consider other critical components of achieving positive outcomes for
22 The report, issued in 2005, recommended the use of the
new technology to expand screening capabilities and include more conditions in newborn panels.
23 The most influential part of the ACMG’s report
was its “core panel” of twenty-nine conditions, identified as primary screening targets, and its additional twenty-five “secondary targets.”
The Federal Newborn Screening Saves Lives Act (NSSLA) was passed
in 2008, three years after the ACMG’s statement. At the time of its passage,
state-mandated NBS panels still included as few as nine conditions, despite
the ACMG’s recommended minimum of twenty-nine.
25 The NSSLA expanded the duties of HRSA to take the lead in developing uniform recommendations for screening and to assist states in satisfying these goals.
Meeting the HRSA’s guidelines was made a prerequisite for receiving certain grant funding to states, made available by the Act for education and
training, development of screening programs, genetic counseling, and postdiagnostic treatment.
27 Finally, the Act assigned the Secretary’s Advisory
Committee on Heritable Disorders in Newborns & Children (SACHDNC)
the role of creating a “Recommended Uniform Screening Panel” and a deci-sion-matrix to apply to future disorders in question, and it created an inter-agency committee to provide guidelines for how the samples and information are handled.
28 The Act is currently up for reauthorization.
29 As of
late May 2014, the Newborn Screening Saves Lives Reauthorization Act of
2013 had passed the U.S. Senate and was referred to the U.S. House Committee on Energy and Commerce.
The SACHDNC’s Recommended Uniform Screening Panel consists of
31 Traditionally, testing has only been done for actiona-
22. Am. Coll. of Med. Genetics, Newborn Screening: Toward A Uniform Screening
Panel and System
7 (2005), http://www.hrsa.gov/advisorycommittees/mchbadvisory
/heritabledisorders/uniformscreening.pdf; see Michael S. Watson et al., Newborn Screening
Panel and System, 8 GENETICS IN MED. 12S, 12S (2006), available at
23. Newborn Screening: Toward A Uniform Screening Panel and System, supra note
22, at 84.
24. Watson, supra note 22, at 14S.
25. Malone, supra note 11. Based on the minimal increase in panel size in the three
years following ACMG’s statement, federal action appears to be a potentially more effective
catalyst for expansions than the recommendation of persuasive scientific authorities.
26. See Newborn Screening Saves Lives Act of 2007, Pub. L. 110-204, 122 Stat. 705
27. § 2, 122 Stat. at 705-6.
28. § 4, 122 Stat. at 707.
29. Newborn Screening Saves Lives Reauthorization Act of 2013, S. 1417, 113th Cong.
(referred to House Committee on Energy and Commerce Subcommittee on Health, Feb. 7,
31. Baby’s First Test, About Newborn Screening: Conditions Screened by State,