Findings presented at ENDO 2023 also confirm
analytical validity of company’s TERT promoter gene mutation
testing for thyroid nodule patients
Veracyte, Inc. (Nasdaq: VCYT) announced that new data presented
at ENDO 2023, the annual meeting of The Endocrine Society, suggest
the company’s Afirma molecular testing and whole-transcriptome
capabilities can provide novel insights that may advance the
scientific understanding of thyroid nodule biology. In addition,
findings from an analytical validity study presented at the meeting
show that the Afirma TERT promoter mutation test performs with high
analytical sensitivity and specificity.
“These data demonstrate that our Afirma molecular testing
capabilities and genomic-profile database are valuable tools that
can help researchers better understand the genomic underpinnings of
thyroid nodules and cancer,” said Joshua Klopper, M.D., Veracyte’s
medical director of Endocrinology. “Additionally, our findings
reinforce the performance of our TERT promoter mutation test, which
we recently began offering with our Afirma Genomic Sequencing
Classifier to help advance patient care.”
In an oral presentation at the conference, Allan Golding, M.D.,
an endocrinologist at Memorial Healthcare System, shared data from
a study designed to evaluate whether novel, predictive, genomic
research signatures derived from Afirma’s whole-transcriptome
gene-expression profiling could predict a low risk of tumor
invasion and lymph node metastases among patients with suspicious
thyroid nodules. Golding and colleagues developed and tested
hundreds of genomic risk signatures, and then evaluated the top
performing signatures using histopathology-based results as a
reference. They assessed the signatures among known malignancies
and indeterminate nodules (Bethesda III-IV) classified as
suspicious for cancer by the Afirma Genomic Sequencing Classifier
(GSC). Results show that, among the 697 patients evaluated, the
top-performing genomic risk signatures classified 40-50% of the
nodules as low risk for lymph node invasion or metastases.
“Our study demonstrates that the Afirma testing platform and
database can be used as a research tool to develop novel genomic
research signatures that may help advance the understanding of
thyroid cancer behavior,” said Dr. Golding. “In this case, being
able to rule out the potential for tumor invasion and metastasis in
a cancerous thyroid nodule could help inform more personalized
surgical decision-making, potentially reducing excess surgery and
other overtreatment.”
In a second study presented at ENDO 2023, researchers led by
Sina Jasmin, M.D., M.P.H., of Washington University in St. Louis
interrogated the Afirma thyroid nodule database to assess cytologic
and molecular differences between thyroid nodules in the isthmus
(the part of the thyroid gland that connects the left and right
lobe) and those in either thyroid lobe. Nodules that arise from the
isthmus are more likely to be malignant and aggressive compared to
those from either thyroid lobe, and researchers sought to further
elucidate the molecular profiles that contribute to this
aggressiveness.
Findings from the study show that, among thyroid samples sent
for Afirma GSC testing, the proportion of nodules with cytology
that was either suspicious for malignancy or malignant (Bethesda
V-VI) from the isthmus was nearly double that of nodules from the
lobes (8.2% vs. 4.3%). Using the Afirma-based RNA
whole-transcriptome database to evaluate molecular alterations in
indeterminate (Bethesda III-IV) thyroid nodules classified as
suspicious by Afirma GSC as well as Bethesda V-VI thyroid nodules,
the researchers identified distinct differences in the frequency of
various mutations and variants that indicate cancer aggressiveness
in isthmus vs. lobar nodules. Isthmus nodules, as an example, had
twice the frequency of BRAFV600E mutations compared to lobar
nodules (21% vs. 10%), an increased frequency of ALK/NTRK/RET
fusions (4.6% vs. 2.5%) and a lower frequency of NRAS and HRAS
variants (7.7% vs. 13% and 4.5% vs. 8.2%, respectively).
In the final Afirma-related presentation at ENDO 2023,
researchers shared findings that confirm the analytical performance
of the Afirma TERT promoter mutation test, which was recently
introduced as a complement to the Afirma GSC. TERT promoter
mutations are relatively enriched in larger, aggressive thyroid
cancers, and knowing a thyroid nodule patient’s TERT promoter
mutation status may help inform personalized treatment decisions
for patients with diagnosed or suspected cancer.
After independently evaluating the test’s analytical
sensitivity, specificity and reproducibility, researchers concluded
that the Afirma TERT promoter mutation test is analytically robust
and reproducible, supporting its routine clinical use among thyroid
nodules that are Afirma GSC suspicious or have Bethesda V-VI
cytology. Specifically, they found that the test is tolerant to
variation in amount of DNA input and can detect positive TERT
promoter variants even when there are low levels of these variants
in a given sample (>95% sensitivity).
“These new study findings underscore the performance of
Veracyte’s TERT promoter mutation test, which was recently added to
our Afirma offering to help physicians further personalize
diagnosis and treatment for their patients with thyroid nodules,”
said Dr. Klopper. “Moreover, this analytical study reinforces the
high clinical-evidence standards to which we hold all of our
tests.”
Veracyte’s flagship Afirma GSC was developed with RNA
whole-transcriptome sequencing and machine learning technology and
helps physicians identify patients with benign thyroid nodules
among those whose fine needle aspiration (FNA) biopsy results are
indeterminate by cytopathology so that they can potentially avoid
unnecessary thyroid surgery. The Afirma GSC also includes the
Xpression Atlas, the largest thyroid gene and fusion variant panel
available, to help inform treatment decisions for patients whose
genomic test or cytopathology results are suspicious for cancer.
With its recently expanded Afirma offering, Veracyte also enables
physicians to order DNA testing of the TERT promoter gene, which is
performed on the same FNA sample, to help further guide treatment
decision-making.
About Veracyte
Veracyte (Nasdaq: VCYT) is a global diagnostics company whose
vision is to transform cancer care for patients all over the world.
We empower clinicians with the high-value insights they need to
guide and assure patients at pivotal moments in the race to
diagnose and treat cancer. Our high-performing tests enable
clinicians to make more confident diagnostic, prognostic, and
treatment decisions for some of the most challenging diseases such
as thyroid, prostate, breast, bladder and lung cancers, as well as
interstitial lung diseases. We help patients avoid unnecessary
procedures and speed time to diagnosis and appropriate treatment.
In addition to making our tests available in the U.S. through our
central laboratories, we also aim to deliver our tests to patients
worldwide through a distributed model to laboratories that can
perform them locally. 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,
including, but not limited to our statements related to our plans,
objectives, expectations (financial and otherwise) or intentions
with respect to our clinical tests in and outside of the United
States. Forward-looking statements can be identified by words such
as: “appears,” "anticipate," "intend," "plan," "expect," "believe,"
"should," "may," "will," “positioned,” “designed” and similar
references to future periods. Examples of forward-looking
statements include, among others, that the Company’s Afirma
molecular testing and whole-transcriptome capabilities can provide
novel insights that may advance the scientific understanding of
thyroid nodule biology; Afirma TERT promoter mutation test performs
accurately and reliably; Afirma molecular testing capabilities and
genomic-profile database are valuable tools that can help
researchers better understand the genomic underpinnings of thyroid
nodules and cancer; Afirma TERT promoter mutation test can help
advance patient care; and the Afirma testing platform and database
can be used to rule out the potential for tumor invasion and
metastasis in a cancerous thyroid nodule could help inform more
personalized surgical decision-making, potentially reducing excess
surgery and other overtreatment. Additional factors that may impact
these forward-looking statements can be found under the caption
“Risk Factors” in our Annual Report on Form 10-K filed on February
22, 2023, and our Quarterly Report on Form 10-Q filed for the three
months ended March 31, 2023. Copies of these documents, when
available, may be found in the Investors section of our website at
https://investor.veracyte.com. These forward-looking statements
speak only as of the date hereof and, except as required by law, we
specifically disclaim any obligation to update these
forward-looking statements or reasons why actual results might
differ, whether as a result of new information, future events or
otherwise.
Veracyte, the Veracyte logo and Afirma are registered trademarks
of Veracyte, Inc. and its subsidiaries in the U.S. and selected
countries.
Veracyte delivers the Afirma Genomic Sequencing Classifier and
TERT DNA analysis from its CLIA laboratory. These tests are not
CE-IVD marked and have not been cleared or approved by the FDA;
their performance characteristics were determined by Veracyte and
they might be considered for Research Use Only in some markets.
Please contact Veracyte for confirmation.
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version on businesswire.com: https://www.businesswire.com/news/home/20230620284194/en/
Investors: Shayla Gorman Director, Investor Relations
investors@veracyte.com 619-393-1545
Media: Tracy Morris Vice President, Global Corporate
Communications tracy.morris@veracyte.com 650-380-4413
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