Two studies published in the Journal of
Cutaneous Pathology and Melanoma Management demonstrate the
significant disagreement that exists in the diagnosis of
melanocytic lesions using pathology alone, the variability of
surgical management of lesions among treating dermatologists, and
the risk-aligned changes and confidence in these decisions that can
result from GEP testing1,2
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced the publication of two recent studies that provide
further support for the clinical need of its MyPath® Melanoma gene
expression profile (GEP) test, designed to aid in providing an
accurate diagnosis for ambiguous melanocytic lesions of uncertain
malignant potential.
“For many concerning pigmented lesions, a definitive
histopathologic diagnosis is clear: a malignant melanoma or a
benign nevus,” said Matthew Goldberg, M.D., board-certified
dermatologist and dermatopathologist, and senior vice president,
medical, of Castle Biosciences. “For a substantial subset of
lesions, however, a final diagnosis can vary widely depending on
which dermatopathologist reviews a biopsy sample, as our study
further illustrated.”
A recent study published in the Journal of Cutaneous Pathology
found that in a large cohort of patients with suspicious lesions
(n=3,317), approximately 24% had differing diagnoses by the nine
board-certified dermatopathologists who reviewed samples in the
study, indicating that these lesions had ambiguous features and
were difficult to diagnose.1 “These findings support the need for
an objective diagnostic tool like MyPath Melanoma to aid in
providing an accurate diagnosis for ambiguous melanocytic lesions
in the context of other clinical and histopathological findings,”
added Goldberg.
Alexander Witkowski, M.D., Ph.D., dermatologist and assistant
professor of dermatology at the Oregon Health & Science
University in Portland, Oregon, a leading institution in the study
and research of melanoma, provided additional evidence supporting
the clinical need for GEP testing in another recent study published
in Melanoma Management, in which management changes in response to
GEP test results were analyzed for patients with ambiguous
melanocytic lesions.2 In the study, 32 board-certified
dermatologists reviewed 24 randomized patient scenarios in which
benign or malignant GEP test results were either provided or
blinded from respondents. The dermatologists were then asked a set
of standardized questions inquiring about how they would treat the
patient (e.g., no further treatment needed, surgical excision with
small margins, wide-local excision, etc.), which follow-up schedule
they would recommend and their confidence in that management
plan.
Without GEP guidance, variation in the surgical management of
each lesion was demonstrated, further supporting the need for GEP
testing in lesions with ambiguous diagnoses. The study data showed
that benign GEP results prompted 84.2% of clinicians to decrease
the recommended surgical margins for lesions, while malignant GEP
results prompted all the clinicians (100%) to increase their
surgical excision recommendations. Further, most clinicians (72.2%)
reduced and nearly all (98.9%) increased their follow-up frequency
for benign or malignant GEP results, respectively. There was also
an overall increase in patient management plan confidence with GEP
results (67.4% with benign results and 54.9% with malignant
results).
“GEP testing with MyPath Melanoma increases confidence and helps
to guide the management decisions dermatologists and other
healthcare providers make when choosing what to do with a
suspicious mole, particularly when the results of a pathology
report are unclear,” added Witkowski. “GEP testing provides
significant value for clinicians and patients, and that’s exactly
what we saw in our study. This molecular test provides an objective
data point that can help improve definitive melanoma diagnosis and
earlier treatment.”
About MyPath® Melanoma
MyPath Melanoma is Castle’s gene expression profile test
designed to provide an accurate, objective result to aid
dermatopathologists and dermatologists in characterizing
difficult-to-diagnose melanocytic lesions. Of the approximately two
million suspicious pigmented lesions biopsied annually in the U.S.,
Castle estimates that approximately 300,000 of those cannot be
confidently classified as either benign or malignant through
traditional histopathology methods. For these cases, the treatment
plan can also be uncertain. Obtaining accurate, objective ancillary
testing can mean the difference between a path of overtreatment or
the risk of undertreatment. Interpreted in the context of other
clinical, laboratory and histopathologic information, MyPath
Melanoma is designed to reduce uncertainty and provide confidence
for dermatopathologists and help dermatologists deliver more
informed patient management plans.
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,
Barrett’s esophagus, mental health conditions and uveal melanoma.
Additionally, the Company has active research and development
programs for tests in other diseases with high clinical need,
including its test in development to help guide systemic therapy
selection for patients with moderate-to-severe atopic dermatitis,
psoriasis and related conditions. To learn more, please visit
www.CastleBiosciences.com and connect with us on LinkedIn,
Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR,
DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher,
IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq 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: our ability to continue building
the evidence supporting our portfolio of clinically actionable
molecular tests and their use to improve decision-making for
patients with skin cancers; and the ability of MyPath Melanoma to
aid in providing an accurate diagnosis, including where
pathological diagnosis is uncertain, to help ensure appropriate
patient management. 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, including with respect to the discussion of MyPath
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 Annual Report on
Form 10-K for the year ended December 31, 2023, our Quarterly
Report on Form 10-Q for the three months ended June 30, 2024, 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.
- Hosler GA, Goldberg MS, Estrada SI, et al. Diagnostic
discordance among histopathological reviewers of melanocytic
lesions. J Cutan Pathol. 2024; 51(8): 624-633.
doi:10.1111/cup.14635
- Witkowski A, Jarell AD, Ahmed KL, et al. A clinical impact
study of dermatologists’ use of diagnostic gene expression profile
testing to guide patient management. Melanoma Manag. 2024;11(1).
doi: 10.2217/mmt-2023-0002
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version on businesswire.com: https://www.businesswire.com/news/home/20241016116017/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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