Every year, 1 in 200 babies in the United States is born with congenital cytomegalovirus (cCMV), and most show no signs of it at birth. That’s the problem.
In a recent webinar hosted by SalivaDirect Inc., Mark R. Schleiss, MD, a Professor of Pediatrics at the University of Minnesota Medical School, made the case for more widespread newborn cCMV screening in order to ensure that affected babies may obtain necessary care and treatment, both in the newborn nursery and into childhood.
During the same program, Jack Hysell, Primary.Health director of solutions engineering, proposed ways that technology like Primary’s digital Newborn Screening Case Management platform could support broader and more efficient cCMV screening.
The most common thing no one warns you about
The leading infectious cause of disability in children in the United States, cCMV is responsible for roughly a quarter of all childhood hearing loss, said Dr. Schleiss, and yet most parents have never heard of it. Obstetricians routinely warn pregnant patients about other causes of infections such as sushi, cat litter, and deli meat, he said, and yet cCMV barely comes up. Although 80–90% of babies born with the infection appear normal at birth, all are at risk for its long-term effects. Hearing loss, developmental delays, and learning disabilities often don’t surface until the toddler years or preschool, well after the early window for several of the treatment approaches has started to close.
Why the standard hearing screen isn’t enough
Standard newborn hearing tests miss nearly half of cCMV-affected infants, he explained. This is because hearing loss may not be present at birth. In fact, a baby can pass the hearing screen on day two of life and still develop significant hearing loss by age two or three years. The only way to find the children destined to have hearing loss before it happens is to test for cCMV at birth, before any symptoms appear. Clinicians can then connect infants who test positive and are confirmed with the infection with audiological care or antiviral treatment while it still can make a difference.
Dr. Schleiss spent years studying nearly 25,000 newborns in Minnesota evaluating how to screen them effectively. His research and advocacy helped make Minnesota the first state to mandate universal cCMV screening in 2023, followed by Connecticut. In Canada, Ontario made universal cCMV screening available to all newborns in 2019; several other provinces followed.
Saliva vs. dried blood spots
Two cCMV screening methods are currently in wide use, he said. Saliva PCR swabs are highly sensitive, but there’s a catch: if a baby has breastfed before the swab is taken, traces of CMV DNA from breast milk can be present in the sample and produce a false positive (meaning that the viral DNA is present, but the baby isn’t truly infected). Dried blood spots, which are the same heel-prick cards already collected during routine newborn screening, sidestep that issue entirely. Earlier studies suggested they were less sensitive, but Dr. Schleiss’s research showed that with improved techniques, dried blood spots can attain cCMV sensitivity above 85%.
Some discussions suggest that a third screening method, urine CMV testing, is also worth considering, but the cost of universally collecting these samples from all newborns is prohibitive.
What happens after a positive result
A positive test for cCMV is only the beginning for the infant and their family. Jack Hysell walked through why digital infrastructure has to be in place to support what comes next. Primary Health, which launched during COVID-19, has since expanded to support public health programs across 25 states. Its platform includes newborn screening tools covering lab ordering, results management, case management, and outcome tracking.
One option Hysell flagged as particularly useful: pairing maternal CMV data with newborn saliva PCR swab results. Most programs don’t have a great way to connect that data right now, but Primary.Health’s smarter data integration could help newborn screening teams do this automatically.
Where things stand
Even without a formal state screening program, Dr. Schleiss urged physicians to pay closer attention to the subtle newborn signs that should prompt a cCMV test. These include unexplained low birth weight, small head size, unusual rashes, minor neurological findings, and (obviously) a failed newborn hearing screen.
Researchers are also looking at whether saliva samples can reveal changes in the newborn oropharyngeal microbiome – essentially the colonizing bacteria that “live in” their mouths – to assess whether CMV infection modifies bacterial colonization. Researchers are also interested in whether the types of bacteria observed might predict which cCMV-positive babies are at highest risk for long-term complications. That research could open the door to earlier, more targeted intervention for the children who need it most.
Discover case management for baby’s critical first test
Primary.Health Newborn Screening Case Management for hearing, critical congenital heart disease (CCHD), and bloodspot screening provides comprehensive case management, automated actionable results tracking, and real-time reporting — ensuring every baby receives timely screening, follow-up evaluations, and intervention.
