IP Library Granted Patent US 12,110,540
Granted Patent B2
US 12,110,540 · App. 16/769,229 · Granted Oct 8, 2024

Compositions and methods for detecting toxigenic

Inventor: Patrick Lynn Peterson (San Diego, CA)
Assignee: GEN-PROBE INCORPORATED
C12Q1/6827C12Q1/689C12Q2537/143C12Q2561/109C12Q2565/101C12Q2600/156C12Q2600/166
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Quick Facts
Patent No.
US 12,110,540
App. No.
16/769,229
Granted
Oct 8, 2024
Kind
B2
Abstract

Provided herein are compositions, kits, and methods for detecting at least one of a C. diffcile tcdA, tcdB, tcdC, cdtA, or cdtB nucleic acid in a sample. In son embodiments, one or more alleles of tcdC such as 117del tcdC or 184T tcdC are detected.

Claims (14)

1. A composition or kit comprising:

a detection oligomer comprising the sequence set forth in positions 7-18 of SEQ ID NO: 305, wherein the detection oligomer further comprises sufficient additional sequence to specifically hybridize to a C. difficile tcdB nucleic acid, and wherein the detection oligomer is non-extendable; and

at least one secondary detection oligomer, comprising a secondary detection oligomer that is configured to interact with a fragment of the detection oligomer, comprises at least two labels, and comprises the sequence of SEQ ID NO: 12.

2. The composition or kit of claim 1 , wherein the detection oligomer comprises the sequence set forth in SEQ ID NO: 305.

3. The composition or kit of claim 1 , wherein the detection oligomer comprises a label.

4. The composition or kit of claim 1 , wherein the detection oligomer has a length of 15 to 55 nucleotides.

5. The composition or kit of claim 1 , wherein the at least two labels include a FRET pair.

6. The composition or kit of claim 1 , wherein the at least two labels include a quencher.

7. The composition or kit of claim 1 , wherein the fragment of the detection oligomer is a 5′-terminal flap of at least six nucleotides.

8. The composition or kit of claim 1 , wherein the composition or kit comprises a plurality of secondary detection oligomers, wherein the secondary detection oligomers comprise FRET cassettes.

9. The composition or kit of claim 1 , wherein the kit or composition further comprises a tedA primary detection oligomer configured to specifically hybridize to a tedA amplicon having a size from 80 to 400 nucleotides; and at least one additional secondary detection oligomer, wherein the secondary detection oligomers include a secondary detection oligomer configured to generate a positive signal in the presence of a tcdB nucleic acid and in the presence of a tcdA nucleic acid.

10. The composition or kit of claim 1 , wherein the composition or kit comprises a nuclease with structure-specific activity toward a three-strand structure formed by 3′-end invasion.

11. The composition or kit of claim 1 , wherein the composition or kit comprises a flap endonuclease or 5′-nuclease.

12. The composition or kit of claim 1 , wherein the composition or kit comprises a FEN1 nuclease.

Assignments (2)
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 15, 2020
From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; FOCAL THERAPEUTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 054089/0804 →