SOUTH SAN FRANCISCO, Calif.,
March 6, 2015 /PRNewswire/
-- Veracyte, Inc. (Nasdaq: VCYT) today announced new data
demonstrating that diagnostic tests that use increasing numbers of
cancer-associated gene mutations to evaluate thyroid nodules can
dramatically reduce the specificity of test results, leading to an
increase in "false positives," in which benign nodules are
erroneously diagnosed as cancerous. In addition, these new data
show that some mutational panels actually miss half of the
malignancies leading to "false negatives." The data were presented
this week at ENDO 2015, the 97th annual meeting of the
Endocrine Society, in San Diego,
Calif., and reinforce the role of the Afirma Gene Expression
Classifier (GEC) to rule out cancer in thyroid nodules with high
negative predictive value and suggest exercising caution in
interpreting mutational data in these nodules.
Researchers evaluated fine needle aspiration (FNA) and other
samples from a total of 239 thyroid nodules using next-generation
sequencing (NGS) technology that measured a progressively larger
set of gene variants associated with thyroid cancer. Results
demonstrate a dramatic, inverse relationship between the
sensitivity and specificity of these tests: While sensitivity to
detect malignancy improved in all groups with the increasing number
of variants evaluated, specificity fell dramatically. In FNA biopsy
samples, for example, the smallest panel resulted in a sensitivity
of 53 percent and a specificity of 93 percent. The largest panel
generated a sensitivity of 100 percent and a specificity of 0.4
percent. Overall, the two largest genomic panels wrongly called as
cancerous 87-90 percent of thyroid nodules that were benign based
on microscopic tissue evaluation.
"False positive" test results can lead to unnecessary surgical
removal of the thyroid gland, as well as significant anxiety for
patients and increased costs to the healthcare system. "False
negative" test results lead to patients with malignancies not
getting the surgery they need.
"As the scientific community gains more experience with NGS, we
will continue to identify greater numbers of thyroid
cancer-associated genomic aberrations," said Giulia C. Kennedy, PhD, Veracyte's chief
scientific officer and lead researcher for the study. "But the
sensitivity gained by applying increasingly larger numbers of
variants to preoperatively evaluate thyroid nodules may come at the
cost of specificity, and create the risk of a cancer diagnosis in
truly benign nodules. Conversely, our data also show that some of
the commonly used panels are not sensitive enough to detect all the
cancers, leading to a conundrum of how best to manage the patient.
Our results suggest that further study is needed to elucidate the
clinical utility of such mutation panels in helping physicians make
surgical decisions on patients with indeterminate thyroid
nodules."
Results from a second study, in collaboration with and presented
by Memorial Sloan Kettering Cancer Center researchers at ENDO 2015
this week, demonstrate the potential for novel molecular
classifiers developed by Veracyte scientists to improve
preoperative prediction of cancer recurrence in malignant thyroid
nodules.
In this study, researchers utilized FNA material from 79 thyroid
nodule samples from patients who were post-surgically diagnosed
with papillary thyroid carcinoma (PTC). Each sample was categorized
as either "low risk" or "intermediate/high risk" of recurrence
using established, post-operative recurrence-risk stratification
guidelines (2009 American Thyroid Association). Employing molecular
classifiers built using 320 genes, researchers were able to
stratify recurrence risk for each of the 79 FNA samples with
relatively high levels of accuracy. The highest-performing
classifier correctly identified 79 percent of ATA "low-risk" tumors
and 82 percent of ATA "intermediate/high risk" tumors.
"This study presents encouraging data that new molecular
classifiers may provide physicians with additional, important
information about thyroid nodules in advance of surgery," said
R. Michael Tuttle, M.D.,
endocrinologist at Memorial Sloan Kettering Cancer Center. "By
stratifying recurrence risk preoperatively among patients with
cancer who are headed to surgery, physicians would be able to
better guide the extent of surgery and radioactive iodine
treatment, which could lead to improved outcomes and reduced costs
and morbidity."
About Afirma®
Veracyte's Afirma Thyroid
FNA Analysis is a comprehensive solution for improved thyroid
nodule assessment. It centers on the Afirma Gene Expression
Classifier (GEC), a molecular test that identifies benign thyroid
nodules among those deemed indeterminate by cytopathology, enabling
these patients to potentially avoid an unnecessary surgery. The
company's Afirma Malignancy Classifiers – comprising tests for
medullary thyroid cancer and BRAF gene mutation status – are
designed to inform surgical strategy for those patients headed to
surgery based on their cytopathology and/or Afirma GEC results.
About Veracyte
Veracyte (Nasdaq: VCYT) is pioneering
the field of molecular cytology, focusing on genomic solutions that
resolve diagnostic ambiguity and enable physicians to make more
informed treatment decisions at an early stage in patient care. By
improving preoperative diagnostic accuracy, the company aims to
help patients avoid unnecessary invasive procedures while reducing
healthcare costs. Veracyte's first commercial solution, the Afirma®
Thyroid FNA Analysis, centers on the proprietary Afirma Gene
Expression Classifier (GEC) to resolve ambiguity in diagnosis and
is becoming a new standard of care in thyroid nodule assessment,
since its launch in 2011. As of September
30, 2014, Veracyte estimates its Afirma solution has helped
approximately 10,000 patients with thyroid nodules avoid
unnecessary surgery, reducing healthcare costs by millions of
dollars. Afirma is recommended in leading practice guidelines and
is covered for more than 140 million lives in the United States, including through Medicare
and most commercial insurance plans. Veracyte intends to expand its
molecular cytology franchise to other clinical areas, beginning
with difficult-to-diagnose lung diseases. The company expects to
launch the Percepta™ Bronchial Genomic Classifier, a test to
resolve preoperative ambiguity in lung nodules that are suspicious
for cancer, in 2015. Veracyte is also developing a second product
in pulmonology, targeting interstitial lung diseases, including
idiopathic pulmonary fibrosis. For more information, please visit
www.veracyte.com.
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, statements we
make regarding the value and potential of our technology and
research and development pipeline. 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: our limited operating history and
history of losses; our ability to increase usage of and
reimbursement for the Afirma Gene Expression Classifier, the Afirma
Malignancy Classifiers and any future products we may develop or
sell; our ability to continue our momentum and growth; our
dependence on a few payers for a significant portion of our
revenue; the complexity, time and expense associated with billing
and collecting from payers for our test; laws and regulations
applicable to our business, including potential regulation by the
Food and Drug Administration or other regulatory bodies; our
dependence on strategic relationships and our ability to
successfully convert new accounts resulting from such
relationships; our ability to develop and commercialize new
products and the timing of commercialization; our ability to
achieve sales penetration in complex commercial accounts; the
occurrence and outcome of clinical studies; the timing and
publication of study results; the applicability of clinical results
to actual outcomes; our inclusion in clinical practice guidelines;
the continued application of clinical guidelines to our products;
our ability to compete; our ability to expand into international
markets; our ability to obtain capital when needed; 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 September 30, 2014. 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, the Veracyte logo, and the Afirma logo are
trademarks of Veracyte, Inc. This press release also contains
trademarks and trade names that are the property of their
respective owners.
Media:
Tracy Morris
650-380-4413
tracy.morris@veracyte.com
Investors:
Ami
Bavishi
Burns McClellan, Inc.
212-213-0006
abavishi@burnsmc.com
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SOURCE Veracyte