Biocept, UT Southwestern Medical Center Announce Clinical Study Agreement

Biocept has entered into a clinical study agreement with the University of Texas Southwestern Medical Center. Led by recognized oncologist and ALK mutation researcher Dr. Saad Khan, the study is designed to evaluate the clinical utility of Biocept's Target Selector platform for patients diagnosed with ALK-positive non-small cell lung cancer and treated with ALK-inhibitor therapy. A second arm of the study will evaluate patients with rare cancers such as anaplastic thyroid cancer to determine if driver mutations such as ALK rearrangements can be identified and treated with targeted therapy to improve patient outcomes.

"Identifying ALK rearrangements in patients with lung cancer has become important as new targeted therapies are available to help manage disease in patients harboring this type of alteration," said Saad Khan, MD, Medical Oncologist and Assistant Professor of Internal Medicine at UT Southwestern Medical Center. "We have designed this study to demonstrate the ability to rapidly identify ALK rearrangements, and to provide further evidence that patients with both non-small cell lung cancer and rare cancers harboring ALK alterations can benefit from targeted therapy and serial monitoring of ALK and other key alterations."

The ALK gene encodes the anaplastic lymphoma kinase (ALK) protein, which belongs to a family of receptor tyrosine kinases involved in transmitting cell surface signals to the inside of the cell. In approximately 5 percent of non-small cell lung cancer patients, a portion of the ALK gene is abnormally rearranged when DNA is replicated during cell division. Fusion of ALK DNA sequences to another gene results in the disruption of normal ALK protein function, causing uncontrolled cell growth as is characteristic in cancer. Various ALK gene arrangements, or translocations, have been observed in NSCLC; the majority of variants involve gene fusions between the ALK and EML4 genes. Biocept's Target Selector™ platform is able to identify ALK translocations in circulating tumor cells (CTCs) using fluorescence in situ hybridization (FISH) probes that are also commonly used for molecular profiling in tissue. Non-small cell lung cancer patients who test positive for an ALK fusion are likely to respond to ALK inhibitor therapy such as Xalkori (crizotinib). Biocept's liquid biopsy testing may be used to identify ALK translocations to guide treatment decisions and selection of an appropriate targeted therapy.