Collaboration to Focus on 9,000-Patient Clinical Trial for Development of Future Lung Cancer Early-Detection Tests

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT) today announced it has expanded its long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson¹. The collaboration will include a focus on the NOBLE trial, a 9,000-patient, prospective, multicenter clinical study designed to distinguish genomic and other differences in lung cancer development and progression among patients with lung nodules detected by CT imaging.

As Veracyte plans for the 2021 launch of the first noninvasive nasal swab test to guide the work-up of patients with potentially cancerous lung nodules, this new study will position the company to develop future tests that benefit broader patient populations, including nonsmokers and those with pre-cancerous changes who are likely to develop lung cancer.

“We are pleased to expand upon our collaboration in our goal of reducing lung cancer deaths,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “The NOBLE trial will provide a robust biorepository of genomic, clinical and outcome data, which we plan to translate into future tests that can help diagnose lung cancer at its earliest stages. It will also further our ability to address a nearly $40 billion global lung cancer market that is now more accessible to Veracyte through our own distributed testing platform, which enables advanced genomic testing to be performed locally by laboratories worldwide.”

The NOBLE trial is a prospective, multicenter study involving up to 50 sites globally. It is anticipated to enroll 9,000 individuals with lung nodules detected through CT imaging either via lung cancer screening or incidentally and will include patients who are benign at initial nodule diagnosis but who subsequently develop lung cancer. Researchers will collect nasal-swab, longitudinal blood and other samples, as well as imaging and clinical information at enrollment and at multiple points throughout the study. Patients will be followed according to current guidelines for three years or until a lung cancer diagnosis.

“We are proud to participate in the NOBLE trial,” said Kim Rieger-Christ, Ph.D., chief scientific officer and director of translational research at Lahey Hospital & Medical Center and the study’s principal investigator. (Read more…) “We believe this study will shed important new light on the natural progression of lung cancer and, more importantly, may enable development of new tests and treatments that will help physicians provide better care for patients and ultimately save more lives.”

In January 2019, Veracyte announced a long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration has focused on accelerating two key lung cancer programs for Veracyte: the commercialization of its Percepta® Genomic Sequencing Classifier on the company’s RNA whole-transcriptome sequencing platform, which was achieved in June 2019, and the development of the first noninvasive nasal swab test for early lung cancer detection.

About Lung Cancer

Lung cancer is the deadliest cancer globally, killing more than 1.75 million people worldwide each year, according to the World Health Organization. Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to six percent when it is found at a later stage, according to the American Lung Association. Lung nodules are typically the first sign of lung cancer. While the vast majority of lung nodules ultimately prove to be benign, physicians currently lack clear diagnostic tools to determine which patients have cancer and which do not. This can lead to unnecessary invasive biopsies, which are costly and risky, as well as to delayed diagnosis and treatment.

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 thyroid cancer, lung cancer, breast cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping test is 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 our Prosigna, Afirma, Percepta, Envisia, and nasal swab tests and products for use in diagnosing and treating diseases. 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. 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 Veracyte’s ability to develop and commercialize a nasal swab and other tests to aid in disease diagnosis, characterization and prognosis to support disease management for patients with lung nodules. Factors that may impact these forward-looking statements can be found in Item 1A – “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on February 25, 2020 and in our Quarterly Report on Form 10-Q filed with the SEC on November 2, 2020. 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 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 in the U.S. and selected countries. We have common law rights and pending trademark applications for LymphMark and “More About You.”

¹ Johnson & Johnson Services, Inc. is the legal entity party to the agreement.

Contacts

Tracy Morris

Vice President of Corporate Communications & Investor Relations

650-380-4413

[email protected]

Collaboration to Focus on 9,000-Patient Clinical Trial for Development of Future Lung Cancer Early-Detection Tests

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT) today announced it has expanded its long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson¹. The collaboration will include a focus on the NOBLE trial, a 9,000-patient, prospective, multicenter clinical study designed to distinguish genomic and other differences in lung cancer development and progression among patients with lung nodules detected by CT imaging.

As Veracyte plans for the 2021 launch of the first noninvasive nasal swab test to guide the work-up of patients with potentially cancerous lung nodules, this new study will position the company to develop future tests that benefit broader patient populations, including nonsmokers and those with pre-cancerous changes who are likely to develop lung cancer.

“We are pleased to expand upon our collaboration in our goal of reducing lung cancer deaths,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “The NOBLE trial will provide a robust biorepository of genomic, clinical and outcome data, which we plan to translate into future tests that can help diagnose lung cancer at its earliest stages. It will also further our ability to address a nearly $40 billion global lung cancer market that is now more accessible to Veracyte through our own distributed testing platform, which enables advanced genomic testing to be performed locally by laboratories worldwide.”

The NOBLE trial is a prospective, multicenter study involving up to 50 sites globally. It is anticipated to enroll 9,000 individuals with lung nodules detected through CT imaging either via lung cancer screening or incidentally and will include patients who are benign at initial nodule diagnosis but who subsequently develop lung cancer. Researchers will collect nasal-swab, longitudinal blood and other samples, as well as imaging and clinical information at enrollment and at multiple points throughout the study. Patients will be followed according to current guidelines for three years or until a lung cancer diagnosis.

“We are proud to participate in the NOBLE trial,” said Kim Rieger-Christ, Ph.D., chief scientific officer and director of translational research at Lahey Hospital & Medical Center and the study’s principal investigator. (Read more…) “We believe this study will shed important new light on the natural progression of lung cancer and, more importantly, may enable development of new tests and treatments that will help physicians provide better care for patients and ultimately save more lives.”

In January 2019, Veracyte announced a long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration has focused on accelerating two key lung cancer programs for Veracyte: the commercialization of its Percepta® Genomic Sequencing Classifier on the company’s RNA whole-transcriptome sequencing platform, which was achieved in June 2019, and the development of the first noninvasive nasal swab test for early lung cancer detection.

About Lung Cancer

Lung cancer is the deadliest cancer globally, killing more than 1.75 million people worldwide each year, according to the World Health Organization. Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to six percent when it is found at a later stage, according to the American Lung Association. Lung nodules are typically the first sign of lung cancer. While the vast majority of lung nodules ultimately prove to be benign, physicians currently lack clear diagnostic tools to determine which patients have cancer and which do not. This can lead to unnecessary invasive biopsies, which are costly and risky, as well as to delayed diagnosis and treatment.

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 thyroid cancer, lung cancer, breast cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping test is 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 our Prosigna, Afirma, Percepta, Envisia, and nasal swab tests and products for use in diagnosing and treating diseases. 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. 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 Veracyte’s ability to develop and commercialize a nasal swab and other tests to aid in disease diagnosis, characterization and prognosis to support disease management for patients with lung nodules. Factors that may impact these forward-looking statements can be found in Item 1A – “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on February 25, 2020 and in our Quarterly Report on Form 10-Q filed with the SEC on November 2, 2020. 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 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 in the U.S. and selected countries. We have common law rights and pending trademark applications for LymphMark and “More About You.”

¹ Johnson & Johnson Services, Inc. is the legal entity party to the agreement.

Contacts

Tracy Morris

Vice President of Corporate Communications & Investor Relations

650-380-4413

[email protected]