Integrated risk assesment for more informed cutaneous squamous cell carcinoma management

The integrated DecisionDx-SCC test result combines the 40-gene expression profile with clinicopathologic risk factor and optimized nested predictive models to deliver refined risk-assessment and treatment guidance for high-risk cSCC patients.

This integrated approach improves metastatic and local recurrence risk assessment and helps identify patients most likely to benefit from adjuvant radiation therapy.

Why DecisionDx-SCC?

Simplified DNA double helix icon with green and blue colors on a light background.

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.

Circle enclosing three horizontal bars of different lengths in green, orange, and red.

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.

Crosshair targeting a green virus or germ icon on a gray gradient background.

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.

Deaths per year in the U.S.

7,200

Melanoma¹

15,000

SCC²

02,0004,0006,0008,00010,00012,00014,00016,000

as many annual SCC deaths in the U.S. as Melanoma

With traditional staging:

1/3

SCC patients under-staged as low risk

1. Estimated annual melanoma deaths in the U.S. 2. Estimated annual cutaneous squamous cell carcinoma deaths in the U.S.

1. SEER Data Release 2019
2. Mansouri B et al. JAMA Dermatology 2017

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)

Get started

Order Test

NEXT UP