s chief scientific officer and chief medical officer. “These findings give us confidence that the Percepta Genomic Atlas will be able to accurately detect gene alterations that may allow patients to be treated with targeted therapies that are available now and that will be available in the future. Importantly, we believe it will be able to provide this critical information near the time of diagnosis, enabling earlier and more appropriate treatment.”

The Percepta Genomic Atlas ATS 2021 abstract can be viewed here. The poster presentation is available on demand to ATS conference registrants through July 2.

The Percepta Genomic Atlas will be a key part of Veracyte’s lung cancer portfolio, which aims to transform care at every step of the patient journey. Collectively, the company’s tests are leveraging cutting-edge genomic science and technology to provide answers and insights that enable physicians and patients to make better, faster and more confident care decisions.

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 Genomic Atlas. 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 the ability of the Percepta Genomic Atlas to accurately detect known lung-cancer gene variants and help to guide treatment with targeted therapies. 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 Medicare 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.

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.

nCounter is the registered trademark of NanoString Technologies, Inc. in the United States and other countries and used by Veracyte under license.

FAQ

What is Veracyte's Percepta Genomic Atlas?

It is a genomic test designed to detect lung cancer gene alterations from small biopsy samples.

When will the Percepta Genomic Atlas be launched?

The test is expected to launch in the second half of 2021.

What percentage of accuracy does the Percepta Genomic Atlas have?

The test shows over 95% accuracy in detecting gene variants.

What role does the Percepta Genomic Atlas play in lung cancer treatment?

It helps guide treatment decisions by providing critical genomic information from initial biopsy samples.

Where were the findings about the Percepta Genomic Atlas presented?

The findings were presented at the ATS 2021 International Conference.

Veracyte, Inc.

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