Lakeside Life Science has more than 25 years of experience in the development of new to the world laboratory tests, design and management of IVD clinical studies, and successful FDA clearances and approvals. We have developed and commercialized multiple known and novel in vitro diagnostic tests. Our clinical experience includes more than 100 research and regulatory trials in oncology, infectious and other diseases. We have designed and managed 21 successful FDA submissions with no submissions rejected or withdrawn.