NEW YORK – Infectious disease diagnostics company MeMed said on Tuesday that it has received the CE-IVD mark for its MeMed BV diagnostic test and its point-of-care MeMed Key platform.
With the clearance MeMed can begin offering the BV test at the point of care. The test measures a set of three host-response proteins to help distinguish between bacterial and viral infections and guide antibiotic use.
The company already offered a CE-IVD-marked ELISA version of the test.
"The CE Mark clearance of our MeMed Key instrument marks an exciting milestone that builds on years of development work," Kfir Oved, MeMed’s co-founder, CTO and chairman, said in a statement. "The MeMed Key platform is not only paving the way for wide implementation of the MeMed BV test, but also opens the way to highly sensitive, rapid, and multiplexed protein measurements at the point of care, which, so far, was mainly available using expensive central lab equipment."
Oved added that the company also plans to use the MeMed Key platform for testing in areas outside infectious disease.
MeMed and its collaborators have evaluated the test's performance in more than 15,000 patients to date and found that it performs with sensitivity and specificity of greater than 90 percent across multiple pathogens.