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Methods, compositions, and kits for determining the sex of a fetus

a technology a kit, which is applied in the field of methods, compositions, and kits for determining the sex of a baby, can solve the problems of a large number of options, carries a risk of miscarriage, and is not available to most women

Pending Publication Date: 2022-08-11
GATEWAY GENOMICS LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The methods, compositions, and kits of this patent make it possible to determine the sex of a fetus with high accuracy. In some cases, the methods have a sensitivity of at least 40%, 50%, 60%, 70%, or 85%. In other cases, the methods have a specificity of at least 40%, 50%, 60%, 70%, or 85%, meaning they can identify the fetal sex with a high level of confidence. In some aspects, the methods can determine the fetal sex with at least 40%, 50%, 60%, 70%, or 80% specificity, meaning they can identify the fetal sex with a high level of confidence. Overall, the patent provides effective tools for identifying the fetal sex with high accuracy.

Problems solved by technology

There are currently a limited number of options for learning the sex of a fetus available to expectant parents during the 40 weeks of the typical human gestational period.
Amniocentesis may be used for determining fetal sex with high accuracy between 15 to 18 weeks gestational age but carries a miscarriage risk and is not available to most women.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

tion of Fetal Sex at 28 Days Gestation

[0065]Whole blood samples are collected from pregnant woman of gestational age 28 days. The samples are used to validate a fetal sex test described herein using circulating cell free fetal DNA (ccffDNA) in maternal plasma.

[0066]One hundred and fifty participants from a clinic are enrolled in this study. Fetal gestational age of participants will be 4 weeks at the time of sample collection. Fetal sex test results are confirmed through subsequent sonographic evaluation after participants reach at least 14 weeks gestation.

[0067]At the time of sample collection, 3-4 mL of maternal blood is drawn from all participants by standard venipuncture. Additionally, 500 ul of maternal capillary blood is collected via fingerstick using a standard lancet. Approximately 500 μL of the collected sample is centrifuged at 1,600 g for 15 minutes to separate plasma from whole blood. Next, 100 μL of the separated plasma is incubated with Proteinase K to help degrade an...

example 2

tion of Fetal Sex at 8 Weeks Gestation

[0072]The purpose of this study was to evaluate the clinical performance of an assay of the disclosure for noninvasive prenatal testing (NIPT) to determine fetal sex at 8 weeks gestation. One hundred and eight participants were enlisted for this study. Fetal gestational age of participants ranged from 7.00-10.57 weeks at the time of sample collection. Fetal sex test results were confirmed through subsequent sonographic evaluation after participants had reached at least 14 weeks gestation.

[0073]At the time of sample collection, 3-4 mL of maternal blood was drawn from all participants by standard venipuncture. Blood samples were sent to a clinical lab where 600 μL of the collected sample was then centrifuged at 1,600 g for 15 minutes to separate plasma from whole blood. Next, 100 μL of the separated plasma was incubated with Proteinase K. Following proteinase K treatment, cfDNA was isolated from the plasma samples using the MagMAX Cell-Free DNA Is...

example 3

tion of Fetal Sex at Six Weeks Gestation

[0077]The purpose of this study was to evaluate the clinical performance of an assay of the disclosure for noninvasive prenatal testing (NIPT) to determine fetal sex at six weeks gestation in assisted reproductive technology achieved (ART) pregnancies. Eighteen participants undergoing ART pregnancy were enrolled in this study. A venipuncture blood draw was collected from each participant at approximately 42 days gestation. Samples were processed and tested approximately 24-48 hours after collection. Fetal sex was known at the time of embryo implantation from preimplantation genetic testing (PGT). The accuracy of the test was assessed by comparing the qPCR test results from maternal blood samples obtained at day 42 of gestation to the fetal sex results obtained from PGT.

[0078]At the time of sample collection, 3 mL of maternal blood was drawn from all participants by standard venipuncture. Blood samples were mailed to a clinical lab and the bloo...

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Abstract

The disclosure relates to methods, compositions, and kits for the early determination of the sex of a fetus. The disclosure also provides methods, compositions, and kits for detecting fetal nucleic acids in biological samples (e.g., cell-free fetal DNA).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of priority of U.S. Provisional Patent Applications No. 62 / 903,945, filed Sep. 23, 2019, and No. 62 / 936,329, filed Nov. 15, 2019, each of which is hereby expressly incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]The disclosure relates to methods, compositions, and kits for the early determination of the sex of a fetus. The disclosure also provides methods, compositions, and kits for detecting fetal nucleic acids in biological samples (e.g., cell-free fetal DNA).BACKGROUND OF THE INVENTION[0003]There are approximately 4 million live births in the United States each year. More than two-thirds of expectant parents want to know the sex of their baby as early as practical into pregnancy. There are currently a limited number of options for learning the sex of a fetus available to expectant parents during the 40 weeks of the typical human gestational period.[0004]Ultrasound imaging has be...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C12Q1/6879C12Q1/6806
CPCC12Q1/6879C12Q1/6806C12Q2527/125
Inventor JACOB, CHRISTOPHER
Owner GATEWAY GENOMICS LLC
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