Bionano Laboratories OGM-Dx Postnatal Whole Genome SV and OGM-Dx Prenatal Whole Genome SV Tests

Bionano Laboratories, the clinical services arm of Bionano Genomics, has launched two new optical genome mapping (OGM)-based laboratory-developed tests (LDTs), OGM-Dx Postnatal Whole Genome SV and OGM-Dx Prenatal Whole Genome SV. The postnatal assay tests peripheral blood samples from individuals who have been diagnosed with autism spectrum disorder (ASD), intellectual disability, developmental delay, epilepsy and rare undiagnosed genetic disease, and others. According to the company, the report of this test will include a whole genome analysis of structural variants (SVs) and will screen for the common CGG expansion in the FMR1 gene that may indicate fragile X syndrome.

The prenatal test may be indicated for fetuses where a genetic anomaly is suspected, including abnormal ultrasound or positive non-invasive prenatal screening (NIPS), previous child with chromosomal abnormality, and history of recurrent pregnancy loss, the company said. This test will generate a report that includes whole-genome analysis to assess for SVs of diagnostic and prognostic value.