Clinician Guide to Negative & Discrepant Screening Results

What is BRIDGES-NBS?

BRIDGES-NBS is an NIH-funded research study assessing the feasibility of incorporating Genome Sequencing into routine newborn screening.

Scope of BRIDGES-NBS

BRIDGES-NBS screens for a select panel of genes (~800 genes) that are connected to conditions that are actionable within the first year of life. BRIDGES-NBS only reports pathogenic/likely pathogenic (P/LP) variants (i.e. variants expected to cause genetic disease).

What is excluded and not reported:

●      Variants of Uncertain Significance (VUS)

●      Adult-onset conditions

●      Carrier status

Click here to view our complete condition list.

Implications of a Negative Result

A Negative (Screen-Normal) BRIDGES-NBS result means that no reportable P/LP variants were identified among the specific genes analyzed on the study’s targeted panel.

●      Reduces, But Does Not Eliminate, Risk: Genomic Sequencing has technical limitations; it may not detect 100% of pathogenic/likely pathogenic variants or structural anomalies.

●      Limited to Panel Scope: Participants were only screened for the conditions on the BRIDGES-NBS panel, we did not look for variants in their entire genome.

●      Clinical Presentation Supersedes Screening: If you suspect that a baby may have a genetic condition due to medical symptoms, developmental delay, or a positive family history, perform a typical standard of care medical work-up, regardless of a negative screening result. You also have the option to contact GeneDx (GenomicsNBS@genedx.com, 888-729-1206), the laboratory performing the BRIDGE-NBS testing, to ask more about the technical details of testing or order additional testing. GeneDx will store the baby’s genetic sequence data for 5 years in case additional clinical testing is needed.

Discrepancies between State Newborn Screening and BRIDGES-NBS Screening

There may be discrepancies between state newborn screening (NBS) results and BRIDGES-NBS results.

Cause of discrepancy Why it happens Clinical context and example
Non-overlapping panels Routine state NBS panels and BRIDGES-NBS screen for different conditions. State NBS panels screen for conditions which are not included in BRIDGES-NBS. 
Carrier status BRIDGES-NBS does not report carrier status. An infant flagged as a carrier for a condition such as Cystic Fibrosis on state NBS will receive a negative BRIDGES-NBS result.
Different screening methods State NBS uses biochemical markers; BRIDGES-NBS uses DNA sequencing. Biochemical assays measure enzyme activity/analytes, which have different detection thresholds than DNA sequencing.

Clinical Support

The BRIDGES-NBS Genome Resource Center (GRC) is available to provide healthcare providers with assistance with result interpretation and testing pathways. If needed, 1:1 assistance from study medical geneticists and genetic counselors is also available.  Click here to fill out a brief form to request to talk with a Medical Geneticist or Genetic Counselor from the BRIDGES-NBS team.