The poster presentation for DecisionDx-Melanoma strengthens the evidence supporting use of the test to provide risk stratification for patients in order to guide risk-appropriate sentinel lymph node biopsy (SLNB) surgery decisions. Additionally, the poster for Castle's inflammatory skin disease pipeline test highlights feedback from clinicians regarding therapy selection strategies, informing the development of Castle's pipeline test and supporting the unmet clinical need for a molecular test to guide therapeutic selection for patients with inflammatory skin diseases.
DecisionDx-Melanoma
Poster title: The i31-gene expression profile test for cutaneous melanoma identifies patients with head and neck tumors who could forego sentinel lymph node biopsy
In the study, no patients who received a low-risk DecisionDx-Melanoma test result, which predicts a less than 5% risk of sentinel lymph node (SLN) positivity, had a positive SLNB. Additionally, the data showed that using DecisionDx-Melanoma to guide risk-aligned patient care could reduce the number of unnecessary SLNBs by 37% overall, 63% for T1a tumors and 50% for T1b tumors, specifically. In the study, DecisionDx-Melanoma achieved 100% sensitivity, demonstrating its potential to identify patients likely to experience SLN metastasis. This study involved patients with cutaneous melanoma (CM) tumors (T1-T2a) located in the head or neck region who had undergone SLNB (n=159). CM tumors on the head or neck tend to be more aggressive and pose unique challenges for SLNB surgery.
'These data reinforce those from our recently published DECIDE study,1 showing that use of DecisionDx-Melanoma to inform decisions around the SLNB surgical procedure could reduce the number of unnecessary procedures performed, particularly in patients with a low risk of metastasis,' said
Inflammatory Skin Disease Pipeline Test
Poster title: Survey results identifying clinician strategies for therapy selection for common inflammatory skin diseases
The poster shares results from a survey of 265 clinicians conducted during the 2022
While there are many effective treatments options available for those with moderate-to-severe AD or PsO, current clinical practice relies on a trial-and-error approach for therapy selection. To answer this unmet clinical need, Castle is developing a gene expression profile (GEP) test to predict response to systemic therapy in patients with moderate-to-severe AD, PsO and related inflammatory skin diseases. Personalized guidance for therapy selection and anticipated efficacy, based on each patient's molecular data, has the potential to improve patient health outcomes by enabling clinicians to better select a medication for their patients' specific skin disease.
Early development data for Castle's pipeline test for inflammatory skin diseases is expected in 2023, with an expected launch by the end of 2025.
About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient's individual risk of sentinel lymph node (SLN) positivity and a patient's personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma's clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test's results. Through
About Psoriasis, Atopic Dermatitis and Related Conditions
Inflammatory skin disease accounts for a significant number of patient visits to both primary care and dermatology clinics across
About
Castle's current portfolio consists of tests for skin cancers, uveal melanoma, Barrett's esophagus and mental health conditions. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate-to-severe psoriasis, atopic dermatitis and related conditions.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the 'safe harbor' created by those sections. These forward-looking statements include, but are not limited to, statements concerning: (i) the potential of DecisionDx-Melanoma test results to reduce the number of unnecessary SLNBs, particularly in patients with a low risk of metastasis, and identify patients likely to experience SLN metastasis and patients that can forego the SLNB procedure; (ii) the potential of p ersonalized guidance for therapy selection and anticipated efficacy, including our pipeline test for inflammatory skin diseases, to improve patient health outcomes by enabling clinicians to better select a medication for their patients' specific skin disease and (iii) our expectation that early development data for our pipeline test for inflammatory skin diseases will be available in 2023 and that the test will launch by the end of 2025. The words 'can,' 'could,' 'expect,' 'potential' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in this study and/or survey, including with respect to the discussion of DecisionDx-Melanoma and our pipeline test for inflammatory skin diseases in this press release; actual application of our tests may not provide the aforementioned benefits to patients and the risks set forth under the heading 'Risk Factors' in our Quarterly Report on Form 10-Q for the three months ended
Contact:
Email: czuckero@castlebiosciences.com
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