DecisionDx®-Melanoma Provides Improved Risk Stratification Over American Joint Committee on Cancer (AJCC) Staging Alone in Stage I Melanoma Patients
April 25 2023 - 7:00AM
Business Wire
New data shared in a poster presentation during
the 19th European Association of Dermato-Oncology (EADO)
Congress
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced new data showing DecisionDx®-Melanoma can improve risk
stratification over American Joint Committee on Cancer (AJCC)
staging alone in patients with stage I cutaneous melanoma (CM).
DecisionDx-Melanoma uses a patient’s tumor biology to provide the
patient’s personalized risk of recurrence and metastasis, while
AJCC staging is based on the clinical and pathologic risk factors
of a patient’s melanoma tumor.
“Patients with stage I cutaneous melanoma are considered to have
a lower risk of recurrence and melanoma-specific mortality;
however, due to the large number of patients diagnosed with stage I
disease, this patient group accounts for the largest number of
deaths from melanoma,” said Sebastian Podlipnik, M.D., Department
of Dermatology, Hospital Clinic of Barcelona, Spain. “As the study
showed, DecisionDx-Melanoma provides more precise risk
stratification over staging alone to better predict which patients
have a low risk of experiencing a poor outcome and those with more
aggressive tumor biology who may benefit from increased clinical
surveillance.”
The data were presented at the 19th European Association of
Dermato-Oncology (EADO) Congress, held in Rome, Italy, in a poster
titled, “The 31-gene expression profile outperforms AJCC in
stratifying risk of recurrence in patients with stage I cutaneous
melanoma.” In the study, DecisionDx-Melanoma provided significant
and independent risk stratification of patients with stage I CM.
Additionally, as reported in the study, the test added valuable
prognostic information to AJCC staging to better stratify
recurrence-free survival (RFS) and melanoma-specific survival (MSS)
among patients with stage I CM.
RFS
AJCC staging
Risk-stratification according to AJCC
staging provided low-risk stage IA vs. high-risk stage IB RFS rates
of 93.3% vs. 87.6%.
DecisionDx-Melanoma
DecisionDx-Melanoma demonstrated improved
risk-stratification of RFS with low-risk Class 1A vs. high-risk
Class 2B RFS rates of 97.3% vs. 77.3%.
MSS
AJCC staging
Risk-stratification according to AJCC
staging provided low-risk stage IA vs. high-risk stage IB MSS rates
of 97.6% vs. 97.9%.
DecisionDx-Melanoma
DecisionDx-Melanoma demonstrated improved
risk-stratification of MSS with low-risk Class 1A vs. high-risk
Class 2B MSS rates of 98.0% vs. 92.3%.
Importantly, the data demonstrate that patients with AJCC stage
I CM who had a high-risk (Class 2B) DecisionDx-Melanoma test result
were 5.4 times more likely to die from melanoma compared to
patients staged as IB according to AJCC staging. The results of the
study support the use of DecisionDx-Melanoma to guide better
risk-aligned care in patients considered low risk by staging by
identifying high-risk patients who may be missed using only AJCC
staging criteria.
About DecisionDx®-Melanoma
DecisionDx-Melanoma is a gene expression profile risk
stratification test. It is designed to inform two clinical
questions in the management of cutaneous melanoma: a patient’s
individual risk of sentinel lymph node (SLN) positivity and a
patient's personal risk of melanoma recurrence and/or metastasis.
By integrating tumor biology with clinical and pathologic factors
using a validated proprietary algorithm, DecisionDx-Melanoma is
designed to provide a comprehensive and clinically actionable
result to guide risk-aligned patient care. DecisionDx-Melanoma has
been shown to be associated with improved patient survival and has
been studied in more than 10,000 patient samples.
DecisionDx-Melanoma’s clinical value is supported by more than 40
peer-reviewed and published studies, providing confidence in
disease management plans that incorporate the test’s results.
Through Dec. 31, 2022, DecisionDx-Melanoma has been ordered 120,287
times for patients diagnosed with cutaneous melanoma. More
information about the test and disease can be found at
www.CastleTestInfo.com.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics
company improving health through innovative tests that guide
patient care. The Company aims to transform disease management by
keeping people first: patients, clinicians, employees and
investors.
Castle’s current portfolio consists of tests for skin cancers,
uveal melanoma, Barrett’s esophagus and mental health conditions.
Additionally, the Company has active research and development
programs for tests in other diseases with high clinical need,
including its test in development to predict systemic therapy
response in patients with moderate-to-severe psoriasis, atopic
dermatitis and related conditions. To learn more, please visit
www.CastleBiosciences.com and connect with us on LinkedIn,
Facebook, Twitter and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath
Melanoma, DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME,
DecisionDx-UMSeq, TissueCypher and IDgenetix are trademarks of
Castle Biosciences, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, which are subject to the “safe harbor” created by those
sections. These forward-looking statements include, but are not
limited to, statements concerning the results of the study reported
in this press release, the ability of DecisionDx-Melanoma to guide
better risk-aligned care in patients considered low risk by
staging, and the potential benefit to patients from increased
clinical surveillance resulting from a DecisionDx-Melanoma test
result. The words “believe,” “can,” “potential,” “will” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. We may not actually achieve the plans,
intentions or expectations disclosed in our forward-looking
statements, and you should not place undue reliance on our
forward-looking statements. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements that we make. These forward-looking
statements involve risks and uncertainties that could cause our
actual results to differ materially from those in the
forward-looking statements, including, without limitation:
subsequent study or trial results and findings may contradict
earlier study or trial results and findings or may not support the
results obtained in this study, including with respect to the
discussion of DecisionDx-Melanoma in this press release; actual
application of our tests may not provide the aforementioned
benefits to patients; and the risks set forth under the heading
“Risk Factors” in our Quarterly Report on Form 10-K for the year
ended December 31, 2022, and in our other filings with the SEC. The
forward-looking statements are applicable only as of the date on
which they are made, and we do not assume any obligation to update
any forward-looking statements, except as may be required by
law.
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Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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