IP Library Granted Patent US 9,605,312
Granted Patent B2
US 9,605,312 · App. 14/363,182 · Granted Mar 28, 2017

Methods of detecting mutations in BRAF and epigenetic changes

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Quick Facts
Patent No.
US 9,605,312
App. No.
14/363,182
Granted
Mar 28, 2017
Kind
B2
Abstract

Disclosed are methods for assessing the methylation and mutation status of nucleic acid in a sample. The methods provide for methylation-dependent modification of the nucleic acid in a sample, and subsequently nucleic acid amplification processes to distinguish between mutated and non-mutated target sequence.

Claims (23)

1. A method for detecting a mutated BRAF target sequence of interest in a DNA-containing sample, the method comprising:

(a) contacting the DNA-containing sample with a modifying reagent which selectively modifies non-methylated cytosine residues in the DNA to produce detectable modified residues but which does not modify methylated cytosine residues,

(b) amplifying the modified DNA-containing sample to produce an amplified target sequence using at least one primer that hybridizes specifically to the mutated BRAF target sequence in the modified DNA-containing sample, and

(c) detecting the amplified target sequence, thereby detecting the mutated BRAF target sequence.

2. The method of claim 1 , further comprising detecting methylation status of the BRAF target sequence by amplifying the modified DNA-containing sample to produce an amplified target sequence using at least one at least one primer that hybridizes specifically to a methylated BRAF target sequence in the modified DNA-containing sample, and detecting the amplified target sequence, thereby detecting the methylated BRAF target sequence.

3. The method of claim 1 , wherein amplification is performed using a primer that hybridizes specifically to the mutated BRAF target sequence and a primer that hybridizes specifically to methylated BRAF DNA.

4. The method of claim 1 , further comprising detecting a mutated KRAS target sequence of interest in the modified DNA-containing sample, the method further comprising amplifying the modified DNA-containing sample to produce an amplified target sequence using at least one primer that hybridizes specifically to the mutated KRAS target sequence in the modified DNA-containing sample, and detecting the amplified target sequence, thereby detecting the mutated KRAS target sequence.

5. The method of claim 1 , wherein the modifying reagent comprises a bisulfite salt.

6. The method of claim 1 , further comprising sequencing the amplified target sequence.

7. A method for detecting a mutated BRAF gene target sequence of interest in a DNA-containing sample, the method comprising:

(a) contacting the DNA-containing sample with a modifying reagent which selectively modifies non-methylated cytosine residues in the DNA to produce detectable modified residues but which does not modify methylated cytosine residues,

(b) amplifying the modified DNA-containing sample to produce an amplified target sequence using a primer pair comprising SEQ ID NO:3 and SEQ ID NO:2; and

(c) detecting the amplified target sequence, thereby detecting the mutated BRAF gene target sequence.

8. The method of claim 7 , further comprising detecting a mutated KRAS target sequence of interest in the modified DNA-containing sample, the method further comprising amplifying the modified DNA-containing sample to produce an amplified target sequence using at least one primer that hybridizes specifically to the mutated KRAS target sequence in the modified DNA-containing sample, and detecting the amplified target sequence, thereby detecting the mutated KRAS target sequence.

9. The method of claim 7 , wherein the modifying reagent comprises a bisulfite salt.

10. The method of claim 7 , further comprising sequencing the amplified target sequence.

11. A method for detecting at least one mutated BRAF gene target sequence of interest in a DNA-containing sample, the method comprising:

(a) contacting the DNA-containing sample with a modifying reagent which selectively modifies non-methylated cytosine residues in the DNA to produce detectable modified residues but which does not modify methylated cytosine residues,

(b) amplifying the modified DNA-containing sample to produce an amplified target sequence using a primer pair comprising SEQ ID NO:3; and

(c) detecting the amplified target sequence, thereby detecting the mutated BRAF gene target sequence.

12. The method of claim 11 , further comprising detecting a mutated KRAS target sequence of interest in the modified DNA-containing sample, the method further comprising amplifying the modified DNA-containing sample to produce an amplified target sequence using at least one primer that hybridizes specifically to the mutated KRAS target sequence in the modified DNA-containing sample, and detecting the amplified target sequence, thereby detecting the mutated KRAS target sequence.

13. The method of claim 11 , wherein the modifying reagent comprises a bisulfite salt.

14. The method of claim 11 , further comprising sequencing the amplified target sequence.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded May 1, 2024
From: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
To: MDXHEALTH SA; MDXHEALTH, INC.
Reel/Frame 067283/0965 →
SECURITY INTEREST Recorded May 1, 2024
From: MDXHEALTH SA
To: ORC SPV LLC
Reel/Frame 067284/0082 →
SECURITY INTEREST Recorded Aug 12, 2022
From: MDXHEALTH SA; MDXHEALTH, INC.
To: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
Reel/Frame 060791/0336 →
SECURITY INTEREST Recorded Aug 2, 2022
From: MDXHEALTH SA
To: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
Reel/Frame 060698/0957 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 13, 2017
From: VAN CRIEKINGE, WIM; CLARK, JAMES S.; VANDERSMISSEN, JOHAN
To: MDXHEALTH SA
Reel/Frame 040974/0915 →