New Mesothelioma Test Available Later This Year

A mesothelioma test created and validated at Brigham and Women/s Hospital in Boston could be available to the public within the next couple of months.

The test, which will be known by the brand name DecisionDx-Mesothelioma, is designed to test patients who are suspected of having mesothelioma for the expression of a variety of genes. By creating a gene profile, the test can give doctors a clearer picture of which patients with mesothelioma symptoms might actually be suffering from the disease.

Friendswood, Texas-based Castle Biosciences has announced that it has acquired the intellectual property and technology rights to the test from Brigham and Women’s. Castle Biosciences specializes in molecular diagnostic tests for rare cancers like mesothelioma. Currently, the company has three proprietary diagnostic assays available to clinicians, including tests for eye cancer (uveal melanoma), thyoma, and brain cancer (gliomas and glioblastoma).

Mesothelioma is a challenging cancer to diagnose. Its symptoms, including cough, chest pain and shortness of breath, can mimic other conditions and may not even occur until the disease is in its later stages. Diagnosis often must be confirmed through a combination of physical exam, history of asbestos exposure, biopsy and tests such as the DecisionDx-Mesothelioma test for gene expression of tell-tale biomarkers. In addition to helping to confirm a mesothelioma diagnosis, the DecisionDx-Mesothelioma test can also be used to predict survival in patients undergoing surgical resection.

“We now have a molecular test that alone as well as in conjunction with other simple clinical parameters can help identify those patients who will most likely benefit from aggressive surgery, as well as assist with fundamental treatment planning,” said lead test developer Raphael Bueno, MD, associate chief of thoracic surgery at Brigham and Women’s Hospital.  Dr. Bueno added that the new test represents a “tremendous advance” in the management of mesothelioma.

Castle Biosciences says that it is completing the validation process for the new test according to standards set by the College of American Pathologists as well as the federal regulatory standards known as the Clinical Laboratory Improvement Amendments (CLIA).  When the new molecular test has completed the process, Castle Biosciences says it hopes to make it available to clinicians in the third quarter of 2012.

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