December 21, 2014 10:33 AM ET

Biotechnology

Company Overview of Castle Biosciences Incorporated

Company Overview

Castle Biosciences Incorporated, a cancer based molecular diagnostics company, designs and develops cancer molecular tests for use by licensed physicians. It offers DecisionDx-uveal melanoma (UM) test that measures the gene expression profile/molecular signature of an individual's tumor and identifies the metastasis; DecisionDX-Thymoma, an objective test that determines the molecular profile of a patient’s tumor and the metastatic risk associated with thymoma; DecisionDX- glioma-CpG island methylator phenotype (G-CIMP) profile test, a multi-methylation test that determines the G-CIMP of gliomas; and DecisionDX-GBM test, a metagene expression assay that determines the molecular signature of a...

2014 San Miguel Drive

Friendswood, TX 77546-5913

United States

Founded in 2007

Phone:

602-535-1997

Fax:

866-431-2924

Key Executives for Castle Biosciences Incorporated

Chief Executive Officer
Age: 52
Executive Director of Operations
Vice President of US Sales and Marketing
Compensation as of Fiscal Year 2014.

Castle Biosciences Incorporated Key Developments

Castle Biosciences Inc. Announces Results from a Second Validation Study of its Proprietary Multi-Analyte Test, DecisionDx-EC

Castle Biosciences Inc. announced that results from a second validation study of its proprietary multi-analyte test, DecisionDx-EC, confirmed the test's ability to identify which esophageal cancer patients are unlikely to benefit from the standard pre-surgical treatment of chemoradiation. The results were reviewed in an oral presentation at the 11th Annual Meeting of the International Society of Gastrointestinal Oncology in Arlington, Virginia. The results suggest that up to 30% of esophageal cancer patients may not benefit from the highly toxic, pre-surgical chemoradiation therapy (CTRT), and instead could have the option of moving directly to surgery and to other treatment options. The DecisionDx-EC test analyzes the localization of three protein biomarkers, NF-kB, Gli1, and SHH, to classify tumors as either responsive to (non-exCTRT) or resistant to CTRT (exCTRT). Testing was performed on formalin-fixed paraffin-embedded esophageal cancer tissue. In this second, multi-center validation study involving 64 patient cases, 67% of whom had been treated with a regimen that included 5-fluorouracil (5FU), researchers reported a 95% specificity, with positive (PPV) and negative (NPV) predictive values of 88% and 83%, respectively. These results confirm a similar analysis of an earlier validation study involving 167 patient cases, all of whom underwent a chemoradiation regimen involving 5FU plus platinum/taxanes. This study showed a specificity of 90% and positive (PPV) and negative (NPV) predictive values of 64% and 98%, respectively. The company also presented data from a parallel study of a gene expression profile (GEP) test in development for esophageal cancer. The study assessed the ability of two preliminary gene signatures to predict responsiveness to chemoradiation therapy in tumor samples from 16 patients. The results from this initial study showed that the GEP test predicted treatment response with high accuracy and specificity of 100% and 100%, respectively. The company plans to further evaluate the GEP test in esophageal and rectal cancer.

Castle Biosciences Incorporated Announces the Completion of an $11.8 Million Financing; Garheng Kong Joins as Board of Directors

Castle Biosciences Incorporated announced the completion of an $11.8 million financing. The round was led by new investor HealthQuest Capital, with participation by Castle Biosciences' current investors including Mountain Group Capital and Affiliates, Longfellow Venture Partners and others. The funds will be used to expand clinical availability of Castle Biosciences' portfolio of practice-changing cancer diagnostic tests, including DecisionDx-Melanoma, its test to determine metastatic risk in patients with melanoma. In conjunction with this financing, Garheng Kong, M.D., Ph.D., Managing Partner of HealthQuest Capital, will join Castle Biosciences' Board of Directors.

Castle Biosciences Announces Encouraging Results from Melanoma Test Study

Castle Biosciences Incorporated has announced study results showing its gene expression profile, or GEP, test, or DecisionDx-Melanoma, can identify primary cutaneous, or skin, melanoma tumors that are likely to metastasize in patients who had a negative sentinel lymph node biopsy. The DecisionDx-Melanoma test completed validation in 2013 and is widely used to determine metastatic risk in Stage I and II melanoma patients. Researchers compared the results of the non-invasive 31-gene GEP test to sentinel lymph node biopsy (SLNB) results in 134 patients with Stage I, II, or III cutaneous melanoma. These 134 patients represented all patients in the initial clinical validation studies who had a documented sentinel lymph node procedure. In patients with a negative sentinel lymph node biopsy (SLNB-), a result interpreted as a lower risk for metastasis, the GEP test identified the vast majority of melanomas that ultimately progressed over the subsequent 5-year period. According to study results, the rate of 5-year metastasis-free survival (MFS) was 55% for SLNB- patients compared to 37% for SLNB+ patients (p=0.003). The GEP test results showed improved prognostic accuracy in these same patients with an MFS of 87% for the low-risk (Class 1) patients and 31% for the high risk (Class 2) patients (p<0.0001). Differences in overall survival (OS) paralleled the MFS rates, with SLNB- patients having a 5-year OS of 67% and SLNB+ having a 5-year OS of 55% (p=0.024). The GEP test again showed improved prognostic accuracy, with an OS for GEP Class 1 patients of 92% compared to 49% for Class 2 patients (p<0.0001). Use of the GEP test was also analyzed in combination with SLNB status. As expected, the 20% of patients who had high risk results for both tests (GEP Class 2 and SLNB+) had lower survival rates (MFS=34%; OS=53%). Similarly, the 31% of patients who had low risk results for both tests (GEP Class 1 and SLNB-) had higher survival rates (MFS=86%; OS=92%). Importantly, in the 49% of patients who had results that were discordant (high risk outcome for one test, low risk for the other) the GEP test result correctly predicted the patients' clinical outcomes. Net reclassification improvement of GEP class over SLNB status was greater than 50%. Cox multivariate analysis comparing the GEP test to SLNB showed the GEP test to be the only independent and highly significant prognostic factor in this analysis (p<0.000003).

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