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Small Biz Grant Funds Prenatal Genetic Test

Pregnant woman

(Freestocks.org, Unsplash)

3 Oct. 2019. A small business set-aside grant is funding early development of a non-invasive prenatal test that simplifies detection of genetic abnormalities in a fetus. The six-month $284,000 project is undertaken by Fluxion Biosciences Inc. in Alameda, California with funds from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of National Institutes of Health.

With current techniques, detecting genetic abnormalities in a fetus, such as Down syndrome, first requires a blood test to screen for DNA circulating in the mother’s blood stream indicating variations associated with inherited birth defects. According to Fluxion Biosciences, those screens have a high false-positive rate, up to 80 percent in some cases. To confirm the presence of these variations, physicians need to conduct two invasive procedures: an amniocentesis, drawing amniotic fluid from the uterus, and chorionic villus sampling that takes a sample of placenta tissue.

Fluxion Biosciences develops liquid biopsy tests, mainly for cancer. The company’s process takes a blood sample from cancer patients, then performs a high-throughput genomic sequencing of circulating tumor DNA to identify cancer-associated mutations. The company says its liquid biopsy technology for cancer is able to isolate rarely occurring cells and analyze DNA from individual cells, including genetic sequencing.

Fluxion proposes applying these tools to analyze one blood sample from the mother for indicators of genetic abnormalities, which would also replace the second-stage invasive procedures. The company says its initial tests show fetal trophoblast cells in the placenta that provide nutrients to the embryo can be isolated from the blood. Furthermore, with single-cell genetic sequencing, Fluxion can analyze and identify genetic abnormalities from those isolated cells.

Under the award, Fluxion will develop a prototype testing workflow that includes cell isolation, lab preparation for single-cell sequencing on commercial sequencers, and bioinformatics software for analysis. The project also calls for validating the technology.

The company expects to make the non-invasive prenatal test, or NIPT, part of its Spotlight line of testing technologies. “Spotlight NIPT brings together several novel technologies pioneered here at Fluxion,” says Jeff Jensen, Fluxion’s CEO in a company statement, ” and we look forward to advancing this important test to routine clinical use.”

The award to Fluxion was made under NIH’s Small Business Innovation Research, or SBIR, program that sets aside a portion of its overall research funding for small U.S.-based companies with science-based products. NIH says it invests more than $1 billion in SBIR and related Small Business Technology Transfer awards.

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