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Castle Biosciences announces availability of DecisionDx-GBM biomarker test for brain cancer (glioblastoma multiforme) patients that predicts overall survival to first-line standard of care treatment

Posted on: 07/16/2009

FOR IMMEDIATE RELEASE                                                                            MEDIA CONTACT:

July 16, 2009                                                                                                       DEREK MAETZOLD

866-788-9007 ext 4



Castle Biosciences announces availability of DecisionDx-GBM biomarker test for brain cancer (glioblastoma multiforme) patients that predicts overall survival to first-line standard of care treatment


- DecisionDx-GBM is a validated, clinically available biomarker panel with predictive power to distinguish treatment sensitive from treatment refractory GBM tumors -

HOUSTON--DecisionDx-GBM - brain cancer test is a molecular diagnostic test developed at and licensed from  The University of Texas M. D. Anderson Cancer Center.  The test is used to prospectively predict patient outcome to treatment for glioblastoma multiforme (GBM), the most common form of primary brain cancer.


“Our goal in developing the first application of this biomarker panel was to be able to prospectively identify GBM patients most likely to have a durable response to standard therapy.  We accomplished this goal with DecisionDx-GBM,” stated Howard Colman, M.D., Ph.D., one of the co-inventors.  Dr. Colman added, “The data indicate that the DecisionDx-GBM assay can serve as the basis for a robust clinical test (amenable to paraffin tissue) which, along with existing clinical and other molecular markers, could be used to optimize therapeutic choices for individual patients, analogous to the predictive test developed for optimization of patient therapy in breast cancer.”


“We started the development of DecisionDx-GBM with the expectation that a biomarker panel would be required to get to a test that would be sensitive in predicting not only outcomes to today’s first line treatment but would likely be useful in the future as new therapies are advanced in the care of GBM.  DecisionDx-GBM robustly predicts progression-free survival and overall survival and in multivariate analysis has been shown to be independent of the current clinical markers of age and KPS as well as MGMT methylation status,” stated Ken Aldape, M.D., a co-inventor of DecisionDx-GBM.  Dr. Aldape also noted, “The identification of specific genes with robust association with outcome can also provide insights into tumor biology that could help to identify therapies for patients resistant to standard therapy.  Specifically, patients resistant to standard therapy have what we term ‘an angiogenic/mesenchymal molecular profile,’ and studies are underway to investigate the response of treatments that target these pathways.”


 “We are committed to bringing the promise of personalized medicine to patients afflicted with underserved orphan cancers by developing tests that assist the physician in achieving better outcomes for their patients. DecisionDx-GBM is the first steps towards achieving this goal,” said Derek Maetzold, President and CEO.



DecisionDx-GBM is only available through a physician’s order.  Requisition forms are available on-line at


Castle Biosciences also has developed an industry leading reimbursement support program.  Its purpose is to enable a physician and a patient to decide primarily on the clinical use value of the DecisionDx-GBM test rather than the economics.



GBM is the most prevalent and aggressive form of primary brain cancer. The incidence of this cancer has been increasing with estimates ranging from 15,000 -21,000 new cases diagnosed per year. GBM is a particularly aggressive cancer with first-line standard of care treatment providing an average survival length of just over 14 months from the time of diagnosis. However, it is well recognized among neuro-oncologists that some patients benefit significantly from first-line standard of care treatment with stable disease and median life expectancy greater than 3 years while other patients appear to be refractory to this same first-line treatment with a median life expectancy of around 6 months. It is believed that the genetic make-up, or molecular signature, of the GBM tumor holds the key to prospectively understanding the likelihood of response to first-line treatment. This aggressive cancer received increased public attention last year with the announcement that Senator Edward Kennedy has been diagnosed with a malignant glioma.



Castle Biosciences is a biomarker based cancer diagnostics company whose mission it is to serve individuals afflicted with orphan cancers and those who care for them.  We are pursuing this mission by commercializing molecular diagnostic assays that assist the oncologist in achieving better outcomes for their patients by providing them with diagnostic information that aids their decision making.  We also believe that the high concentration of oncologists managing orphan cancers will allow us to efficiently and effectively serve our customers’ needs. We intend to accomplish our objectives by identifying, in-licensing, developing, validating, and commercializing multiple prognostic molecular diagnostic assays that have been developed at leading institutions around the United States.  We will be announcing our second product shortly.


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