Veracyte Announces Pivotal Clinical Validation Data for Afirma Genomic Sequencing Classifier Presented at World Congress on Thyroid Cancer
Enhanced Classifier Identifies 30% More Benign Patients Than Original, Flagship Test
"The Afirma GEC has already enabled nearly 30,000 patients to avoid
unnecessary thyroid surgeries," said
The Afirma GSC uniquely combines RNA sequencing and machine learning to
leverage more enriched, previously undetectable genomic information.
Researchers validated the Afirma GSC on a prospective, multicenter,
blinded cohort of 191 indeterminate thyroid nodule fine needle
aspiration samples - the same sample set previously used to validate the
first-generation Afirma GEC. Data shared by
The Afirma GSC identifies benign Hurthle cells, which are usually very
difficult to discern from cancer, with increased specificity of 59
percent compared with just 12 percent with the Afirma GEC. In addition,
"We are pleased to introduce the next-generation Afirma classifier,
further solidifying our leadership in thyroid cancer diagnosis," said
About Afirma
The Afirma Genomic Sequencing Classifier is the next-generation version
of the Afirma Gene Expression Classifier, and is used to identify
patients with benign thyroid nodules among those with indeterminate
cytopathology results in order to preserve the thyroid. Each year in
About Veracyte
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 beliefs with respect to the benefits of our Afirma GSC to providers, patients and payors, including that it will identify more patients who can avoid unnecessary thyroid surgery, our belief that the scientific rigor and validation and clinical utility data behind the company's classifiers demonstrate its commitment to lead in diagnostic genomics, and the applicability of clinicl results to actual outcomes. 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 applicability of clinical results to actual outcomes; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; the size of the market opportunity for our products; our ability to successfully achieve 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; the timing and publication of clinical study results; and other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.
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