Nucleic acid-based tests for prenatal gender determination
AssigneeSequenom, Inc.
InventorsPaul Andrew Oeth, Payam Mahboubi, Min Seob Lee
Life of this patent
Estimating the term…
Abstract
Provided herein are compositions, processes and kits for noninvasive, early determination of fetal sex from, and/or amount of fetal nucleic acid in, an extracellular nucleic acid sample from a pregnant female. Such compositions, processes and kits are useful for detection of low genomic copy numbers of male fetal nucleic acid in a high copy number background of female nucleic acid, thereby determining the sex of a fetus and/or amount of fetal nucleic acid in a sample.
Claims27
A method for identifying the presence or absence of Y-chromosome nucleic acid in extracellular nucleic acid from a pregnant female, which comprises:
- (a) contacting under amplification conditions extracellular nucleic acid from a pregnant female with three or more primer sets selected from the group consisting of:
- SEQ
- SEQ
- ID
- corresponding
- ID
- first primer
- NO:
- second primer
- NO:
- AGATGGCTCTAGAGAATCCC
- 104
- GCATTTTCCACTGGTATCCC
- 137
- TTTCCTCTCTCTCCACCCC
- 105
- AAAGTTGCCTTTCTGCCTGC
- 138
- AGAGAAGGCGGATTCCTTTG
- 106
- GAAGTTGGGAGAGTTACTCG
- 139
- ACGAAGGGCTACTTCTCTAC
- 107
- CTCTGGCTAGCATCACAATG
- 136
- GAACCTCAGGCTCTTTGTCC
- 108
- TCTATTCTTGCCGAGAGACC
- 140
- ATGACCCCAAAAGCACAGAC
- 109
- TCCCTCTGTGGTACAGAAAC
- 141
- TCCCAGACTGAAATCCCAAG
- 110
- TCGAATTTGATTCCCAGAGG
- 142
- CTGGCCCTACGAATTTGTTG
- 111
- GTCAGGAGATCGAGACAATC;
- 143
- wherein (i) the nucleic acid comprises maternal nucleic acid and fetal nucleic acid, (ii) each primer of each primer set hybridizes to Y-chromosome nucleic acid, and (iii) each primer set consists of a first primer and a corresponding second primer;
- and
- (b) detecting the presence or absence of amplification products from three or more of the primer sets, whereby the presence of Y-chromosome nucleic acid is based on detecting the presence of the amplification products and whereby the absence of Y-chromosome nucleic acid is based on detecting the absence of the amplification products.
A kit that comprises three or more primer sets selected from the group consisting of:
- SEQ
- SEQ
- ID
- corresponding second
- ID
- first primer
- NO:
- primer
- NO:
- AGATGGCTCTAGAGAATCCC
- 104
- GCATTTTCCACTGGTATCCC
- 137
- TTTCCTCTCTCTCCACCCC
- 105
- AAAGTTGCCTTTCTGCCTGC
- 138
- AGAGAAGGCGGATTCCTTTG
- 106
- GAAGTTGGGAGAGTTACTCG
- 139
- ACGAAGGGCTACTTCTCTAC
- 107
- CTCTGGCTAGCATCACAATG
- 136
- GAACCTCAGGCTCTTTGTCC
- 108
- TCTATTCTTGCCGAGAGACC
- 140
- ATGACCCCAAAAGCACAGAC
- 109
- TCCCTCTGTGGTACAGAAAC
- 141
- TCCCAGACTGAAATCCCAAG
- 110
- TCGAATTTGATTCCCAGAGG
- 142
- CTGGCCCTACGAATTTGTTG
- 111
- GTCAGGAGATCGAGACAATC
- 143
- wherein the primers comprise a 5′ tag sequence.
A method for determining the amount of fetal nucleic acid in a sample of extracellular nucleic acid from a pregnant female, which comprises:
- (a) contacting under amplification conditions extracellular nucleic acid from a pregnant female with three or more primer sets selected from the group consisting of:
- SEQ
- SEQ
- ID
- corresponding
- ID
- first primer
- NO:
- second primer
- NO:
- AGATGGCTCTAGAGAATCCC
- 104
- GCATTTTCCACTGGTATCCC
- 137
- TTTCCTCTCTCTCCACCCC
- 105
- AAAGTTGCCTTTCTGCCTGC
- 138
- AGAGAAGGCGGATTCCTTTG
- 106
- GAAGTTGGGAGAGTTACTCG
- 139
- ACGAAGGGCTACTTCTCTAC
- 107
- CTCTGGCTAGCATCACAATG
- 136
- GAACCTCAGGCTCTTTGTCC
- 108
- TCTATTCTTGCCGAGAGACC
- 140
- ATGACCCCAAAAGCACAGAC
- 109
- TCCCTCTGTGGTACAGAAAC
- 141
- TCCCAGACTGAAATCCCAAG
- 110
- TCGAATTTGATTCCCAGAGG
- 142
- CTGGCCCTACGAATTTGTTG
- 111
- GTCAGGAGATCGAGACAATC;
- 143
- (b) detecting the amount of amplification products from three or more of the primer sets, whereby the amount of fetal nucleic acid in the extracellular nucleic acid is determined based on the amount of the amplification product.
Dependencies are inferred from the claim text.