Veracyte announces new data demonstrating that Afirma Xpression Atlas identifies clinically relevant gene fusions in thyroid cancer FNA samples
SOUTH SAN FRANCISCO, Calif .– (BUSINESS WIRE) –Veracyte, Inc., (Nasdaq: VCYT) today announced new data that shows the company’s Afirma Xpression Atlas (XA) can identify clinically relevant gene fusions in thyroid nodule samples collected by needle aspiration fine (FNA). The results, which will be presented on June 4 at the 2021 American Society of Clinical Oncology (ASCO) annual meeting, support the use of the entire transcriptome RNA sequencing assay to detect gene fusions. that may guide the use of targeted therapies for thyroid cancer.
“The increasing availability of targeted therapies for thyroid cancer, including tyrosine kinase inhibitors, means that physicians need to have tools that reliably identify patients who may benefit from these therapies,” said Lori J. Wirth, MD, medical director of the Center for Head and Neck Cancers, Mass General Cancer Center, who will present the data. “Using the Afirma XA assay, we were able to identify and report the prevalence of clinically relevant gene variants and fusions in actual thyroid nodule samples.”
The American Cancer Society predicts that more than 44,000 people will be diagnosed with thyroid cancer in the United States this year. Pathologists use the Bethesda System to classify thyroid nodules into several categories – from benign to malignant – using FNA samples. The Afirma XA uses whole transcriptome RNA sequencing to identify 905 DNA variants and 235 RNA fusions in 593 genes on ANFs taken from thyroid nodules. An increasing number of these gene fusions can be targeted with small molecule therapies.
In the study that will be presented to ASCO (Abstract 6803), the researchers analyzed data from 50,644 FNA thyroid samples submitted to Veracyte’s CLIA lab to determine the prevalence of certain receptor tyrosine kinase (RTK) fusions of ALK, BRAF, NTRK1 / 3 or RET mergers. The Afirma Genomic Sequencing Classifier (GSC) had been used to classify samples as benign or suspect following an indeterminate cytopathologic result (Bethesda III-IV). The researchers performed the Afirma XA on samples deemed suspicious by the GSC or susceptible or confirmed to be cancerous by cytopathology (Bethesda V / VI).
Over 32,000 samples were classified as benign with the Afirma GSC and no RTK fusion was identified. Of the 16,594 samples classified as suspect by the Afirma GSC, 3% contained RTK fusions. Of the nearly 1,700 samples classified as suspect or malignant, 8% had RTK fusions. The most common fusion was ETV6 / NTRK3, while BRAF fusions had the greatest diversity with 80 different gene partners.
“These results suggest that using the Afirma GSC and XA tests, physicians can confidently classify each patient’s thyroid nodules and, for malignant nodules, determine whether treatment with targeted therapy is appropriate,” said Richard. T. Kloos, MD, Executive Medical Director of Veracyte. “We look forward to future analyzes of the impact of Afirma XA test results on initial treatment and patient outcomes.”
Veracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnostic and treatment decisions throughout the cancer patient journey and others diseases. The company’s growing menu of genomic testing takes advantage of advances in genomic science and technology, enabling patients to avoid risky and expensive diagnostic procedures and shorten appropriate treatment time. 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 subtyping tests lymphoma and kidney cancer are developing. With Veracyte’s exclusive worldwide license for a premier diagnostic instrument platform, the company is positioned to deliver its tests to patients around the world. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, our statements regarding our plans, objectives, expectations (financial and otherwise) or intentions regarding the Afirma Genomic Sequencing Classifier (GSC) and the Atlas Afirma Xpression (XA) test. Forward-looking statements may be identified by words such as: “anticipate”, “intend”, “plan”, “expect”, “believe”, “should”, “suggest”, “may”, ” want ”and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statement. Examples of forward-looking statements include, among others, statements regarding Veracyte’s belief that its Afirma XA can identify clinically relevant gene variants and thus help healthcare providers select treatment options for thyroid cancer. . 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 testing; and the applicability of clinical results to actual results. Additional factors that may affect these forward-looking statements can be found under the heading “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 is available in the Investors section of our website at www.veracyte.com. The risks and uncertainties may be magnified by the COVID-19 pandemic, which has caused significant economic uncertainty. The extent to which the COVID-19 pandemic impacts Veracyte’s business, operations and financial results, including the duration and magnitude of those effects, will depend on many factors, which are unpredictable, including but not limited to y limit, the duration and spread of the epidemic, its severity, the measures to be taken to contain the virus or address its impact, and how quickly and to what extent normal economic and operational 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 the reasons why actual results could differ, whether in due to new information, future events. or otherwise.
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