Study Data from Castle Biosciences’ Collaboration with the National Cancer Institute’s SEER Program Registries Published in JCO Precision Oncology
June 30 2023 - 7:00AM
Business Wire
Data shows testing with DecisionDx®-Melanoma
provided significant prognostic information regarding survival
outcomes
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced the publication of a study in JCO Precision Oncology1 in
which DecisionDx®-Melanoma provided significant, independent risk
stratification of patients with cutaneous melanoma (CM), beyond
American Joint Committee on Cancer Eighth Edition (AJCC8) stage,
which may help inform more personalized patient management
decisions. Additionally, data from the study shows that testing
with DecisionDx-Melanoma was associated with lower
melanoma-specific and overall mortality relative to untested
patients. The study can be found here.
“Management decisions for melanoma patients, such as referrals
for sentinel lymph node biopsy or frequency and intensity of
surveillance, are guided by a patient’s risk of disease recurrence
or metastasis, and improvements in the accuracy of risk prediction
can inform these decisions,” said Matthew Goldberg, M.D., F.A.A.D.,
board-certified dermatologist and dermatopathologist, and senior
vice president, medical, of Castle Biosciences. “The independent
risk-stratification provided by DecisionDx-Melanoma has already
been demonstrated in numerous retrospective and prospective
studies. This large study of real-world, unselected, clinically
tested patients who received our test as part of their ongoing
melanoma care further supports these findings.
“The statistically significant risk stratification for survival
between patients who received a Class 1A test result (lowest risk
of metastasis) and those with a Class 2B test result (highest risk
of metastasis) highlights the value that testing with
DecisionDx-Melanoma can bring to personalizing patient care
decisions when interpreted in the context of the extensive,
published clinical utility data for DecisionDx-Melanoma, including
the recently published study from Dhillon et al.”2
In the study, to assess the effect of the DecisionDx-Melanoma
test on survival outcomes, a group of tested patients (n=3,258) was
matched to a group of patients who did not receive
DecisionDx-Melanoma test results as part of their clinical care
(n=9,774); the matching was performed using propensity score
matching with three untested patients for each tested patient and
was based on 11 clinicopathologic and socioeconomic variables.
Key findings of the study include:
- DecisionDx-Melanoma independently risk-stratified patients
according to their risk of dying from melanoma, consistent with
previously published retrospective and prospective studies.
- DecisionDx-Melanoma was an independent predictor of patient
outcomes; a Class 2B (high risk) DecisionDx-Melanoma test
result was an independent predictor of melanoma-specific survival
(HR= 7.00, 95% CI 2.70-18.00) and overall survival (HR= 2.39, 95%
CI 1.54-3.70). Additionally, a Class 2B result conferred the
highest risk of all clinicopathologic factors included in
multivariable analyses that included ulceration status, Breslow
thickness and nodal status, the three risk factors used in the
AJCC8 staging system.
- DecisionDx-Melanoma testing was associated with 29% lower
melanoma-specific mortality (HR=0.71, 95% CI 0.53-0.94) and 17%
lower overall mortality (HR=0.83, 95% CI 0.70-0.99) relative to
patients who did not receive DecisionDx-Melanoma testing.
“We believe that DecisionDx-Melanoma will be a practice-changing
test, providing personalized information based on the genomic
profile of a patient’s tumor that can help guide more informed and
risk-aligned patient care decisions,” said Derek Maetzold,
president and chief executive officer of Castle Biosciences. “We
are looking forward to continuing our collaboration with the NCI
SEER Program’s Registries to provide DecisionDx Melanoma data to
the SEER registries as part of public health reporting to further
advance research and patient care.”
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 March 31, 2023, DecisionDx-Melanoma has been ordered more
than 128,000 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: (i) the potential of
DecisionDx-Melanoma to provide significant prognostic information
regarding survival outcomes which may allow for more personalized
patient care, guide and inform management decisions for melanoma
patients through risk prediction, and bring value to personalizing
patient care decisions; and (ii) our belief that
DecisionDx-Melanoma will be a practice-changing test, providing
personalized information based on the genomic profile of a
patient’s tumor that can help guide more informed and risk-aligned
patient care decisions. The words “believe,” “can,” “may,”
“potential” 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 shown 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-Q for the three
months ended March 31, 2023, 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.
- Bailey C, Martin B, Petkov V, et al. 31-Gene Expression Profile
Testing in Cutaneous Melanoma and Survival Outcomes in a
Population-Based Analysis: A SEER Collaboration. JCO Precis. Oncol.
2023; 7. DOI: 10.1200/PO.23.00044
- Dhillon S, Duarte-Bateman D, Fowler G, et al. Routine imaging
guided by a 31-gene expression profile assay results in earlier
detection of melanoma with decreased metastatic tumor burden
compared to patients without surveillance imaging studies. Arch
Dermatol Res. 2023. https://doi.org/10.1007/s00403-023-02613-6
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Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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