Please call our customer service staff at 866-788-9007 or email.
Castle offers three tests for patients with uveal melanoma that can all be run from a single tumor biopsy sample: DecisionDx-UM (standard of care-adopted by ~90% of ocular oncology centers); DecisionDx-PRAME (optional supplemental test); DecisionDx-UMSeq (optional supplemental test). The DecisionDx-UM test is the most extensively validated prognostic method for uveal melanoma and is considered standard of care due to its wide acceptance by physicians and its inclusion in national guidelines.
DecisionDx-UM is Castle’s 15-gene expression profile (GEP) test that uses tumor biology to predict a patient’s individual risk of cancer metastasizing (spreading to other parts of the body). DecisionDx-UM is the standard of care in the management of uveal melanoma in the majority of ocular oncology practices in the United States. Since its availability in 2009, over 15,000 patients have been clinically tested with DecisionDx-UM.
The DecisionDx-UM test measures the gene expression profile (GEP), or molecular signature, of a patient’s primary tumor to determine the risk that the tumor will spread (metastasize) from the eye to other parts of the body. The test is validated for expression profile (GEP), or molecular signature, of a patient’s primary tumor to determine the risk that the tumor will spread (metastasize) from the eye to other parts of the body. The test is validated for use on both fine needle aspirate biopsy (FNAB) tissue and formalin-fixed, paraffin-embedded (FFPE) tissue. Test results are typically reported within two weeks of receiving the biopsy sample from the treating physician.
The DecisionDx-UM test can tell you whether your eye tumor falls into one of three classes, identifying the statistical risk of metastasis over the next five years, the period for which scientific data has been collected. These include:
- Class 1A: Low risk, with a 2% chance of metastasis over five years
- Class 1B: Intermediate risk, with a 21% chance of metastasis over five years
- Class 2: High risk, with a 72% chance of metastasis over five years
If you choose to have the test, timing is critical. For patients undergoing radiation treatment, a small sample of the tumor tissue must be taken before surgery as radiation may alter the genes in your tumor and skew the lab results. If the treatment plan is enucleation, the tumor sample can be provided either from a biopsy taken at the time of enucleation, or by obtaining tissue slides from the wax block (FFPE) made following surgery and maintained in the pathology lab.
The DecisionDx-UM test requires a tiny sample of your tumor, commonly taken with a very thin needle (called a fine needle aspirate biopsy or FNAB). If you are having radiation treatment, your doctor must take the sample before surgery. Thousands of biopsy procedures have been performed safely in uveal melanoma, and the literature suggests that complications are rare. However, as with any surgical intervention, the potential risks should be fully discussed and considered with your doctor.
The DecisionDx-UM test can only be ordered by your physician or other appropriate healthcare provider—usually an ocular oncologist, retinal specialist, or ophthalmologist. Currently, a majority of ocular oncology specialists in the country offer DecisionDx-UM to their patients. If your doctor does not perform the test and you would like further information, you can call Castle Biosciences customer service at 866-788-9007 option #1.
DecisionDx-UM results provide critical prognostic information for you and your doctor to determine the most appropriate plan for monitoring for metastatic disease and potential treatment. While the test cannot, at this point, guide your doctor toward a specific treatment, recent studies show that the results are being used to develop personalized monitoring plans based on a patient’s metastatic risk, initiate referral to a medical oncologist for treatment planning, and refer appropriate high-risk patients to clinical trials.
The DecisionDx-UM test is the most accurate prognostic test for uveal melanoma available. Data from an independent, prospective study of 494 patients conducted by the Collaborative Ocular Oncology Group (COOG) showed that the GEP test (DecisionDx-UM) could successfully classify tumors more than 97 percent of the time. There are now more than 20 published studies supporting use of the DecisionDx-UM test.
Castle’s Clinical Services Team can tell you whether there is residual sample remaining after testing is complete. For inquiries regarding residual sample, call 866-788-9007 and select option #1.
Castle began storing residual tissue after DecisionDx-UM testing in mid-2015. If your biopsy was collected after that time, Castle may have residual tumor tissue remaining following your DecisionDx-UM test. If enough residual tissue is remaining, your provider may request that these additional tests be performed on your sample.
Castle Biosciences works with all insurance providers, including Medicare, Medicaid, commercial insurers, and the VA, to secure payment for the DecisionDx-UM test. Castle will submit insurance claims and manage the insurance billing process on behalf of patients. The company also sponsors an industry-leading Patient Assistance program with the belief that quality care should not depend on financial considerations. For more information about insurance coverage, claims processing and financial assistance call 866-788-9007 and select option #3.
Please call our customer service staff at 866-788-9007 or email.
TissueCypher provides a risk score and probability of development of high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) within five years. In a recent study by the Mayo Clinic, TissueCypher was shown to independently predict increased risk of progression to HGD/EAC and was also shown to be a stronger predictor of progression than other traditional risk factors like age, sex, segment length, and even expert pathology. Multiple published studies have shown that TissueCypher has a higher positive predictive value than these traditional risk factors, e.g., patients who receive a TissueCypher high-risk score progress at a higher rate than patients with confirmed low-grade dysplasia.
The majority of people tested with TissueCypher receive a low-risk score, which is expected because most Barrett’s esophagus patients don’t progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). A high-risk score gives your healthcare provider an opportunity to align your treatment to your predicted risk of progression, to escalate care and intervene early.
TissueCypher has been in clinical use since 2016 and has been validated in five clinical validation studies using one of the largest sets of BE progressors ever assembled.
The goal of the TissueCypher test is to predict your personalized risk of progressing to high-grade dysplasia or esophageal cancer. Knowing this potential risk helps your physician gauge how aggressively to treat your Barrett’s esophagus. Your TissueCypher test result includes a risk score and a five-year probability of progression to high-grade dysplasia or esophageal cancer. For example, a risk score of 8.0 has an associated five-year probability of progression of 27%. This means that during the clinical validation studies, 27% of patients with a risk score of 8.0 progressed to high-grade dysplasia or esophageal cancer within five years. Knowing your personalized risk enables your physician to make risk-aligned adjustments to your care plan.
This type of testing is an emerging, fast-growing field, so your doctor may not be aware of all of the tests that are now available to guide disease management decisions. If your doctor is interested in more information beyond our test descriptions on this website, please refer them to Castle Biosciences’ customer service (at 412-920-3050 or email).
Barrett's esophagus is a condition in which healthy cells in the esophagus turn into unhealthy cells. The esophagus is the tube that carries food from the mouth to the stomach. When acid from the stomach comes up into the esophagus (called Gastroesophageal Reflux Disease, or GERD), it can damage the cells that line the esophagus. In some people, Barrett's esophagus can become more serious and develop into cancer. While very serious, esophageal cancer can be prevented if the unhealthy cells found in high-risk Barrett's esophagus patients are treated before they turn into cancer.
The TissueCypher Barrett’s Esophagus test is the first test of its kind that predicts your risk for developing esophageal cancer if you have Barrett’s esophagus. It is intended for people with Barrett’s esophagus who have had an endoscopy procedure with biopsies. The test analyzes the biopsies taken during your endoscopy to produce a risk score that ranges from 0-10, with 0 being the lowest risk and 10 being the highest risk for developing more serious esophageal disease or cancer. Importantly, the test provides personalized information that can predict your chances for developing cancer.
TissueCypher provides increased confidence that treatment decisions are tailored to each individual patient, leading to more personalized and precise care. The TissueCypher test is designed to:
- Be performed on existing biopsies taken during previous endoscopies; a repeat biopsy is NOT necessary.
- Identify patients at high risk of progression to esophageal cancer within five years of biopsy.
- Help detect existing high-risk disease or cancer that might have been missed by standard endoscopic surveillance.
- Identify patients who have a very low risk of progressing to cancer within five years of biopsy, providing additional information to help optimize surveillance strategy.
Additionally, the test has been shown to outperform predictions based on standard pathology alone.
The TissueCypher test can be used after you have had an endoscopy with biopsies that have been confirmed by a pathologist to contain Barrett’s esophagus. Test results are reported directly to your healthcare provider approximately 18 to 20 business days from the date your sample is received by Castle Biosciences.
Castle Biosciences works with all insurance providers, including Medicare, Medicaid, commercial insurers, and the VA, to secure payment for your TissueCypher test. Castle will submit your insurance claim and manage the insurance billing process on your behalf. The company also offers an industry-leading Patient Assistance Program with the belief that quality care should not depend on financial considerations.
You can get more information about insurance coverage, claims processing and financial assistance by calling 866-788-9007 and selecting option #3.
Only a physician, physician assistant, or nurse practitioner can order a TissueCypher test.
Please call our customer service staff at 866-788-9007 or email.
The MyPath Melanoma GEP test will return a result of suggestive of benign, intermediate, or suggestive of malignant. The results are incorporated with all other clinical and pathological findings to inform a more definitive diagnosis and guide patient management.
Only a physician, physician assistant, or nurse practitioner can order MyPath Melanoma.
The accuracy of MyPath Melanoma has been assessed in multiple studies. The sensitivity and specificity of MyPath Melanoma have been reported as 90-97% and 89-86% respectively.
Please call our customer service staff at 866-788-9007 or email.
Castle Biosciences works with all insurance providers, including Medicare, Medicaid, commercial insurers, and the VA, to secure payment for the DecisionDx-SCC test. Castle will submit insurance claims and manage the insurance billing process on behalf of patients. The company also sponsors an industry-leading Patient Assistance program with the belief that quality care should not depend on financial considerations. For more information about insurance coverage, claims processing and financial assistance call 866-788-9007 and select option #3.
If you wish to have the DecisionDx-SCC test, please discuss it with your healthcare provider. Only a healthcare provider (physician, physician assistants, or nurse practitioner) can order this test.
Your healthcare provider can use your test results, in combination with other information and procedures, to personalize your treatment and follow-up care. For example, if your tumor is low (Class 1), routine treatment options may be a reasonable choice, avoiding unnecessary treatments and frequent follow-up unless they become necessary later. Conversely, if your test results identify your tumor as moderate or high biological risk (Class 2A or 2B) perhaps a more aggressive approach to treatment.
The DecisionDx-SCC genomic test measures the biological activity of specific genes in your tumor that tell how likely it is for your tumor to spread or metastasize. The DecisionDx-SCC test identifies the risk of squamous cell tumors spreading better than traditional measures alone. It is intended to be used in patients with an SCC diagnosis and the presence of one or more traditional risk factors.
Having an accurate understanding of the risk of your cancer metastasizing (spreading) is a critical part of determining the right approach to your treatment and ongoing management of SCC. Similar to other cancers, treatment plans for SCC are based upon the likelihood that your tumor may spread or metastasize. Traditionally, this was estimated using only the presence or absence of risk factors. Traditional factors that indicate your tumor may be at a higher risk include: tumors that are large in size or appear in specific locations (i.e., ear, lip and temple); tumors that look “poorly differentiated” (disorganized) under the microscope; tumors that approach and invade nerves (perineural involvement); tumors that are found to be deep; during surgery, you have immunosuppression; tumors that are growing rapidly.
The DecisionDx-SCC test sample is taken from your original biopsy or surgery, so there is no need for another procedure. Once completed, test results are sent directly to your healthcare provider.
The DecisionDx-SCC test result provides a genomic-based determination of your tumor’s likelihood to metastasize within the next 3 years. The test classifies Class 1 (low), Class 2A (moderate), and Class 2B (high) biological risk of metastasis. Most patients have low or moderate biological risk.
The laboratory will send a report with the test results to your healthcare professional within approximately 5 days after receiving the tumor sample in our laboratory.
Your healthcare professional (physician, physician assistant, or nurse practitioner) needs to order the test for you. The test can also be requested via an online portal.
DecisionDx-Melanoma provides you and your healthcare professional with personalized information to help inform decisions about your follow-up management and care plan. The test identifies the likelihood that your tumor could recur or spread within the next five years. For most patients eligible for a sentinel lymph node biopsy, the test can also provide information to help make decisions about this surgical procedure. This information should be helpful for you and your healthcare professional to decide on a treatment plan. Your care team will incorporate the DecisionDx-Melanoma results based on your individual situation, together with results from other tests and procedures.
Please call our customer service staff at 866-788-9007 or email.
Molecular diagnostic testing is a fast-growing field, so your healthcare professional may not know about all of the tests that are now available. If your healthcare professional is interested in more information, please ask them to contact us at 866-788-9007.
Castle Biosciences works with all insurance providers, including Medicare, commercial insurers, and the VA, to secure payment coverage for tests. Castle will submit insurance claims and manage the insurance billing process on behalf of patients. The company also sponsors an industry-leading Patient Assistance Program with the belief that quality care should not depend on financial considerations.
Castle Biosciences operates clinical laboratories in Phoenix and Pittsburgh. The Company’s laboratories are College of American Pathologists (CAP) accredited and Clinical Laboratory Improvement Amendments (CLIA) certified, reflecting the Company’s commitment to high-quality standards and excellence in patient care. Castle's laboratories are licensed to perform tests throughout the United States.
No. Only healthcare professionals (physician, physician assistants, or nurse practitioner) can order a test from Castle Biosciences. If you need help finding a healthcare professional who can order the test for you, please contact our customer service team at 866-788-9007 or email us..