Overview of our Tests
Overview of our Tests
Providing Personalized, Tumor-Specific Information
We are dedicated to helping cancer patients and their healthcare providers make more accurate treatment plan decisions. Nearly all treatment plan decisions for patients diagnosed with skin cancers is based upon the expected risk of metastasis or recurrence – also called prognosis.
Traditionally, these treatment decisions have been based solely on clinical and pathology factors, such as the thickness or width of your tumor, other features like ulceration or evidence the tumor may have spread to a sentinel lymph node, or SLN. Physicians use these factors to group, or stage, patients into stage-related populations. The average risk of metastasis within a population then guides treatment decisions for all patients within a respective population. However, an individual patient’s risk of metastasis can be significantly different from these stage-related population averages, thereby resulting in some patients receiving unnecessary medical and surgical interventions and some patients being undertreated. This treatment paradigm has led to suboptimal patient care and unnecessary costs to the healthcare system.
We use the biological behavior, as measured through the activity or expression of genes, from your specific tumor to identify the risk of recurrence or metastasis. This biological behavior has been shown to be an independent predictor of your specific tumor’s risk of recurrence or metastasis, that is, the information is independent of what your healthcare provider and pathologist may see clinically or upon evaluation of your tumor biopsy under a microscope.
Helping You And Your Doctor Make Better Treatment Decisions
Healthcare providers can use our test results to consider changing the direction of the treatment plan that was considered when solely relying upon clinical and pathology factors only. In the case of our test for use in cutaneous melanoma, DecisionDx®-Melanoma, four out of four studies have shown that the treatment plan considered before our test results are incorporated changes 50% of the time – or rather every one of two tests results in a change in the treatment plan.
Our Current Tests Focus On Skin Cancers And Uveal Melanoma
Approximately 130,000 patients are diagnosed each year with cutaneous melanoma, which we believe is underreported.
Treatment plan decisions made just after the time of diagnosis of melanoma are based on the risk of recurrence or metastasis as estimated from traditional clinical and pathology factors. These factors may lead to a recommendation to perform a sentinel lymph node biopsy surgical procedure – which is a prognostic procedure to gain additional information on the likelihood of your tumor’s risk of metastasis. Unfortunately, these traditional factors often miss many early-stage (Stage I and II) patients who later develop aggressive metastatic disease. In fact, two out of three patients who develop metastatic disease and die from their primary melanoma tumor were initially classified as Stage I or II, many of whom received an SLN-negative biopsy result following SLNB surgery.
DecisionDx-Melanoma is designed to identify those tumors at high risk of recurrence as well as at low risk of recurrence, thereby enabling their doctors to make more informed treatment plan decisions – some of which may lead to an increase in actions and some of which may lead to a decrease.
Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (SCC), non-melanoma skin cancer, is one of the most common cancers with an estimated incidence of more than 1,000,000 cases in the U.S. each year. Approximately 20% of patients have high-risk factors based on tumor depth, histology, anatomic location, and/or immunosuppression. Most patients have a favorable prognosis, but a subset of patients will develop metastasis and up to 15,000 patients, each year die from their disease – more than are estimated to die from cutaneous melanoma.
Squamous cell skin cancer (SCC) is one of the most common types of skin cancer. If you are diagnosed with SCC and one or more risk factors, DecisionDx-SCC can provide you with accurate and personalized information to help guide decisions about your treatment and ongoing management. The DecisionDx-SCC test identifies the risk of squamous cell tumors spreading better than traditional measures alone. Your healthcare provider can use the test information in combination with other clinical information to personalize your treatment and follow-up care. For example, if your tumor is Class 1 (low risk), routine treatment options may be a reasonable choice, avoiding unnecessary treatments and frequent follow-up unless they become necessary later. However, if your test results identify your tumor as Class 2A or 2B (moderate or high risk), perhaps a more aggressive approach to treatment would now be considered.
Following treatment of the primary eye tumor, treatment plan decisions focus on the monitoring schedule (frequency and type of tests), management by medical oncology or ocular oncology, and clinical trial enrollment. The DecisionDx®-UM prognostic test is a highly accurate predictor of the risk of your cancer returning and spreading. It is being used by more than 90% of the ocular oncology institutions to individualize their patients’ care plans after eye surgery with the potential to de-escalate or reduce the intensity of post-eye surgery treatment plans as well as assist in decisions to enroll in clinical trials.
Only a physician, physician’s assistant or nurse practitioner can order Castle Biosciences’ diagnostic and prognostic tests.
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