Laena D'Alton, Dênio Emanuel Pires Souto, Chamindie Punyadeera, Brian Abbey, Nicolas H. Voelcker, Conor Hogan and Saimon M. Silva
{"title":"生物传感器转化的整体途径","authors":"Laena D'Alton, Dênio Emanuel Pires Souto, Chamindie Punyadeera, Brian Abbey, Nicolas H. Voelcker, Conor Hogan and Saimon M. Silva","doi":"10.1039/D4SD00088A","DOIUrl":null,"url":null,"abstract":"<p >Point-of-care (POC) biosensors have enormous potential to help guide and inform clinical decisions at a patient's location. They are particularly relevant to underserved populations, and people living in remote locations where healthcare infrastructure and resources are often limited. The translation of effective POC biosensors into commercial products is rapidly growing across many research fields. A significant quantity of scientific articles focused on the fundamental, applied, and proof-of-concept aspects of biosensing are reported each year. However, this extensive body of work is not reflected in the comparatively small number of commercial biosensors available on the market. Here, we discuss key aspects of the biosensor translation process including the selection of analytical biomarkers in various body fluids, clinical trials, regulatory approval, consumer engagement, manufacturing and scale-up strategies, health economics, and legal and ethical considerations.</p>","PeriodicalId":74786,"journal":{"name":"Sensors & diagnostics","volume":null,"pages":null},"PeriodicalIF":3.5000,"publicationDate":"2024-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://pubs.rsc.org/en/content/articlepdf/2024/sd/d4sd00088a?page=search","citationCount":"0","resultStr":"{\"title\":\"A holistic pathway to biosensor translation\",\"authors\":\"Laena D'Alton, Dênio Emanuel Pires Souto, Chamindie Punyadeera, Brian Abbey, Nicolas H. Voelcker, Conor Hogan and Saimon M. Silva\",\"doi\":\"10.1039/D4SD00088A\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p >Point-of-care (POC) biosensors have enormous potential to help guide and inform clinical decisions at a patient's location. They are particularly relevant to underserved populations, and people living in remote locations where healthcare infrastructure and resources are often limited. The translation of effective POC biosensors into commercial products is rapidly growing across many research fields. A significant quantity of scientific articles focused on the fundamental, applied, and proof-of-concept aspects of biosensing are reported each year. However, this extensive body of work is not reflected in the comparatively small number of commercial biosensors available on the market. Here, we discuss key aspects of the biosensor translation process including the selection of analytical biomarkers in various body fluids, clinical trials, regulatory approval, consumer engagement, manufacturing and scale-up strategies, health economics, and legal and ethical considerations.</p>\",\"PeriodicalId\":74786,\"journal\":{\"name\":\"Sensors & diagnostics\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2024-07-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://pubs.rsc.org/en/content/articlepdf/2024/sd/d4sd00088a?page=search\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Sensors & diagnostics\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://pubs.rsc.org/en/content/articlelanding/2024/sd/d4sd00088a\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CHEMISTRY, ANALYTICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Sensors & diagnostics","FirstCategoryId":"1085","ListUrlMain":"https://pubs.rsc.org/en/content/articlelanding/2024/sd/d4sd00088a","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
Point-of-care (POC) biosensors have enormous potential to help guide and inform clinical decisions at a patient's location. They are particularly relevant to underserved populations, and people living in remote locations where healthcare infrastructure and resources are often limited. The translation of effective POC biosensors into commercial products is rapidly growing across many research fields. A significant quantity of scientific articles focused on the fundamental, applied, and proof-of-concept aspects of biosensing are reported each year. However, this extensive body of work is not reflected in the comparatively small number of commercial biosensors available on the market. Here, we discuss key aspects of the biosensor translation process including the selection of analytical biomarkers in various body fluids, clinical trials, regulatory approval, consumer engagement, manufacturing and scale-up strategies, health economics, and legal and ethical considerations.