Veracyte Announces New Data on Immuno-Oncology Offerings Presented at SITC 2021

Brightplex technology is designed to enable biopharmaceutical researchers to assess the complex tumor micro-environment to aid in development of new therapeutics

Veracyte, Inc. (Nasdaq: VCYT) today announced that new data from three posters were presented at the Society for Immunotherapy of Cancer's (SITC) 36^th Annual Meeting, highlighting the company’s immuno-oncology offerings for biopharmaceutical and academic researchers.

The data demonstrate the ability of Brightplex to assess the spatial distribution of targeted immune cell subpopulations in tumors, which could potentially help clinical researchers design more effective immunotherapies in cancer treatment. Veracyte acquired the novel Brightplex technology – which combines information from multiplex immunohistochemistry (IHC) and advanced digital pathology analysis to provide a comprehensive picture of the tumor micro-environment – through its acquisition of HalioDx in August 2021.

The posters include new data regarding the use of Brightplex TCE (for T Cells Exhaustion) to stratify non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors in the “Biomarker analysis” part of the PIONeeR project^1,2. This research program, promoted by the French government, is designed to better understand, predict and overcome anti-PD-1/PD-L1 resistance in advanced lung cancer patients and includes the analysis of hundreds of circulating and tumor biomarkers. The new findings on a preliminary PIONeeR patient data set suggest that one of those tests, the Brightplex TCE assay, can stratify NSCLC patients eligible for anti-PD-1/PD-L1 therapy into four Spatial Tumor-infiltrating lymphocyte (TILs) subtypes – Cold, Stroma-infiltrated, Parenchyma Hot and Hot – which may predict their outcomes. In the Hot subtype, for example, long-term progression-free survival (PFS) is observed for more than 40% of patients, regardless of PD-L1 status. In this Hot subtype, activated T-cell densities seem higher in tumors of patients with longer PFS, suggesting that immune-response evaluation with the Brightplex TCE assay could refine the stratification of patients, enriching responders to immune checkpoint inhibitor therapy.

“We are delighted to highlight these new data on our Brightplex assays from the PIONeeR project, which help confirm its potential role in patient stratification for anti-PD-1/PD-L1 therapeutics,” said Corinne Danan, Veracyte’s general manager, Biopharma. “Our Brightplex assays are a key technology for a growing number of biopharmaceutical researchers as we can develop multiplex, customized panels using more than 80 distinct, validated biomarkers to decipher the tumor micro-environment, to help meet our partners’ needs.”

The following posters can be accessed here:

• “Spatial distribution of infiltrating T lymphocytes with Immunoscore® CR T Cells Exhaustion test helps stratification of NSCLC patients treated with PD1/L1 inhibitors in the PIONeeR project” (poster #460)

• “Assessment of the spatial distribution of B cells subpopulations in the tumor microenvironment and tertiary lymphoid structures by Brightplex®, a sequential chromogenic multiplex assay” (Poster #57)

• Assessment of the spatial distribution of CD4+ T cells subpopulations in the tumor microenvironment by Brightplex®, a sequential chromogenic multiplex assay” (Poster #41)

About Veracyte

Veracyte (Nasdaq: VCYT) is a global 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 diagnostic tests leverages 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, colon cancer, and idiopathic pulmonary fibrosis are available to patients and its renal cancer and lymphoma subtyping tests are in development, the latter as a companion diagnostic. With Veracyte’s exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its genomic 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 Brightplex technology. 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 Brightplex technology can help clinical researchers to design more effective immunotherapies in cancer treatment. 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. 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, Brightplex, Decipher, Decipher GRID, Afirma, Percepta, Envisia, Prosigna, Lymphmark, “Know by Design” and “More about You” are registered trademarks of Veracyte, Inc. and its affiliates 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. Immunoscore is the registered trademark of Inserm in the U.S. and selected countries, and is used by Veracyte under license.

¹ The PIONeeR Project is supported by the French National Research Agency (ANR), a 5-year research program that aims to better understand, predict and overcome anti-PD-1/PD-L1 resistance in advanced lung cancer patients.

² This work is supported by French National Research Agency (17-RHUS-0007); a partnership of AMU, AP-HM, CNRS, Inserm, Centre Léon Bérard, Institut Paoli-Calmettes, AstraZeneca, HalioDx, Innate Pharma & ImCheck Therapeutics, sponsored by AP-HM and initiated by Marseille Immunopole. Drug supply is funded by AstraZeneca.

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