Castle Biosciences Announces Multiple Data Presentations at the 2023 American Society for Dermatologic Surgery Annual Meeting
14 Noviembre 2023 - 6:00AM
Business Wire
Video abstracts reinforce the clinical validity
and utility of the Company’s skin cancer test portfolio, including
DecisionDx®-Melanoma, DecisionDx®-SCC and MyPath® Melanoma
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced that data spanning its dermatologic portfolio of gene
expression profile (GEP) tests was recently presented at the 2023
American Society for Dermatologic Surgery (ASDS) Annual Meeting in
Chicago.
“The robust data presented at ASDS underscores the value of GEP
testing across multiple skin cancer indications” said Robert Cook,
Ph.D., senior vice president of research and development at Castle
Biosciences. “The studies presented reinforce our commitment to
research and development and showcase the utility of our tests in
guiding more informed and risk-aligned patient care.”
Highlights from Castle’s seven video abstracts presented at ASDS
are included below.
DecisionDx®-Melanoma
- Clinically significant risk-stratification prediction in
stage I cutaneous melanoma with the integrated 31-gene expression
profile (i31-GEP) Presenting Author: Michael Tassavor,
M.D., Skin Cancer Center, Cincinnati Summary: No specific
risk threshold provides clinicians guidance regarding when to alter
treatment plans or increase management intensity for patients with
stage I cutaneous melanoma (CM). The study data demonstrated the
ability of the DecisionDx-Melanoma test to identify patients with
stage I CM at high risk of tumor recurrence (recurrence free
survival of 89.8%, p=0.002).
- View video abstract here.
- Validation of the i31-GEP for sentinel lymph node biopsy
metastasis in patients with T1b-T2a cutaneous melanoma: Results of
an independent performance study First Author: Peter A.
Prieto, M.D., MPH, University of Rochester Medical Center,
Rochester, New York Summary: National Comprehensive Cancer
Network (NCCN) guidelines recommend that the sentinel lymph node
biopsy (SLNB) procedure can be considered for patients with an
expected risk of SLN positivity above 5%. In this independent
cohort of patients with T1b-T2a tumors (n=177), the
DecisionDx-Melanoma test identified patients with less than 5% risk
of SLN positivity who may consider foregoing the procedure and
could have reduced the number of SLNBs by 45% in T1b tumors, 14% in
T2a tumors and 28% overall.
- View video abstract here.
DecisionDx®-SCC
- Association of a 40-gene expression profile with risk of
metastatic disease progression of cutaneous squamous cell carcinoma
(cSCC) and benefit of adjuvant radiation therapy (ART)
Presenting Author: Sarah Arron, M.D., Ph.D., Peninsula
Dermatology, Burlingame, California Summary: ART is
recommended based on high-risk clinicopathologic features of SCC,
but these criteria are wide-ranging, encompassing a broad range of
patients. Thus, many patients receive treatment with only a subset
appearing to benefit. This study determined that the DecisionDx-SCC
test can identify patients who would most likely benefit from ART
to reduce metastatic disease progression. Specifically, patients
with a Class 2B (highest metastatic risk) test result who were
treated with ART had 50% higher metastasis-free survival rates than
Class 2B patients who did not receive ART. Additionally, a
DecisionDx-SCC Class 2B result was the only risk factor that
successfully identified patients who would benefit from ART.
- View video abstract here.
- Using the 40-gene expression profile (40-GEP) test in
Medicare-eligible cutaneous squamous cell carcinoma (cSCC) patients
reduces healthcare costs when guiding adjuvant radiation therapy
(ART) decisions Presenting Author: Aaron S. Farberg,
M.D., Baylor Scott & White Health System, Dallas
Summary: The study aimed to determine if using the
DecisionDx-SCC test to guide ART decisions could reduce healthcare
costs in the management of cSCC. The study found that using the
DecisionDx-SCC test to guide ART decisions for Medicare-eligible
cSCC patients could result in cost savings to the healthcare system
ranging from $145 million to approximately $1 billion
annually.
- View video abstract here.
- Incorporating the 40-gene expression profile (40-GEP) test
in clinicopathologic staging improves metastatic risk assessment
for cutaneous squamous cell carcinoma (cSCC) patients with one or
more high-risk factors Presenting Author: Sarah Arron,
M.D., Ph.D. Summary: Three clinicopathologic-based risk
assessment systems (Brigham and Women’s Hospital (BWH) staging,
American Joint Committee on Cancer 8th Edition (AJCC8) staging and
NCCN) are used to guide treatment pathway decisions in patients
with high-risk cSCC; however, each has accuracy limitations. The
large, combined cohort (including 420 patients from the initial
validation cohort and 534 patients from a novel, independent
cohort) confirmed that the DecisionDx-SCC test provides significant
risk stratification within high-risk cSCC patients. Multivariate
and likelihood analyses demonstrate the improvement of metastatic
risk prediction by the addition of DecisionDx-SCC in models that
include NCCN, BWH or AJCC8 systems.
- View video abstract here.
- The 40-gene expression profile (40-GEP) test demonstrates
impactful clinical utility in the management of cutaneous squamous
cell carcinoma (cSCC) patients Presenting Author: Brent R.
Moody, M.D., Skin Cancer Surgery Center, Nashville, Tennessee
Summary: This multicenter, retrospective study was designed
to explore physician management patterns for patient follow-up,
surveillance and treatments when including DecisionDx-SCC test
results as part of clinical care of patients with high-risk cSCC.
The study found that in a real-world patient cohort, the risk
stratification provided by the DecisionDx-SCC test was the most
influential factor in risk-aligned management changes.
Additionally, the test’s results were more significant in the
physicians’ decision to escalate or de-escalate care than any other
traditional risk factor considered in the study.
- View video abstract here.
MyPath® Melanoma
- Gene expression profiling in the diagnostic work-up of
melanocytic lesions Presenting Author: Hadas Skupsky, M.D.,
F.A.A.D., Laser Skin Care Center, Long Beach, California;
University of California Irvine, Irvine, California Summary:
MyPath Melanoma testing is available for ambiguous melanocytic
neoplasms to add clarity to diagnoses. Case studies were presented
utilizing a variety of immunohistochemical stains and testing with
MyPath Melanoma to aid in the determination of a final diagnosis
and inform surgical planning for otherwise diagnostically ambiguous
cases.
- View video abstract here.
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 Sept. 30, 2023, DecisionDx-Melanoma has been ordered more
than 146,000 times for patients diagnosed with cutaneous
melanoma.
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.
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.
More information about Castle’s tests 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 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, 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 continued value of GEP
testing across multiple skin cancer indications; our ability to
improve the care of patients with skin cancers and inflammatory
skin conditions through innovative tests that can guide more
informed disease management decisions; the potential of the
DecisionDx-Melanoma test to identify patients with stage I CM at
high risk of tumor recurrence; the continued ability of the
DecisionDx-Melanoma test was validated to identify patients with
less than 5% risk of SLN positivity; the ability of the
DecisionDx-SCC test to (i) identify patients who would most likely
benefit from ART to reduce metastatic disease progression, (ii)
result in cost savings to the healthcare system ranging from $145
million to approximately $1 billion annually, (iii) provide
significant risk stratification within high-risk cSCC patients,
(iv) influence physicians’ decisions to escalate or de-escalate
care; the ability of MyPath Melanoma to (i) aid in the
determination of a final diagnosis and inform surgical planning for
otherwise diagnostically ambiguous cases and (ii) reduce
uncertainty and provide confidence for dermatopathologists and help
dermatologists deliver more informed patient management plans; and
the ability of DecisionDx-Melanoma to provide a comprehensive and
clinically actionable result to guide risk-aligned patient care.
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
DecisionDx-Melanoma, DecisionDx-SCC, MyPath Melanoma and Castle’s
inflammatory skin disease pipeline test 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, 2022, our Quarterly Report on Form 10-Q for the three
months ended September 30, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231114709329/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com Media Contact: Allison
Marshall amarshall@castlebiosciences.com
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