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1. (WO2018067935) METHODS AND KITS FOR DETECTING A FUSION MESSENGER RNA TRANSCRIPT OR A POLYPEPTIDE ENCODED BY THE FUSION MESSENGER RNA TRANSCRIPT
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WHAT IS CLAIMED IS:

1. A method of detecting a fusion mRNA transcript or polypeptide encoded by the fusion mRNA transcript, said method comprising:

obtaining a biological sample from a subject;

providing one or more reagents capable of binding a fusion mRNA transcript or polypeptide encoded by the fusion mRNA transcript, wherein the fusion mRNA transcript or polypeptide encoded by the fusion mRNA transcript comprises the 3' end of ex on 25 of INPP5D fused to the 5' end of exon 2 of ATG16L1 or the polypeptide encoded by the 3' end of exon 25 of INPP5D fused to the 5' end of exon 2 of ATG16L1, respectively;

contacting the biological sample with said reagents under conditions effective to permit binding to said fusion mRNA transcript or polypeptide encoded by the fusion mRNA transcript, if present, in the biological sample; and

detecting, based on said contacting, the fusion mRNA transcript or polypeptide encoded by the fusion mRNA transcript in the sample.

2. The method according to claim 1 further comprising:

identifying the subject as having IBD based on said detecting, wherein if the fusion mRNA transcript or polypeptide encoded by the fusion mRNA transcript is detected, the subject is identified as having IBD.

3. The method according to claim 1 further comprising:

identifying the subject as having Crohn's Disease based on said detecting, wherein if the fusion mRNA transcript or polypeptide encoded by the fusion mRNA transcript is detected, the subject is identified as having Crohn's Disease.

4. The method according to claim 1 further comprising:

administering an IBD or Crohn's Disease therapeutic based on said detecting.

5. The method according to claim 1, wherein the biological sample is sputum, blood, a blood fraction, tissue or fine needle biopsy sample, urine, stool, peritoneal fluid, or pleural fluid.

6. The method according to claim 1, wherein said contacting is carried out using an amplification assay.

7. The method according to claim 1, wherein said contacting is carried out using a hybridization assay.

8. The method according to claim 1, wherein said contacting is carried out using an immunoassay.

9. The method according to claim 1, wherein said detecting comprises detecting the level of the fusion mRNA transcript or polypeptide encoded by the fusion mRNA transcript in the sample.

10. A kit suitable for diagnosing IBD and/or Crohn's Disease, said kit comprising: one or more reagents suitable for detecting a fusion mRNA transcript or polypeptide encoded by the fusion mRNA transcript, wherein the fusion mRNA transcript or polypeptide encoded by the fusion mRNA transcript comprises the 3' end of exon 25 of INPP5D fused to the 5' end of exon 2 of ATG16L1 or the polypeptide encoded by the 3 ' end of exon 25 of INPP5D fused to the 5' end of exon 2 of ATG16L1, respectively.

11. The kit according to claim 10, wherein said reagents comprise oligonucleotide primers suitable for a nucleic acid amplification assay, oligonucleotide probes suitable for a hybridization assay, or antibodies or binding fragments thereof suitable for an immunoassay.

12. The kit according to claim 10 further comprising a substrate pre-coated with a probe.

13. The kit according to claim 12, wherein said substrate is an ELISA plate or a microarray.

14. The kit according to claim 13, wherein said microarray is a DNA microarray or an antibody microarray.

15. The kit according to claim 12, wherein said probe is an antibody, an oligonucleotide, or both.