The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is the creation of a reliable, highly sensitive, cost-effective, and easy-to-implement congenital cytomegalovirus (cCMV) screening that can be run with other newborn screening tests. cCMV affects about 25,000 babies born in the U.S. each year with moderate to severe long-term impairment (hearing loss and delayed neurological development) being diagnosed in almost 25% of infected children with an overall mortality of 0.5%. Efforts to address cCMV are complicated by the fact that 78-92% of cases show no symptoms at birth and despite its prevalence, cCMV is not universally screened largely due to limitations in current diagnostic workflows. Early detection and treatment within the first 72 hours of life greatly reduces lifelong disabilities and healthcare costs by approximately $1.3M per case. By providing a cost-effective, rapid, and scalable diagnostic tool that meets clinical needs, this solution will enable universal newborn screening for cCMV of the 3.6M live births that happen in the U.S. every year. Future extensions will adapt the platform to detect additional pathogens, broadening its public health impact through detecting infectious agents such as SARS-CoV-2, Epstein-Barr Virus, Herpes Simplex Virus type 1, and Human Herpesvirus 6B. This Small Business Technology Transfer (STTR) Phase I project aims to develop a one-step molecular diagnostic that employs Cluster