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Off and Running

This post has been updated to clarify the funding level for the BabySeq trial.

The BabySeq project has enrolled its first few in infants in its bid to understand the implications of sequencing newborns, Technology Review reports. Three healthy infants and one baby from the neonatal ICU have joined the study, and the researchers received the first baby's genomic data last week, as GenomeWeb has noted.

The five-year, $6 million randomized, controlled trial aims to eventually enroll 240 healthy babies from Brigham and Women's Hospital and 240 babies in the neonatal ICU at Boston Children's Hospital. Half of the infants from each group undergo sequencing and have some 1,700 genes associated with childhood-onset diseases analyzed. The rest of the infants won't undergo sequencing.

The researchers, led by Harvard Medical School's Robert Green, will then follow how having this genetic information affects the infants' medical care and costs as well as the parents' thoughts about it and the development of the parent-child bond.

"There is no scientific consensus that it is appropriate or useful to sequence healthy individuals," Green tells Tech Review. "Therefore, the only way this would be considered a public health mandate would be if we had a tremendous amount of evidence that sequencing a large number of people would be beneficial."

For some of the diseases the trial will screen for, there are certain courses of action that physicians and parents can take, and the study will examine those as well. Tech Review notes, for instance, that the researchers will look to see whether the infants carry a gene variant linked to childhood-onset colon cancer and then whether regular screening enables early detection and successful treatment.

More widespread newborn sequencing is still likely years off, it says. "I'd love to see more studies done first," Muin Khoury, director of the CDC's Office of Public Health Genomics adds. "I would see more sequencing done first in adults, and first in adults who are sick with genetic diseases. And pending the results of studies, I would see newborns sequenced last."