BioMedomics Receives CE Mark Approval for Sickle SCAN (TM)
BioMedomics is proud to announce that we have received CE Mark approval for our sickle cell point-of-care diagnostic test, Sickle SCAN (TM). The Sickle SCAN (TM) test is a rapid, lateral flow immunoassay to aid in the diagnosis of sickle cell disorders. Currently there are other sickle cell disease related tests. Solubility tests for hemoglobin S, is inexpensive, but is also inaccurate and ineffective in distinguishing sickle cell disease, sickle cell trait, and SC disease. Another alternative is hemoglobin electrophoresis, which is time consuming, expensive, and requires a high level of technical training. Our sickle cell disease test is rapid, comprehensive, and easy to use. Sickle SCAN (TM) has been tested by BioMedomics and its clinical collaborators to have a sensitivity of >99% and specificity >99% (n = 140) in distinguishing HbSS, HbAS, HbSC, HbAC, and HbAA. The time to result is 5 minutes, with the result stability being over 24 hours. The test has been developed for point-of-care use in low resource environments for users with minimal training. Receiving CE Mark approval is an important milestone for us, and marks the beginning of our global commercialization process. BioMedomics is seeking distribution partners for this innovative product. If you are interested, please don’t hesitate to contact us.