DK2385143T3 - Ikke-invasiv føtal genetisk screening ved digital analyse - Google Patents

Ikke-invasiv føtal genetisk screening ved digital analyse Download PDF

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Publication number
DK2385143T3
DK2385143T3 DK11175845.4T DK11175845T DK2385143T3 DK 2385143 T3 DK2385143 T3 DK 2385143T3 DK 11175845 T DK11175845 T DK 11175845T DK 2385143 T3 DK2385143 T3 DK 2385143T3
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dna
maternal
pcr
fetal
chromosome
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DK11175845.4T
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Stephen Quake
Hei-Mun Christina Fan
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Univ Leland Stanford Junior
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • 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
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • 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
    • C12Q1/6809—Methods for determination or identification of nucleic acids involving differential detection
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • 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
    • C12Q1/6844—Nucleic acid amplification reactions
    • C12Q1/6851—Quantitative amplification
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • 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
    • C12Q1/6844—Nucleic acid amplification reactions
    • C12Q1/6858—Allele-specific amplification
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • 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
    • C12Q1/6881—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for tissue or cell typing, e.g. human leukocyte antigen [HLA] probes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/158—Expression markers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
    • Y10T436/142222—Hetero-O [e.g., ascorbic acid, etc.]
    • Y10T436/143333—Saccharide [e.g., DNA, etc.]

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Analytical Chemistry (AREA)
  • Genetics & Genomics (AREA)
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  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
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  • General Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pathology (AREA)
  • Cell Biology (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Dispersion Chemistry (AREA)

Claims (9)

1. Fremgangsmåde til påvisning af en genetisk abnormalitet der involverer en kvantitativ forskel mellem materneile og føtale genetiske sekvenser ved differentialpåvisning af målsekvenser i en blanding af maternelt og føtalt genetisk materiale, omfattende trinnene at: a) fordele det genetiske materiale i separate prøver, hver prøve indeholdende i gennemsnit ikke mere end en målsekvens pr. prøve, hvor de separate prøver er i reaktionsprøver hvor målsekvenserne kan analyseres; b) måle tilstedeværelsen af forskellige målsekvenser i de separate prøver, hvor målingen omfatter direkte sekvensering af det genetiske materiale eller sekvensering af forstærkede derivater af målsekvenserne i kloner eller amplikoner af det genetiske materiale; og, c) analysere et antal af de separate prøver, hvor antallet af de separate prøver analyseres og resultaterne fra de separate prøver tilvejebringer data der er tilstrækkelige til at opnå resultater der adskiller de forskellige målsekvenser, hvor en af de forskellige målsekvenser er diploid i det materneile genetiske materiale og aneuploid i det føtale genetiske materiale og en anden af de forskellige målsekvenser er diploid i både det materneile og det føtale genetiske materiale, derved påvise en genetisk abnormalitet der involverer en kvantitativ forskel mellem materneile og føtale genetiske sekvenser.
2. Fremgangsmåden ifølge krav 1, hvor fremgangsmåden involvereren analyse af en trisomi.
3. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor blandingen af maternelt og føtalt genetisk materiale er indeholdt i maternelt væv og hvor det materneile væv er maternelt blod eller blodplasma.
4. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor det genetiske materiale er genomisk DNA.
5. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor de separate prøver er i reaktionsprøver valgt fra gruppen bestående af: fordybninger i en mikrotiterplade, vandige faser i en emulsion, områder på en array-overflade; og reaktionskamre i en mikrofluid-indretning.
6. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor sekvenseringen omfatter enkelt molekylesekvensering.
7. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor genomisk DNA fra væv taget fra moderen fordeles i separate prøver der forankres til en overflade og sekvenseres.
8. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor sekvenseringen er massiv parallel sekvensering af millioner af genomiske DNA-fragmenter ved en fremgangsmåde omfattende fastgørelse af tilfældigt fragmenteret genomisk DNA til en plan, optisk transparent flade og fastfaseamplifikation for at danne en højdensitets-sekvenserende flowcelle med millioner af klynger, hver indeholdende ca. 1000 kopier af template pr. kvadratcentimeter, og hvor templates sekvenseres ved en fire-farve DNA sekvensering-ved synteseteknologi.
9. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, yderligere omfattende trinnet at berige blandingen for føtalt genetisk materiale ved størrelsesseparation, hvorved et præparat omfattende kun DNA-fragmenter mindre end ca. 300 bp anvendes til målingen i trin (c).
DK11175845.4T 2006-02-02 2007-02-02 Ikke-invasiv føtal genetisk screening ved digital analyse DK2385143T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US76442006P 2006-02-02 2006-02-02
EP07763674.4A EP1981995B2 (en) 2006-02-02 2007-02-02 Non-invasive fetal genetic screening by digital analysis

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DK2385143T3 true DK2385143T3 (da) 2016-09-19

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DK07763674.4T DK1981995T4 (da) 2006-02-02 2007-02-02 Ikke-invasiv føtal genetisk screening ved digital analyse
DK15195663.8T DK3002338T3 (da) 2006-02-02 2007-02-02 Ikke-invasiv føtal genetisk screening ved digital analyse

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US (11) US7888017B2 (da)
EP (6) EP3591068A1 (da)
CY (2) CY1118095T1 (da)
DK (3) DK2385143T3 (da)
ES (4) ES2429408T5 (da)
HU (2) HUE030215T2 (da)
LT (2) LT2385143T (da)
PL (3) PL3002338T3 (da)
PT (2) PT3002338T (da)
SI (3) SI2385143T1 (da)
TR (1) TR201910868T4 (da)
WO (1) WO2007092473A2 (da)

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