Veracyte Announces New Study Published in JAMA Surgery Demonstrates Afirma GSC’s Ability to Significantly Reduce Unnecessary Surgeries in Thyroid Cancer Diagnosis
“Thyroid nodules are often challenging to diagnose with traditional
methods and, as a result, many patients undergo surgery only to find out
their nodules were benign,” said
The Afirma GSC uniquely combines RNA sequencing and advanced machine learning methods to leverage extensive genomic content – including gene expression, variants, fusions, copy number and loss of heterozygosity – from thyroid fine needle aspiration samples. This approach provides a more granular genomic picture of thyroid nodules, enabling the test to further distinguish between benign cases and those that are suspicious for cancer and to provide additional diagnostic information that can inform patient care.
In the newly published study, researchers evaluated the Afirma GSC’s clinical validity using a prospective, multicenter, blinded cohort of 191 indeterminate thyroid nodule fine needle aspiration samples – from the same sample set previously used to validate the first-generation Afirma Gene Expression Classifier (GEC). Using histopathology results as the reference standard, the researchers found that the Afirma GSC maintained the original Afirma test's high sensitivity (91 percent vs. 90 percent) and increased its specificity by 30 percent (from 52 percent to 68 percent). The Afirma GSC also identified benign Hürthle cells – which are usually very difficult to discern from cancer – with an increased specificity of 59 percent, compared to 12 percent with the Afirma GEC. Among the primary categories of indeterminate thyroid nodules – known as Bethesda III and IV – the negative predictive value of the Afirma GSC was 96 percent.
The Afirma product offering also includes tests for medullary thyroid cancer and the presence of gene alterations such as the BRAF V600E mutation and RET/PTC gene fusions, which may inform surgery and treatment decisions for patients with suspected thyroid cancer. In the current study, when these relatively rare conditions were found among the 191 study samples, the results were concordant with reference methods.
“Our original Afirma test has already transformed thyroid cancer
diagnosis, helping an estimated 40,000 patients to date avoid
unnecessary surgery,” said
“Real world” studies presented last week at the AACE 27th
Veracyte’s Afirma solution provides a comprehensive solution for
physicians evaluating patients with potentially cancerous thyroid
nodules. The Afirma Genomic Sequencing Classifier combines RNA
sequencing data with machine learning to identify patients with benign
thyroid nodules among those with indeterminate cytopathology results in
order to avoid unnecessary surgery and preserve the thyroid. Since the
commercial introduction of Afirma in 2011,
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, our belief that our genomic tests will transform the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis; statements regarding the Afirma GSC’s ability to identify more benign thyroid nodules than the original Afirma test; and Afirma’s ability to significantly improve patient care and reduce healthcare costs. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the benefits of our tests, the applicability of clinical results to actual outcomes; the laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our ability to sell our Afirma tests and successfully transition to our next-generation Afirma GSC; our ability to successfully achieve and maintain adoption of and reimbursement for our products; the amount by which use of our products are able to reduce invasive procedures and misdiagnosis, and reduce healthcare costs; the occurrence and outcomes of clinical studies; and other risks set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our quarterly report on Form 10-Q for the quarter ended March 31, 2018. 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, except as required by law.