Next-Generation Test is First to Distinguish Benign from Cancerous Hürthle Cells;
New Algorithms Identified MTC with 100 Percent Sensitivity and Specificity
In the first oral presentation, Dr.
In the second oral presentation, Dr.
"Knowing that a patient has medullary thyroid cancer before surgery will
enable the surgeon to plan appropriately. This includes ordering the
necessary imaging studies to inform whether the cancer has spread
regionally to the cervical lymph nodes, as well as anticipating
potential complications such as hypertension that can accompany MTC,"
"The ensemble machine learning algorithms, which underlie the
performance of Afirma GSC, derive from years of thoughtful scientific
research, data analysis and statistical modeling," said Giulia C.
Kennedy, chief scientific officer of
Earlier in the week, three validation studies demonstrating the performance of the Afirma GSC were presented as posters at the ATA annual meeting. Key findings include: the Afirma GSC's 100 percent sensitivity and 99 percent specificity in the detection of BRAF V600E; sensitivity and specificity of 100 percent each in distinguishing parathyroid from non-parathyroid tissue; and strong analytical verification data demonstrating robust Afirma GSC performance on thyroid nodule FNA samples with as little as 5 nanograms of RNA and in situations where contaminants such as blood are present.
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. The classifier
uses machine learning that is based on Ensemble methods in which
multiple algorithms - each playing its own role - are used to obtain a
better predictive performance than any single algorithm on its own. Each
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 the Afirma GSC significantly improves Hürthle cell classification, which may result in more patients with benign nodules avoiding unnecessary diagnostic surgery, our belief that our next-generation Afirma GSC may empower surgeons and their patients with information they need for optimal treatment in certain circumstances, our belief that our deep molecular analysis of the genomic differences in complex biological subtypes of thyroid cancer is a differentiating factor and enables our test to provide a high degree of confidence to physicians who want to provide state-of-the-art patient care in thyroid cancer analysis, and the applicability of clinical 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: demand for our tests, 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 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; 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 June 30, 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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