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Lab Instrument for Cell Nano-Tomography

Periodic Reporting for period 2 - LICENT (Lab Instrument for Cell Nano-Tomography)

Reporting period: 2021-05-01 to 2023-01-31

Problem being addressed:
The measurement of the three-dimensional size and shape of a biological cell’s internal organelle is critical for understanding the mechanisms of disease causation and propagation, as well for the development of therapies and vaccines to treat disease. For this reason, 3D imaging of the whole internal structure of intact cells is playing an increasingly important role in helping scientists to understand and treat disease. The only technology available today that can image through a whole cell, without needing to slice it or stain it, is soft x-ray microscopy (SXM).
The ‘problem’ for scientists is that the soft x-ray illumination required for a soft x-ray microscope is currently only available at four football-stadium sized facilities, called synchrotrons, and they need to queue for up to twelve months to get a few hours of access to these synchrotron-based microscopes. This bottleneck has resulted in limited access to soft x-ray microscopy and has slowed down the treatment of poorly-understood diseases, such as cancer and dementia, as well as infectious bacterial and viral diseases. There is a clear business need for a lab-scale soft x-ray microscope that would give scientists access to whole-cell structural imaging of intact cells in their own laboratories.
SiriusXT’s breakthrough innovation is its ability to miniaturize the synchrotron into a small chamber that will easily fit on a laboratory bench. This novel and patented innovation, will allow SiriusXT to build a lab-scale soft x-ray microscope (the SXT-100), which will give our target customers 24/7 access to this imaging modality in their own labs.

Why is this important for society?
EU countries spent €1.47 trillion on healthcare costs in 2017 (ref Eurostat), representing 9.6% of total GDP and representing a 140% increase in costs over twenty years. A growing proportion of these costs are resulting from increases in the cost of treating diseases such as cancer, dementia and infectious diseases where the root causes or transmission mechanisms of the diseases are still poorly understood.
The direct health cost of cancer in the EU was €86 billion in 2015 with €19.8 billion of this being spent on cancer drug research. The advances made in cancer drug discovery have led to a 50% to 60% increase in cancer survival times since 1975 so that today, close to 5% of the population in the western world is living with cancer. Similar improvements in drug discovery for cardiovascular and other high-mortality diseases have resulted in increased life expectancy and a greater propensity for people to contract cancer before they die. As a result, cancer has become the number one cause of death within the EU, accounting for 26% of all deaths. Ironically, the advances in drug discovery have resulted in increased cancer-related deaths and higher cumulative cancer treatment costs.
It is important for cancer researchers is to understand and prevent cancer causation before the costs associated with cancer patient care increase to unmanageable levels. A similar challenge is also valid for dementia where the annual cost of patient care is expected to reach €250 billion by 2030 due to increasing life expectancy.
Viral diseases also carry a significant social and economic cost to humanity. The cost of the influenza virus care in 2018 was estimated at about €29 billion, or 2% of healthcare costs of the EU. Hepatitis viruses, such as hepatitis C virus (HCV), with incidence of 8.7 per 100 000 people in EU, can cause a lifelong infection and is a major cause of liver cancer. The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) global pandemic causing high number of deaths and infected people will lead to 50-fold or more increase in flu healthcare costs in Europe.
Society will benefit greatly from the development of disease therapies and preventative vaccines, not just economically, but also in terms of physical, social and mental well-being.

What are the overall objectives?
i) To demonstrate the ability of the SXT-100 to generate 3D cryo-images of biological samples.
ii) To offer a 3D cell-imaging service to scientists working in disease research and drug discovery
iii) To CE-mark the SXT-100 and to sell the microscope to organisations working in disease research and drug discovery.
Work Package 1: Project Management, Dissemination and Communication
Update: All the project objectives have been achieved.

Work Package 2: Demonstrate SXT-100 3D-cryo capability on sample biological cells
Workplan:
Task 1: Complete integration and test of the cryo-module into the SXT-100 is 100% complete
Task 2: Prepare cryo-cell samples inhouse and image on SXT-100 is 100% complete
Task 3: Develop procedure for receiving and storing customer samples and imaging them without ice contamination is 100% complete
Task 4: Generate 3D images of customer-supplied cryo-cell samples, including organelle segmentation to show 3D is 100% complete

Deliverable: 3D image of customer cell samples is 100% achieved
Milestone: First target customer visit - over 10 targeted customer organisations have visited SiriusXT to see and evaluate the SXT-100

Work Package 3: Build and Regulatory Approval of Market Ready Product
Workplan:
Task 1: FMEA review of the SXT100-Pilot design is 100% complete
Task 2: Redesign and document components that have been identified as needing improvement in the FMEA is 100% complete
Task 3: Procurement, Assembly & Test of SXT100-Ver1 is 100% complete
Task 4: CE-marking of SXT100-Ver1 is overall 100% complete

Work Package 4: Pilot testing of SXT-100 at Conway Biomedical Institute
Workplan:
(with SiriusXT Labs replacing Conway Labs;
Task 1: Prepare facilities at SiriusXT Lab to locate the SXT-100 Pilot is 100% complete
Task 2: Commission the SXT-100 Pilot at SiriusXT Lab and demonstrate 3D imaging capability is 100% complete
Task 3: Procure cells an demonstrate system performance is 100% complete
Task 4: Publish scientific papers, in conjunction with the end user community is 100% complete (publications listed in the final report)
At the project end date in January, 2023;
- We have fully demonstrated the SXT-100 3D-cryo capability on sample biological cells
- We have built a microscope and had it CE-marked.
- SXT-100 pilot was commissioned at SiriusXT's own premises in July, 2022, and to the end of the project in January 2023, over 20 organisations have either evaluated or have committed to evaluate the SXT-100 in the following months. First commercial images of customer supplied cells. The actual commissioning of the microscope at Conway is scheduled for May, 2023. A laboratory for the installation is currently being fitted with the utilities required for operation.
- The SXT-100 will be moved to the Conway Institute in May, 2023

Impact: The lab-based SXT-100 will make soft x-ray microscopy available to the whole community of disease and drug researchers. This will help accelerate research progress and lead to better and faster therapies for diseases, such as cancer as well as neurodegenerative and infectious diseases.
SXT-100 ver-1 (CE-marked)