Reforming the Greek health system: A role for non-medical, clinical bioscientists

Kazanis, Ilias

doi:10.1016/j.healthpol.2012.03.020

Cited by 2 publications

(1 citation statement)

References 11 publications

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“…In the meantime, the number of laboratories that offer various genetic services directly to consumers is steadily growing in Greece. Since nonmedical scientists are allowed to manage laboratories, a measure supported by the government, the introduction of new business models in the genetic industry is likely [31]. This coupled with the lack of explicit laws about DTC genetics and the flexibility of the Greek regulatory framework creates a rather favorable environment for DTC genetics companies to be established in Greece.…”

Section: Conclusion and Future Perspectivesmentioning

confidence: 99%

Personal Genomics in Greece: An Overview of Available Direct-to-Consumer Genomic Services and the Relevant Legal Framework

Kechagia

Mai

Vidalis

et al. 2014

Public Health Genomics

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Background: This article provides an overview of direct-to-consumer (DTC) genomic services that are currently available in Greece and the legal framework within which they operate. Methods: Here, we describe the landscape of the DTC genomic testing companies and laboratories by conducting a systematic Ιnternet search for relevant websites. We examine the existing legal framework regarding genetic testing in Greece by a review of present regulation. Although Greece does not have explicit legal provisions for DTC genomics, several other laws, including soft law mechanisms, create the broader legal framework within which DTC genomic services may exist. Results/Conclusions: While the current legal framework creates a flexible environment that is conducive to DTC genomic operations, it is also ambiguous about the legality of some specific services. Given the growing DTC activity in Greece, we argue that it is important to both enforce compliance with existing law and clarify legal ambiguities that may risk limiting the power of legal protections that ought to be afforded to consumers.

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Section: Conclusion and Future Perspectivesmentioning

confidence: 99%

Personal Genomics in Greece: An Overview of Available Direct-to-Consumer Genomic Services and the Relevant Legal Framework

Kechagia

Mai

Vidalis

et al. 2014

Public Health Genomics

View full text Add to dashboard Cite

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External Quality Assessment Identifies Training Needs to Determine the Neoplastic Cell Content for Biomarker Testing

Dufraing

Hertogh

Tack

et al. 2018

The Journal of Molecular Diagnostics

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Neoplastic cell content determination is crucial for biomarker testing. It is known that interobserver variation exists, but largescale data are missing about variation in tumor delineation and cell content determination. Results were obtained from the external quality assessment program for metastatic colorectal cancer from the European Society of Pathology (N = 5776 observations). The study included three parts: current practices were surveyed, neoplastic cell content estimations and delineations were retrieved from stained slides, and clinical reports were analyzed. Seventeen of 43 pathologists determined the neoplastic cell content in a tumor-rich area for DNA extraction and took immune cells (n = 37), tumor cell distribution (n = 33), desmoplastic stroma (n = 30), necrosis (n = 29), and mucus (n = 23) into account. The selected area was highly variable, and the average difference between the highest and lowest estimation ranged between 51% and 78% (2011 to 2017). The number of overestimations was alarmingly high in samples containing <30% tumor cells. Of concern is that 33 of 105 laboratories reported a wild-type result in a sample without tumor in 2017. Standardization of neoplastic cell content determination is needed for test outcome interpretation. The authors' data show variation in estimation practices, tumor delineations and estimations, and interpretation problems (n = 226 reports). Further training for selecting the most suitable block and creating clear reports is urgently needed.

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Reforming the Greek health system: A role for non-medical, clinical bioscientists

Cited by 2 publications

References 11 publications

Personal Genomics in Greece: An Overview of Available Direct-to-Consumer Genomic Services and the Relevant Legal Framework

Personal Genomics in Greece: An Overview of Available Direct-to-Consumer Genomic Services and the Relevant Legal Framework

External Quality Assessment Identifies Training Needs to Determine the Neoplastic Cell Content for Biomarker Testing

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