Originally Published IVD Technology
July 2003
INDUSTRY NEWS
State-mandated tests for screening newborns likely to expand
The menu of state-mandated newborn-screening IVDs may soon increase as the result of a bill introduced by senators Christopher Dodd (D–CT) and Mike DeWine (R–OH). If passed, the “Newborn Screening Saves Lives Act of 2003” would provide improved resources for newborn-screening initiatives by enabling more healthcare facilities to purchase tandem mass spectrometry (MS/MS) technology.
“Currently, the number of tests performed on a newborn is dictated by the state where the child is born. It is absurd that a newborn’s birthplace could dictate whether or not a child has a healthy start,” says Senator DeWine. MS/MS technology enables improvements in and consolidation of metabolic screening methods to detect amino acid disorders (e.g., PKU, maple syrup urine disease, and homocystinuria) among newborns. MS/MS technology expands the number of disorders that can be detected on screening panels by incorporating an acylcarnitine profile, which enables detection of fatty acid oxidation and other organic acid disorders.
Organizations such as the March of Dimes and Save Babies Through Screening are working to expand the central panel of mandatory screening tests for newborns and promote consistency between states. In May, the March of Dimes testified before Congress to request that $25 million be allocated to fund the Health Resources and Services Administration’s (HRSA; Rockville, MD) newborn-screening program. In April, HRSA announced that it will provide grants totaling $1.5 million to five projects aimed at expanding newborn-screening efforts.
Although many states already have private laboratories that offer MS/MS testing, access to such testing is dependent upon parents’ access to financial resources. Mary Maguire, MD, a practicing pediatrician in Denver, notes, “in my state, there is a supplemental MS/MS screen available to families who wish to purchase it above and beyond the required state screen. An unacceptable dichotomy of access exists as a result. This defeats the purpose of mandated, funded newborn screening, the purpose of which is to equalize every child’s access to accurate and timely diagnosis and treatment of congenital metabolic and genetic disease.”
Although all states mandate at least three newborn screening tests, some states may require as many as 40. In addition to the number of tests, the relative sophistication of techniques employed varies greatly between states. If the average number of tests required in each state increases, several states will need to expand testing in their public health laboratories, and manufacturers and distributors are likely to reap the rewards.
This trend of more widely used MS/MS testing may affect the current market for IVDs used as newborn screening tests. “It seems logical to expect that current enzymatic assays, for example, will eventually be replaced by tandem mass spectrometry and molecular assays,” says Maguire. “I don’t doubt that the development of more-sophisticated assays than are currently available for newborn screening will be fueled by the competition for federal contracts and dollars.”
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