Use of circulating microrna profiles for identification of brca1 or brca2 mutations

A method of identifying a subject as having a BRCA mutation, the method comprising:

• (a) obtaining a sample collected from the subject;
• (b) determining an amount of a circulating microRNA selected from the group consisting of:
• hsa-miR-20b-5p (SEQ ID NO:
• 4), hsa-miR-19b-3p (SEQ ID NO:
• 3), hsa-let-7b-5p (SEQ ID NO:
• 1), hsa-miR-320b (SEQ ID NO:
• 8), hsa-miR-139-3p (SEQ ID NO:
• 6), hsa-miR-30d-5p, (SEQ ID NO 5), hsa-miR-17-5p (SEQ ID NO:
• 2), hsa-miR-182-5p (SEQ ID NO:
• 7), hsa-miR-421 (SEQ ID NO:
• 9), hsa-miR-375-3p (SEQ ID NO:
• 10);
• hsa-miRNA-106b-5p (SEQ ID NO:
• 11);
• hsa-miRNA-134-5p (SEQ ID NO:
• 12), hsa-miRNA-493-5p (SEQ ID NO:
• 13), hsa-miRNA-500a-3p (SEQ ID NO:
• 14), hsa-miR-1273 h-3p (SEQ ID NO:
• 15), hsa-miR-4433a-3p (SEQ ID NO:
• 16), hsa-miR-4433b-5p (SEQ ID NO:
• 17), hsa-miR-485-3p (SEQ ID NO:
• 18), and has-miR-1304-3p (SEQ ID NO:
• 19).
• (c) comparing the amounts of circulating microRNA as determined in step (b) to a statistical model;
• (d) predicting a lifetime risk of the subject developing one or more cancers based on identifying the presence of at least one mutation in the BRCA1 or BRCA2 gene;
• and
• (e) performing genetic testing on the subject.

A method of treating a patient suspected of having a BRCA associated cancer, the method comprising:

• (a) obtaining a sample collected from the subject;
• (b) determining the amounts of a circulating microRNA selected from the group consisting of:
• hsa-miR-20b-5p (SEQ ID NO:
• 4), hsa-miR-19b-3p (SEQ ID NO:
• 3), hsa-let-7b-5p (SEQ ID NO:
• 1), hsa-miR-320b (SEQ ID NO:
• 8), hsa-miR-139-3p (SEQ ID NO:
• 6), hsa-miR-30d-5p, (SEQ ID NO 5), hsa-miR-17-5p (SEQ ID NO:
• 2), hsa-miR-182-5p (SEQ ID NO:
• 7), hsa-miR-421 (SEQ ID NO:
• 9), hsa-miR-375-3p (SEQ ID NO:
• 10);
• hsa-miRNA-106b-5p (SEQ ID NO:
• 11);
• hsa-miRNA-134-5p (SEQ ID NO:
• 12), hsa-miRNA-493-5p (SEQ ID NO:
• 13), hsa-miRNA-500a-3p (SEQ ID NO:
• 14), hsa-miR-1273 h-3p (SEQ ID NO:
• 15), hsa-miR-4433a-3p (SEQ ID NO:
• 16), hsa-miR-4433b-5p (SEQ ID NO:
• 17), hsa-miR-485-3p (SEQ ID NO:
• 18), and has-miR-1304-3p (SEQ ID NO:
• 19);
• (c) comparing the amounts of circulating microRNA as determined in step (b) to a statistical model;
• (d) predicting a lifetime risk of the subject developing one or more cancer based on identifying the presence of at least one mutation in the BRCA1 or BRCA2 gene;
• and
• (e) administering to the subject a treatment selected from the group consisting of surgery, chemotherapy, immunotherapy, radiation therapy, hormone therapy, and stem cell transplant.

A kit comprising at least one test probe capable of specifically hybridizing to a microRNA selected from the group consisting of hsa-miR-20b-5p (SEQ ID NO:

• 4), hsa-miR-19b-3p (SEQ ID NO:
• 3), hsa-let-7b-5p (SEQ ID NO:
• 1), hsa-miR-320b (SEQ ID NO:
• 8), hsa-miR-139-3p (SEQ ID NO:
• 6), hsa-miR-30d-5p, (SEQ ID NO 5), hsa-miR-17-5p (SEQ ID NO:
• 2), hsa-miR-182-5p (SEQ ID NO:
• 7), hsa-miR-421 (SEQ ID NO:
• 9), hsa-miR-375-3p (SEQ ID NO:
• 10);
• hsa-miRNA-106b-5p (SEQ ID NO:
• 11);
• hsa-miRNA-134-5p (SEQ ID NO:
• 12), hsa-miRNA-493-5p (SEQ ID NO:
• 13), hsa-miRNA-500a-3p (SEQ ID NO:
• 14), hsa-miR-1273 h-3p (SEQ ID NO:
• 15), hsa-miR-4433a-3p (SEQ ID NO:
• 16), hsa-miR-4433b-5p (SEQ ID NO:
• 17), hsa-miR-485-3p (SEQ ID NO:
• 18), and has-miR-1304-3p (SEQ ID NO:
• 19).