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Rapid heat inactivation of pathogens to enable biomarker research

Periodic Reporting for period 1 - RIPEB (Rapid heat inactivation of pathogens to enable biomarker research)

Reporting period: 2015-07-01 to 2015-12-31

The risk of epidemics due to infectious diseases caused by pathogens is an immense global challenge. The need for rapid development of vaccines, antiretroviral drugs and treatment schemes is at the top of most countries’ and organizations’ agenda. Performing biomarker research on infectious diseases is an important research area to understand and monitor disease state and progression as well as enable diagnosis and vaccine- and drug development.
Denator’s Stabilizor system preserves the quality of biological samples from the moment of excision allowing researchers to confidently identify and verify potential biomarkers. The novelty lies in the ability to rapidly heat inactive tissue samples (within 60 seconds) to achieve both complete pathogen inactivation and ensure biomarker stability.
The overall objectives of this project is to further develop and verify the Stabilizor system to enable complete inactivation of pathogens, while still preserving sensitive biological biomarkers, in a rapid and secure manner. This would ensure that more efficient and reliable biomarker research can be conducted on infectious diseases.
The phase 1 project will explore the technical feasibility and commercial potential of Denator’s proprietary Stabilizor system to enable efficient biomarker research on infectious diseases through the combination of complete pathogen inactivation and biomarker preservation using a single rapid and reliable system.
In this project, Denator has investigate several important aspects before venturing into this new market opportunity:
• Analysis of customer segment & competing technologies (Task 1 & 2)
• Market analysis (Task 3)
• Investigation of regulatory issues & compliance with current directives (Task 4)
• Technical specification of a modified instrument & consumable (Task 5)
• IP analysis (Task 6)
These activities will be the base of a road map/marketing plan enabling Denator to plan and handle an upcoming market introduction.

Task 1. Identification of customer segments and potential collaborators to target
Denator has conducted a thorough mapping of the potential customer segments. To understand specific customer requirements, in-depth interviews has been conducted with > 10 potential customers, both from BSL-4 and BSL-3 labs. Potential collaborators for further development of the application was compiled and we now have collaborations with USAMRIID, CDC and the University of Marburg.
Task 2. Mapping of existing sample handling processes and analysis of competitive technologies
An overview of current sample handling workflows, competing technologies and their respective pros and cons compared to the Stabilizor system has been summarized in the report ‘Pathogen Inactivation Track (PIT). Information was largely found via internet-based resources such as publications, product description sheets, company profiles etc but also by attending conferences and conducting interviews with a selection of potential customers.
Task 3. Analysis of market size and growth potential
A high level market size analysis has been done based on information gathered via market reports, publications and articles, conferences and other internet-based sources. A comprehensive mapping of physical locations of BSL-4 labs worldwide and initial point-of-contact is included in the PIT-report. This mapping will provide a list of potential customers to approach for Denator’s distributors or sales agents in their respective geographical region.
Task 4. Investigation of specific laboratory directives and regulatory issues that apply
Denator has investigated if there are any additional regulatory issues that could be applicable for the product. The current Stabilizor system is classified as electronic machinery intended for laboratory use and as long as the instrument is used outside the near-patient zone in the OR it is deemed that there is no need to comply with the medical device directive (MDD) or in-vitro diagnostics directive (IVDD). Denator has also investigate the aspects of product liability and updated the standard ‘Terms & Conditions’ to increase protection prior to entering into the market.
Task 5. Technical specification for a modified consumable
Denator has reviewed the current Stabilizor system specifications to determine any modifications required. As an outcome Denator has deigned in a HEPA filter that is mounted on the air-outlet tubing which will be included for the coming model of the Stabilizor system. Denator will also create an insert or amendment in the existing instrument manual for how to inactive pathogens using the Stabilizor system.
Task 6. IP investigation and strategy formulation
A mapping of the technological landscape concerning pathogen inactivation has been done. The conclusion from the review is that existing IPR protection should cover also the use of the products for pathogen inactivation and thereby also freedom to operate in this new market segment. Current granted patents and patent applications pending should ensure that the company has sufficient protection for its product portfolio.
The application of heat stabilization will enable an accelerated process of developing vaccines and antiretroviral drugs, especially in the exploratory- and pre-clinical stages where identifying and assessing disease targets and biomarker candidates is the main focus. Also, laboratory safety and safe transportation of infected samples from the collection site in-field or between different laboratories to facilitate proper analysis is very high on the agenda of the regulatory bodies.
Recent and ongoing collaboration with the Center of Decease Control in USA has further emphasized the importance of lab safety also when doing genomic analysis on infectious material and the CDC has conducted a proof-of-principle that the integrity of the genomic material is better preserved with the Stabilizor system that with current methods.

In summary, using the Stabilizor system in the workflow for infectious decease analysis will have profound social- and economic impact globally. Samples can be transported from areas of disease outbreak in a much safer way and a considerably lower cost. Safety for personnel working with highly contagious pathogens in enclosed laboratory facilities such as BSL-3 and -4 laboratories will be significantly increased and special analysis that cannot normally be performed in high safety labs will now be possible. Pathogens include, amongst others, Marburg virus, Ebola virus, Lassa virus, Crimean-Congo hemorrhagic fever, SARS, HIV, tuberculosis and hepatitis C.
Stabilizor T1 instrument. For inactivation of pathogens and preservation of biomarkers