The US Federal Circuit on the patentability of in vitro diagnostic methods—no light at the end of the tunnel

2019 ◽  
Vol 14 (10) ◽  
pp. 744-746
Author(s):  
Carsten D Richter
Keyword(s):  
Diagnostic Methods ◽  
The Us ◽  
In Vitro Diagnostic ◽  
Federal Circuit

Evaluation of in-vitro diagnostic methods for identifying the culprit drugs in drug hypersensitivity

2017 ◽  
Vol 86 (2) ◽  
pp. e67
Author(s):  
Kenichi Kato ◽  
Hiroaki Azukizawa ◽  
Takaaki Hanafusa ◽  
Yukinobu Nakagawa ◽  
Ichiro Katayama
Keyword(s):  
Drug Hypersensitivity ◽  
Diagnostic Methods ◽  
In Vitro Diagnostic

scholarly journals Regulatory hurdles in bringing an in vitro diagnostic device to market

1996 ◽  
Vol 42 (9) ◽  
pp. 1556-1557 ◽  
Author(s):  
K M Smith ◽  
J A Kates
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
New Products ◽  
New Product ◽  
Diagnostic Device ◽  
Regulatory Strategy ◽  
The Us ◽  
In Vitro Diagnostic ◽  
Medical Device Regulation

Abstract We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US. A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches of new products. Finally, it is critical for manufacturers to establish a working partnership with the Food and Drug Administration to expedite their new product applications.

In Vitro Diagnostic Methods in the Evaluation of Food Hypersensitivity

Food Allergy ◽  
2009 ◽  
pp. 251-266
Author(s):  
Staffan Ahlstedt ◽  
Lars Sderstrm ◽  
Anita Kober
Keyword(s):  
Food Hypersensitivity ◽  
Diagnostic Methods ◽  
In Vitro Diagnostic

scholarly journals Protein-Based Multiplex Assays: Mock Presubmissions to the US Food and Drug Administration

2010 ◽  
Vol 56 (2) ◽  
pp. 165-171 ◽  
Author(s):  
Fred E Regnier ◽  
Steven J Skates ◽  
Mehdi Mesri ◽  
Henry Rodriguez ◽  
Živana Težak ◽  
...  
Keyword(s):  
Drug Administration ◽  
Task Force ◽  
Food And Drug Administration ◽  
Protein Quantification ◽  
Diagnostic Device ◽  
Multiplex Assays ◽  
Array Platform ◽  
The Us ◽  
In Vitro Diagnostic

Abstract As a part of ongoing efforts of the NCI-FDA Interagency Oncology Task Force subcommittee on molecular diagnostics, members of the Clinical Proteomic Technology Assessment for Cancer program of the National Cancer Institute have submitted 2 protein-based multiplex assay descriptions to the Office of In Vitro Diagnostic Device Evaluation and Safety, US Food and Drug Administration. The objective was to evaluate the analytical measurement criteria and studies needed to validate protein-based multiplex assays. Each submission described a different protein-based platform: a multiplex immunoaffinity mass spectrometry platform for protein quantification, and an immunological array platform quantifying glycoprotein isoforms. Submissions provided a mutually beneficial way for members of the proteomics and regulatory communities to identify the analytical issues that the field should address when developing protein-based multiplex clinical assays.

scholarly journals Metabolomic Laboratory-Developed Tests: Current Status and Perspectives

Metabolites ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 423
Author(s):  
Steven Lichtenberg ◽  
Oxana P. Trifonova ◽  
Dmitry L. Maslov ◽  
Elena E. Balashova ◽  
Petr G. Lokhov
Keyword(s):  
The United States ◽  
Legal Aspects ◽  
Current Status ◽  
Current State ◽  
The Us ◽  
Metabolomics Study ◽  
In Vitro Diagnostic ◽  
History Of ◽  
Characteristic Features

Laboratory-developed tests (LDTs) are a subset of in vitro diagnostic devices, which the US Food and Drug Administration defines as “tests that are manufactured by and used within a single laboratory”. The review describes the emergence and history of LDTs. The current state and development prospects of LDTs based on metabolomics are analyzed. By comparing LDTs with the scientific metabolomics study of human bio samples, the characteristic features of metabolomic LDT are shown, revealing its essence, strengths, and limitations. The possibilities for further developments and scaling of metabolomic LDTs and their potential significance for healthcare are discussed. The legal aspects of LDT regulation in the United States, European Union, and Singapore, demonstrating different approaches to this issue, are also provided. Based on the data presented in the review, recommendations were made on the feasibility and ways of further introducing metabolomic LDTs into practice.

Diagnostic methods for confirming drug-allergy – the lymphocyte transformation test in dermatology

2008 ◽  
Vol 149 (24) ◽  
pp. 1107-1114
Author(s):  
Sarolta Makó ◽  
Réka Lepesi-Benkő ◽  
Márta Marschalkó ◽  
Gyöngyvér Soós ◽  
Sarolta Kárpáti
Keyword(s):  
Drug Allergy ◽  
Lymphocyte Transformation ◽  
Lymphocyte Transformation Test ◽  
Diagnostic Methods

A gyógyszermellékhatások felismerése és a tüneteket kiváltó gyógyszer oki szerepének bizonyítása komoly felkészültséget igényel. E közlemény célja a gyógyszerallergiás reakciók diagnosztikai lehetőségeinek rövid áttekintése és a lymphocytatranszformációs teszt gyógyszer-hiperszenzitivitási reakciókban való bizonyító szerepének bőrgyógyászati szempontok szerinti értékelése. A lymphocytatranszformációs teszt azon a megfigyelésen alapul, hogy a gyógyszerrel való első találkozáskor kialakult antigénspecifikus T-sejtek osztódni kezdenek az antigénnel való in vitro megismételt találkozás után. A szenzibilizációt az osztódó T-sejtekbe történő 3 H-timidin-beépülés mértéke jelzi. A hatóanyag-specifikus T-sejtek szinte mindig részt vesznek a gyógyszerallergiás reakciókban, ezért a vizsgálat előnye, hogy sok gyógyszernél és különböző immunreakciók eseteiben egyaránt jól alkalmazható. Hátránya a munkaigényesség, valamint az, hogy specificitásának és szenzitivitásának bizonyításához hiányoznak a széles körű, nagy beteganyagon elvégzett tanulmányok. Emiatt a teszt nem egyértelműen elfogadott a gyógyszerallergia igazolására. Hiányosságai ellenére azonban, jobb prediktív értékű egyéb vizsgálatok hiányában, a lymphocytatranszformációs tesztnek fontos szerepe van a gyógyszerallergiák diagnosztizálása terén.

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