DecisionDx-SCC Test: Identifying SCC Metastasis Risk

Accurately identifies the risk of metastasis in high-risk squamous cell carcinoma patients and predicts which patients are most likely to benefit from adjuvant radiation therapy (ART)

DecisionDx-SCC is a validated 40-GEP test that is designed to identify the risk of nodal or distant metastasis in squamous cell carcinoma patients (SCC) with at least one high-risk feature, based on the biological profile of 40 genes within their tumor tissue. In addition to being the strongest independent predictor of SCC metastasis, DecisionDx-SCC is shown to be a significant predictor of local recurrence, adding prognostic value to support tailored post-surgery* management decisions. The test also identifies which patients are most likely to benefit from ART. Test results deliver precision patient classification, complementing commonly used traditional risk factors and improving risk assessment in SCC to inform key clinical management decisions:

Adjuvant radiation therapy (ART)
Nodal evaluation; imaging and sentinel lymph node biopsy (SLNB)
Frequency of follow-up and surveillance

*Definitive Mohs surgery with no residual disease

Why DecisionDx-SCC?

TRADITIONAL RISK FACTORS MISS BIOLOGICAL RISK

The DecisionDx-SCC test provides strong, consistent information and is an independent risk stratification tool for SCC patients with one or more risk factors. The DecisionDx-SCC test is prognostic and predictive, and provides individualized information about the estimated risk of metastasis of SCC.

DECISIONDX-SCC INFORMS RISK-APPROPRIATE PATIENT MANAGEMENT

Results deliver precision patient classification to identify patients with high biological risk who would otherwise be deemed low risk using traditional risk stratification methods.

DecisionDx-SCC informs treatment pathway decisions

By identifying patients most likely to benefit, and not benefit, from ART, DecisionDx-SCC can aid in ART-decision making for patients with high-risk SCC.

Meets an increasing unmet clinical need

Managing SCC in patients with one or more risk factors is a significant clinical challenge, especially as SCC-related deaths are now estimated to exceed those from melanoma. Since treatment and management plans rely heavily on the risk of local recurrence and metastasis, accurate prognostic information is essential for guiding care. However, traditional clinicopathological risk factors alone are often not specific enough to determine risk-appropriate treatment and management strategies for SCC.

[.text-size-tiny_small-underline]1. SEER Data Release 2019[.text-size-tiny_small-underline]
[.text-size-tiny_small-underline]2. Mansouri B et al. JAMA Dermatology 2017[.text-size-tiny_small-underline]

Provides more precise and individualized risk prediction of metastasis

Knowing the risk of metastasis helps inform the best management and treatment strategy for patients. The utility of traditional clinicopathologic risk factors is limited by their low positive predictive value, and these traditional risk factors alone are often not specific enough to determine a risk appropriate SCC treatment pathway. Incorporating DecisionDx-SCC test results with traditional risk factors provides enhanced accuracy, helping clinicians tailor risk predictions and personalize treatment or management plans based on each patient's unique tumor profile.

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DecisionDx-SCC addresses two critical clinical questions

What is my patient's biological risk of regional or distant metastasis?

DecisionDx-SCC test results classify patients as low (Class 1), higher (Class 2A), or highest (Class 2B) biological risk of metastasis.

Is my patient likely to benefit from ART?

Squamous cell carcinoma (SCC) patients who are at high risk of metastasis may benefit from ART. While clinicopathological factors long used in stage-based risk assessment of disease progression are used to determine ART eligibility, they do not reliably identify which of these high-risk patients will benefit from the treatment.

Now, the largest and second largest studies evaluating the benefit of ART in over 1,300 SCC patients show that DecisionDx-SCC can independently identify patients likely to benefit and not benefit from ART.

In both studies, patients with Class 2B results who received ART showed a significant decrease (~50%) in median risk of disease progression compared to patients who did not receive ART.
In both studies, Class 1 patients show a lower likelihood for ART benefit in addition to a low rate of metastasis observed for Class 1.

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Who is eligible for the DecisionDx-SCC test?

DecisionDx-SCC intended use reflects NCCN high and very-high-risk factors.

Patients are eligible for the DecisionDx-SCC test if they have recently been diagnosed with squamous cell carcinoma and have one or more of the risk factors listed below.

Tumor size ≥2 cm anywhere on the body

Tumor location on the head, neck, hands, genitals, feet or pretibial surface (areas H or M)

Immunosuppression

Rapidly growing tumor

Tumor with poorly defined borders

Tumor at site of prior radiation therapy or chronic inflammation

Neurologic symptoms in region of tumor

Perineural involvement: (1) Large (≥0.1 mm) or named nerve involvement; (2) Small (<0.1 mm in caliber)

Poorly differentiated tumor histology

Depth: (1) Invasion beyond subcutaneous fat; (2) Invasion beyond ≥2mm; (3) Clark level ≥ IV

Aggressive histologic subtype^a

Lymphovascular invasion

Desmoplastic SCC

^aAcantholytic (adenoid), adenosquamous (showing mucin production), or carcinosarcomtaous (metaplastic) subtypes (others will be considered on a case-by-case basis)

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