Abstract: The present invention provides compositions comprising a solution of a compound useful for lysing biological cells and methods for using the compositions to lyse biological cells and to isolate nucleic acid.

Abstract: The present invention provides methods and kits useful for genetic testing or screening of fetuses using nucleic acid samples isolated from cervical mucus samples of fetus hosts.

Abstract: The present invention provides a device for isolating target biomolecules or cells from samples, particularly biological samples. In particular, the device comprises a loading mixture, which contains the biological sample and a first binding entity that specifically binds to the target biomolecule or target cell; and a micro-channel coated with a second binding entity that binds directly or indirectly to the first binding entity. Methods of capturing, detecting, and/or evaluating target biomolecules or target cells (e.g. cancer cells) in biological samples are also disclosed.

Abstract: The present invention provides methods, antibodies and kits useful for detecting the presence of a fetal cell and/or fetal nucleic acids in a biological sample obtained from a maternal host. It also provides methods and kits for isolating fetal nucleic acid from maternal cervical mucus samples, and for testing or screening the isolated fetal nucleic acid for genetic abnormalities in fetuses.

Abstract: A microflow device for separating or isolating cells from a bodily fluid or other liquid sample uses a flow path where straight-line flow is interrupted by a pattern of transverse posts which are arranged across the width of a collection region in an irregular or set random pattern so as to disrupt streamlined flow. Sequestering agents, such as Abs, are attached to all surfaces in the collection region via a hydrophilic permeable hydrogel coating. The collection region is formed as a cavity in a body molded from PDMS, which flexible body is sandwiched between a glass slide or comparable flat plate and a rigid top cap plate, both of which are pressed into abutting relation with the PDMS body by a heat-shrunk polymeric sleeve. Following cell separation and washing, cells can be released from the sequestering agents and the device centrifuged to force said cells to collect adjacent the hydrogel-coated slide or plate.

Abstract: A microflow device for separating or isolating cells from a bodily fluid or other liquid sample uses a flow path where straight-line flow is interrupted by a pattern of transverse posts which are arranged across the width of a collection region in an irregular or set random pattern so as to disrupt streamlined flow. Sequestering agents, such as Abs, are attached to all surfaces in the collection region via a hydrophilic permeable hydrogel coating. The collection region is formed as a cavity in a body molded from PDMS, which flexible body is sandwiched between a glass slide or comparable flat plate and a rigid top cap plate, both of which are pressed into abutting relation with the PDMS body by a heat-shrunk polymeric sleeve. Following cell separation and washing, cells can be released from the sequestering agents and the device centrifuged to force said cells to collect adjacent the hydrogel-coated slide or plate.

Abstract: A biochip is formed with a plurality of optically clear hydrogel cells attached to the top surface of a solid substrate in the form of an array. Each of the cells is formed of a hydrogel of polyethylene glycol, polypropylene glycol or a copolymer thereof having reactive isocyanate groups. Binding entities are immobilized in these cells, which entities are effective to selectively hybridize to or sequester a target biomolecule. Different binding entities are immobilized in different cells in an array to create a biochip that can be used to assay for a number of target biomolecules.

Abstract: A method of making a microarray by coating a flat substrate with a polymerizable hydrogel layer which contains anchoring moieties dispersed uniformly therethroughout. Following curing, a continuous layer of uniform thickness is securely attached to the upper surface of the substrate through an array region thereof. A plurality of different probes are then attached to create microspots at distinct spatial locations on the surface of this slab layer by linking the probes to the anchoring moieties in the cured hydrogel. Such anchoring moieties may employ linking systems such as organic chelators, that are activated by copper or some other metal, and complementary pairs such as avidin-biotin.

Abstract: A micro now device (11, 71) for separating or isolating cells from a bodily fluid or other liquid sample uses a flow path where straight-line flow is interrupted by a pattern of transverse posts (23, 81). The posts are spaced across the width of an expanded collection chamber region (17, 75) in the flow path, extending between the upper and lower surfaces thereof: they have rectilinear surfaces, being curved in cross-sections, e.g. circular or tear-drop shaped, and are randomly arranged so as to disrupt streamlined flow. The device is oriented so that its lower surface is aligned at about 45° to the horizontal. Sequestering agents, such as Abs, which are attached to surfaces of the collection region via a hydrophilic coating, preferably a permeable hydrogel containing isocyanate moieties, are highly effective in capturing cells or other targeted biomolecules while the remainder of the liquid sample exits horizontally.

Abstract: Methods for detecting in a single assay any one of multiple chromosomal disorders that result from aneuploidy or certain mutations, particularly microdeletions, and kits for use therein. A polymerase chain reaction (PCR) is carried out to amplify eukaryotic genomic DNA using a plurality of primer oligonucleotide pairs wherein one primer of each pair has a detectable label attached 5? thereto. A plurality of the primer pairs are targeted to DNA segments of different chromosomes of interest which are indicative of potential chromosomal disorders, and one pair is targeted for a control gene. The amplified PCR products are purified, and single-stranded DNA having the detectable labels is obtained therefrom and hybridized with spots on a microarray that each contain DNA oligonucleotide probes having nucleotide sequences complementary to a nucleotide sequence of one strand of each segment.

Abstract: The present invention provides a non-invasive method of obtaining a sample of endometrial cells for use in the diagnosis of endometrial cancer, as well as methods and kits for diagnosing, determining the prognosis of, and monitoring endometrial cancer.

Abstract: Spheroidal beads present an exterior surface of a hydrophilic hydrogel, which is an isocyanate-functional polymer that is polymerized by urethane bonds and cross-linked by urethane and urea bonds. Sequestering agents present at the surface are covalently bound to isocyanate groups or to intermediate linkers that are so bound. These beads allow sequestering agents to retain their native three-dimensional configuration, and as a result of such surface characteristics and hydrophilicity, they achieve highly effective capture of very small subpopulations of rare cells from bodily fluids or the like and very effectively deter nonspecific binding of other biomaterials present in such bodily fluid. They may be all-hydrogel spheroids or hydrogel-coated substrates.

Abstract: The present invention provides methods and kits useful for genetic testing or screening of fetuses using nucleic acid samples isolated from cervical mucus samples of fetus hosts.

Abstract: A non-invasive screening or diagnostic method for determining the likelihood of a fetus with a genetic abnormality or a potential pregnancy complication, which utilizes a liquid blood sample from a pregnant woman. Antibodies specific to a section of histone 3.1 which is exposed to a far greater extent in chromatin of fetal origin than in chromatin of maternal origin are used to sequester and isolate such fetal nucleosomes including the associated fetal DNA. Following isolation/enrichment of such fetal DNA, genetic analysis is carried out using known molecular diagnostics.

Abstract: Methods for isolating and purifying fetal trophoblasts from a mucus sample obtained from the uterine cavity of a pregnant female. The mucus sample is transported from a clinical collection facility to a laboratory in a transportation medium so the cells remain viable. The mucus sample is then subjected to precise processing steps, including treatment with mucolytic agents or mucinases, sugar hydrolysis enzymes, nucleases, and proteases to provide fetal cells, the outer surfaces of which are so essentially completely devoid of attached mucosal biological material that they are then isolated in greater numbers than previously had been possible. The isolated cells are in appropriate condition to immediately be effectively subjected to FISH or to other molecular diagnostics.

Abstract: An aqueous preservation medium for the selective preservation of trophoblasts obtained in a sample of cervical mucus which permits transportation of such sample to a laboratory facility for analysis and selectively preserves fetal trophoblasts in said sample while presenting conditions that are antagonistic to many maternal cells.

Abstract: A post-incubation treatment is employed to effectively remove targets, such as proteins/protein complexes, or other label-bearing moieties that may non-specifically bind to a microarray substrate during a binding assay. Following incubation, a one-step wash is carried out with a liquid containing digester, e.g., a digestive enzyme (protease) or lysosome, which is effective to remove non-specifically bound targets or at least labeled portions of such targets from the substrate. Proteases are bound to or coated onto large molecules or onto solid particles of such a size such that they are prohibited from entering the porous surfaces of 3-D hydrogel microspots and are unable to reach and digest labeled target-probe complexes that are disposed within such porous hydrogel microspots. Digested segments of such protein which contain labels (or of essentially the entire protein) are carried away in the wash liquid and thus are not present to create background noise during imaging.

Abstract: A microflow device for separating or isolating cells from a bodily fluid or other liquid sample uses a flow path where straight-line flow is interrupted by a pattern of transverse posts which are arranged across the width of a collection region in an irregular or set random pattern so as to disrupt streamlined flow. Sequestering agents, such as Abs, are attached to all surfaces in the collection region via a hydrophilic permeable hydrogel coating. The collection region is formed as a cavity in a body molded from PDMS, which flexible body is sandwiched between a glass slide or comparable flat plate and a rigid top cap plate, both of which are pressed into abutting relation with the PDMS body by a heat-shrunk polymeric sleeve. Following cell separation and washing, cells can be released from the sequestering agents and the device centrifuged to force said cells to collect adjacent the hydrogel-coated slide or plate.

Abstract: A novel hybridization device that improves the efficiency and consistency of microarray hybridization reactions by achieving a greater degree of internal mixing of target solution. The device provides a gasket-and-cover-type chamber wherein solution mixing is achieved by the creation of a multitude of microbubbles. One or more of the inner walls that define the chamber contain bubble-rupturing elements that extend into the chamber and terminate in sharp edges. They are typically located on opposite sides of a rectangular chamber and are pointed in a direction opposing bubble movement. Their interference with larger bubbles causes their breakup into microbubbles which travel separate and distinct paths as a result of external agitation and thereby provide improved solution mixing that results in a uniform distribution of target molecules to the probe molecules bound to the substrate. The sensitivity and consistency of the hybridization reaction is significantly increased.

Abstract: A method for encapsulating biologics within a hydrogel by using an aqueous solution of an isocyanate-functional polyurethane prepolymer which is mixed with an amount of biologics and an aqueous solution containing a dithiol crosslinking agent under physiological pH conditions to create a hydrogel. An additional bidentate crosslinking agent is optionally included. The product of such method may be a bioreactor or an assay device having a plurality of different biologics encapsulated at predetermined locations in a substrate.