How standardization of the pre-analytical phase of both research and diagnostic biomaterials can increase reproducibility of biomedical research and diagnostics

Riegman, Peter; Becker, Karl‐Friedrich; Zatloukal, Kurt; Pazzagli, Mario; Schröder, Ulrike; Oelmüller, Uwe

doi:10.1016/j.nbt.2019.06.007

Cited by 15 publications

(12 citation statements)

References 35 publications

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“…Recent publications discuss automation and standardization of processing for a potential miRNA marker candidates. 49,50 For instance, the Revos Tissue Processor (Thermo-Fisher) and high resolution slide scanners, such as those from 3DHISTECH, reduce labor time and maintain efficiency during reduced staff schedules. It will also be advantageous to pair these technologies with archiving solutions like the ARCOS platform from EPREDIA for efficient data storage and recovery and potentially to be combined with machine learning and predictive algorithms.…”

Section: Technologies and Resources To Fight Covid-19mentioning

confidence: 99%

“…Social distancing requirements will be imposed on laboratories in response to the COVID‐19 pandemic, so automation will improve the standard workflow in the laboratory and minimize the use of people and personal protective equipment. Recent publications discuss automation and standardization of processing for a potential miRNA marker candidates 49,50 . For instance, the Revos Tissue Processor (Thermo‐Fisher) and high resolution slide scanners, such as those from 3DHISTECH, reduce labor time and maintain efficiency during reduced staff schedules.…”

Section: Technologies and Resources To Fight Covid‐19mentioning

confidence: 99%

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Regen med therapeutic opportunities for fighting COVID-19

Atala

Henn²,

Lundberg

et al. 2020

Stem Cells Translational Medicine

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This perspective from a Regenerative Medicine Manufacturing Society working group highlights regenerative medicine therapeutic opportunities for fighting COVID-19. This article addresses why SARS-CoV-2 is so different from other viruses and how regenerative medicine is poised to deliver new therapeutic opportunities to battle COVID-19. We describe animal models that depict the mechanism of action for COVID-19 and that may help identify new treatments. Additionally, organoid platforms that can recapitulate some of the physiological properties of human organ systems, such as the lungs and the heart, are discussed as potential platforms that may prove useful in rapidly screening new drugs and identifying at-risk patients. This article critically evaluates some of the promising regenerative medicine-based therapies for treating COVID-19 and presents some of the collective technologies and resources that the scientific community currently has available to confront this pandemic.

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Section: Technologies and Resources To Fight Covid-19mentioning

confidence: 99%

Section: Technologies and Resources To Fight Covid‐19mentioning

confidence: 99%

Regen med therapeutic opportunities for fighting COVID-19

Atala

Henn²,

Lundberg

et al. 2020

Stem Cells Translational Medicine

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“…Testing data would be captured to inform service improvement, benchmarking and research. And new tests would be rapidly made available to patients [14].…”

Section: Minimum Testingmentioning

confidence: 99%

“…Additionally, biomarker tests need to meet technical and quality standards to ensure consistent results. Barriers here include lack of clarity, at the point of reimbursement, on the implementation procedures, and lab and regional variability in testing quality due to a lack of implementation standards on sample and testing quality [14, 73].…”

Section: Wider Lessonsmentioning

confidence: 99%

“…This can best be organised in centralised biobank facilities in every academic medical centre, which are for the collection of the biomaterials integrated in the existing diagnostic pathways and accredited for ISO 15189 (or equivalent) and the complementary pre-analytical ISO/CEN standards. This way, the scientists use standardised samples to discover biomarkers which are better reproducible in the validation process needed for the test to become a diagnostic test [14]. The sample metadata describing the complete pre-analytical phase of the sample needs to be included in the publication can be used to analyse and define the precisely needed pre-analytical conditions for a robust test result.…”

Section: Optimum Testingmentioning

confidence: 99%

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Bringing Greater Accuracy to Europe’s Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology

Horgan¹,

Ciliberto²,

Conté³

et al. 2020

Biomed Hub

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Rapid and continuing advances in biomarker testing are not being matched by take-up in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. This paper sets out the potential of biomarker testing, the unfolding precision and range of possible diagnosis and prediction, and the many obstacles to adoption. It offers case studies of biomarker testing in breast, ovarian, prostate, lung, thyroid and colon cancers, and derives specific lessons as to the potential and actual use of each of them. It also draws lessons about how to improve access and alignment, and to remedy the data deficiencies that impede development. And it suggests solutions to outstanding issues – notably including funding and the tangled web of obtaining reimbursement or equivalent coverage that Europe’s fragmented health system implies. It urges a European evolution towards an initial minimum testing scenario, which would guarantee universal access to a suite of biomarker tests for the currently most common conditions, and, further into the future, to an optimum testing scenario in which a much wider range of biomarker tests would be introduced and become part of a more sophisticated health system articulated around personalised medicine. For exploiting genomics to the full, it argues the need for a new policy framework for Europe. Biomarker testing is not an issue that can be treated in isolation, since the purpose of testing is to improve health. Its use is therefore always closely linked to specific health challenges and needs to be viewed in the broader policy context in the EU and more widely. The paper is the result of extensive engagement with experts and decision makers to develop the framework, and consequently represents a wide consensus of views on how healthcare systems should respond from push and pull factors at local, national and cross-border and EU level. It contains strong views and clear recommendations springing from the convictions of patients, clinicians, academics, medicines authorities, HTA bodies, payers, the diagnostic, pharmaceutical and ICT industries, and national policy makers.

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Tissue Preservation and Factors Affecting Tissue Quality

Riegman

2021

Biobanking of Human Biospecimens

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How standardization of the pre-analytical phase of both research and diagnostic biomaterials can increase reproducibility of biomedical research and diagnostics

Cited by 15 publications

References 35 publications

Regen med therapeutic opportunities for fighting COVID-19

Regen med therapeutic opportunities for fighting COVID-19

Bringing Greater Accuracy to Europe’s Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology

Tissue Preservation and Factors Affecting Tissue Quality

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