Kypha seeks to discover, develop and commercialize innovative in-vitro diagnostic biomarker tests within the inflammation and autoimmune space. Our plan is for these tests to become standard of care, having application across a wide range of indications that include: lupus, stroke, traumatic brain injury, preeclampsia, infection, kidney disease, and transplant rejection. Potential implications include earlier prediction of adverse events, optimizing treatment options, and overall better patient disease management.
Driven by the desire to deliver a reliable measure of complement activation within the body, the Company is validating a point of care platform called COMP ACT™ which is intended to deliver near real-time results to the physicians. The tests are designed to be clinically practicable and actionable, enabling high-value complement testing to finally become standard of care and improve the way inflammatory and immune disorders are monitored and treated. Kypha has an extensive clinical collaborator network to support clinical trials as well as identify and validate additional biomarkers across multiple indications.
Kypha’s first Comp ACT products launched will be C3 and iC3b lateral assay biomarker tests for C3 and iC3b levels in the body. The Company seeks to capture the clinical value of complement and the central role that it plays in inflammation as well as identifying indicators for the onset, progression and resolution of inflammation in disease, injury or infection. Physicians are very interested in measuring the changes in C3 and iC3b levels, and are expecting this data to help diagnose disease, assess severity, follow disease progression, and help determine effectiveness of a treatment. These products are currently under review process with the FDA.
Kypha has been an established member of the Cortex portfolio of companies since 2011. Cortex is the Midwest’s premier innovation hub of bioscience and technology research, development and commercialization, serving as the anchor of St. Louis’ growing ecosystem for innovative startup programs and established companies. http://www/cortexstl.com/