IP Library Granted Patent US 12,486,539
Granted Patent B2
US 12,486,539 · App. 16/577,510 · Granted Dec 2, 2025

Discriminating BRAF mutations

Inventors: Amber C. Donahue (Rancho Santa Margarita, CA); Yen-lin Peng (Mission Viejo, CA)
Assignee: Quest Diagnostics Investments LLC
C12Q1/6886C12Q2600/106C12Q2600/118C12Q2600/156
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Quick Facts
Patent No.
US 12,486,539
App. No.
16/577,510
Granted
Dec 2, 2025
Kind
B2
Abstract

Provided herein are methods for detecting and discriminating BRAF V600 mutations. Also provided herein are methods for diagnosis, prognosis, management, and treatment decisions of BRAF V600 mutation-related diseases or conditions.

Claims (9)

1 . A kit for distinguishing a V600K mutation from a V600E mutation in the BRAF gene in a sample DNA from an individual, said kit comprising:

(a) a forward primer and a reverse primer and no more than two primers, wherein the forward primer and the reverse primer selectively generate an amplicon when a thymidine (T) to adenosine (A) mutation at position 1799 of the BRAF gene is present, wherein the primers are configured to generate an amplicon comprising a V600E (1799T>A) mutation and an amplicon comprising a V600K (1798-1799GT>AA) mutation in the BRAF gene, and

(b) a restriction enzyme for distinguishing a V600K mutation from a V600E mutation in the BRAF gene, wherein the restriction enzyme digests the amplicon comprising the BRAF V600E mutation (1799T>A) and does not digest the amplicon comprising the BRAF V600K mutation (1798_1799GT>AA),

wherein the forward and/or reverse primer are labeled with a detectable moiety.

2 . The kit of claim 1 , wherein the restriction enzyme recognizes a 6-base motif that matches the sequence of the BRAF gene immediately upstream of the thymidine (T) to adenosine (A) mutation at position 1799 of the BRAF gene.

3 . The kit of claim 1 , wherein the restriction enzyme is SfcI.

4 . The kit of claim 1 , wherein the detectable moiety is a fluorophore.

5 . The kit of claim 1 , wherein the sample DNA is extracted from the plasma of the individual.

6 . The kit of claim 1 , wherein the individual is a melanoma patient.

Continuity (3)
Continuation 15120345
Provisional Application 61943577 · Feb 24, 2014
Related Publication 20200115760A1 · Apr 16, 2020
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