New independent, multi-center study found that
patients who received high-risk DecisionDx-Melanoma test results
received routine imaging, which led to earlier detection of
recurrences, when the tumor burden was lower, which could result in
better clinical outcomes
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced the publication of an independent, multi-center study in
the Archives of Dermatological Research providing a direct chain of
evidence that use of DecisionDx®-Melanoma test results to guide
radiological surveillance could lead to improved patient outcomes.1
The study, authored by Dhillon et al., can be found here.
“Published clinical use data, coupled with improved responses
with immunotherapy when the metastatic tumor burden is lower, has
previously shown an indirect chain of evidence between the clinical
use of our DecisionDx-Melanoma test and improved outcomes due to
early detection of metastasis and therefore early treatment
intervention,” said Derek Maetzold, president and chief executive
officer of Castle Biosciences. “We believe this study is
significant in that it provides a direct chain of evidence between
the use of DecisionDx-Melanoma to guide treatment plan decisions,
which could result in improved survival compared to patients from
the same institution who did not have their treatment plans
informed by our test.”
DecisionDx-Melanoma has been validated to inform two clinical
decisions in the management of patients with cutaneous melanoma
(CM) that are made in the acute post-diagnosis time period:
1) Use of a sentinel lymph node biopsy (SLNB)
surgical procedure,2 and 2) The subsequent risk-guided follow-up
and management plans that are differentiated between patients who
have a high versus a low likelihood of metastasis.3
“In melanoma, as in all cancers, treatment plan decisions are
guided by the risk of disease recurrence and metastasis,” continued
Maetzold. “In this study, the authors controlled for SLNB (all
patients underwent the procedure and were negative) and evaluated
the impact of implementing risk-guided metastatic surveillance
treatment plans for patients with a high-risk DecisionDx-Melanoma
test result versus standard of care under the current guidelines.
The direct improvement in melanoma-specific survival is what we
would expect based upon indirect chain of evidence analyses.”
The Dhillon et al. study, conducted at three National Cancer
Institute-designated cancer centers, included patients with Stage I
or II CM who had a negative SLNB. The experimental group was
comprised of patients who had received high-risk
DecisionDx-Melanoma test results and thus received routine imaging
every six to twelve months. Patients in the control group did not
receive DecisionDx-Melanoma testing and had imaging studies driven
only by clinical symptoms or physical exam findings.
Key findings of the study include:
- Patients in the experimental group who received
DecisionDx-Melanoma testing and surveillance imaging had melanoma
recurrences detected approximately ten months earlier than patients
in the control group (p=0.049).
- The average tumor burden detected at patients’ melanoma
recurrence was significantly lower in the experimental group
compared to the control group (27.6 mm vs. 73.1 mm; p=0.027). Note:
recent studies cited in the paper suggest a survival benefit when
metastatic melanoma is treated at a lower tumor burden.
- Of the patients with a recurrence, 82% in the experimental
group and 71% in the control group started immunotherapy.
- At patients’ last follow up, 76% of the patients with melanoma
recurrence in the experimental group were alive (average follow-up
time=45.6 months), compared to 50% of recurrent melanoma patients
in the control group (average follow-up time=63.3 months)
(p=0.027).
Overall, the study found that using DecisionDx-Melanoma to
risk-stratify patients to guide care resulted in earlier detection
of melanoma recurrence while the tumor burden was lower, which
could lead to improved patient outcomes.
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 potential of
DecisionDx-Melanoma to improve patient outcomes, including improved
survival, as a result of treatment plans being informed by the
DecisionDx-Melanoma test result. The words “can,” “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
recommendations and guidelines presented in this report, 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; the design of the study
referenced in this press release is subject to certain limitations,
including the retrospective nature of the study, limited sample
size of patients, lack of uniform imaging protocols among the three
sites (including the type of imaging study recommended),
differences in surveillance intervals, and differences in patient
follow-up lengths for patients with recurrence; and the risks set
forth under the heading “Risk Factors” in our Annual Report on Form
10-K for the twelve months 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.
- 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.
Accessed April 10, 2023.
- Whitman E, Koshenkov V, Gastman B, et al. Integrating 31-Gene
Expression Profiling with Clinicopathologic Features to Optimize
Cutaneous Melanoma Sentinel Lymph Node Metastasis Prediction. JCO
Precis Oncol. 2021;(5):1466-1479. doi:10.1200/PO.21.00162
- Jarell A, Gastman B, Dillon L, et al. Optimizing treatment
approaches for patients with cutaneous melanoma by integrating
clinical and pathologic features with the 31-gene expression
profile test. J Am Acad Dermatol. 2022. doi:
https://doi.org/10.1016/j.jaad.2022.06.1202
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Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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