BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

87 related articles for article (PubMed ID: 35673983)

  • 1. Impact of the new European Union
    Hermans AMM; Maliepaard M; Boon WPC; Pasmooij AMG
    Expert Rev Mol Diagn; 2022 May; 22(5):583-590. PubMed ID: 35673983
    [TBL] [Abstract][Full Text] [Related]  

  • 2. ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European
    Vanstapel FJLA; Orth M; Streichert T; Capoluongo ED; Oosterhuis WP; Çubukçu HC; Bernabeu-Andreu FA; Thelen M; Jacobs LHJ; Linko S; Bhattoa HP; Bossuyt PMM; Meško Brguljan P; Boursier G; Cobbaert CM; Neumaier M
    Clin Chem Lab Med; 2023 Mar; 61(4):608-626. PubMed ID: 36716120
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Structure and content of the EU-IVDR : Current status and implications for pathology.
    Kahles A; Goldschmid H; Volckmar AL; Ploeger C; Kazdal D; Penzel R; Budczies J; Kempny G; Kazmierczak M; Flechtenmacher C; Baretton G; Weichert W; Horst D; Klauschen F; Gassner UM; Brüggemann M; Vogeser M; Schirmacher P; Stenzinger A
    Pathologie (Heidelb); 2023 Nov; 44(Suppl 2):73-85. PubMed ID: 36735063
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Regulation (EU) 2017/746 (IVDR): practical implementation of annex I in pathology.
    Kahles A; Goldschmid H; Volckmar AL; Ploeger C; Kazdal D; Penzel R; Budczies J; Flechtenmacher C; Gassner UM; Brüggemann M; Vogeser M; Schirmacher P; Stenzinger A
    Pathologie (Heidelb); 2023 Nov; 44(Suppl 2):86-95. PubMed ID: 38047950
    [TBL] [Abstract][Full Text] [Related]  

  • 5. [Regulation (EU) 2017/746 (IVDR): practical implementation of annex I in pathology].
    Kahles A; Goldschmid H; Volckmar AL; Ploeger C; Kazdal D; Penzel R; Budczies J; Flechtenmacher C; Gassner UM; Brüggemann M; Vogeser M; Schirmacher P; Stenzinger A
    Pathologie (Heidelb); 2023 Nov; 44(6):381-391. PubMed ID: 37792098
    [TBL] [Abstract][Full Text] [Related]  

  • 6. 2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (
    Kholmanskikh O; Wang YM; Hersey S; Wadhwa M; Block K; Bandukwala A; Szapacs M; Weiner R; Awwad K; Dessy F; Downing S; Du X; Garofolo F; Harris S; Hou V; Jones J; Kar S; Kinhikar A; Li M; Mathews J; Meissen J; Sumner GO; Pan L; Sanderink G; Scully I; Stanta J; Tanaka Y; Vauleon S; Wagner L; Wang K; Zhu L; Eck S; Lin YD; Azadeh M; Decman V; Diebold S; Du X; Goihberg P; Alcaide EG; Gonneau C; Hedrick MN; Hopkins G; Kar S; Loschko J; McCausland M; Mendez L; Sehra S; Stevens E; Sun YS; Tangri S; Trampont PC; Cludts I; Dysinger M; Kavita U; Sugimoto H; Chilewski S; Grimaldi C; Jiang Y; Kamerud J; Liu S; Owen C; Palackal N; Petit-Frere C; Pine S; Abhari MR; Scheibner K; Williams L; Xu T; Zhang G
    Bioanalysis; 2024; 16(8):179-220. PubMed ID: 38899739
    [TBL] [Abstract][Full Text] [Related]  

  • 7. The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications.
    Bank PCD; Jacobs LHJ; van den Berg SAA; van Deutekom HWM; Hamann D; Molenkamp R; Ruivenkamp CAL; Swen JJ; Tops BBJ; Wamelink MMC; Wessels E; Oosterhuis WP
    Clin Chem Lab Med; 2020 Nov; ():. PubMed ID: 33554568
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS.
    Kang SL; Woo JH; Kim NH; Kwon JY; Kim SM
    Mol Ther Methods Clin Dev; 2023 Sep; 30():447-458. PubMed ID: 37663648
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Twenty-five years with companion diagnostics.
    Jørgensen JT
    Chin Clin Oncol; 2023 Dec; 12(6):65. PubMed ID: 37953243
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devices.
    Song C; Xiong X; Kim S; Xu Z; Xu D; Biswas B
    J Biopharm Stat; 2024 May; 34(3):441-452. PubMed ID: 37330676
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation]).
    Spitzenberger F; Patel J; Gebuhr I; Kruttwig K; Safi A; Meisel C
    Ther Innov Regul Sci; 2022 Jan; 56(1):47-64. PubMed ID: 34291407
    [TBL] [Abstract][Full Text] [Related]  

  • 12. [Current Status and Regulatory Issues of Companion Diagnostics in Japan].
    Tsukumo Y; Inoue T
    Gan To Kagaku Ryoho; 2024 Apr; 51(4):368-377. PubMed ID: 38644299
    [TBL] [Abstract][Full Text] [Related]  

  • 13. IVDR: Analysis of the Social, Economic, and Practical Consequences of the Application of an Ordinance of the In Vitro Diagnostic Ordinance in Switzerland.
    Coste AT; Egli A; Schrenzel J; Nickel B; Zbinden A; Lienhard R; Dumoulin A; Risch M; Greub G;
    Diagnostics (Basel); 2023 Sep; 13(18):. PubMed ID: 37761277
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Clinical evidence requirements according to the IVDR 2017/746: practical tools and references for underpinning clinical evidence of IVD-MDs.
    Charrière K; Pazart L
    Clin Chem Lab Med; 2023 Jun; 61(7):1150-1157. PubMed ID: 36919280
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Implementation of the new EU IVD regulation - urgent initiatives are needed to avert impending crisis.
    Cobbaert C; Capoluongo ED; Vanstapel FJLA; Bossuyt PMM; Bhattoa HP; Nissen PH; Orth M; Streichert T; Young IS; Macintyre E; Fraser AG; Neumaier M
    Clin Chem Lab Med; 2021 Sep; ():. PubMed ID: 34533005
    [TBL] [Abstract][Full Text] [Related]  

  • 16. AWMF statement on medical services in laboratory diagnostics and pathology with regard to the IVDR.
    Vogeser M; Brüggemann M; Stenzinger A;
    Clin Chem Lab Med; 2024 Jul; 62(8):e173-e174. PubMed ID: 38456739
    [No Abstract]   [Full Text] [Related]  

  • 17. Analysis of recurrent research pathways for assessing and improving effectiveness in life sciences laboratories.
    Balas EA; Patel C; Ewing B; Patel N; McCoy TC; Wise S; Abdelgawad YH
    medRxiv; 2023 Jan; ():. PubMed ID: 36712074
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Advancing precision oncology in metastatic colorectal cancer: The food and drug administration approval of foundation one liquid CDx as a companion diagnostic a correspondence.
    Shahnoor S; Mansha M; Farhat S; Maryyum A; Khan AN; Khan AM
    Rare Tumors; 2023; 15():20363613231204798. PubMed ID: 37767464
    [No Abstract]   [Full Text] [Related]  

  • 19. In-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency.
    Vanstapel FJLA; Boursier G; Cobbaert CM
    Clin Chem Lab Med; 2024 Jan; 62(1):e1-e3. PubMed ID: 37494024
    [No Abstract]   [Full Text] [Related]  

  • 20. The impact of companion diagnostic testing on medical decision making and IVD regulations.
    Jørgensen JT
    Expert Rev Mol Diagn; 2024 Apr; 24(4):245-247. PubMed ID: 38346227
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 5.