References
- Hood L, Flores M. A personal view on systems medicine and the emergence of proactive P4 medicine: predictive, preventive, personalized and participatory. N Biotechnol. 2012 Sep 15;29(6):613–624. PubMed PMID: 22450380; eng.
- Schmidt KT, Chau CH, Price DK, et al. Precision oncology medicine: the clinical relevance of patient-specific biomarkers used to optimize cancer treatment. J Clin Pharmacol. 2016 Dec;56(12):1484–1499. PubMed PMID: 27197880; PubMed Central PMCID: PMCPMC5112148. eng.
- La Thangue NB, Kerr DJ. Predictive biomarkers: a paradigm shift towards personalized cancer medicine. Nat Rev Clin Oncol. 2011 Aug 23;8(10):587–596. PubMed PMID: 21862978; eng.
- Knowles L, Luth W, Bubela T. Paving the road to personalized medicine: recommendations on regulatory, intellectual property and reimbursement challenges. J Law Biosci. 2017 Dec;4(3):453–506. PubMed PMID: 29868182; PubMed Central PMCID: PMCPMC5965495. eng.
- Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al. [cited 2018 Oct 4]. Available from: https://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf
- Komatani TS. Patent protection of diagnostic technology: will recent US supreme court decisions change patent strategy? Pharm Pat Anal. 2015;4(5):357–362. PubMed PMID: 26451906; eng.
- Schneider D, Bublak W. Personalized medicine: its implications and its impact on patents. Pharm Pat Anal. 2015;4(6):415–419. PubMed PMID: 26580989; eng.
- Aboy M, Crespo C, Liddell K, et al. Was the Myriad decision a ‘surgical strike’ on isolated DNA patents, or does it have wider impacts? [Editorial Material]. Nat Biotechnol. 2018 Dec;36(12):1146–1150. PubMed PMID: WOS:000452395100009; English.
- Glorikian H, Warburg RJ, Moore K, et al. Intellectual property considerations for molecular diagnostic development with emphasis on companion diagnostics. Expert Opin Ther Pat. 2018 Feb;28(2):123–128. PubMed PMID: 29224409; eng.
- Conesa-Zamora P. Role of cell cycle biomarkers in human papillomavirus related uterine lesions. Curr Pharm Des. 2013;19(8):1412–1424. PubMed PMID: 23016774; eng.
- Investor update: Roche to acquire Ventana for $89.50 per share. 2008 [cited 2018 Oct 4]. Available from: https://www.roche.com/investors/updates/inv-update-2008-01-22.htm
- Piaton E, Advenier AS, Carre C, et al. p16/Ki-67 dual labeling and urinary cytology results according to the New Paris system for reporting urinary cytology: impact of extended follow-up. Cancer Cytopathol. 2017 Jul;125(7):552–562. PubMed PMID: 28371465; eng.
- Scheerens H, Malong A, Bassett K, et al. Current status of companion and complementary diagnostics: strategic considerations for development and launch. Clin Transl Sci. 2017 Mar;10(2):84–92. PubMed PMID: 28121072; PubMed Central PMCID: PMCPMC5355969. eng.
- Giugni D, Giugni V. Intellectual property: a powerful tool to develop biotech research. Microb Biotechnol. 2010 Sep;3(5):493–506. PubMed PMID: 21255349; PubMed Central PMCID: PMCPMC3815763. eng.
- Holman CM. Vanda v. West-Ward Pharmaceuticals: Good News for the patent eligibility of diagnostics and personalized medicine, with some important caveats [Editorial Material]. Biotechnol Law Rep. 2018 Jun;37(3):117–125. PubMed PMID: WOS:000435327500005; English.
- Vargas AJ, Harris CC. Biomarker development in the precision medicine era: lung cancer as a case study. Nat Rev Cancer. 2016 Aug;16(8):525–537. PubMed PMID: 27388699; eng.
- Friedman AA, Letai A, Fisher DE, et al. Precision medicine for cancer with next-generation functional diagnostics. Nat Rev Cancer. 2015 Dec;15(12):747–756. PubMed PMID: 26536825; PubMed Central PMCID: PMCPMC4970460. eng.
- Sant GR, Knopf KB, Albala DM. Live-single-cell phenotypic cancer biomarkers-future role in precision oncology? NPJ Precis Oncol. 2017;1(1):21. PubMed PMID: 29872705; PubMed Central PMCID: PMCPMC5871838 Scientific Advisory Board, and K. Knopf and D. Albala are Members of the Scientific Advisory Board. eng.
- Wu P, Nielsen TE, Clausen MH. Small-molecule kinase inhibitors: an analysis of FDA-approved drugs. Drug Discov Today. 2016 Jan;21(1):5–10. PubMed PMID: 26210956; eng.
- Cheng S, Koch WH, Wu L. Co-development of a companion diagnostic for targeted cancer therapy. N Biotechnol. 2012 Sep 15;29(6):682–688. PubMed PMID: 22391147; eng.
- Ou SH, Soo RA, Kubo A, et al. Will the requirement by the US FDA to simultaneously Co-Develop Companion Diagnostics (CDx) delay the approval of receptor tyrosine kinase inhibitors for RTK-Rearranged (ROS1-, RET-, AXL-, PDGFR-alpha-, NTRK1-) non-small cell lung cancer globally? Front Oncol. 2014;4:58. PubMed PMID: 24744988; PubMed Central PMCID: PMCPMC3978317. eng.
- Alekseyev YO, Fazeli R, Yang S, et al. A next-generation sequencing primer-how does it work and what can it do? Acad Pathol. 2018 Jan–Dec;5:2374289518766521. PubMed PMID: 29761157; PubMed Central PMCID: PMCPMC5944141. eng.
- Huang Y, Burns DJ, Rich BE, et al. A functional signal profiling test for identifying a subset of HER2-negative breast cancers with abnormally amplified HER2 signaling activity. Oncotarget. 2016 Nov 29;7(48):78577–78590. PubMed PMID: 27713176; PubMed Central PMCID: PMCPMC5346661. eng.
- Huang Y, Burns DJ, Rich BE, et al. Development of a test that measures real-time HER2 signaling function in live breast cancer cell lines and primary cells. BMC Cancer. 2017 Mar 16;17(1):199. PubMed PMID: 28302091; PubMed Central PMCID: PMCPMC5356237. eng.
- Al Idrus A. News of Note—cancer diagnostics startup Celcuity files for $15M IPO. 2017 [cited 2018 Oct 5]. Available from: https://www.fiercebiotech.com/medtech/news-note-cancer-diagnostics-startup-celcuity-files-for-15m-ipo
- Karbownik MS, Nowak JZ. Hyaluronan: towards novel anti-cancer therapeutics. Pharmacol Rep. 2013;65(5):1056–1074. PubMed PMID: 24399703; eng.
- ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 Feb 29 - . Identifier NCT03634332, Second-line study of PEGPH20 and Pembro for HA high metastatic PDAC; 2018 Aug 16 [cited 2019 Feb 4 2019]. Available from: https://clinicaltrials.gov/ct2/show/NCT03634332
- Krizman D Prostate cancer prognosis by FFPE tissue proteomics (Grant No. 1R43CA110697-01). National Institutes of Health; 2004.
- Expression Pathology, Inc.. The Liquid Tissue® MS Protein Prep Kit (Manual). [cited 2018 Oct 5]. Available from: http://www.expressionpathology.com/pdf/LiquidTissueMSKit_Rev5_Mar2011.pdf
- Expression pathology raises $6.5 million to develop personalized medicine assays for protein biomarkers in FFPE tissue. 2009 [cited 2018 Oct 5]. Available from: https://www.biospace.com/article/releases/expression-pathology-raises-6-5-million-to-develop-personalized-medicine-assays-for-protein-biomarkers-in-ffpe-tissue-/
- Mayo clinic licenses expression pathology technology for MS-based amyloidosis assay. 2009 [cited 2018 Oct 5]. Available from: https://www.genomeweb.com/proteomics/mayo-clinic-licenses-expression-pathology-technology-ms-based-amyloidosis-assay#.W7eILWhKg2w
- Thermo Fisher’s BRIMS center, expression pathology developing SRM workflow for cancer biomarker identification. 2009 [cited 2018 Oct 5]. Available from: https://www.genomeweb.com/proteomics/thermo-fishers-brims-center-expression-pathology-developing-srm-workflow-cancer-#.W7eLEmhKg2w
- Expression pathology in PGx pact with Toronto Hospitals. 2010 [cited 2018 Oct 5]. Available from: https://www.genomeweb.com/dxpgx/expression-pathology-pgx-pact-toronto-hospitals#.W7eLrGhKg2w
- Expression pathology, MD Anderson evaluating technology for lung cancer therapy selection. 2012 [cited 2018 Oct 5]. Available from: https://www.genomeweb.com/mdx/expression-pathology-md-anderson-evaluating-technology-lung-cancer-therapy-selec#.W7eXvGhKg2w
- Expression pathology, flagship partner to offer translational biomarker services. 2010 [cited 2018 Oct 5]. Available from: https://www.genomeweb.com/dxpgx/expression-pathology-flagship-partner-offer-translational-biomarker-services#.W7eXLGhKg2w
- Roche pharma to use expression pathology’s assays. 2011 [cited 2018 Oct 5]. Available from: https://www.genomeweb.com/proteomics/roche-pharma-use-expression-pathologys-assays#.W7eMi2hKg2w
- Garrison LP, Towse A. Value-based pricing and reimbursement in personalised healthcare: introduction to the basic health economics. J Pers Med. 2017 Sep 4;7(3):10. PubMed PMID: 28869571; PubMed Central PMCID: PMCPMC5618156. eng.
- Hsiao SJ, Mansukhani MM, Carter MC, et al. The history and impact of molecular coding changes on coverage and reimbursement of molecular diagnostic tests: transition from stacking codes to the current molecular code set including genomic sequencing procedures. J Mol Diagn. 2018 Mar;20(2):177–183. PubMed PMID: 29269278; eng.
- Goldberg KB, Blumenthal GM, McKee AE, et al. The FDA oncology center of excellence and precision medicine. Exp biol med. 2018 Feb;243(3):308–312. PubMed PMID: 29105511; PubMed Central PMCID: PMCPMC5813869. eng.
- Janiaud P, Serghiou S, Ioannidis JPA. New clinical trial designs in the era of precision medicine: an overview of definitions, strengths, weaknesses, and current use in oncology. Cancer Treat Rev. 2019 Dec 11;73:20–30. PubMed PMID: 30572165; eng.