Second Systematic Review & Meta-Analysis Published Demonstrating DecisionDx-Melanoma as Independent Predictor of Recurrence, ...
09 Julio 2020 - 7:17AM
Business Wire
Published Recently in SKIN: The Journal of
Cutaneous Medicine
Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer
diagnostics company providing personalized genomic information to
improve cancer treatment decisions, today announced the publication
of an independent, systematic review and meta-analysis
demonstrating that its DecisionDx®-Melanoma test is a significant
predictor of recurrence and metastatic risk in patients with
invasive cutaneous melanoma.
The article titled, “A Systematic Review and Meta-Analysis of
Gene Expression Profiling for Primary Cutaneous Melanoma
Prognosis,” appeared in SKIN: The Journal of Cutaneous
Medicine.
The study found that of all gene expression profile tests
reported for cutaneous melanoma, DecisionDx-Melanoma was the only
test described in the literature or commercially available with
sufficient evidence to qualify for inclusion in the study. This is
the second recently published systematic review and meta-analysis
that demonstrates the independence and significance of
DecisionDx-Melanoma prognosis for recurrence and metastatic risk in
patients with invasive cutaneous melanoma.
Lichtman et al. Study Background and Results:
- The purpose of this systematic review and meta-analysis was to
consolidate the rapidly evolving body of data on gene expression
profiling (GEP) in melanoma prognosis.
- This study was performed according to the Preferred Reporting
Items for Systematic Reviews and Meta-Analyses (PRISMA)1.
- The systematic review identified several GEP assays that have
been described in the literature. However, aside from
DecisionDx-Melanoma, none of the reported studies were supported by
consistent reporting of results or enough evidence for inclusion in
the meta-analysis performed by study co-authors.
- The DecisionDx-Melanoma test was found to be a consistent,
independent and significant predictor of survival, with a
significant association between Class 2 test results and
recurrence-free (Hazard Ratio [HR] = 7.22; p <0.00001), distant
metastasis-free (HR = 6.62; p <0.00001) and overall (HR = 7.06;
p <0.00001) survival rates.
- DecisionDx-Melanoma test results were also associated with
sentinel lymph node biopsy status (odds ratio calculation;
p<0.00001).
Results of the study indicate that the DecisionDx-Melanoma test
achieved the highest Strength of Recommendation Taxonomy (SORT)
level of evidence for a prognostic biomarker (Level 1 evidence).
The SORT system is used by the American Academy of Dermatology
(AAD) and other organizations to evaluate the quality, quantity and
consistency of evidence supporting tests such as
DecisionDx-Melanoma. The SORT scale evaluates both the quality of
the evidence (Level 1, 2 or 3) and strength of the recommendation
(A, B or C).
About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile test that uses
an individual patient’s tumor biology to predict individual risk of
cutaneous melanoma metastasis or recurrence, as well as sentinel
lymph node positivity, independent of traditional staging factors,
and has been studied in more than 5,700 patient samples. Using
tissue from the primary melanoma, the test measures the expression
of 31 genes. The test has been validated in four archival risk of
recurrence studies of 901 patients and six prospective risk of
recurrence studies including more than 1,600 patients. Prediction
of the likelihood of sentinel lymph node positivity has also been
validated in two prospective multicenter studies that included more
than 3,000 patients. Impact on patient management plans for one of
every two patients tested has been demonstrated in four multicenter
and single-center studies including more than 560 patients. The
consistent performance and accuracy demonstrated in these studies
provides confidence in disease management plans that incorporate
DecisionDx-Melanoma test results. Through March 31, 2020,
DecisionDx-Melanoma has been ordered more than 56,800 times for use
in patients with cutaneous melanoma.
More information about the test and disease can be found at
www.SkinMelanoma.com.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a commercial-stage
dermatologic cancer company focused on providing physicians and
their patients with personalized, clinically actionable genomic
information to make more accurate treatment decisions. The Company
currently offers tests for patients with cutaneous melanoma
(DecisionDx®-Melanoma, DecisionDx®-CMSeq; www.SkinMelanoma.com) and uveal melanoma
(DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq;
www.MyUvealMelanoma.com), with
products in development for other underserved cancers, the two most
advanced of which are focused on patients with cutaneous squamous
cell carcinoma, and patients who have a difficult-to-diagnose
pigmented lesion. Castle Biosciences is based in Friendswood, Texas
(Houston), and has laboratory operations in Phoenix, Arizona. For
more information, visit www.CastleBiosciences.com.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-UM,
DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle
Biosciences, Inc.
Forward-Looking Statements
The information in this press release contains forward-looking
statements and information 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 ability of DecisionDx-Melanoma test results to predict
recurrence and metastatic risk in patients with invasive cutaneous
melanoma. The words “anticipates,” “believes,” “estimates,”
“expects,” “intends,” “may,” “plans,” “projects,” “will,” “would”
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, the
risks set forth in our Annual Report on Form 10-K for the year
ended December 31, 2019, filed with the SEC on March 10, 2020, our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2020,
filed with the SEC on May 11, 2020, 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.
1 From the Preferred Reporting Items for Systematic Reviews and
Meta-Analyses (PRISMA) statement: Under PRISMA, a systematic review
evaluates a clearly formulated question using systematic and
explicit methods to identify, select, and critically appraise
relevant research, and to collect and analyze data from the studies
that are included in the review. Statistical methods
(meta-analysis) may or may not be used to analyze and summarize the
results of the included studies. Meta-analysis refers to the use of
statistical techniques in a systematic review to integrate the
results of included studies.
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Media and Investor Contact: Camilla Zuckero 832-835-5158
czuckero@castlebiosciences.com
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