Castle Biosciences Licenses Thymoma Test Technology; Availability on Track for End of 1st Quarter of 2012
Published: Jan 25, 2012
Sunil Badve, M.B.B.S., M.D., Yesim Gökmen-Polar, Ph.D., and Patrick Loehrer, Sr., M.D., researchers at Indiana University, first presented their preliminary results at the American Society of Clinical Oncology in 2011, suggesting that a gene signature could reliably predict the clinical behavior of thymomas (J Clin Oncol 29: 2011 (suppl; abstr 10599). To date, data have shown that the test, branded DecisionDx-Thymoma test, accurately predicts metastatic risk in patients with thymoma. The test has also been shown to accurately confirm the stage of the disease at diagnosis.
The treatment of thymomas consists of surgical resection followed in some cases by radiation or chemotherapy for patients at high risk of metastasis. Unfortunately, histologic assessment of tumor type is of limited value as all types of thymomas can give rise to metastases.
Thymomas are rare tumors but one of the most common tumors found in the anterior mediastinum (upper chest). These tumors are often found coincidentally on chest radiographs, but can spread throughout the chest and body. Derived from the thymus gland, which is critical for the establishment of the immune system, thymomas are frequently associated with other abnormalities of the immune system such as myasthenia gravis, hypogammaglobulinemia and anemia.
Dr. Loehrer, director of the Indiana University Melvin and Bren Simon Cancer Center in Indianapolis, said, “The ability to accurately assess metastatic risk based upon the thymoma’s molecular signature will enable personalizing therapeutic options and assist in deciding which patients should receive post-operative therapy.” Dr. Badve, professor of pathology and laboratory medicine at IU School of Medicine, added, “Obtaining objective molecular data to support traditional histological assessment will lead to improved diagnostic accuracy.”
Castle Biosciences recently completed the technical validation. The training set was analyzed under CAP-accredited, CLIA certified laboratory protocols. In collaboration with Indiana University, the company is completing the clinical validation on an independent test set with a target clinical availability date at the end of the first quarter of 2012.
The studies were supported in part by the Indiana Clinical Translational Sciences Institute (CTSI), a National Institutes of Health-supported partnership between IU, Purdue University and the University of Notre to translate laboratory research into new medical treatments and therapies.
Background on Castle Biosciences:
Castle Biosciences is a cancer based molecular diagnostics company whose mission it is to serve individuals afflicted with rare or orphan cancers and those who care for them. The company has commercially available tests for use in eye cancer (uveal melanoma) and brain cancer (glioblastoma). The company’s tests can only be ordered by a licensed physician.
For more information on the DecisionDx-Thymoma assay, please visit us online or call Castle Biosciences at 866-788-9007