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State health lab to add spinal muscular atrophy and three other newborn screens; $10 fee increase slated
Summary
Arkansas Department of Health told the committee it will add four newborn screening tests—including spinal muscular atrophy—and assess an additional $10 fee; the lab is validating an FDA‑alternative molecular assay for SMA and expects to meet national recommendations after implementation.
Laura Shue (general counsel) and Dr. Glenn Baker (director, public health lab) presented proposed rule amendments to implement Act 58 of 2019 by adding four newborn‑screening assays to Arkansas’ panel: spinal muscular atrophy (SMA), Pompe disease, MPS I spectrum disorders, and childhood‑onset cerebral adrenoleukodystrophy (ALD). The agency said the Board of Health approved the additions and the rules were filed with the secretary of state and legislative bureau.
DOH said approximately 29 assays are currently performed for ~37,000–40,000 births annually in Arkansas. The proposed amendment would add SMA and three additional tests, with a proposed $10 fee increase for the SMA test (the current fee cited as $121). Dr. Baker explained that three of the four tests are commercially available FDA‑cleared assays but SMA requires a molecular approach involving DNA extraction from the newborn blood spot; the lab is completing validation and has obtained positive and negative samples from other states to confirm assay performance.
Representative Ferguson and others asked whether the additions align with the federal recommended uniform screening panel. Dr. Baker said the federal advisory body recommends tests but does not mandate them; he noted SMA was recently added to national recommendations and that Arkansas will be "current" with the recommended assays once these four are implemented, barring any subsequent additions.
On genetic records, Dr. Baker clarified the lab does not retain a comprehensive genetic profile: "We take the sample, extract the DNA from that sample, and analyze only for the presence or absence of this 1 particular gene, and there's no DNA spectrum obtained." The committee accepted the Department of Health’s presentation for review.
