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Last Updated: March 29, 2024

Claims for Patent: 9,175,350


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Summary for Patent: 9,175,350
Title:EML4-ALK translocations in lung cancer
Abstract: The present disclosure relates to methods for the diagnosis and evaluation of neoplastic disorders, particularly non-small cell lung cancer. Assays are described in which patient test samples are analyzed for the presence of one or more specific EML4-ALK fusion genes associated with neoplastic disorders.
Inventor(s): Sanders; Heather R. (Winchester, CA), Albitar; Maher (Coto De Caza, CA), Meloni-Ehrig; Aurelia (Gainesville, VA)
Assignee: QUEST DIAGNOSTICS INVESTMENTS INCORPORATED (Wilmington, DE)
Application Number:13/518,232
Patent Claims:1. A method for diagnosing a non-small cell lung cancer or susceptibility to non-small cell lung cancer in human subject comprising: (a) performing a nucleic acid detection assay on a nucleic acid sample from a human subject to detect the presence of an EML4-ALK gene fusion in the nucleic acid sample, wherein the EML4-ALK gene fusion is (i) an E17;ins30A20 gene fusion between exon 17 of EML4 and intron 19 of ALK having a breakpoint region comprising SEQ ID NO: 1, or (ii) an E17ins30;ins65A20 gene fusion between exon 17 of EML4 and intron 19 of ALK having a breakpoint region comprising SEQ ID NO:2; and (b) diagnosing the subject as having or being susceptible to non-small cell lung cancer based on the presence of the EML4-ALK gene fusion in the nucleic acid sample, wherein the nucleic acid detection assay comprises amplification of a nucleic acid molecule with at least a primer pair, said primer pair comprising a forward primer comprising the nucleotide sequence set forth in SEQ ID NO: 19 and a reverse primer that hybridizes to exon 20 of ALK to produce amplified nucleic acid, and wherein the amplified nucleic acid comprises the sequence of SEQ ID NO: 1 or 2.

2. The method of claim 1, wherein the sample is selected from the group consisting of: plasma, serum, and biopsy tissue.

3. The method of claim 2, wherein the sample is a lung biopsy sample.

4. The method of claim 1, wherein amplification of a nucleic acid comprises PCR or real time PCR (RT-PCR).

5. The method of claim 1, wherein the amplification of a nucleic acid comprises reverse transcriptase PCR.

6. The method of claim 1, wherein the forward and/or the reverse primer and detectable labeled.

7. The method of claim 1, further comprising electrophoresis of the amplified nucleic acid.

8. The method of claim 1, further comprising using a real-time PCR detection system.

9. The method of claim 1, further comprising performing a nucleic acid detection assay on the nucleic acid sample to detect one or more additional EML4-ALK gene fusions selected from the group consisting of: variant 1, variant 2, variant 3a, variant 3b, variant 4, variant 5a, variant 5b, variant 6, and variant 7.

10. The method of claim 1, wherein both E17;ins30A20 and E17ins30;ins65A20 gene fusions are detected.

11. The method of claim 1, wherein the EML4-ALK gene fusion is Detected by sequencing the amplified nucleic acid.

12. The method of claim 1, wherein the reverse primer comprises the Sequence set forth is SEQ ID NO: 25.

13. The method of claim 1, wherein the EML4ALK gene fusion is detected by hybridizing a labeled oligonucleotide probe to the amplified nucleic acid.

14. A method for detecting an E17;ins30A20 or E17ins30;ins65A20 EML4-ALK gene fusion comprising amplifying a nucleic acid molecule with at least a primer pair, said primer pair comprising a forward primer that hybridizes to exon 17 of EML4 and a reverse primer that hybridizes to exon 20 of ALK to produce amplified nucleic acid, and detecting amplified nucleic acid comprising the sequence of SEQ ID NO: 1 or SEQ ID NO: 2, thereby detecting the E17;ins30A20 or E17ins30;ins65A20 EML4-ALK gene fusion, wherein detecting the amplified nucleic acid comprising the sequence of SEQ ID NO: 1 indicated the presence of the E17ins30;ins65A20 EML4-ALK gene fusion.

15. The method of claim 14, wherein the E17;ins30A20 or E17ins30;ins65A20 EML4-ALK gene fusion is detected in a sample selected from the group consisting of: plasma, serum, and biopsy tissue.

16. The method of claim 14, wherein the E17;ins30A20 or E17ins30;ins65A20 EML4-ALK gene fusion is detected in a lung biopsy sample.

17. The method of claim 14, wherein the nucleic acid amplification comprises PCR or real time PCR (RT-PCR).

18. The method of claim 14, wherein the nucleic acid amplification comprises reverse transcriptase PCR.

19. The method of claim 14, wherein the forward and/or the reverse primer are detectably labeled.

20. The method of claim 14, further comprising electrophoresis of the amplified nucleic acid.

21. The method of claim 14, further comprising using real-time PCR detection system.

22. The method of claim 14, wherein the forward primer comprises the nucleotide sequence set forth in SEQ ID NO: 19.

23. The method of claim 14, wherein the reverse primer comprises the nucleotide sequence set forth in SEQ ID NO: 25.

24. The method of claim 14, wherein the forward primer comprises the nucleotide sequence set forth in SEQ ID NO: 19 and the reverse primer comprises the nucleotide sequence set forth in SEQ ID NO: 25.

25. A method for detecting an E17;ins30A20 or an E17ins30;ins65A20 EML4-ALK gene fusion in a nucleic acid sample, comprising hybridizing an oligonucleotide probe to target nucleic acid in the nucleic acid sample to form a hybridization complex between the oligonucleotide probe and target nucleic acid wherein the oligonucleotide probe comprises the nucleotide sequence set forth in any of SEQ ID NOs: 26-28, or the complements thereof; and detecting the presence of hybridization complexes comprising target nucleic acid comprising the nucleotide sequence of SEQ ID NO: 1 to thereby detect the presence of the E17;ins30A20 EML4-ALK gene fusion in the nucleic acid sample or detecting the presence of hybridization complexed comprising target nucleic acid comprising the nucleotide sequence of SEQ ID NO: 2 to the thereby detect the presence of the E17ins30;ins65A20 EML4ALK gene fusion in the nucleic acid sample.

26. The method of claim 25, wherein the oligonucleotide probe is detectable labeled.

Details for Patent 9,175,350

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Corp. INTRON A interferon alfa-2b For Injection 103132 06/04/1986 ⤷  Try a Trial 2029-12-22
Merck Sharp & Dohme Corp. INTRON A interferon alfa-2b For Injection 103132 ⤷  Try a Trial 2029-12-22
Merck Sharp & Dohme Corp. INTRON A interferon alfa-2b Injection 103132 ⤷  Try a Trial 2029-12-22
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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