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Newly Published Independent Study on a Prospective Cohort Highlights DecisionDx-Melanoma Prognostic Test's Ability to Accurately Identify High-Risk Melanoma Patients

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Results from this second prospective study are consistent with prior
four clinical validation studies

Castle Biosciences, Inc., the skin cancer diagnostics company providing
molecular diagnostics to improve cancer management decisions, today
announced the publication of an independent study from a dermatology
practice, in a prospectively collected cohort, showing that the
DecisionDx®-Melanoma prognostic test can accurately identify
patients at high and low risk of metastasis and death from melanoma.
Patients identified as high risk were found to be 22 times more likely
to develop metastasis than those with a low-risk test result. Overall
this 256-patient study is consistent with previous prospective and
retrospective studies and confirms the prognostic value of the
DecisionDx-Melanoma test. The study was authored by Dr. Bradley Greenhaw
and colleagues and published in Dermatologic Surgery.

Study Findings:

  • High negative predictive value of 98.6% provides a high degree of
    confidence in a low risk of metastasis for Class 1 patients.
  • Class 2 patients were 22 times more likely to develop metastasis than
    patients with a Class 1 result.
  • The 5-year melanoma-specific survival (MSS) rate was also
    significantly different between groups with 99% survival for Class 1
    patients and 79% survival for Class 2 patients (p<0.0001).
  • The authors indicate that they now offer the DecisionDx-Melanoma test
    to all patients with invasive cutaneous melanoma and provide more
    intensive follow-up for Class 2 patients to support timely detection
    of metastasis and earlier intervention with therapy.

"These robust findings from an independent study demonstrating that the
DecisionDx-Melanoma test can identify early-stage melanoma patients who
are at high risk for metastasis and death are consistent with previous
retrospective and prospective studies," said lead author Bradley
Greenhaw, M.D., Dermatology Center of North Mississippi, Tupelo,
Mississippi. "In this dermatology practice, as in many others across the
country, the DecisionDx-Melanoma test has been incorporated into
practice protocols to improve patient management decisions based on
recurrence risk beyond clinicopathologic staging alone."

Study Details:

  • The study was conducted at a single dermatology center and included
    256 patients who were identified using the center's prospectively
    collected melanoma registry. Patients were diagnosed with cutaneous
    melanoma during the previous 5 years and were prospectively tested
    with DecisionDx-Melanoma as part of their initial diagnostic work-up
    or tested as part of their follow-up care. Retrospective chart review
    was used in cases of missing data in the registry.
  • 86% of patients had American Joint Committee on Cancer (AJCC) Stage I
    melanoma, and 14% had Stage II disease.
  • 214 patients had a Class 1 DecisionDx-Melanoma test result; 42
    patients were Class 2. Mean follow-up time was 23 months.

The paper can be accessed at the Dermatologic
Surgery
website
.

About DecisionDx-Melanoma

The DecisionDx-Melanoma test uses tumor biology to predict individual
risk of melanoma recurrence and sentinel lymph node positivity
independent of traditional factors. Using tissue from the primary
melanoma, the test measures the expression of 31 genes. The test has
been validated in three multi-center studies that have included 690
patients and have demonstrated consistent results. Performance has also
been confirmed in four prospective studies including 702 patients. The
consistent high performance and accuracy demonstrated in these studies,
which combined have included over 1,300 patients, provides confidence in
disease management plans that incorporate DecisionDx-Melanoma test
results.

Prediction of the likelihood of sentinel lymph node positivity has also
been validated in two prospective multicenter studies that included over
1,400 patients. Impact on patient management plans for one of every two
patients tested has been demonstrated in multi-center and single-center
studies. More information about the test and disease can be found at www.SkinMelanoma.com.

About Castle Biosciences

Castle Biosciences is a molecular diagnostics company dedicated to
helping patients and their physicians make the best possible decisions
about their treatment and follow up care based on the individual
molecular signature of their tumor. 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 development programs in other underserved cancers. Castle
Biosciences is based in Friendswood, Texas (Houston), and has laboratory
operations in Phoenix, Arizona. More information can be found at www.CastleBiosciences.com.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-UM,
DecisionDx-PRAME and DecisionDx-UMSeq are the trademarks of
Castle Biosciences, Inc. Any other trademarks are the property of their
respective owners.

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