Business methods for prenatal Diagnosis
The present invention relates to business methods in which screening services and diagnostics for the condition of a fetus are provided. Fetal abnormalities, include chromosomal and other genetic ies, are detected through the analysis of fetal cells obtained from maternal blood samples.
1 . A business method for providing a prenatal diagnostic comprising:
obtaining a blood sample of a mammal who is or has been pregnant with a fetus;
enriching from said blood sample one or more fetal cells;
analyzing said fetal cells to determine a condition of said fetus; and
providing a report on said condition in exchange for a service fee.
2 . The business method of claim 1 wherein said business licenses a CLIA laboratory to perform said analyzing step.
3 . The business method of claim 1 wherein said enriching step is performed in a fluid system adapted to separate said fetal cell from maternal cells by directing said cells in different directions by size.
4 . The business method of claim 1 wherein said business conducts said service.
5 . The business method of claim 1 wherein said condition is selected from the group consisting of: trisomy 13, trisomy 18, trisomy 21 (Down Syndrome), Turner Syndrome (damaged X chromosome), Klinefelter Syndrome (XXY) and other irregular number of sex or autosomal chromosomes.
6 . The business method of claim 1 wherein said condition is selected from the group consisting of: Wolf-Hirschhorn (4p-), Cri-du-chat (5p-), Williams syndrome (7q11.23), Prader-Willi syndrome (15q11.2-q13), Angelman syndrome (15q11.2-q13), Miller-Dieker syndrome (17p 13.3), Smith-Magenis syndrome (17p 11.2), DiGeorge and Velo-cardio-facial syndromes (22q11.2), Kallman syndrome (Xp22.3), Steroid Sulfatase Deficiency (STS) (Xp22.3), X-Linked Ichthiosis (Xp22.3), and Retinoblastoma (13 q 14).
7 . The business method of claim 1 wherein said report is performed for a health care provider or a health insurance company.
8 . The business method of claim 1 wherein said business licenses a CLIA laboratory to perform said enrichment step.
9 . A business method comprising commercializing a diagnostic product for conducting a prenatal screen for a genetic defect in a fetus, wherein said diagnostic product enriches fetal cells from a maternal blood sample.
10 . The business method of claim 9 wherein said business manufactures said diagnostic product.
11 . The business method of claim 10 wherein said diagnostic product is manufactured from a polymer material.
12 . The business method of claim 9 wherein said diagnostic is disposable.
13 . The business method of claim 9 wherein said diagnostic product selectively directs fetal cells in a direction away from maternal enucleated red blood cells.
14 . The business method of claim 9 wherein said diagnostic product detects genetic abnormalities in said fetal cells.
15 . The business method of claim 14 wherein said genetic abnormalities are detected using a label that binds nucleic acids.
16 . The business method of claim 15 wherein said label is a fluorescence label.
17 . The business method of claim 15 wherein said label is a colorimetric label.
18 . A business method for isolating fetal cells from maternal blood comprising:
obtaining a blood sample of a mammal who is or has been pregnant with a fetus; and
enriching from said blood sample one or more fetal cells in exchange for a fee.