Atopic dermatitis (AD) is an inflammatory skin disease driven by complex biological interplay between type 1, 2, and 17 inflammatory processes. Systemic therapies, including biologics that target T helper type 2 inflammatory pathway (Th2-targeted therapies) and small molecules targeting multiple inflammatory pathways (JAK inhibitors, JAKi), have improved care for AD. However, current therapy selection is trial and error without consideration of each patient’s underlying biology, resulting in inadequate disease control for approximately 45% of patients taking systemic therapies for AD. An objective test to measure each patient’s underlying disease biology to guide therapy selection with the goal of reducing the trial-and-error phase of therapy selection should lead to earlier response to treatment and an improved proportion of patients who achieve adequate disease control. The objective of this study was to develop and validate a non-invasive gene expression profile (GEP) test to guide systemic therapy selection for AD to improve health outcomes.

Validate use of the 40-gene expression profile (GEP) to identify patients with National Comprehensive Cancer Network (NCCN) high-risk (HR) cutaneous squamous cell carcinoma (cSCC) who are at increased risk for local recurrence (LR) and metastasis, despite negative margins after surgical resection.

Two gene expression profile (GEP) tests, the CP-GEP and the 31-GEP, have been developed to identify patients at low risk of SLN positivity who may consider avoiding SLNB. We analyzed the accuracy of the CP-GEP and 31-GEP in identifying patients with <5% risk of SLN positivity across the five validation studies of the CP-GEP and four validation studies of the 31-GEP in T1-T2 tumors.

Although most patients with cutaneous melanoma (CM) will have a negative sentinel lymph node biopsy (SLNB), up to 20%-30% of these patients will recur. The 31-gene expression profile (31-GEP) test has been prospectively validated to identify patients at low (Class 1A), intermediate (Class 1B/2A), and high (Class 2B) risk of SLN positivity and recurrence.

This prospective study confirmed the performance and clinical utility of the i31-SLNB for improving risk-aligned care and demonstrated a significantly reduced SLNB performance rate when incorporating the i31-SLNB into clinical decision-making.

Data from multiple studies was systematically reviewed and analyzed to assess the 31-GEP test’s efficacy in predicting melanoma patient outcomes. Our findings suggest that the 31-GEP test may improve risk prediction when used alongside standard clinical and pathological assessments. By using 31-GEP, physicians may be better able to make more informed decisions about treatment and follow-up care, potentially improving outcomes for melanoma patients.

DecisionDx-SCC further stratified immune suppressed patients with T2a tumors into those with more favorable (Class 1 test result; 3-yr MFS of 83%) and less favorable survival (Class 2A/2B test result; 3-yr MFS of 57%). Given the study data, treatment intensification such as ART should be strongly considered in immune suppressed patients with BWH T2a SCC tumors guided by DecisionDx-SCC test results.

A health economics study using a microsimulation model showed that TissueCypher-guided management is both cost-saving and helps improve patient health outcomes.

The i31-GEP identified patients with < 5% risk of SLN positivity who could safely forego SLNB. Combining the 31-GEP with clinicopathologic features for a precise risk estimate can help guide risk-aligned patient care decisions for SLNB to reduce the number of unnecessary SLNBs and increase the SLNB positivity yield if the procedure is performed.

The 40-GEP identified patients most likely to benefit from ART (Class 2B) and those that can consider deferring treatment (Class 1).