# US 2010/0167948 A1 · MicroRNA Expression Profiling of Cerebrospinal Fluid > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2010/0167948 A1 - Document ID: US20100167948A1 - Status: Published application - Kind: A1 - Application number: 12/600,704 - Filed: 2008-05-21 - Published: 2010-07-01 - Earliest claimed: 2007-05-22 - Assignees: The Brigham and Women's Hospital, Inc. - Inventors: Anna Krichevsky; Brit Mollenhauer - Web page: https://patentgrep.com/patent/US20100167948A1 ## CPC - C12Q 1/6883: for diseases caused by alterations of genetic material - C12Q 2600/16: Primer sets for multiplex assays - C12Q 2600/178: miRNA, siRNA or ncRNA - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES ## Abstract The present invention is directed to assay methods in which the levels of certain specific microRNAs are determined in the cerebrospinal fluid of a subject. These methods may be used in the diagnosis or monitoring of neurological diseases, especially brain tumors. ## Claims ### Claim 1 A method of diagnosing or monitoring a neurological disease in a subject, comprising: a) obtaining a test sample of cerebrospinal fluid (CSF) from said subject; b) assaying said test sample to determine the concentration or amount of one or more microRNAs; c) comparing the concentration or amount determined in step b) with the concentration or amount determined for the same one or more microRNAs in one or more control samples of CSF; and d) concluding that said subject has said neurological disease, or that said neurological disease has progressed or recurred, if the concentration or amount of said microRNA is at least 25% higher or lower in said test sample than in said one or more control samples. ### Claim 2 (depends on 1) The method of claim 1, wherein it is concluded in step d) that said subject has said neurological disease, or that said neurological disease has progressed or recurred, if the concentration or amount of said microRNA is at least 50% higher or lower in said test sample than in said one or more controls samples. ### Claim 3 (canceled) ### Claim 4 (depends on 1) The method of claim 1, wherein said microRNA is selected from the group consisting of: miR-21; miR-17-5p; miR-18; miR-19; miR-20; miR-92; mir-10a; mir-10b; mir-96; mir-182/182*; mir-183; mir-15a; mir-15b; mir-16; mir-125b; mir-124; mir-1; mir-7; mir-103; mir-134; mir-137; mir-345; mir-200a; mir-330; mir-485-5p; mir-151; mir-22; mir-181; mir-219; mir-30a; mir-128; mir-29a; mir-29b; mir-29c; mir-139; mir-338; mir-324-3p; mir-135; mir-296; mir-467; mir-521; mir-155; mir-26b; mir-132; and mir-212. ### Claim 5 (depends on 1) The assay of claim 1, wherein said microRNA is mir-21or mir-10b and the presence or progression of said neurological disease is based upon the concentration or amount of said microRNA being increased by at least 25% relative to the concentration or amount present in said control sample. ### Claim 6 (depends on 5) The assay of claim 5, wherein said neurological disease is a cancer of the brain. ### Claim 7 (canceled) ### Claim 8 (depends on 1) The assay of claim 1, wherein said microRNA is mir-125b or mir-124 and the presence or progression of said neurological disease is based upon the concentration or amount of said microRNA being decreased by at least 25% relative to the concentration or amount present in said control sample. ### Claim 9 (depends on 8) The assay of claim 8, wherein said neurological disease is a cancer of the brain. ### Claim 10 (canceled) ### Claim 11 (depends on 1) The assay of claim 1, wherein said microRNA is mir-30a or mir-26b and the presence or progression of said neurological disease is based upon the concentration or amount of said microRNA being increased by at least 25% relative to the concentration or amount present in said control sample. ### Claim 12 (depends on 11) The assay of claim 11, wherein said neurological disease is Alzheimer's disease. ### Claim 13 (depends on 1) The assay of claim 1, wherein said microRNA is mir-132 or mir-212 and the presence or progression of said neurological disease is based upon the concentration or amount of said microRNA being decreased by at least 25% relative to the concentration or amount present in said control sample. ### Claim 14 (depends on 13) The assay of claim 13, wherein said neurological disease is Alzheimer's disease. ### Claim 15 (depends on 1) The method of claim 1, wherein said method is used to monitor a patient that has been treated for a neurological disease by surgery, radiation or medication and wherein said control sample is a CSF sample taken from said patient at an earlier time. ### Claim at position 16 16-22. (canceled) ### Claim 23 A microarray useful for diagnosing neurological diseases comprising: a) a solid support comprising a membrane, glass or plastic dish, plate or slide; and b) at least 5 distinct polynucleotides, each of which is attached to said solid support at a separate site and each of which hybridizes under stringent conditions to a different microRNA or complement thereof, wherein said microRNA is selected from the group consisting of: miR-21; miR-17-5p; miR-18; miR-19; miR-20; miR-92; mir-10a; mir10b; mir-96; mir-182/182*; mir-83; mir-15 a; mir-15b; mir-16; mir-125b; mir-124; mir-1; mir-7; mir-103; mir-134; mir-137; mir-345; mir-200a; mir-330; mir-485-5p ; mir-151; mir-22; mir-181; mir-219; mir-30; mir-128; mir-29a; mir-29b; mir-29c; mir-139; mir-338; mir-324-3p; mir-135; mir-296; mir-467; mir-521; mir-155; mir-26b; mir-132; and mir-212. ### Claim 24 (canceled) ### Claim 25 (depends on 23) The microarray of claim 23, wherein said microarray includes distinct polynucleotides, hybridizing to at least 20 of said microRNAs or complements thereof ### Claim 26 (depends on 23) The microarray of claim 23, wherein said microarray includes distinct polynucleotides, hybridizing to at least 40 of said microRNAs or complements thereof ### Claim 27 (depends on 23) The microarray of claim 23, wherein said microarray includes distinct polynucleotides, hybridizing to 5-45 of said microRNAs or complements thereof. ### Claim 28 (canceled) ### Claim 29 (depends on 23) The microarray of claim 23, wherein said microarray includes no more than 20 distinct polynucleotides, hybridizing to said microRNAs or complements thereof. ### Claim 30 (depends on 23) The microarray of claim 23, wherein said microRNAs include miR-21 and mir-10b. ### Claim 31 (depends on 30) The microarray of claim 30, wherein said microRNAs include miR-125b and mir-124. ### Claim 32 (depends on 23) An diagnostic assay for cancer of the brain comprising determining the amount or concentration of at least 5 distinct microRNAs in cerebrospinal fluid from a subject by performing a hybridization with the micrarray microarray of claim 23.