DETECTION OF NUCLEIC ACIDS FROM MULTIPLE TYPES OF HUMAN PAPILLOMAVIRUS

• US 20190002995A1
• Filed: 07/20/2018
• Published: 01/03/2019
• Est. Priority Date: 12/08/2004
• Status: Active Grant

• Current Assignee: Gen-Probe Incorporated (Hologic Incorporated)
• Original Assignee: Gen-Probe Incorporated (Hologic Incorporated)
• Inventors: NORMAN, Sylvia A., BUNGO, Jennifer J., HANNA, William L., RAO, Neeraj P.
• Granted Patent: US 10,640,836 B2
• Time in Patent Office: Days
• CPC Class Codes: C07K 14/005 from viruses
• CPC Class Codes: C12N 2710/20022 New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
• CPC Class Codes: C12Q 1/708 for papilloma
• CPC Class Codes: C12Q 2600/156 Polymorphic or mutational markers
• CPC Class Codes: C12Q 2600/158 Expression markers
• CPC Class Codes: C12Q 2600/16 Primer sets for multiplex assays

Abstract

Nucleic acid oligonucleotide sequences are disclosed which include amplification oligomers and probe oligomers which are useful for detecting multiple types of human papillomaviruses (HPV) associated with cervical cancer. Methods for detecting multiple HPV types in biological specimens by amplifying HPV nucleic acid sequences in vitro and detecting the amplified products are disclosed.

Claims

1-3. -3. (canceled)

4. A reaction mixture containing a detection probe oligomer for selectively detecting HPV types in group C1 in the presence of HPV types from one or more of groups A1, A2, B, C2, and D, wherein the detection probe oligomer comprises:

(i) a target-specific sequence consisting of a nucleotide sequence selected from the group consisting of SEQ ID NOs;

13, 46, 45, complements thereof, and RNA equivalents thereof; and

(ii) a detectable label.

5. The reaction mixture of claim 4, wherein the detectable label is joined directly to the oligomer.

6. The reaction mixture claim 4, wherein the detectable label is a chemiluminescent compound.

7. The reaction mixture of oligomers of claim 4, wherein the detection probe oligomer nucleotide sequence has a backbone comprising at least one 2′

-methoxy RNA group.

8. (canceled)

9. A mixture of at least two oligomers in which individual oligomer sequences are selected from the group consisting of SEQ ID Nos. 1 to 10, which includes the complementary oligomer sequences or RNA equivalents of the specified sequences, wherein the mixture includes:

at least two oligomers selected from SEQ ID Nos. 2, 4, 6, 8 and 10 with a ligand moiety joined to each oligomer;

oligomers of SEQ ID Nos. 2, 4, 6, 8 and 10 with a ligand moiety joined to each oligomer;

at least two oligomers selected from SEQ ID Nos. 1, 3, 5, 7 and 9;

or

oligomers of SEQ ID Nos. 1, 3, 5, 7 and 9.

10. The mixture of oligomers of claim 9, wherein at least one oligomer comprises a backbone that includes at least one 2′

-methoxy RNA group, at least one 2′

fluoro-substituted RNA group, at least one peptide nucleic acid linkage, at least one phosphorothioate linkage, or at least one methylphosphonate linkage.

11. The mixture of oligomers of claim 9 contained in a kit.

12. A method of separating a human papillomavirus (HPV) nucleic acid from other components present within a biological sample, comprising the steps of:

contacting nucleic acid in a biological sample containing RNA of at least one of HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 with a capture oligomer comprising an oligomer sequence selected from the group consisting of SEQ ID Nos. 1 to 10, which includes the complementary oligomer sequences or RNA equivalents of the specified sequences.

15. The method of claim 12, wherein the capture oligomer is present in a mixture of capture oligomers made up of:

at least two oligomers selected from SEQ ID Nos. 2, 4, 6, 8 and 10 with a ligand moiety joined to each oligomer;

oligomers of SEQ ID Nos. 2, 4, 6, 8 and 10 with a ligand moiety joined to each oligomer;

at least two oligomers selected from SEQ ID Nos. 1, 3, 5, 7 and 9;

or

oligomers of SEQ ID Nos. 1, 3, 5, 7 and 9.

13. (canceled)

14. (canceled)

16-20. -20. (canceled)