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Emerging Potential of In Vitro Diagnostic Devices: Applications and Current Status
Published in Debarshi Kar Mahapatra, Sanjay Kumar Bharti, Medicinal Chemistry with Pharmaceutical Product Development, 2019
Swarnali Das Paul, Gunjan Jeswani
According to the definition of In vitro diagnostic/medical device they are basically “a device, whether used alone or in combination, is specimen derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purpose.” They comprise of calibrators, reagents, software, specimen, receptacles, control materials, instruments or other items according to USFDA [1]. Here reagent signifies as biological, chemical, or immunological articles, proposed by the manufacturer. In vitro diagnostic (IVD) devices also include the genetic investigations which reveal information for healthcare decision making [2, 3]. An IVD may be either an entire test or a part of a test. Part of the test includes both non-diagnostic components, known as “general purpose reagents” (GPRs), and also the active element of the diagnostic test, called as “analyte specific reagent” (ASR). IVDs which are used in the clinical monitoring of patients also referred as a medical device. Thus, due to their critical requirements, they are subjected to regulation by the FDA.
The regulatory landscape
Published in Priya Hays, Advancing Healthcare Through Personalized Medicine, 2017
The vast majority of currently marketed genomic tests are laboratory-developed tests (LDTs) that have not undergone FDA review. These tests either are fully developed by a laboratory or use a purchased analyte-specific reagent (ASR), which the laboratory that carries out the test as a service configures into an assay. Such LDTs are not shipped for use outside the originating site.
Evolution of the Molecular Microbiology Laboratory
Published in Attila Lorincz, Nucleic Acid Testing for Human Disease, 2016
Gary W. Procop, Belinda Yen-Lieberman
Many of these vendors are competing for the same subset of consumers. For example, consumers who seek Group B Streptococcus detection have more than one kit to choose from. This environment produces competitive pressure on a manufacturer to produce technically sound assays that are easy to use and available at reasonable prices. These kits may be approved by the FDA or produced as an analyte-specific reagent (ASR) kit. If an ASR kit is used, the responsibility for validation of the performance of the assay is shifted from the manufacturer to the laboratory, as with currently used, laboratory-validated (“home-brew”) assays. The pursuit of FDA approval versus the manufacturing of ASR kits is the choice of the manufacturer and is part of strategic planning for the use of finite resources, since FDA submission is costly. The future of ASR kits will largely be dictated by decisions made by the FDA. If the current situation persists, we predict these kits will become more widely used, and, as cost-competitive kits are produced for particular organisms, they will begin to replace many of the currently used, laboratory-validated assays. This should produce better standardization of test results because many of the variables (e.g., different vendors used for primer and probe synthesis) that differ among laboratories performing the same types of assays will be removed. In addition, we anticipate continued progress in clinical applications of DNA sequencing technologies, as instruments and software become more user friendly and microarrays for the assessment of infectious diseases become more routine.
Intellectual property considerations for molecular diagnostic development with emphasis on companion diagnostics
Published in Expert Opinion on Therapeutic Patents, 2018
Harry Glorikian, Richard Jeremy Warburg, Kelly Moore, Jennifer Malinowski
Regulatory requirements vary from country to country. In the United States, the regulatory pathway dictates the requirements for IVDs through the Pre-market Approval (PMA) pathway, or 510(k) clearance options and an Investigational Device Exemption (IDE) may be pursued for clinical trials that take place during development. Alternate methods, such as pursuing commercialization as an analyte-specific reagent or a lab-developed test (LDT) also exist [5]. Material submitted for regulatory consideration or the IDE often includes IP and trade secrets. To accommodate the need to keep these data private while enabling the Agency to accurately assess the product, the FDA uses the Master File (MAF) system. An MAF may include preclinical and clinical study data and information about the design, manufacturing, and use of the diagnostic product [6].