Informs risk appropriate patient management

DecisionDx-SCC is a qRT-PCR assay of 6 control and 34 discriminant genes (40 in total) that uses a validated, proprietary neural network algorithm comprised of two gene expression signatures to classify patients into risk categories. The more personalized risk stratification or prognosis helps guide the most appropriate and individualized care for patients with SCC.

More biological insight, more appropriate patient management

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Assesses

40 genes
34 discriminating and 6 endogenous control genes

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Provides

Precise, personalized risk of metastasis and likelihood to benefit from adjuvant radiation therapy to better inform patient management decisions

Informs

Patient management decisions including appropriateness of adjuvant radiation therapy, imaging, and frequency of surveillance

DecisionDx-SCC testing process

DecisionDx-SCC is performed in Castle Biosciences’ CLIA certified, CAP-accredited and NY state approved laboratory using formalin-fixed, paraffin embedded (FFPE) primary tumor tissue from either a biopsy or excision.

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‍Tissue biopsy submitted

Tissue blocks or slides from the primary tumor tissue biopsies are sent to our laboratory for testing.

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RNA/DNA preparation

Once tissue is received in our laboratory, RNA is isolated from the tissue and converted to cDNA. The cDNA for each of the 40 genes is amplified and the gene signature recorded.

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Signature interpretation

Using an independently validated algorithm, the individual patient's gene expression signature is assessed and a class score is provided.

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DecisionDx-SCC reporting

The integrated DecisionDx-SCC report provides a class result based on a patient’s risk for metastasis and local recurrence:

Class 1: Low biological risk
Class 2A: Higher biological risk
Class 2B: Highest biological risk

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Provides precise, personalized risk of metastasis to inform patient management

40-GEP

PNI, poor differentiation, immunosuppression, tumor diameter and tumor location

i40-GEP result
(MFS on validation cohort)

Clinical utility
Based on metastatic risk

Class 1A

Low risk

MFS 97.3% | LRFS 96.8%

ART benefit
Low likelihood
0–5% metastatic risk
- Safe to defer imaging
- Safe to defer ART
Class 1B

Moderate risk

MFS 94.6% | LRFS 90.0%

ART benefit
Low likelihood
5–10% metastatic risk
- Consider increased surveillance
- Consider imaging
- Safe to defer ART
Class 2A

High risk

MFS 77.9% | LRFS 83.1%

ART benefit
Low likelihood
>20% metastatic risk
- Recommend increased surveillance
- Recommend imaging
- Recommend multidisciplinary consult
- Unlikely benefit from ART
Class 2B

Highest risk

MFS 66.2% | LRFS 82.1%

ART benefit
High likelihood
>20% metastatic risk
- Recommend increased surveillance
- Recommend imaging
- Recommend multidisciplinary consult
- Likely benefit from ART

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Informs risk appropriate patient management

More biological insight, more appropriate patient management

Assesses

Provides

Informs

DecisionDx-SCC testing process

‍Tissue biopsy submitted

RNA/DNA preparation

Signature interpretation

DecisionDx-SCC reporting

Provides precise, personalized risk of metastasis to inform patient management

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40-GEP

i40-GEP result(MFS on validation cohort)

Clinical utilityBased on metastatic risk

Class 1A

Class 1B

Class 2A

Class 2B

Get started with DecisionDx-SCC

Scientific Evidence

i40-GEP result
(MFS on validation cohort)

Clinical utility
Based on metastatic risk