IP Library Granted Patent US 10,961,594
Granted Patent B2
US 10,961,594 · App. 16/156,100 · Granted Mar 30, 2021

Compositions to detect Atopobium vaginae nucleic acid

Inventor: Damon K. Getman (San Diego, CA)
Assignee: GEN-PROBE INCORPORATED
C12Q1/689C12Q1/6865C12Q2600/158
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Quick Facts
Patent No.
US 10,961,594
App. No.
16/156,100
Granted
Mar 30, 2021
Kind
B2
Abstract

The disclosed invention include nucleic acid oligomers that may be used as amplification oligomers, including primers, as capture probes for sample preparation, and detection probes for detection of 16S rRNA from Atopobium vaginae in samples by using methods of specific nucleic acid amplification and detection.

Claims (20)

1. A composition comprising at least two amplification oligomers for amplifying a 16S rRNA of A. vaginae or a gene encoding 16S rRNA of A. vaginae , wherein said amplification oligomers are configured to specifically hybridize to said 16S rRNA of A. vaginae or a gene encoding 16S rRNA of A. vaginae and generate an amplicon comprising a nucleotide sequence that is SEQ ID NO:43, wherein at least one of the amplification oligomers comprises a target-specific sequence selected from the group consisting of SEQ ID NO:2 and SEQ ID NO:27, and wherein at least one of the amplification oligomers comprises a 5′ promoter sequence, and

wherein the composition further comprises a detection probe oligomer comprising (i) a nucleotide sequence of from 10 nucleotides in length to 40 nucleotides in length configured to specifically hybridize to all or a portion of a region of a target sequence of an A. vaginae 16S rRNA nucleic acid or amplified nucleic acid sequence, said region corresponding to SEQ ID NO:44; and (ii) a label selected from a luminescent compound and a fluorophore.

2. The composition of claim 1 , wherein a first oligomer member of the at least two amplification oligomers comprises the target-specific sequence of SEQ ID NO:2 and a second oligomer member of the at least two amplification oligomers comprises the target-specific sequence of SEQ ID NO:27.

3. The composition of claim 2 , wherein the second oligomer member comprises the sequence of SEQ ID NO:3.

4. The composition of claim 1 , wherein said promoter sequence is a T7 RNA polymerase promoter sequence.

5. The composition of claim 4 , wherein said promoter sequence is SEQ ID NO:25.

6. The composition of claim 5 , wherein at least one of the amplification oligomers comprises the sequence of SEQ ID NO:3.

7. The composition of claim 1 , wherein the detection probe comprises a sequence selected from the group consisting of SEQ ID NO:4, SEQ ID NO:15, SEQ ID NO:16, and SEQ ID NO:17.

8. The composition of claim 1 , wherein the label is a chemiluminescent label.

9. The composition of claim 1 , wherein said region corresponds to SEQ ID NO:45.

10. The composition of claim 1 , wherein said region corresponds to SEQ ID NO:46.

11. The composition of claim 1 , wherein said detection probe oligomer is from 11 nucleotides in length to 29 nucleotides in length, contains a sequence corresponding to SEQ ID NO:48, and specifically hybridizes to all or a portion of a region of an A. vaginae nucleic acid or amplified nucleic acid sequence corresponding to SEQ ID NO:44.

12. The composition of claim 1 , wherein the sequence of said detection probe oligomer is SEQ ID NO:4.

13. A kit comprising at least two amplification oligomers for amplifying a 16S rRNA of A. vaginae or a gene encoding 16S rRNA of A. vaginae , wherein said amplification oligomers are configured to specifically hybridize to said 16S rRNA of A. vaginae or a gene encoding 16S rRNA of A. vaginae and generate an amplicon comprising a nucleotide sequence that is SEQ ID NO:43, wherein at least one of the amplification oligomers comprises a target-specific sequence selected from the group consisting of SEQ ID NO:2 and SEQ ID NO:27, and wherein at least one of the amplification oligomers comprises a 5′ promoter sequence, and

wherein the kit further comprises a detection probe oligomer comprising (i) a nucleotide sequence of from 10 nucleotides in length to 40 nucleotides in length configured to specifically hybridize to all or a portion of a region of a target sequence of an A. vaginae 16S rRNA nucleic acid or amplified nucleic acid sequence, said region corresponding to SEQ ID NO:44; and (ii) a label selected from a luminescent compound and a fluorophore.

14. The kit of claim 13 , wherein a first oligomer member of the at least two amplification oligomers comprises the target-specific sequence of SEQ ID NO:2 and a second oligomer member of the at least two amplification oligomers comprises the target-specific sequence of SEQ ID NO:27.

15. The kit of claim 14 , wherein the second oligomer member comprises the sequence of SEQ ID NO:3.

16. The kit of claim 13 , wherein said promoter sequence is a T7 RNA polymerase promoter sequence.

17. The kit of claim 16 , wherein said promoter sequence is SEQ ID NO:25.

18. The kit of claim 17 , wherein at least one of the amplification oligomers comprises the sequence of SEQ ID NO:3.

Assignments (4)
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 075462/0440 →
SECURITY INTEREST Recorded Oct 12, 2021
From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 057787/0526 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 18, 2021
From: GETMAN, DAMON K
To: GEN-PROBE INCORPORATED
Reel/Frame 055325/0560 →
SECURITY INTEREST Recorded Oct 14, 2019
From: HOLOGIC, INC.; CYNOSURE, LLC; CYTYC CORPORATION; FAXITRON BIOPTICS, LLC; FOCAL THERAPEUTICS, INC.; GEN-PROBE INCORPORATED
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 050719/0701 →
Continuity (5)
Division 14925812 · Oct 28, 2015
Continuation 13029720 · Feb 17, 2011
Continuation PCTUS2011025215 · Feb 17, 2011
Provisional Application 61305319 · Feb 17, 2010
Related Publication 20190024147A1 · Jan 24, 2019