SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte, Inc. (NASDAQ: VCYT) announced that data presented at the 87th Annual Meeting of the American Thyroid Association (ATA) being held October 18-22 in Victoria, BC, Canada demonstrate the accuracy of identification of BRAF V600E and parathyroid tissue through new classifiers developed in conjunction with the next-generation Afirma Genomic Sequencing Classifier. The BRAF V600E and parathyroid classifiers were designed to further reduce unnecessary surgeries in thyroid cancer diagnosis and guide appropriate treatment for patients whose thyroid nodules are likely cancerous.
In the first study, researchers used the BRAF classifier to blindly evaluate 264 indeterminate thyroid nodule fine needle aspiration (FNA) samples for the BRAF V600E mutation. They found that the Afirma classifier had a 100 percent sensitivity and a 99 percent specificity for the mutation when compared to castPCR results as the reference standard.
“The presence of the BRAF V600E mutation in thyroid nodules has multiple clinical implications. First, it confirms the presence of thyroid cancer. Additionally, since some aggressive thyroid cancers tend to have this mutation, knowing a tumor's BRAF status before surgery can enable the surgeon to perform a more appropriate oncologic procedure,” said Kepal N. Patel, M.D., FACS, Chief, Division of Endocrine Surgery, NYU Langone Medical Center, and an investigator in the study presented at the meeting. “Our findings suggest that the Afirma GSC for BRAF is very accurate in determining whether the BRAF V600E mutation is present preoperatively.”
The second Afirma classifier poster showed that in a study of 195 indeterminate thyroid nodule FNA samples, the next-generation classifier was highly accurate at distinguishing parathyroid from non-parathyroid tissue (sensitivity and specificity of 100 percent each). Enlarged and embedded parathyroid glands are often mistaken for thyroid nodules and cytopathology is often indeterminate. The ability to accurately distinguish between the two cell types can help reduce unnecessary surgeries, as well as complications related to surgery. These data were presented by Dr. Julie Ann Sosa of Duke University Medical Center.
“Our original Afirma Gene Expression Classifier has already set new standards in thyroid cancer diagnosis, where we estimate it has helped save tens of thousands of patients from unnecessary thyroid surgery,” said Giulia C. Kennedy. Ph.D., Veracyte’s chief scientific officer. “Our next-generation Afirma Genomic Sequencing Classifier is now enabling us to extract and interpret more genomic data from a patient FNA sample than was previously possible. The result is that we can identify even more patients whose thyroid nodules are benign – and who can thus avoid an unnecessary surgery – while also providing additional information that can better inform treatment decisions.”
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 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 beliefs regarding the benefits and attributes
of our Afirma products, including reducing unnecessary surgeries and
surgical complications, and better-informing treatment decisions, our
belief that our Afirma GEC products have set new standards of care in
thyroid cancer diagnosis, 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, better-inform treatment decisions 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.
