Fluxion Biosciences, a leading developer of precision solutions for life science research and diagnostics, today announced that it has received a National Institutes of Health grant for development of its novel Spotlight™ NIPT non-invasive prenatal test (NIPT). The Phase I grant will have a duration of 6-9 months, with clinical support from researchers at the University of California, San Francisco.
NIPT has achieved broad adoption in screening for chromosomal abnormalities such as Down syndrome. The tests are easy to administer and most importantly they are non-invasive. For the vast majority of test takers the results are negative and no further action is required. However, positive results require additional invasive testing such as amniocentesis, since the current NIPT assays do not provide a definitive diagnosis. Fluxion has demonstrated that a cell-based approach can provide the levels of sensitivity and specificity needed for a true diagnostic test, eliminating the requirement for follow-up invasive testing.
The Spotlight™ NIPT development project includes validation of a model system for test development, integration of the key test components, and clinical testing to compare Spotlight™ NIPT performance to competitive NIPT tests that are currently used for screening. The test will be based on a novel isolation technology that selectively removes fetal cells from the mother’s blood sample. The cells are then separated and tested for chromosomal abnormalities and other genetic variants using a single-cell next-generation sequencing (NGS) method pioneered by Fluxion.