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US 2020/0263167 A1Published application
Devices, systems and methods for biomarker analysis
AssigneeJuno Diagnostics, Inc.
InventorsDirk VAN DEN BOOM, Mathias EHRICH, Paul OETH, Jim CHAUVAPUN
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Abstract
Provided herein are devices, systems, kits and methods for predicting or determining the gender of a fetus using cell free fetal nucleic acids in a small amount of maternal biological sample. Devices can be used at point of need during early stages of pregnancy and are compatible with communication devices.
Claims50
1) A device comprising:
- a) a sample purifier for removing a cell from a biological fluid sample to produce a cell-depleted sample;
- and
- b) at least one of a detection reagent and a signal detector for detecting a plurality of cell-free DNA fragments in the cell-depleted sample.
20) A method comprising:
- a) obtaining a fluid sample from a subject, wherein the volume of the biological sample is not greater than about 120 microliters;
- b) contacting at least one cell free nucleic acid in the fluid sample with an amplification reagent and an oligonucleotide primer that anneals to a sequence corresponding to a sequence of interest in order to produce an amplification product;
- and
- c) detecting the presence or absence of the amplification product, wherein the presence or absence indicates a health status of the subject.
1 more element
42) A device comprising:
- a) a sample purifier that removes a cell from a fluid sample of a female subject;
- b) at least one nucleic acid amplification reagent;
- c) at least one oligonucleotide comprising a sequence corresponding to a Y chromosome, wherein the at least one oligonucleotide and nucleic acid amplification reagent are capable of producing an amplification product;
- and
- d) at least one of a detection reagent or a signal detector for detecting the amplification product.
2 more elements
44) A method comprising:
- a) obtaining a fluid sample from a female pregnant subject, wherein the volume of the biological sample is not greater than about 300 microliters;
- b) contacting at least one cell free nucleic acid in the fluid sample with an amplification reagent and an oligonucleotide primer that anneals to a sequence corresponding to a sex chromosome;
- and
- c) detecting the presence or absence of an amplification product, wherein the presence or absence indicates the gender of a fetus of the female pregnant subject.
1 more element
Dependencies are inferred from the claim text.