Framework Incorporating DecisionDx®-SCC Test Results into Clinical Decision-Making for Patients with High-Risk Cutaneous Squamous Cell Carcinoma Published in Clinical, Cosmetic and Investigational Dermatology
June 05 2023 - 07:00AM
Business Wire
Treatment algorithm can assist clinicians in
tailoring their care for patients with high-risk cutaneous squamous
cell carcinoma (cSCC) based on individual patient’s unique tumor
biology, while adhering to guideline recommendations
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced the publication of a paper in Clinical, Cosmetic and
Investigational Dermatology highlighting a clinician-derived,
real-world algorithm that provides a framework to incorporate
DecisionDx®-SCC test results into clinical practice within National
Comprehensive Cancer Network (NCCN) guideline recommendations.1
This framework for stratifying patients with advanced cSCC includes
a treatment algorithm that demonstrates how use of DecisionDx-SCC
test results can assist clinicians in identifying personalized,
risk-aligned treatment pathway improvements for patients with
high-risk cSCC, based on the patient’s tumor biology, which may
help improve their disease outcome.
“While current guidelines and staging frameworks for cSCC
provide guidance for stratifying patients based on their risk of
metastasis, the recommendations can be challenging to implement as
they are based on a broad set of clinicopathologic risk factors,”
said first author Gaurav Singh, M.D., M.P.H., F.A.A.D.,
board-certified dermatologist and fellowship-trained Mohs surgeon
in Milwaukee. “The algorithm that we developed is not meant to
challenge these established guidelines. Rather, it is designed to
enhance existing risk-stratification approaches by integrating a
patient’s tumor biology into the decision-making process through
the use of DecisionDx-SCC test results and providing options for
clinicians to consider when deciding future steps in the care of
each patient.”
The DecisionDx-SCC test has been validated to independently
identify cSCC patients who have tumors with high metastatic
potential. In the study, three private-practice Mohs surgeons, who
routinely use the test to risk-stratify their high-risk cSCC
patients, merged their management approaches for three real-world,
high-risk cSCC patients into a singular algorithm that provides a
framework for incorporating each of the test’s three potential
results into current NCCN guidelines. This algorithm adds greater
specificity to the broad guidelines for the treatment of high-risk
cSCC patients, including surveillance imaging, sentinel lymph node
biopsy, adjuvant radiation therapy and clinical follow-up, which
frequently result in disparities in clinical practice and
management, and provide guidance on how to use each based on the
patient’s DecisionDx-SCC test results.
The three patient cases discussed in the paper provide support
for the clinical utility of DecisionDx-SCC to provide a more
definitive, risk-aligned use of these treatment modalities in an
effort to improve patient care and overall health outcomes. In all
three cases presented in the study, use of the algorithm
incorporating DecisionDx-SCC test results led to no evidence of
disease recurrence or metastasis post-treatment, based on the
timing described in the study. The study findings support the use
of DecisionDx-SCC test results within established guidelines to
enable personalized, risk-aligned management of high-risk cSCC
patients and the allocation of healthcare resources to patients at
the highest risk of a poor outcome.
About DecisionDx®-SCC
DecisionDx-SCC is a 40-gene expression profile test that uses an
individual patient’s tumor biology to predict individual risk of
cutaneous squamous cell carcinoma metastasis for patients with one
or more risk factors. The test result, in which patients are
stratified into a Class 1 (low), Class 2A (moderate) or Class 2B
(high) risk category, predicts individual metastatic risk to inform
risk-appropriate management. Peer-reviewed publications have
demonstrated that DecisionDx-SCC is an independent predictor of
metastatic risk and that integrating DecisionDx-SCC with current
prognostic methods can add positive predictive value to clinician
decisions regarding staging and management. More information about
the disease and test 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, 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 potential of DecisionDx-SCC
test results to assist clinicians in (i) tailoring their care for
patients with high-risk cSCC based on the patient’s unique tumor
biology, while adhering to guideline recommendations, and (ii)
identifying personalized, risk-aligned treatment pathway
improvements for patients with high-risk cSCC, based on the
patient’s tumor biology, which may help improve their disease
outcome. The words “can,” “may” 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-SCC 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 quarter 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.
- Singh G, Tolkachjov SN, Farberg AS. Incorporation of the
40-Gene Expression Profile (40-GEP) Test to Improve Treatment
Decisions in High-Risk Cutaneous Squamous Cell Carcinoma (cSCC)
Patients: Case Series and Algorithm. Clin Cosmet Investig Dermatol.
2023;16:925-935. https://doi.org/10.2147/CCID.S403330
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version on businesswire.com: https://www.businesswire.com/news/home/20230605005147/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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