IP Library › Granted Patent US 11,834,719
Granted Patent B2
US 11,834,719 · App. 17/325,644 · Granted Dec 5, 2023

Genes and gene signatures for diagnosis and treatement of melanoma

Inventors: Michael Bryan Warf (Salt Lake City, UT); Benjamin Roa (Salt Lake City, UT); Alexander Gutin (Salt Lake City, UT); Darl Flake (Salt Lake City, UT)
Assignee: MYRIAD MYPATH, LLC
C12Q1/6886G16B20/00C12Q2600/158
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Quick Facts
Patent No.
US 11,834,719
App. No.
17/325,644
Granted
Dec 5, 2023
Kind
B2
Abstract

Panels of biomarkers, methods and systems are disclosed for determining gene expression, and diagnosing and treating melanoma.

Claims (35)

1. A method for treating melanoma in a patient, the method comprising:

measuring in a sample from the patient mRNA expression of a panel of genes normalized to one or more housekeeping genes, the panel of genes comprising a combination of:

PRAME;

S100-related genes S100A9, S100A7, S100A8, S100A12, and P13; and

one or more immune genes selected from CXCL9, CCL5, CXCL10, IRF1, PTPN22, PTPRC, LCP2, SELL, and CD38;

calculating a combined score of the measured mRNA expression of the panel of genes;

classifying the sample as being a malignant melanoma based on the combined score exceeding a reference value; and

administering to the patient having the malignant melanoma a treatment comprising one or more of:

excising the malignant melanoma;

excising the malignant melanoma and a border of normal skin,

reexcising the site of the sample to remove additional tissue;

reexcising additional tissue surrounding a biopsy site;

removal of a lymph node;

lymph node dissection;

chemotherapy;

radiation therapy;

biological therapy;

immunotherapy; and

targeted therapy.

2. The method of claim 1 , wherein the panel of genes further comprises S100A10 and S100A14.

3. The method of claim 1 , wherein the one or more immune genes comprises CXCL9.

4. The method of claim 1 , wherein the housekeeping genes comprise one or more of CLTC, MRFAP1, PSMA1, RPL13A, TXNL1, SLC25A3, RPS29, RPL8, PSMC1, and RPL4.

5. The method of claim 1 , further comprising combining the combined score with a value of a clinical parameter.

6. The method of claim 5 , wherein the clinical parameter is a clinical staging.

7. The method of claim 1 , wherein the sample is a skin lesion.

8. The method of claim 1 , wherein the sample is an FFPE sample, a fresh frozen sample, or contains predominantly melanoma suspect cells.

9. The method of claim 1 , wherein the sample is a malignant melanoma.

10. The method of claim 1 , wherein the sample is a superficial spreading melanoma, a nodular melanoma, a lentigo maligna melanoma, a desmoplastic melanoma, or an acral melanoma.

11. The method of claim 1 , wherein the expression of the panel of genes is measured by qPCR.

12. The method of claim 1 , wherein the expression of the panel of genes is measured by hybridization.

13. The method of claim 1 , wherein the combined score is recorded in a report.

14. The method of claim 1 , wherein the combined score is recorded in a report communicated to the patient's medical provider.

15. The method of claim 1 , wherein the combined score is recorded in a report communicated to the patient's medical provider who administers treatment to the patient.

16. The method of claim 1 , wherein the combined score is recorded in a report with an additional clinical parameter value communicated to the patient's medical provider who administers treatment to the patient.

17. The method of claim 1 , wherein the treatment further comprises watchful waiting.