CLIA-waived Point of Care Test of Infection by Cocci, Blasto, and Histo

Human cytomegalovirus (CMV) infection causes more cases of congenital disease than 29 currently screened conditions in the US combined & several newborn screening disorders in EU countries. Congenital CMV infection rate is 0.7% in developed countries with 18% of infected newborns developing permanent hearing & vision loss, or intellectual disability (5,000 in the US each year). Ninety percent of CMV infected newborns are asymptomatic at first, but many will suffer moderate to severe sequelae, the economic burden of which is estimated at >$1B. This public health burden can be reduced through early detection followed by intervention to improve secondary outcomes. PCR amplification has been used to identify CMV followed by intervention to improve secondary outcomes. PCRA amplification has been used to identify CMV DNA, but a molecular diagnostic test for newborn CMV testing has not been FDA cleared. Lucigen is developing a new diagnostic platform to achieve 30 minute sample-to-answer point-of-care molecular testing of infectious diseases, with CLIA-waiver as the ultimate goal. Lucigen's prototype CMV molecular test platform will achieve high sensitivity & specificity at point-of-care in the newborn nursery, enabling early detection of infected infants before symptoms occur. This information will allow preemptive intervention that could limit certain long term-disabilities, thereby providing patients with improved health care outcomes.