COMP ACT™ System
Kypha is developing game-changing inflammation and immune diagnostics to improve the way human health and disease activity is monitored and treated in patients. Kypha is preparing to launch a new inflammation monitoring product called COMP ACT™. This instrument which runs lateral flow assays, was created to avoid several current diagnostic challenges, and is intended to address a major unmet clinical need which is objective, real-time monitoring of complement and immune activity.
- Easily portable
The COMP ACT™’s platform stems from its ability to rapidly detect and quantify an individual’s current inflammatory status, and monitor it over time, with a simple test that can be performed virtually anywhere. Potential implications include detecting the onset of adverse events earlier and optimizing treatment sooner, predicting outcomes more accurately, and managing disease and patient more effectively. In the emergency, critical care and ICU environment, monitoring inflammatory/immune status and obtaining results rapidly at the bedside are key factors impacting patient outcomes and healthcare costs. In chronic conditions like lupus, COMP ACT can help provide more precise measurement of underlying disease activity and response to treatment, and it could enable at-home/remote testing. In short, COMP ACT can help answer 4 basic but vital questions – Is something wrong (abnormal/inflamed)? How severe is it? Is it getting better or worse? Has it been resolved (normal/healthy)?
Several challenges related to accuracy, speed, complexity and cost have limited the clinical utility of existing inflammation diagnostics, and especially complement tests. With the right combination of technology, clinical protocol and complement markers, Kypha’s COMP ACT™ has surmounted many of the current obstacles. Roughly the size of a stick of gum, tests require only a drop of blood/sample and a small handheld reader delivers quantitative results in 20 minutes or less. To maximize impact, COMP ACT had to be versatile and robust. As such, it shares several features with finger stick-based glucose testing – portable, easy to use, rapid, quantitative results, and minimal volume. Additionally, the standard point-of-care test platform can accommodate lab, office, field or home use, and can easily support additional biomarkers. Together, the broad potential clinical utility associated with complement and the versatility and ease-of-use of the test platform creates a tremendous market opportunity for COMP ACT. The product is clearly differentiated and will be uniquely positioned in the market as a rapid point-of-care blood test to quantitatively measure inflammation and immune activity in near-real time.
COMP ACT was developed under stringent design control and has been transferred to GMP manufacturing. FDA 510(k) submissions are currently in process. Kypha has an impressive network of clinical collaborations at more than 10 major medical centers, supporting over 15 clinical research studies in rheumatology, neurosurgery, critical care and emergency medicine, obstetrics, nephrology and hematology. In addition, broader relationships have developed within each institution, generating valuable market data and facilitating a better understanding of clinical algorithms, reimbursement, pricing, politics, healthcare economics, etc.