IP Library Granted Patent US 10,865,433
Granted Patent B2
US 10,865,433 · App. 15/543,944 · Granted Dec 15, 2020

Reaction mixtures for diagnosing bacterial vaginosis

Inventors: Michael Graham (Madison, WI); Jeff G. Hall (Waunakee, WI); Joseph J. King (Madison, WI)
Assignee: GEN-PROBE INCORPORATED
C12Q1/04C12Q1/689C12Q1/6883G01N33/533G01N33/6893G01N2800/26G01N2800/36
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Quick Facts
Patent No.
US 10,865,433
App. No.
15/543,944
Granted
Dec 15, 2020
Kind
B2
Abstract

Disclosed are methods for diagnosing Bacterial Vaginosis (BV). The disclosed methods generally include detecting select species of Eggerthella and/or Prevotella , and optionally detecting select species of Lactobacillus . Also disclosed are nucleic acid oligomers and related compositions for detection of a 16S rRNA or its encoding gene from select species of Eggerthella, Prevotella , or Lactobacillus.

Claims (16)

1. A reaction mixture for specific detection of an Eggerthella target nucleic acid and a Prevotella target nucleic acid in the presence of other nucleic acids that may be in a sample, the reaction mixture comprising:

an Eggerthella -specific oligonucleotide that specifically hybridizes to a target sequence within a target nucleic acid of an Eggerthella species characterized by the presence of a 16S rRNA gene having a nucleobase sequence that is at least 98% identical to the sequence shown in SEQ ID NO:1, but does not specifically hybridize to a sequence within a nucleic acid from other Eggerthella species, wherein the Eggerthella -specific oligonucleotide comprises a 3′ portion that specifically hybridizes to the target sequence within the Eggerthella target nucleic acid and a 5′ portion that does not specifically hybridize to the Eggerthella target nucleic acid, wherein the 3′ portion of the Eggerthella -specific oligonucleotide is a target-hybridizing sequence consisting of the sequence shown in residues 11-27 of SEQ ID NO:4, and

a Prevotella -specific oligonucleotide that specifically hybridizes to a target sequence within a target nucleic acid of P. amnii, P. disiens , and P. bivia , but does not specifically hybridize to a sequence within a nucleic acid from other Prevotella species, wherein the Prevotella -specific oligonucleotide comprises a 3′ portion that specifically hybridizes to the target sequence within the Prevotella target nucleic acid and a 5′ portion that does not specifically hybridize to the Prevotella target nucleic acid, wherein the 3′ portion of the Prevotella -specific oligonucleotide is a target-hybridizing sequence consisting of the sequence shown in residues 11-25 of SEQ ID NO:7,

optionally wherein the reaction mixture further comprises a Lactobacillus -specific oligonucleotide that specifically hybridizes to a target sequence within a target nucleic acid of Lactobacillus species, but does not specifically hybridize to a sequence within a nucleic acid from L. iners , wherein the Lactobacillus -specific oligonucleotide comprises a 3′ portion that specifically hybridizes to the target sequence within the Lactobacillus target nucleic acid and a 5′ portion that does not specifically hybridize to the Lactobacillus target nucleic acid.

2. The reaction mixture of claim 1 , wherein the Eggerthella and Prevotella target nucleic acids are 16S rRNAs of Eggerthella and Prevotella , respectively, and wherein if the reaction mixture further comprises the Lactobacillus -specific oligonucleotide, then the Lactobacillus target nucleic acid is a 16S rRNA of Lactobacillus.

3. The reaction mixture of claim 2 , wherein

the 3′ portion of the Lactobacillus -specific oligonucleotide, if present, is a target-hybridizing sequence consisting of the sequence shown in residues 11-27 of SEQ ID NO:10.

4. The reaction mixture of claim 3 , wherein the reaction mixture comprises the Lactobacillus -specific oligonucleotide, and wherein the reaction mixture further comprises

(i) second and third Eggerthella -specific oligonucleotides that target a sequence within an Eggerthella 16S rRNA region corresponding to nucleotide positions 615 to 679 of SEQ ID NO: 1; and/or

(ii) second and third Prevotella -specific oligonucleotides that target a sequence within a Prevotella 16S rRNA region corresponding to nucleotide positions 954 to 1037 of SEQ ID NO:2; and/or

(iii) second and third Lactobacillus -specific oligonucleotides that target a sequence within a Lactobacillus 16S rRNA region corresponding to nucleotide positions 837 to 944 of SEQ ID NO:3.

5. The reaction mixture of claim 3 , wherein the reaction mixture comprises the Lactobacillus -specific oligonucleotide.

6. The reaction mixture of claim 4 , wherein the second Eggerthella -specific oligonucleotide comprises a target-hybridizing sequence corresponding to the sequence shown in residues 1-20 of SEQ ID NO:5, and wherein the third Eggerthella -specific oligonucleotide comprises a target-hybridizing sequence corresponding to the sequence shown in SEQ ID NO:6.

7. The reaction mixture of claim 4 , wherein the second Prevotella -specific oligonucleotide comprises a target-hybridizing sequence corresponding to the sequence shown in residues 1-24 of SEQ ID NO:8, and wherein the third Prevotella -specific oligonucleotide comprises a target-hybridizing sequence corresponding to the sequence shown in SEQ D NO:9.

8. The reaction mixture of claim 4 , wherein the second Lactobacillus -specific oligonucleotide is selected from the group consisting of (i) an oligonucleotide comprising a target-hybridizing sequence corresponding to the sequence shown in residues 1-27 of SEQ ID NO: 11 and (ii) an oligonucleotide comprising a target-hybridizing sequence corresponding to the sequence shown in residues 1-32 of SEQ ID NO: 12, and wherein the third Lactobacillus -specific oligonucleotide comprises a target-hybridizing sequence corresponding to the sequence shown in SEQ ID NO: 13.

9. The reaction mixture of claim 1 , wherein the reaction mixture comprises the Lactobacillus -specific oligonucleotide.

Assignments (5)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 043791/0031 Recorded Apr 23, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC.; GEN-PROBE INCORPORATED; CYNOSURE, LLC, AS SUCCESSOR-BY-CONVERSION TO CYNOSURE, INC.
Reel/Frame 075459/0575 →
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 →
SECURITY INTEREST Recorded Oct 5, 2017
From: HOLOGIC, INC.; GEN-PROBE INCORPORATED; CYNOSURE, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 043791/0031 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2017
From: KING, JOSEPH J.; HALL, JEFF G.; GRAHAM, MICHAEL
To: GEN-PROBE INCORPORATED
Reel/Frame 043159/0823 →
Continuity (2)
Provisional Application 62101907 · Jan 9, 2015
Related Publication 20180171375A1 · Jun 21, 2018