Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1998-09-25
1999-10-05
Stucker, Jeffrey
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
435 75, 435 772, 435 79, 435 792, 435 794, 435 405, 435 4051, 436518, 436524, 436527, 436 66, 530385, 5303887, 5303896, G01N 3353
Patent
active
059622342
DESCRIPTION:
BRIEF SUMMARY
This invention relates to a method for separating and recognizing fetal cells from a blood sample. More particularly, it relates to the isolation and recognition of fetal nucleated erythrocytes or erythroblasts from maternal cells in a blood sample from a pregnant woman.
BACKGROUND OF THE INVENTION
Fetal tissue, and in particular fetal DNA and chromosomes, is routinely used in prenatal diagnosis and other medical procedures that require an accurate assessment of the genome of the fetus. Currently, the fetal tissue is obtained by the use of amniocentesis, chorionic villus sampling (CVS), fetoscopy, or cordocentesis, as described in Thompson and Thompson Genetics in Medicine, 5th Edition, W. B. Saunders Co., Philadelphia, 1991.
In amniocentesis, a sample of amniotic fluid, which contains fetal cells, is transabdominally removed from the mother with a needle and syringe. Amniocentesis has inherent associated risks. The major risk is induction of miscarriage which is estimated to occur in 1 in 200 amniocenteses. Other risks include maternal infection and physical damage to the fetus. In CVS, trophoblast tissue is aspirated from the villous area of the chorion transcervically or transabdominally. The rate of fetal loss by this method may be as high as 1 in 100. Cordocentesis or percutaneous umbilical blood sampling provides a method of obtaining fetal blood directly from the umbilical cord with ultrasonic guidance. Each of these invasive methods carries risks to both the mother and the fetus.
Accordingly, it would be desirable to have a noninvasive method for obtaining fetal tissue or fetal DNA. It would also be desirable to have a method that is rapid and reliable for isolating and enriching the fetal tissue from maternal tissue in order to facilitate screening and pre-natal diagnosis in clinical laboratories. Recently, the preferred methodology has been the identification of fetal cells in the peripheral maternal circulation and then garnering of those cells for genetic analysis.
Identification or isolation of fetal cells from maternal blood has relied upon distinguishing the rare population of fetal cells from the more prevalent maternal cells. Although various fetal cell types, such as fetal lymphocytes and trophoblasts, have been utilized in the identification process as target cells for fetal DNA, more efforts have been directed to fetal nucleated red blood cells (nRBC), also known as nucleated erythrocytes. See Cheuh and Golbus, "The Search for Fetal Cells in the Maternal Circulation", J. Perinatol. Med., 19:411 (1991); Simpson, et al., "Noninvasive Screening for Prenatal Genetic Diagnosis", Bull. WHO, 73:799 (1995); and Cheuh and Golbus, "Prenatal Diagnosis Using Fetal Cells from Maternal Circulation", West. J. Med., 159(3):308 (1993).
Fetal RBCs are thought to cross the placenta as a result of transplacental bleeding. Since the fetus has a large number of nucleated erythrocytes, which nucleated erythrocytes are rarely found in adult blood, the difference in nucleation is useful in separating and identifying fetal cells from maternal ones.
Antibodies to cell surface antigens particular to nRBCs, such as the transferrin receptor, have been utilized to identify and enrich for these fetal cells. See Bianchi, et al., "Isolation of Fetal DNA from Nucleated Erythrocytes in Maternal Blood", Proc. Natl. Acad. Sci, 87:3279 (1990). See also Bianchi, et al. PCT International Application No. PCT/US90/06623 (WO 91/07660), which describes a method for enriching fetal nucleated red blood cells from a peripheral blood sample by the use of an antibody which binds an antigen on the cell surface of the fetal cells.
Bresser, et al., PCT International Application No. PCT/US94/08342 (WO 95/03431) describes the use of fetal hemoglobin antibodies and mRNA probes to enrich for fetal cells in maternal blood. The presence of fetal hemoglobin also has been demonstrated by the Kleihauer-Betke reaction that differentiates fetal from adult hemoglobin by acid elution characteristics. See Kleihauer, et al., "Demonstration von fetale
REFERENCES:
patent: 5731156 (1998-03-01), Golbus
Zheng et al. "Flow Sorting of Fetal Erythroblasts Using Intracytoplasmic Anti-Fetal Haemoglobin: Preliminary Observations on Maternal Samples", Prenatal Diagnosis, vol. 15(1995), pp. 897-905.
Kutlar et al. "Quantities of Adult, Fetal and Embryonic Globin Chains in the Blood of Eighteen-to Twenty-Week-Old Human Fetuses", Journal of Chromatography, vol. 567, No. 2(Jul. 5, 1991), pp. 359-368. Abstract Only, complete reference unavailable at this time.
Pierce Catalog, 1992-1993, Rockford, IL, 800-8-Pierce, pp. D1-3 and D29-31. TP202.P43.
Saunder et al. "Enrichment of Fetal Cells From Maternal Blood for Genetic Analysis", Abstracts of the American Society of Human Genetics, A287, abstract No. 1672(1995).
Bianchi, et al., "Prenatal Diagnosis by analysis of fetal cells in material blood", J. Pediatr., 127(6): 847-856 (1995).
Bianchi, et al., "Isolation of Fetal DNA from Nucleated Erythrocytes in Maternal Blood", Proc. Natl. Acad. Sci. USA, 87:3279-3283 (1990).
Bischoff, et al., "Fetal cells in maternal blood: more efficacious Fish analysis by using gamma globin mRNA to identify fetal cells after flow-sorting," Abstracts of American Journal of Human Genetics, 57(4 Suppl.):A33 #162 (1995).
Chueh and Globus. "The Search for Fetal Cells in the Maternal Circulation," J. Perinat. Med., 19:411-420 (1991).
Chueh and Golbus, "Prenatal Diagnosis Using Fetal Cells from Maternal Circulation," West. J. Med., 159(3):308-311 (1993).
Cheung, et al., "Prenatal diagnosis of single gene disorders by analysis of fetal cells in maternal blood: Successful application in sickle cell anemia and .beta.-thalassemia," Abstracts of the American Journal of Human Genetics, 4(59) Suppl.) :All #46 (1996).
de la Cruz, et al., "Prenatal diagnosis by use of fetal cells isolated from maternal blood," Am. J. Obstet. Gynecol., 173(4): 1354-1355 (1955).
Emery and Rimoin (as edited), "Haemoglobinopathies and thalassaemias," Principles and Practice of Medical Genetics, J.A. Phillips and H.H. Kazazian, 1023-1024 (1983).
Iwahara, et al., "Identification of Five Embryonic Hemoglobins of Rat and Ontogeny of Their Constituent Globins During Fetal Development," J. Biochem, 119(2): 360-366 (1966).
Kleihauer, et al., "Demonstration von Fetalem Hamoglobin in Den Erythrocyten Eines Blutasstrichs", Klin. Wschr. 35:637-638 (1957).
Kutlar, et al., "Quantities of Adult, Fetal and Embryonic Globin Chains in the Blood of Eighteen-to Twenty-Week-Old Human Fetuses." Journal of Chromatography, 567:2 (Jul. 5, 1991), 359-368. Abstract Only.
Lo, et al., "Prenatal Sex Determination by DNA Amplification from Maternal Peripheral Blood," Lancet, 2:1363-1365 (1989).
Martens, et al., "A New Method of Detection and Confirmation of Fetal Nucleated Red Blood Cells from Maternal Blood," Abstracts of the American Journal of Obstetrics and Gynecology, 170 (1 Pt. 2):282 #43 (1994).
O'Kelly, et al., "Instrumentation for the genetic evaluation of fetal cells from maternal blood," Abstracts of the Amer. Coc. Hum. Genet., A286 #1661 (1995).
Oosterwijk, et al., "Detection of fetal erythroblasts in maternal blood by one-step enrichment, immunocytochemical recognition, Fish analysis and automated microscopy," Abstracts of the American Journal of Human Genetics, 4(59) Suppl.):A327 #1903 (1996).
Park, et al., "A Model System Using Fetal Hemoglobin to Distinguish Fetal Cells Enriched from Maternal Blood," Ann. NY Acad. Sci., 731:133-135 (1994).
Saunders, et al., "Enrichment of Fetal Cells from Maternal Blood for Genetic Analysis", Abstracts of the Amer. Soc. Hum. Genet., Abstract No. A287 1672 (1995).
Simpson, et al., "Isolating fetal cells in maternal circulation," Human Reproduction Update, 1(4):409-418 (1995).
Simpson, et al., "Fetal Cells in Maternal Blood, Overview and Historical Perspective," Ann. NY Acad. Sci., 731:1-8 (1994).
Simpson, et al., "Isolating Fetal Cells in Maternal Circulation for Prenatal Diagnosis," Prenat. Diagn., 14:1229-1242 (1994).
Simpson, et al., "Isolating Fetal Nucleate
Applied Imaging Corporation
Stucker Jeffrey
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