Earlier this week Vax-Immune Diagnostics annoucned that it has received CE Mark approval for its first-in-class medical device, LabReady GBS. LabReady’s Group B Strep product is the first in Vax-Immune Diagnostics’ lineup of women’s health solutions that helps avoid life-threatening complications and expensive consequences for mothers and their babies.
With CE Mark approval, LabReady is now available to European physicians, patients, and hospital systems. The brainchild of neonatalist Dr. Leonard E. Weisman, LabReady aims to protect patients from the dangers and costs of misdiagnosis by giving physicians and microbiology labs a safer, smarter, and more economical way to treat patients’ samples.
“I have spent over 40 years watching newborns die or have developmental problems due to infections in the pregnant moms which could have been avoided. By using LabReady, infections can be detected prior to delivery, treated appropriately, thereby reducing infant mortality related to infection,” states Dr. Weisman.
Vax-Immune Diagnostics estimates the LabReady solution will be available in European markets as soon as Summer 2021. LabReady will be available through provider channels, as well as in direct-to-consumer/home testing markets. Vax-Immune Diagnostics hopes to greatly decrease global infection mortality by making high-quality specimen collection accessible to everyone around the world.