DK2668290T3 - Rnascope®-hpv-assay til bestemmelse af hpv-status af kræft i hoved og hals og læsioner i livmoderhalsen - Google Patents
Rnascope®-hpv-assay til bestemmelse af hpv-status af kræft i hoved og hals og læsioner i livmoderhalsen Download PDFInfo
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- DK2668290T3 DK2668290T3 DK12702157.4T DK12702157T DK2668290T3 DK 2668290 T3 DK2668290 T3 DK 2668290T3 DK 12702157 T DK12702157 T DK 12702157T DK 2668290 T3 DK2668290 T3 DK 2668290T3
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Claims (14)
1. Fremgangsmåde til at bestemme hvorvidt en kræft i hoved og hals i et menneske er HPV-relateret, omfattende at udføre et RNA-/'n s/'tu-hybridiserings (ISH) -assay på en prøve af kræft i hoved og hals opnået fra mennesket, hvor prøven er i et vævssnit, hvor ISH-assayet omfatter: (i) mere end et målprobesæt, der er designet til individuelt at hybridisere til E6/E7 mRNA af mere end en højrisiko HPV-undertype, og (ii) et universelt signalamplifikationssystem, hvor hvert målprobesæt indeholder en flerhed af målprober, hvor hver målprobe i et målprobesæt omfatter en første polynukleotidsekvens, der er komplementær til E6/E7 mRNA afen højrisiko HPV-undertype, og en anden polynukleotidsekvens, der er komplementærtil en polynukleotidsekvens af det universelle signalamplifikationssystem, og hvor den anden polynukleotidsekvens er identisk på tværs af forskellige målprobesæt, og hvor tilstedeværelsen af E6/E7 mRNA af den ene eller flere højrisiko HPV-undertyper indikerer, at kræften i hoved og hals i mennesket er HPV-relateret.
2. Fremgangsmåde til at bestemme udviklingen af kræft i hoved og hals i et menneske, omfattende: (a) at udføre et RNA-/n s/tu-hybridiserings (ISH) -assay på en prøve af kræft i hoved og hals opnået fra mennesket, hvor prøven er i et vævssnit, hvor ISH-assayet omfatter: (i) mere end et målprobesæt, der er designet til individuelt at hybridisere til E6/E7 mRNA af mere end en højrisiko HPV-undertype, og (ii) et universelt signalamplifikationssystem; og (b) at måle niveauerne af E6/E7 mRNA af den ene eller flere højrisiko HPV-undertyper detekteret i trin (a); hvor hvert målprobesæt indeholder en flerhed af målprober, hvor hver målprobe i et målprobesæt omfatter en første polynukleotidsekvens, der er komplementær til E6/E7 mRNA af en højrisiko HPV-undertype, og en anden polynukleotidsekvens, der er komplementærtil en polynukleotidsekvens af det universelle signalamplifikationssystem, og hvor den anden polynukleotidsekvens er identisk på tværs af forskellige målprobesæt, og hvor niveauerne af E6/E7 mRNA af den ene eller flere højrisiko HPV-undertyper bestemmer udviklingen af kræften i hoved og hals.
3. Fremgangsmåde til at bestemme hvorvidt en læsion i livmoderhalsen i et menneske er en godartet læsion eller en livmoderhals-intraepitelneoplasme (CIN) læsion, omfattende at udføre et RNA-/'n situ-hybridiserings (ISH) -assay på en livmoderhalsvævsprøve opnået fra mennesket, hvor prøven er i et vævssnit, hvor ISH-assayet omfatter: (i) mere end et målprobesæt, der er designet til individuelt at hybridisere til E6/E7 mRNA af mere end en højrisiko HPV-undertype, (ii) et universelt signalamplifikationssystem; hvor hvert målprobesæt indeholder en flerhed af målprober, hvor hver målprobe i et målprobesæt omfatter en første polynukleotidsekvens, der er komplementær til E6/E7 mRNA afen højrisiko HPV-undertype, og en anden polynukleotidsekvens, der er komplementær til en polynukleotidsekvens af det universelle signalamplifikationssystem, og hvor den anden polynukleotidsekvens er identisk på tværs af forskellige målprobesæt, og hvor fraværet af E6/E7 mRNA af alle højrisiko HPV-undertyper indikerer en godartet læsion, og tilstedeværelsen af E6/E7 mRNA af den ene eller flere højrisiko HPV-undertyper indikereren CIN-læsion.
4. Fremgangsmåde til at bestemme udviklingen af livmoderhals-intraepitelneoplasme (CIN) i et menneske, omfattende: (a) at udføre et RNA-/n s/tu-hybridiserings (ISH) -assay på en livmoderhalsvævsprøve opnået fra mennesket, hvor prøven er i et vævssnit, hvor ISH-assayet omfatter: (i) mere end et målprobesæt, der er designet til individuelt at hybridisere til E6/E7 mRNA af mere end en højrisiko HPV-undertype, og (ii) et universelt signalamplifikationssystem; og (b) at analysere det rumlige mønster og at måle niveauerne af E6/E7 mRNA af den ene eller flere højrisiko HPV-undertyper detekteret i trin (a); hvor hvert målprobesæt indeholder en flerhed af målprober, hvor hver målprobe i et målprobesæt omfatter en første polynukleotidsekvens, der er komplementær til E6/E7 mRNA afen højrisiko HPV-undertype, og en anden polynukleotidsekvens, der er komplementær til en polynukleotidsekvens af det universelle signalamplifikationssystem, og hvor den anden polynukleotidsekvens er identisk på tværs af forskellige målprobesæt, og hvor det rumlige mønster og niveauerne af E6/E7 mRNA af den ene eller flere højrisiko HPV-undertyper bestemmer udviklingen af CIN.
5. Fremgangsmåde til at bestemme risikoen for at udvikle livmoderhalskræft i et menneske diagnosticeret med livmoderhals-intraepitelneoplasme (CIN), omfattende at udføre et RNA-/'n s/tu-hybridiserings (ISH) -assay på en livmoderhalsvævsprøve opnået fra mennesket, hvor prøven er i et vævssnit, hvor ISH-assayet omfatter: (i) mere end et målprobesæt, der er designet til individuelt at hybridisere til E6/E7 mRNA af mere end en højrisiko HPV-undertype, og (ii) et universelt signalamplifikationssystem; hvor hvert målprobesæt indeholder en flerhed af målprober, hvor hver målprobe i et målprobesæt omfatter en første polynukleotidsekvens, der er komplementær til E6/E7 mRNA af en højrisiko HPV-undertype, og en anden polynukleotidsekvens, der er komplementær til en polynukleotidsekvens af det universelle signalamplifikationssystem, og hvor den anden polynukleotidsekvens er identisk på tværs af forskellige målprobesæt, hvor den ene eller flere højrisiko HPV-undertyper er organiseret i tre grupper af HPV-undertyper, hver med et forskelligt risikoniveau for transformation af CIN til livmoderhalskræft, og hvor tilstedeværelsen af E6/E7 mRNA af gruppe (1) HPV-undertyper indikerer den højeste risiko for at udvikle livmoderhalskræft, tilstedeværelsen af E6/E7 mRNA af gruppe (2) HPV-undertyper indikerer en mindre risiko for at udvikle livmoderhalskræft, og tilstedeværelsen af E6/E7 mRNA af gruppe (3) HPV-undertyper indikerer den laveste risiko forat udvikle livmoderhalskræft; og hvor gruppen (1) HPV-undertyper inkluderer HPV-16; gruppen (2) HPV-undertyper inkluderer HPV-18, HPV-31, og HPV-33; og gruppen (3) HPV-undertyper inkluderer HPV-26, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-53, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-73, og HPV-82.
6. Fremgangsmåden ifølge et hvilket som helst af kravene 1 til 5, hvor vævssnittet er et formalin-fikseret, paraffin-indstøbt vævssnit.
7. Kit omfattende, i et egnet beholderorgan, stoffer til at udføre et RNA-situ-hybridiserings (ISH) -assay, der inkluderer (i) mere end et målprobesæt, der er designet til individuelt at hybridisere til E6/E7 mRNA af mere end en højrisiko HPV-undertype, og (ii) et universelt signalamplifikationssystem, hvor hvert målprobesæt indeholder en flerhed af målprober, hvor hver målprobe i et målprobesæt omfatter en første polynukleotidsekvens, der er komplementær til E6/E7 mRNA af en højrisiko HPV-undertype, og en anden polynukleotidsekvens, der er komplementær til en polynukleotidsekvens af det universelle signalamplifikationssystem, og hvor den anden polynukleotidsekvens er identisk på tværs af forskellige målprobesæt, og hvor kittet er til at bestemme hvorvidt en kræft i hoved og hals i et menneske er HPV-relateret, eller hvorvidt en læsion i livmoderhalsen i et menneske er en godartet læsion eller en livmoderhals-intraepitelneoplasme (CIN) -læsion.
8. Fremgangsmåden ifølge et hvilket som helst af kravene 1 til 6, eller kittet ifølge krav 7, hvor det universelle signalamplifikationssystem indeholder enten et peberrodsperoxidase (HRP) eller alkalisk phosphatase (AP) mærke, der kan detekteres ved dannelsen af et præcipitat følgende inkubering med henholdsvis DAB- eller Fast Red-substrater.
9. Fremgangsmåden ifølge et hvilket som helst af kravene 1 til 6, eller kittet ifølge krav 7, hvor det universelle signalamplifikationssystem indeholder amplifikatorer og præ-amplifikatorer, der er designet til at hjælpe med at amplificere signalerne fra E6/E7 mRNA.
10. Fremgangsmåden ifølge et hvilket som helst af kravene 1 til 9, eller kittet ifølge et hvilket som helst af kravene 7 til 9, hvor den ene eller flere højrisiko HPV-undertyper vælges fra en gruppe bestående af HPV-16, HPV-18, HPV-26, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-53, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-73, og HPV-82, eller en hvilken som helst kombination deraf.
11. Fremgangsmåden eller kit ifølge krav 10, hvor gruppen består af HPV-undertyper af: HPV-16, HPV-18, HPV-26, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-53, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-73, og HPV-82.
12. Fremgangsmåden eller kit ifølge krav 10, hvor gruppen består af HPV-undertyper af: HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-68, HPV-73, og HPV-82.
13. Fremgangsmåden eller kit ifølge krav 10, hvor gruppen består af HPV-undertyper af: HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-52, og HPV-58.
14. Fremgangsmåden eller kit ifølge krav 10, hvor gruppen består af HPV undertype HPV-16.
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| US20140031250A1 (en) | 2010-10-07 | 2014-01-30 | David Tsai Ting | Biomarkers of Cancer |
| CN104849472A (zh) | 2010-10-21 | 2015-08-19 | 领先细胞医疗诊断有限公司 | 用于原位检测核酸的超灵敏方法 |
| US9273349B2 (en) * | 2013-03-14 | 2016-03-01 | Affymetrix, Inc. | Detection of nucleic acids |
| US20140357509A1 (en) * | 2013-03-28 | 2014-12-04 | Advanced Cell Diagnostics, Inc. | Differentiation between transient and persistent high-risk hpv infection by in situ hybridization |
| US20150247204A1 (en) | 2014-02-07 | 2015-09-03 | The General Hopital Corporation | Differential diagnosis of hepatic neoplasms |
| WO2015123565A1 (en) | 2014-02-14 | 2015-08-20 | The General Hospital Corporation | Methods for diagnosing igg4-related disease |
| WO2015131099A1 (en) | 2014-02-28 | 2015-09-03 | The General Hospital Corporation | Diagnosis of multiple myeloma and lymphoma |
| US10301624B2 (en) | 2014-06-25 | 2019-05-28 | The General Hospital Corporation | Targeting human satellite II (HSATII) |
| DK3362462T3 (da) | 2015-10-12 | 2021-10-11 | Advanced Cell Diagnostics Inc | In situ-detektion af nukleotidvarianter i prøver med højt støjniveau, og sammensætninger og fremgangsmåder relateret dertil |
| KR102313431B1 (ko) | 2016-11-21 | 2021-10-18 | 나노스트링 테크놀로지스, 인크. | 화학적 조성물 및 이것을 사용하는 방법 |
| JP2021512956A (ja) | 2018-02-06 | 2021-05-20 | ザ ジェネラル ホスピタル コーポレイション | 腫瘍免疫応答のバイオマーカーとしてのリピートｒｎａ |
| WO2019199643A1 (en) | 2018-04-09 | 2019-10-17 | Bio-Techne Corporation | Methods to further enhance signal amplification for the in situ detection of nucleic acids |
| AU2019271028B2 (en) | 2018-05-14 | 2025-09-18 | Bruker Spatial Biology, Inc. | Chemical compositions and methods of using same |
| WO2021231891A1 (en) * | 2020-05-15 | 2021-11-18 | Quidel Corporation | Method for direct amplification and detection of rna |
| CN112014187A (zh) * | 2020-09-07 | 2020-12-01 | 四川大学华西医院 | 一种非脱钙骨软骨组织的切片制备方法及其细胞示踪和RNAscope联合测试方法 |
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| US3939350A (en) | 1974-04-29 | 1976-02-17 | Board Of Trustees Of The Leland Stanford Junior University | Fluorescent immunoassay employing total reflection for activation |
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| WO2012103414A2 (en) | 2012-08-02 |
| WO2012103414A3 (en) | 2012-10-11 |
| US20120214152A1 (en) | 2012-08-23 |
| EP2668290A2 (en) | 2013-12-04 |
| EP2668290B1 (en) | 2017-05-31 |
| CN103476948A (zh) | 2013-12-25 |
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