DK2567226T3 - Monitorere helse- og sygdomsstatus ved hjælp af klonotypeprofiler - Google Patents

Monitorere helse- og sygdomsstatus ved hjælp af klonotypeprofiler Download PDF

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DK2567226T3
DK2567226T3 DK11777704.5T DK11777704T DK2567226T3 DK 2567226 T3 DK2567226 T3 DK 2567226T3 DK 11777704 T DK11777704 T DK 11777704T DK 2567226 T3 DK2567226 T3 DK 2567226T3
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cells
disease
clonotypes
sample
clonotype
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Malek Faham
Thomas Willis
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Adaptive Biotechnologies Corp
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    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6888—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/5044—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics involving specific cell types
    • G01N33/5047—Cells of the immune system
    • G01N33/505—Cells of the immune system involving T-cells
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/5044—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics involving specific cell types
    • G01N33/5047—Cells of the immune system
    • G01N33/5052—Cells of the immune system involving B-cells
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    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
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    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/158—Expression markers

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  • Health & Medical Sciences (AREA)
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Claims (12)

1. Fremgangsmåde til påvisning af tilbagevenden af en iymfoid neopiasme hos en patient med definerede cancerklonotyper, omfattende trinnene: (a) at bestemme en profil af rekombinerede DNA-sekvenser i T-eeiler og / eller i B-ceiler, omfattende trinnene: (i) amplifikation af nukieinsyremolekyler fra T-celler og / eller B-celier fra en prøve opnået fra patienten; (ii) spatial isolering af individuelle molekyler af den amplificerede nukleinsyre; og (iii) sekventering af de individuelle nukieinsyremolekyler ved næste generation sekventering til dannelse af profilen af rekombinerede DNA-sekvenser; (b) at evaluere profilen af rekombinerede DNA-sekvenser til bestemmelse af niveauerne af de definerede cancerklonotyper og kloner udviklet derfra; og (c) at anvende niveauerne til påvisning af tilbagevenden af det lymfoide neopiasme.
2. Fremgangsmåden ifølge krav 1, yderligere omfattende trinnet at gentage trin (a) og (b) til overvågning af nævnte lymfoide neopiasme i patienten.
3. Fremgangsmåden ifølge krav 1 eller krav 2, hvor klonerne udvikles fra de definerede cancerklonotyper ved VH udskiftning.
4. Fremgangsmåden ifølge krav 3, hvor VH udskiftning identifices ved påvisning af D-J krydsningen.
5. Fremgangsmåden ifølge krav 1 eller krav 2, hvor de nævnte kloner udvikles fra de definerede cancerklonotyper ved somatisk hypermutation.
6. Fremgangsmåden ifølge krav 1 eller krav 2, hvor de nævnte kloner udvikles fra de definerede cancerklonotyper ved en eller flere insertioner og / eller deiefioner af fra 1 -10 baser.
7. Fremgangsmåden ifølge krav 1 eller krav 2, hvor klonerne udviklet fra de definerede cancerklonotyper har en identisk muteret V-region og J-region, og en forskellig NDN-region.
8. Fremgangsmåden ifølge krav 1 eller krav 2, hvor klonerne udviklet fra de definerede cancerklonotyper beregnes baseret på: a) antallet af forskelle i NDN-regionen, b) længden af NDN-regionen, og c) nærvær af andre somatiske hyper-mutatiøner i V og / eller J-segmenterne.
9. Fremgangsmåden ifølge et hvilket som helst af kravene 1 til 8, hvor den nævnte lymfoide neoplasme er en ondartet iymfoid neoplasme.
10. Fremgangsmåde ifølge et hvilket som helst af kravene 1 fil 9, hvor nukleinsyren er genomisk DNA.
11. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 10, hvor de nævnte, rekombinerede sekvenser omfatter en genomisk omlejring valgt fra gruppen bestående af en VDJ omiejring af igh, en DJ omlejring af IgH, en VJ omlejring af IgK, en VJ omlejring af IgL, en VDJ omiejring af TCR β, en DJ omlejring af TCR β, en VJ omiejring af TCR a, en VJ omiejring af TCR A, en VDJ omiejring af TCR δ, og en VD omlejring af TCR δ.
12. Fremgangsmåde ifølge et hvilket søm helst af kravene 1 tiM 1, hvor det nævnte sekventeringstrin inkluderer at danne sekvensudskrifter i et område på fra 30 til 400 nukleotider.
DK11777704.5T 2010-05-06 2011-05-04 Monitorere helse- og sygdomsstatus ved hjælp af klonotypeprofiler DK2567226T3 (da)

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US33217510P 2010-05-06 2010-05-06
US45574310P 2010-10-25 2010-10-25
US201161446822P 2011-02-25 2011-02-25
PCT/US2011/000791 WO2011139371A1 (en) 2010-05-06 2011-05-04 Monitoring health and disease status using clonotype profiles

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DK16183402.3T DK3144673T3 (da) 2010-05-06 2011-05-04 Overvågning af en lymfoid neoplasma anvendende klontypeprofiler

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EP (4) EP2567226B1 (da)
JP (4) JP6085249B2 (da)
CN (2) CN104673899A (da)
AU (1) AU2011249041B2 (da)
CA (1) CA2798431C (da)
DK (2) DK2567226T3 (da)
ES (2) ES2740802T3 (da)
SG (2) SG10201503534RA (da)
WO (2) WO2011139371A1 (da)

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