RD246 - The Virginia Genetics Advisory Committee’s Report to the State Health Commissioner and Virginia Board of Health on the Addition of Krabbe Disease to the Virginia Newborn Screening Panel - May 5, 2015

  • Published: 2015
  • Author: Department of Health
  • Enabling Authority: Letter Request from Senator John S. Edwards

Executive Summary:
During the 2015 General Assembly Session, two bills were introduced, HB 1420 (Sponsor Plum) and SB 835 (Sponsor Edwards), both proposing the addition of “…Krabbe Disease and other lysosomal storage disorders…" to the Virginia Newborn Screening Panel. The proposed language was to be added to the Code of Virginia, specifically § 32.1-65.

Section 32.1-65 of the Code of Virginia states that “every infant who is born in the Commonwealth shall be subjected to screening tests for various disorders consistent with, but not necessarily identical to, the uniform condition panel recommended by the U.S. Secretary of Health and Human Services and the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children” (SACHDNC). For future reference in this document the uniform screening panel is also known and referred to as the Recommended Uniform Screening Panel (RUSP).

The specific screening tests that are included in Virginia’s panel are defined in the Virginia Administrative Code 12VAC5-71-30 Core Panel of Heritable Disorders and Genetic Diseases. Currently, the Virginia newborn screening regulations cover 31 of 32 disorders that are included in the RUSP.

Section 12 VACS-71-30 also outlines the process by which disorders are added to Virginia’s panel. This process requires any disorders being considered for addition to the VA core panel to be reviewed by the Virginia Genetics Advisory Committee (VAGAC) resulting in a formal report to the Board of Health through the State Health Commissioner. This process was made known to both sponsors during their respective subcommittee meetings. As a result, in a letter dated January 26, 2015, Senator Edwards requested that the Commissioner initiate a review of Krabbe Disease and make formal recommendations for or against addition to Virginia’s newborn screening panel.

In response to Senator Edwards, the Commissioner of Health, in a letter dated February 3, 2015, charged the VAGAC to review the SACHDNC’s evidence-based review of Krabbe Disease from 2009 and to make recommendations to the Board of Health on “…the potential costs, risks, and benefits of adding Krabbe Disease to the Virginia Newborn Screening Panel.“