Business methods for prenatal Diagnosis

• US 20070059719A1
• Filed: 09/15/2005
• Published: 03/15/2007
• Est. Priority Date: 09/15/2005
• Status: Abandoned Application

• Current Assignee: Gpb Scientific, LLC, Mehmet Toner
• Original Assignee: Mehmet Toner
• Inventors: Schmidt, Martin, Toner, Mehmet, Kapur, Ravi, Grisham, Michael, Tompkins, Ron
• Application Number:
  US11/229,332
• Publication Number:
  US 20070059719A1
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: B01L 2200/0652 Sorting or classification of particles or molecules
• CPC Class Codes: B01L 2200/0668 Trapping microscopic beads
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2400/043 magnetic forces
• CPC Class Codes: B01L 3/502753 characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation separation in general B01D; microapparatus for analysis using electrophoresis G01N27/44791; sample preparation G01N1/28
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06Q 40/08 Insurance
• CPC Class Codes: G16B 20/00 ICT specially adapted for functional genomics or proteomics, e.g. genotype-phenotype associations
• CPC Class Codes: G16B 20/10 Ploidy or copy number detection
• CPC Class Codes: G16B 20/20 Allele or variant detection, e.g. single nucleotide polymorphism [SNP] detection
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

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.

Claims

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.