Who can order our tests?

Castle Biosciences only accepts laboratory service orders from appropriate healthcare providers.

US: Castle's laboratory is a CAP accredited/
CLIA certified laboratory and has obtained its California laboratory license.

Other countries: We are able to accept orders from physicians in Canada, Latin America, Europe, Israel, and Australia

Welcome to Castle Biosciences,

a rare cancer molecular diagnostics company

Castle has six proprietary molecular diagnostic assays that are available for clinical use today:

DecisionDx-Melanoma

Test for cutaneous melanoma (DecisionDx-Melanoma)

The 60,000 people diagnosed each year with Stage I or II cutaneous melanoma are considered to be at low risk of their cancer spreading. However, approximately 8,500 of them will develop metastatic disease within 5 years. The new molecular test, DecisionDx-Melanoma, was developed to identify those patients whose tumor biology suggests they are at high risk of metastasis.

Validated in the largest cutaneous melanoma biomarker study of its kind, DecisionDx-Melanoma accurately distinguished between skin melanomas at low and high risk of metastasis and has been proven to add a much-needed level of clarity to the traditional process of determining metastatic risk.

The DecisionDx-Melanoma test is now available for clinical use.

To learn more, please visit
SkinMelanoma.com, a Castle site
dedicated to cutaneous melanoma
and the DecisionDx-Melanoma test.
click to learn more about DecisionDx-Melanoma
click to order DecisionDx-Melanoma

DecisionDx-EC

Test for esophageal cancer (DecisionDx-EC)

Today, standard of care for esophageal cancer includes pre-operative chemoradiation therapy for tumor shrinkage and stabilization as well as improved overall survival (National Comprehensive Cancer Network, 2013). Unfortunately, 20 to 35% of patients receiving chemoradiation do not experience clinical benefit, yet are exposed to the risks of therapy and potential unnecessary delay of surgery (Rohatgi, 2005; Dittrick, 2012).

The new DecisionDx-EC test is the first laboratory developed test to offer a way to predict the likelihood of response or extreme resistance to pre-operative chemoradiation therapy in individual patients with esophageal cancer. The test assesses three protein biomarkers from diagnostic biopsy tissue to provide validated biological information to help design personalized treatment plans. Initial clinical validation was performed at The University of Texas MD Anderson Cancer Center (Ajani, 2011). Castle Biosciences recently completed two parallel, multi-center independent validation studies (Lassen, 2013; Shan, 2014; Shan, 2014; Badve, 2014). The data from all three validation studies demonstrates that the DecisionDx-EC test is able to predict extreme resistance to chemoradiation therapy with very high specificity (>0.95), Positive Predictive Value (>0.95) and area under the Receiver Operating Characteristic curve (>0.95).

The DecisionDx-EC test is not currently available for clinical use while we are moving our facilities. We expect to have the move completed to be able to offer this laboratory developed test in the near future.

For inquiries, please contact us at 866-788-9007.

To learn more, please visit
MyEsophagealCancer.com, a Castle site
dedicated to esophageal cancer
and the DecisionDx-EC test.
click to learn more about DecisionDx-EC

The DecisionDx-UM uveal melanoma gene expression profile test is standard of care in the management of uveal melanoma, also known as ocular melanoma, choroidal melanoma, ciliary body melanoma, and iris melanoma.

Test for uveal melanoma (DecisionDx-UM)

Ocular melanoma, commonly known as uveal melanoma or choroidal melanoma, is a rare cancer of the eye. While the primary eye tumor is highly treatable, about half of patients are at high risk for metastasis (tumor spreading). Unfortunately, traditional staging methods used to assess the risk of metastasis are unreliable (have poor accuracy) and have not been routinely used to make clinical decisions regarding surveillance plans and treatment decisions.

The DecisionDx-UM test measures the gene expression profile, also called GEP, molecular signature, or gene expression patterns, of an ocular melanoma tumor and identifies with high accuracy the likelihood of metastasis. The DecisionDx-UM test has been formally compared in a prospective, multi-center 5-year study to both the traditional staging methods and to chromosome 3 testing. The DecisionDx-UM test was found to be clinically and statistically superior to both of these methods (Onken, 2012).

Today, the DecisionDx-UM test is standard of care in the management of ocular melanoma in the majority of ocular oncology practices. As of October, 2012, over 100 of the estimated 110 U.S. ocular oncology centers have adopted the DecisionDx-UM test for their patients with ocular melanoma. The National Comprehensive Cancer Network (NCCN), a group of the most recognized and respected comprehensive cancer centers in the US, recommends that the clinical utility of tumor markers in oncology be determined in a prospective clinical trial, similar to the type of study required for new drugs (Febbo, 2011). Though the NCCN has not specifically evaluated DecisionDx-UM, it is the only prognostic test in uveal melanoma that would meet this strict standard for the highest level of evidence as it is the only such test to be validated in a prospective, multi-center study. Additionally the American Joint Committee on Cancer recommends gene expression profile testing for use as the results are "clinically significant." The American Joint Committee on Cancer (AJCC, version 7, 2010) is the only national organization that reviews uveal melanoma and the DecisionDx-UM test is the only clinically available gene expression profile test for use in the U.S.

To learn more, please visit
MyUvealMelanoma.com, a Castle site
dedicated to uveal melanoma
and the DecisionDx-UM test.
click to learn more about DecisionDx-UM
click to order DecisionDx-UM

The DecisionDx-Thymoma gene expression profile test has been shown to be more accurate than Masaoka stage, extent of resection, and WHO classification in predicting the likelihood of metastasis or recurrence.

Test for thymic cancer (DecisionDx-Thymoma)

DecisionDx-Thymoma is a gene expression profile test that diagnoses which thymic cancer patients have, as well as predicts how aggressive the tumor may be. Based on recent advances in genomic medicine, the DecisionDx-Thymoma test adds objective, biology-based information to the traditional means of determining a thymic tumor’s likely behavior. Designed to measure the activity of 23 genes within the tumor, DecisionDx-Thymoma can help doctors make the difficult distinction between thymic carcinoma, an aggressive cancer, and thymoma, a slower-growing tumor that can eventually spread beyond the thymus. For those patients diagnosed with thymoma, the DecisionDx-Thymoma test can also provide a prognosis, or the likelihood that the tumor will metastasize.

DecisionDx-Thymoma was validated in an independent, multi-institutional study that found the molecular test to be more accurate than, and independent of, current staging methods used to predict metastasis and guide pre- and post-operative treatment in thymoma. With the test’s added information, patients and their doctors can make more accurate, personalized decisions about appropriate treatment options based on their individual tumor biology.

The DecisionDx-Thymoma test should be used in conjunction with the other clinical and pathologic factors in determining the appropriate treatment plan for an individual patient.

To learn more, please visit
ThymicCancer.com, a Castle site
dedicated to thymic cancer
and the DecisionDx-Thymoma test.
click to learn more about DecisionDx-Thymoma
click to order DecisionDx-Thymoma

The DecisionDx-G-CIMP test is an objective test that identifies the methylation profile (so called CIMP+ or CIMP-) of a  glioma and predicts survival for patients treated with standard of care.

Test for methylation profile of gliomas (DecisionDx-G-CIMP)

Gliomas are graded as either WHO grade 2, 3 or 4. These WHO grades are primarily used to determine the appropriate treatment plan for an individual patient. Interventions such as surgical approach and dosing with radiation and/or chemotherapy are based largely on subjective WHO grading, imaging, and other clinical and pathologic factors.

The WHO grades are achieved through traditional, subjective histopathological techniques and are meant to predict likelihood of survival (prognosis). Multiple studies have shown clinically significant inter-observer and intra-observer variances – some showing error rates of 40% or more. While the WHO grading system does distinguish differences in overall survival between grades (with grade 2 having the longest overall survival and grade 4 the shortest), there is a wide range in overall survival between grade 2 and 3 and significant overlap. What this means is some patients with a grade 2 diagnosis may have a tumor-specific (functional) prognosis that is closer to an average grade 3. Receiving a grade 2 treatment plan may represent under-treatment relative to the tumor-specific prognosis. Likewise, the tumor-specific prognosis of some grade 3 tumors may be closer to the median grade 2 survival and these patients may be relatively over-treated.

The DecisionDx-G-CIMP test is an objective test that identifies the methylation profile (so called CIMP+ or CIMP-) of a glioma and predicts survival for patients treated with standard of care. The DecisionDx-G-CIMP test has been prospectively validated as a secondary endpoint in the multi-center Radiation Therapy Oncology Group 0525 study (RTOG-0525). Thus, the DecisionDx-G-CIMP test has achieved the National Comprehensive Cancer Network (NCCN) Level of Evidence 2B. The DecisionDx-G-CIMP test is intended to be used in conjunction with WHO grade, imaging and other clinical factors in determining the appropriate treatment plan for an individual patient.

click to learn more about DecisionDx-G-CIMP
The DecisionDx-GBM gene expression profile test has been compared to MGMT methylation status and clinical factors and found to be an independent predictor of survival for patients receiving temozolomide.

Test for glioblastoma (DecisionDx-GBM)

Glioblastoma, also known as glioblastoma multiforme or GBM, is the most common and aggressive form of brain cancer.

GBM is graded using traditional histopathology techniques, but these fail to identify an individual's prognosis or likelihood of response to today’s standard of care treatment which consists of radiation with temozolomide. The DecisionDx-GBM test was developed to enable doctors to identify those patients with a high likelihood of long-term response to this treatment compared to those who may be refractory to the same treatment. The results are reported as a Class 1 pro-neural phenotype or a Class 2 mesenchymal / angiogenic phenotype. The DecisionDx-GBM test has been compared to MGMT methylation status and clinical factors and found to be an independent predictor of survival for patients receiving temozolomide. The DecisionDx-GBM test was also evaluated as a secondary endpoint in the prospective multi-center Radiation Therapy Oncology Group 0525 study (RTOG-0525). Similar to the earlier studies, this study found that the DecisionDx-GBM test demonstrated greater differentiation between long-term (Class 1) and average (Class 2) overall survival than methylation status using MGMT testing (Aldape, 2011). The DecisionDx-GBM test has achieved the National Comprehensive Cancer Network (NCCN) Level of Evidence 2B.

The DecisionDx-GBM test is intended to be used in conjunction with WHO grade and other clinical factors in determining the appropriate treatment plan for an individual patient.

click to learn more about DecisionDx-GBM
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