Next-Generation Test is First to Distinguish
Benign from Cancerous Hürthle Cells;
New Algorithms Identified MTC with 100 Percent
Sensitivity and Specificity
Veracyte, Inc. (NASDAQ: VCYT) announced that data presented
today at the 87th Annual Meeting of the American Thyroid
Association (ATA) being held October 18-22 in Victoria, BC, Canada
show that the Afirma Genomic Sequencing Classifier’s (GSC) ensemble
machine learning algorithms can effectively distinguish
challenging-to-interpret thyroid cancer subtypes among thyroid
nodules deemed indeterminate – not clearly benign or malignant – by
cytopathology. The findings, shared in two oral presentations, show
significant advances in identifying benign versus cancerous Hürthle
cells and 100 percent accuracy in identification of medullary
thyroid cancer in patients with indeterminate thyroid nodules.
In the first oral presentation, Dr. Quan-Yan Duh, professor of
surgery and chief, Section of Endocrine Surgery, at the University
of California San Francisco, shared data from the Afirma GSC’s
evaluation of 26 Hürthle-cell fine needle aspiration (FNA) samples.
The test showed a sensitivity of 89 percent for malignancy and a
specificity of 59 percent for benign nodules – a 47 percent
improvement in specificity compared to the original Afirma Gene
Expression Classifier. The study was conducted on samples that were
used to validate the original Afirma classifier in a prospective,
multicenter trial. Hürthle cells account for approximately 20
percent of all indeterminate thyroid nodules.
According to Dr. Duh, “Hürthle cells are among the most
challenging thyroid nodule cell types to distinguish and until now
have largely eluded identification through traditional and genomic
testing techniques. Our findings suggest that the Afirma GSC
significantly improves Hürthle cell classification, which means
that more patients with benign nodules should be able to avoid
unnecessary diagnostic surgery.”
In the second oral presentation, Dr. Gregory Randolph, Professor
of Otolaryngology Head and Neck Surgery and the Clair and John
Bertucci Endowed Chair in Thyroid Surgical Oncology at Harvard
Medical School, shared data showing the Afirma GSC’s high accuracy
in identifying medullary thyroid cancer (MTC), a rare but highly
aggressive malignancy that typically requires more extensive
surgical treatment. When tested on 211 indeterminate thyroid nodule
FNA samples, the enhanced genomic test had a sensitivity and
specificity of 100 percent each.
“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,” said Dr. Randolph. “With its high
sensitivity and specificity for MTC, as demonstrated in our study,
the Afirma GSC should empower surgeons and their patients with
information they need for optimal treatment.”
“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 Veracyte. “Our deep
molecular analysis of the genomic differences in complex biological
subtypes of thyroid cancer is what sets us apart and enables us to
provide a high level of confidence to physicians who want to
provide state-of-the-art patient care in thyroid cancer
analysis.”
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.
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. 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 year in the United States,
more than 525,000 fine needle aspiration biopsies are performed to
assess patients with potentially cancerous thyroid nodules. Up to
30 percent of the results are indeterminate (not clearly benign or
malignant) and physicians have traditionally recommended thyroid
surgery for a more definitive diagnosis. Following surgery,
however, 70 to 80 percent of patients' nodules are diagnosed as
benign, meaning the surgery was unnecessary. Such surgery is
invasive, costly and often leads to the need for lifelong daily
thyroid hormone replacement drugs. The Afirma classifier is
included in most leading medical guidelines and is covered as
medically necessary by Medicare and all of the major U.S. insurance
companies.
About Veracyte
Veracyte (NASDAQ: VCYT) is a leading genomic diagnostics company
that is providing trustworthy and actionable answers that
fundamentally improve patient care when current diagnostic tests
are uncertain. The company’s products uniquely combine genomic
technology, clinical science and machine learning to provide
answers that give physicians and patients a clear path forward
without risky, costly surgery that is often unnecessary. Since its
founding in 2008, Veracyte has commercialized three genomic tests,
which are transforming the diagnosis of thyroid cancer, lung cancer
and idiopathic pulmonary fibrosis and collectively target a $2
billion market opportunity. 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" 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.
Veracyte, Afirma, Percepta, Envisia, the Veracyte logo, and the
Afirma logo are trademarks of Veracyte, Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20171021005015/en/
Veracyte, Inc.Media:Tracy Morris,
650-380-4413tracy.morris@veracyte.comorInvestors:Jackie
Cossmon ,650-243-6371jackie@veracyte.com
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