WREN LABORATORIES LLC
BRANFORD, CT

Company Sir Christopher Wren embodies the concept of integrating different forms of knowledge and the arts to solve clinical problems that result in a clinical benefit. He was among the first to draw blood from human veins and helped developed mathematics to a fine art that could then be applied to understanding science. The “W” of Wren also embraces the name of Watson, inspiration of the basis of human DNA and role of genetics in disease. Irvin M. Modlin, MD, PhD, DSc, an expert in the area of Neuroendocrine Tumor (NET) disease, is the Medical Director of Wren Laboratories and is a Clinical Consultant to the testing laboratory. He is formerly the director of the Gastrointestinal Pathobiology Research Group and is now an Emeritus Professor at Yale University. Dr Modlin has studied Neuroendocrine Tumor (NET) disease for three decades, authored many of the seminal publications on the subject and has extensive global experience in novel therapeutic and diagnostic advances. His background also includes gastrointestinal surgery, endocrine surgery, endoscopy and gut hormone physiology. With over five hundred peer-reviewed publications and more than thirty years of experience working with neuroendocrine tumor and carcinoid patients, he has recently focused on the development and implementation of novel molecular testing protocols for these cancers. Mark Kidd, PhD, DABCC has worked and published extensively in the area of Neuroendocrine Tumor (NET) disease, and is the Scientific Director of Wren Laboratories. He is credentialed with the American Board of Clinical Chemistry in Molecular Diagnostics to perform and report on molecular-based diagnostic testing. He is also the CLIA-certified Laboratory Director and Technical Consultant for Wren Laboratories (07D2081388). His professional and academic research interests have focused on the biology of neuroendocrine cells and development of tumor models of the disease. Dr. Kidd's publications cover diverse areas including global gene analysis, tissue microarrays, tumor biology, bacterial genetics as well as gastric and pancreatic pathology. Dr. Kidd has more than fifteen years of molecular and cancer biology laboratory experience specifically focused on NETs. The NETest is a non-invasive procedure that uses a blood sample to inform your doctor what the activity of your tumor is at the time your blood was drawn. Use of the NETest provides additional information about disease status that is complimentary to imaging and may decrease radiation exposure by decreasing the need for repetitive imaging. NETesting provides an assessment of treatment responses in neuroendocrine tumor patients in conjunction with standard clinical assessment. Interpretation of the test will facilitate identification of active disease and enable a determination of the efficacy of the current treatment modality. NETesting is as easy as having your blood drawn, and provides clinicians and patients with the information to better manage treatment. When disease recurrence occurs, a series of tests need to be undertaken to identify the location of the disease and to assess the extent and progress. Acquiring this information is critical in defining a new management strategy to prevent the disease from spreading. The NETest represents a molecular measurement of a variety of different gene transcripts in the blood (molecular information) which indicate the biological nature of the tumor and the extent of its progression. In addition, measurement of these values can be used to determine whether new treatment is effective or not. This information is critical both for the physician and the patient. It allows the former to adjust therapy appropriately to better manage the disease and provides the patient with added information to understand, in real-time, the status of their disease. Both clinicians and patients are therefore far better informed and supported. The patient has a more precise understanding of their condition and the clinician has an added tool to gauge the effectiveness of the therapy that is being administered. Our scientific strategy is the development of a series of gene signatures that identify the disease state of the cancer – the level of progression – and provide information that can be used both for a timely identification of disease recurrence or determining the efficacy of therapy. A key component of the strategy is the development of specific biomathematical algorithms to identify clusters of genes that provide unique information regarding tumor cell proliferation and metastatic potential. These strategies have facilitated the first identification of circulating neuroendocrine and other tumor cells as well as defined the specific transcript signatures of the cells that identify disease undetectable by current standard of care methodology. These can also be used to delineate the rate of growth, the likelihood of metastasis and sensitivity to specific targeted therapy. We have been funded to accelerate the development of its proprietary diagnostic tests based on patent-pending gene signature technology. This funding marks the achievement of our NET Molecular Biomarker technology and confirms completion of development milestones, including in situ detection of specific tumor transcripts in blood and tissues, multiplex gene network cluster analysis, and predictive tissue/blood assessment. We can now offer world class assay development expertise in transcript analysis for biomarker validation and companion diagnostic development in partnership with pharmaceutical and biotechnology companies. We partner with pharmaceutical and biotechnology companies to validate biomarkers for disease assessment and targeted therapeutic development in cancer and other diseases. These partnerships also provide the foundation for us to develop companion diagnostic/prognostic tests in conjunction with partners’ targeted therapeutics. We also pursue internal programs to develop proprietary diagnostic tests in specific areas of cancer.