Veracyte Announces that New Afirma GRID Data Suggest Prognostic Ability of Molecular Testing for Thyroid Tumors
04 6월 2024 - 5:05AM
Business Wire
Findings presented at the ENDO 2024
conference
Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics
company, today announced new research findings suggesting the
potential of novel molecular signatures to identify patients with
thyroid nodules or cancer who have aggressive disease. The
findings, which could potentially help clinicians further
individualize care based on each patient’s tumor biology, are
derived from research using Veracyte’s Afirma GRID (Genomic
Resource for Intelligent Discovery) tool. The results were
presented today at ENDO 2024, the annual meeting of The Endocrine
Society in Boston.
“Clinicians generally want to avoid overtreatment of patients
with non-aggressive thyroid tumors while targeting more-intensive
treatment to those patients with aggressive disease. The challenge
is distinguishing between them, especially given the heterogeneity
of thyroid tumors,” said Joshua Klopper, M.D., Veracyte’s medical
director for Endocrinology. “The studies presented at ENDO 2024
today show how our Research-Use-Only Afirma GRID tool, which
leverages our whole-transcriptome-derived testing approach, is
helping scientists better understand important nuances in the
molecular underpinnings of thyroid tumors. These insights may
ultimately enable more-personalized care for patients.”
Following are highlights of the three Afirma GRID-focused
studies presented at the ENDO 2024 conference:
- Poster presentation (MON-640): Retrospective Analysis
of mRNA Expression Based Signatures of Thyroid Tumor Invasion and
Metastases. Presented by Sara Ahmadi, M.D., Brigham and Women’s
Hospital. Summary: Researchers analyzed novel
whole-transcriptome-based signatures, previously presented at the
ENDO 2023 meeting, that were designed to help rule out significant
thyroid tumor invasion or regional lymph node metastases in
patients with indeterminate thyroid nodules. This was a
retrospective study of 203 thyroid nodule patients with
indeterminate cytology who had Afirma GSC-suspicious results and
pathology results from subsequent thyroid surgery. The molecular
signatures ruled out the clinically significant features in more
than 50% of patients, with a greater than 95% negative predictive
value. “Today, most patients with thyroid nodules that are
suspicious for cancer are directed to surgery,” said Sara Ahmadi,
M.D., of Brigham and Women’s Hospital who presented the findings.
“Our results suggest that molecular testing may potentially help to
further stratify risk so that clinicians could confidently perform
a less-invasive surgical procedure that would reduce complications
and potentially mitigate the need for lifelong thyroid hormone
replacement therapy. While more study is needed, these findings are
an exciting step towards the future of personalized medicine in
thyroid nodules and cancer.”
- Oral presentation (OR28-04): Cancer-associated
Fibroblasts Correlate with Aggressive Thyroid Cancer Behavior:
Insights from Four Large Patient Cohorts. Presented by Matthew
A. Loberg, B.A., Vanderbilt University Medical Center. Summary:
Researchers identified cancer-associated fibroblasts (CAFs) in the
thyroid tumor microenvironment that correlate with aggression in
thyroid cancers largely by leveraging the Afirma GRID database,
which includes whole-transcriptome data derived from the Afirma
assay. In this multicenter study involving nearly 50,000 patients,
they identified CAFs for the first time in pre-operative fine
needle aspiration (FNA) samples. Notably, they found that the
SFRP2+ CAF was associated with shorter progression-free survival,
tumor invasion and lymph node metastasis. It was also enriched in
thyroid nodules that were deemed suspicious by the Afirma Genomic
Sequencing Classifier (GSC) or Bethesda V/VI by cytopathology,
compared to Afirma GSC-benign nodules. While more study is needed,
such insights could potentially help inform more-personalized
management strategies for patients with thyroid nodules or
cancer.
- Poster Presentation (MON-649) and Rapid-Fire Oral
Presentation (RF28-01): Prostate-specific Membrane Antigen (PSMA)
Expression in Cytologically Indeterminate and Malignant Thyroid
Nodules. Presented by Rabail Sadiq, M.B.B.S., Johns Hopkins
University School of Medicine. Prostate-specific membrane
antigen (PSMA) is a protein found on the surface of cancer cells
and is increasingly used as a biomarker in prostate cancer
detection and treatment. Higher PSMA levels have also been
associated with more-aggressive thyroid cancers. Researchers
leveraged the Afirma GRID database to characterize the expression
of PSMA (FOLH1) in a cohort of nearly 50,000 thyroid nodules sent
for Afirma GSC molecular testing. They found that PSMA gene
expression was higher in indeterminate nodules that were Afirma
GSC-suspicious and in nodules whose cytopathology was classified as
Bethesda V/VI, compared to Afirma GSC-benign nodules. They also
found variability in PSMA expression in the context of certain
molecular driver mutations. The authors conclude that PSMA
expression may potentially help provide further prognostic
information to inform care for thyroid nodule patients.
“The studies presented at ENDO 2024 reinforce our commitment to
not only developing high-performing tests, but also to helping the
research community advance the science around thyroid cancer and
the other indications we serve,” said Phillip Febbo, M.D., chief
scientific officer and chief medical officer at Veracyte. “They
also demonstrate the power of our Veracyte Diagnostics Platform,
through which our comprehensive, whole-transcriptome-derived
testing approach helps drive continued innovation to ultimately
help more patients.”
About Afirma GRID
The Afirma GRID database is derived from the sequencing of over
21,000 expressed genes for nearly 200,000 patients with thyroid
nodules (benign and malignant) and is used by Veracyte and its
partners to contribute to continued research that helps advance
understanding of thyroid tumors. Afirma GRID information is
available on a Research-Use-Only basis. More information about
Afirma GRID can be found here.
About the Afirma GSC
Veracyte’s flagship Afirma Genomic Sequencing Classifier (GSC)
was developed with RNA whole-transcriptome-derived 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 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. 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. More information about the Afirma GSC can be found
here.
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 Veracyte Diagnostics Platform
delivers high-performing cancer tests that are fueled by broad
genomic and clinical data, deep bioinformatic and AI capabilities,
and a powerful evidence-generation engine, which ultimately drives
durable reimbursement and guideline inclusion for our tests, along
with new insights to support continued innovation and pipeline
development. For more information, please visit www.veracyte.com
and follow the company on X (formerly Twitter) at @veracyte.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to our statements related to the
potential for the Afirma GRID research-use-only tool to help
scientists better understand important nuances in the molecular
underpinnings of thyroid tumors, such insights which may ultimately
enable more-personalized care for patients. Forward-looking
statements can be identified by words such as: “appears,”
“anticipate,” “intend,” “plan,” “expect,” “believe,” “should,”
“may,” “will,” “enable,” “positioned,” “offers,” “designed,”
"ultimately," and similar references to future periods. Actual
results may differ materially from those projected or suggested in
any forward-looking statements. These statements involve risks and
uncertainties, which could cause actual results to differ
materially from our predictions, and include, but are not limited
to the potential impact Afirma GRID can have on scientific
advancements in thyroid cancer and, in turn, patients. 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 29, 2024, and our 10-Q filed on May 8, 2024.
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. 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.
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Investors: Shayla Gorman investors@veracyte.com
619-393-1545
Media: Tracy Morris media@veracyte.com 650-380-4413
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