GE/UPMC bids to change the face of pathology

The Medical Technology Blog

Welcome back to our Canada Healthcare series from the Medical Technology Blog,

GE Healthcare

GE Healthcare has profiled efforts it is making to change the way in which pathology imaging is conducted across the globe. The opportunities, should its technology gain acceptance, looks set to deliver the final blow to an analogue-based procedure for looking at images that has largely remained unchanged over the past 120 years.

University of Pittsburgh Medical Center

Omnyx is a 50:50 digital pathology joint venture set up in partnership with the University of Pittsburgh Medical Center (UPMC) and GE. The business has chosen Canada as the location for its first Global Pathology Imaging Centre of Excellence (PICOE), located in the MaRS Excite campus in Toronto. The JV is investing C$7.75 million in the health technology programme, which is also backed by a C$2.25 million contribution from the Healthcare Technology Exchange (HTX). It is hoped that further collaborative R&D partnerships in the area will boost the over research figure by an additional C$7.2 million over the next three years.

In some ways, Canada represents ideal territory to test the benefits of digital pathology, mainly due to the sheer scale of the country and low population dispersion. The digitisation of pathology opens up the potential for remote medical centres to send contentious images fast and directly to regional centres and right into the lap of experienced pathologists.

The process would not only increase the number of images processed by pathologists, but it also comes as the healthcare environment suffers from a shortage of pathologists that has limited the capacity to get the most out of the resources available. GE believes that Canada has the level of awareness and political will to do something to fix the problem. The large regionalised healthcare system also lends itself to the Omnyx model, along with the clinical knowhow, and the number of trained clinicians able to support the rapid introduction of such an advanced technology.

Buoyed by an “ideal collaborative framework”, PICOE has government support, institutional backing community, including some of the biggest universities in Canada, as well as potential clinical partners such as the Ontario Institute for Cancer Research and hospitals. PICOE is not just about developing a new technology, but investigating how to take the system and deploy it across a nationwide, regionalised healthcare environment. The company says it benefits from the collaboration as it can apply this technology and methodology to other global healthcare markets.

Whilst PICOE is currently a research-use only tool that GE hopes will convince pathologists to ditch the old, cumbersome method and embrace a new form of working that will meet the challenges of modern pathology. As with all technologies that require a change in working techniques, it’s not a straightforward task that will be adopted overnight. However, the combination of innovative research and the influence of such a large business in GE Healthcare, could give PICOE a toe-hold in an industry that needs to be dragged kicking into the modern age.

The patent-pending Omnyx Integrated Digital Pathology (IDP) system includes whole slide scanners, pathologist and histology workstations and an integrated software platform that aims to deliver the scale and reliability for demanding pathology departments. The combination of a workflow server and digital archive combine to offer benefits such as: real-time image access from anywhere; the ability to automatically retrieve case information for individuals; image storage and retrieval; and, most notably, low entry cost and scalability.

The University Health Network is the first site to participate in the PICOE programme and will conduct both beta and clinical testing for primary diagnostics. It will also help to formulate guidelines and best practices for model pathology.

As of November 2011, UHN had scanned and reviewed over 2,000 slides as part of its testing activities.  This testing process started with five pathologists but within seven weeks had been expanded to 22 pathologists from nine specialty areas. A total of six Omnyx VL4 scanners, forming part of the DIP package, have so been shipped to beta customers worldwide.

At its core, the PICOE approach represents a “holistic” approach to pathology imaging, including scanners, servers, healthcare information systems and workstations, to provide a means of getting information out to the virtual community. GE will act as the exclusive distributor for Omnyx, and provides the implementation, training and support for the Omnyx Integrated Digital Pathology system.

Article provided by Lawrence Miller, editor of Medical Industry Week.

Next in the series….

…..Sick Kids takes centre stage in robotics, imaging and simulation technology development

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Canada’s Healthcare Support System – Part 2

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Medical Industry WeekPrivate and public sectors working to boost Canada’s healthcare system

This model differs from the usual avenues for non-profit organisations looking to develop treatments. Traditionally, these parties have been required to beg for cash from companies on a donation basis with various degrees of success. A prime example of the OCE model in practice is the Ontario Diabetes Association, which is conducting research that will be supported by OCE funding with an industry partner.

At the core of the OCE philosophy is the requirement that any research that it backs has to be a product that the industry partner can use to create jobs. The process helps these non-profit organisations to get research done but also spurs on economic development. SIP’s initial proposals are focused on collaborations in the health improvement sector (first area to attract proposals in 2011), followed by sustainability environment and poverty reduction initiatives.

Healthcare Technology Exchange

Representing a major lynchpin in efforts to continue the turnaround of the Canadian Med-Tech industry is the Healthcare Technology Exchange (HTX), a Federal and Ontario government-funded organisation that aims to support the research and development of advanced healthcare technologies.

Originally set up by the Ontario government, the HTX bids to help companies bridge, what John Soloninka, HTX’ President & CEO, describes as, the “valley of death”. The rather dramatic phrase refers to the pre-commercialisation gap where companies need some financial assistance before showing up on the radar of banks, institutions, public investors or venture capitalists. This important contribution has largely come in the form of government “angel tax-relief”, a process that allows small companies to apply the necessary capital to support R&D, trials, reimbursement and other activities.

HTX manages its C$21.4 million budget, provided by the Ontario Ministry of Economic Development Innovation to help SMEs and start-ups to get funding to reach the domestic and global market and to attract multi-nationals to set up R&D in Ontario through incentives. The agency co-invests with other investors in R&D in small medium enterprises (SMEs), but also provides persuasive incentive funding for large organisations.

Over the last 12 months, HTX investments include GE Healthcare digital pathology; as well an October 2010 investment in Xagenic, a company that came out of Ontario universities and is developing rapid POC molecular diagnostics focused on infectious diseases and cancer. Other low key investments include e-health, tissue simulation, radiology applications and embedded micro processors that have led to partnerships with multi-nationals, FDA clearance and licensing. In effect, HTX believes that a small amount of assistance in the right area makes all the difference.

HTX Research Grants

HTX awards research grants of C$350,000 and C$750,000 to come such as Baylis Medical, Tornado Medical Systems, RNA Diagnostics, XLR Imaging and Patient, Colibri Technologies (catheter-based 3D imaging), Profound Medico. Collectively, they provide an infrastructure – effectively engines of commercialisation – and create assets that benefit the province of Ontario as a whole.

One of the HTX’s leading investments is PICOE, an initiative that is bidding to transform digital pathology, a market that is comparable in development of that for digital radiography ten years ago. HTX invested C$2.25 million in support of GE’s development plan, of which more is featured later in this article.

Centre for Imaging Technology Commercialization

Also being backed by HTX is the Centre for Imaging Technology Commercialization (CImTeC), an organisation that helps small companies to compete in markets and overcome regulatory issues to make a fully viable product. One such example is a joint initiative between Sunnybrook Hospital and the University of Western Ontario that is focused on medical imaging opportunities. This has resulted in a C$28 million incubator-style five-year project for small local and international companies to get the expertise and help needed to commercialise technologies at a faster rate.

The Ontario Brain Institute

The Ontario Brain Institute (OBI), which is focused on neurosurgery/brain health opportunities, is also seen as a potential catalyst for growth for Ontario and Canada as a whole. Although highly competitive, neuroscience is still regarded to be in its infancy despite its potential to become as big as cardiovascular care in the next five to ten years.

Supported by local philanthropist investment. OBI is acting as single umbrella for the provinces’ neuroscience area, encouraging synergy across all institutes, and focusing on marketing innovative devices worldwide. Providing a template for other sectors, a total of 22 companies, spanning diagnostics, imaging, prosthetics and devices, and brain fitness, have benefited from C$20 million in investment that has resulted in the commercialisation of 22 technologies. Operating at the heart of ONE is the MaRS organisation and its most recent incarnation – MaRS Excellence in Clinical Innovation and Technology Evaluation (Excite), an innovation incubator that was publicly revealed for the first time in Toronto in late December 2011. The alliance brings together a health system ((Ontario Health Technology Advisory Committee); Federal Government departments; Academia (Council of Academic Hospitals of Ontario and over ten academic health institutions across Ontario); Industry (MEDEC and HTX) and the MaRS Discovery District in Toronto.

The goal of MaRS Excite is to respond to increasing demand for effective and reliable healthcare technology assessment. Whilst the emphasis has been on finding out that a device is safe and effective, there is also the need to establish its cost effectiveness by comparing the technology against substitutes and competing technologies. Uniquely, MaRS Excite aims to move this process, usually done after the product is approved and on the market, back to the development stage.

The initiative will seek to harmonise health technology evaluation into a single, pre-market evidence-based evaluation process for technologies with disruptive potential and specific relevance to health system priorities. Medical technologies considered for EXCITE pilot studies include devices and equipment used to maintain, restore and promote health. They encompass interventions at any stage of health care, including primary prevention, early detection of disease and risk factors, diagnosis, treatment, rehabilitation and palliative care.

Currently, the evaluation of medical technology is conducted and funded by the provincial government and occurs after regulatory approval and market introduction. However, the post-market approach can be inefficient, fragmenting pre-market risk-based evaluation from post-market evidence-based evaluation.

The deadline for the initial phase of the MaRS Excite plan passed in December and 2012 promises to be a big year for the programme, which will have to match the ambitions of the MaRs organisation to more effectively capture the commercial potential of Toronto’s science and technology research activities.

Since opening in 2005, MaRS has steadily grown to reach full capacity, paving the way for the plans to commence the second stage of its development, which involves a significant expansion of its facilities – a process that is expected to be completed in 2013.

Excite is just one aspect of the MaRS alliance and is symbolic of the collaborative framework within Ontario. A framework of partners that include:

  • MaRS Innovation, a member-based partnership designed to transform the Toronto-based academic research enterprise into an established cluster;
  • Business Acceleration Programme (BAP), a range of entrepreneur support programmes and services coordinated by MaRS and delivered through the Ontario Network of Excellence;
  •  Social Innovation Generation, which actively develops programmes to support the launch and growth of a social nature;
  • The Investment Accelerator Fund (IAF) and the C$7 million fund for life science companies that provide sustainable economic benefit to Ontario;
  • The Ontario Network of Excellence (ONE); and
  • The Centre for Impact Investing, a national hub focused on increasing the awareness and effectiveness of social finance to catalyse new capital, talent and initiatives dedicated to tackling social and environmental problems in Canada.

This network of organisations all provide the ingredients that has the ultimate aim of ensuring that Ontario and Canada compete effectively in the healthcare industry on both a macro and micro economic level.

Over the next series of articles, Medical Industry Week focuses on how some of these businesses and organisations are using these programmes in practice throughout Canada and with a view to competing globally.

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NICE delivers its verdict on next-generation cardiac CT scanners

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cardiac catheterization: my own heart, visible...

Image via Wikipedia

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It’s good news this week for some of the biggest medical imaging companies

GE Healthcare, Siemens Healthcare, Philips Healthcare and Toshiba Medical Systems – with all four receiving tentative backing for their respective next-generation cardiac CT scanners in draft guidance drawn up by the National Institute for Health and Clinical Excellence (NICE) in its latest draft guidance on the subject.

Now available for a period of public consultation, the draft guidance specifically applies to the use of the Somatom Definition Flash CT scanner (Siemens), Aquilion One (Toshiba), Brilliance iCT (Philips) and Discovery CT750 (GE) in the NHS in England for people with suspected or known coronary artery disease (CAD) in whom imaging is difficult with earlier generation CT scanners. A review team looked at 24 studies, with the vast majority (20) using Siemens’ Somatom Definition Flash (1) or an earlier model, Somatom Definition (19). Interestingly, despite its glowing endorsement only two of the studies referenced actually used the cutting edge CT scanner technology. In 2007, CAD was estimated to have claimed 91,000 deaths in the UK.

CT scans are performed to evaluate the arteries of the heart, and can also be used to assess the function of the heart, the anatomy of the heart, and the degree of coronary calcification in the heart. The technology survived a review of five recognised models for assessing the cost effectiveness of next-generation cardiac CT scanners, including the Europa model, for the prognosis of people with CAD, and the York Radiation Model, which estimates the impact of imaging in terms of radiation dose on cancer mobidity and mortality.

The recent NICE clinical guideline on chest pain recommends CT coronary angiography and invasive coronary angiography to assess the state of arteries and identify significant narrowing in people with an estimated probability of coronary artery disease of 10 to 29 per cent and a calcium score of <400 or less. People with a calcium score >400 are considered difficult to image using earlier generation CT technologies. Other reasons that make CT imaging difficult are obesity, arrhythmias (irregular heart beat), high heart rates (above 70 beats per minute) or previous coronary stents or bypass grafts.

The latest generation cardiac CT scanners have technical features that aim to overcome these difficulties, including the ability to acquire images much faster than earlier generation CT scanners, better image quality and reduced radiation doses. The NICE guidance recommends the use of these scanners for first line imaging of the coronary arteries in people with suspected stable coronary artery disease who are difficult to image with earlier generation CT scanners and whose estimated probability of having CAD is 10 to 29 per cent. In addition, the draft guidance recommends their use in people with known CAD for first line evaluation of disease progression to establish the need for revascularisation where imaging with earlier generation CT scanners is difficult.

Imaging companies will not quite be celebrating at the moment as final guidance on this topic is not expected until the new year, but they will be quietly confident that there is now a recognised need for the technology within the National Health Service in the UK.

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Smiths Group reject US$2.45 billion offer!

Smiths Group, a UK-based engineering company, has rejected a US$2.45 billion offer for its largest division, Smiths Medical, from an undisclosed suitor. In a statement, Smiths Group turned down the “best and final” offer and said it would not be in the interests of shareholders to pursue discussions on the basis of an indication “at this price level.” The approach follows fever pitch takeover speculation over another UK company, Smith & Nephew, and is a further sign that the market is looking to start 2011 with some big deals.

Smiths Group remains one of the last significant remaining conglomerates left in the UK and its Medical division has long been seen as a candidate for a spin-off or disposal. In recent times, such talk has intensified as the division has been restructured and revived, emerging as the group’s largest operating subsidiary. The medical business accounted for over one-third of Smiths’ total operating profit (£184 million) in 2009, and contributed just over 30 per cent (£858 million) to the company’s total sales during the same year.

A potential break-up of Smiths Group, which consists of three core divisions, Detection, Medical and Specialty Engineering, has arguably been on the cards for a long time. However, management has always been able to resist such pressure to shed the Medical division because of its ability to deliver sustained revenues. The company specialises in airway management, needle protection, ambulatory infusion, medication delivery, patient monitoring and temperature management products, and operating margins in 2009 of nearly 22 per cent. So for Smiths Group, the sale of a reliable contributor to revenues is a big decision, and with the company not under immediate financial pressure to sell, any acceptable offer for Smiths Medical would have to be on its terms.

Despite this, the appointment of a new chief executive, Philip Bowman, who has a history of breaking up businesses and selling companies, seems to have encouraged a bidder that now is the right time to make its move. Although the identity of the unsuccessful offer has not been disclosed, media reports suggest that the approach came from Apax Partners, the UK private equity group. The rejected offer may have been described as “final”, but is unlikely to be the end of discussions and Apax could still find itself returning with a more attractive offer. Other private equity groups have been touted as potential bidders, but talk has also switched to rivals in the industry, including the possibility of Baxter, Covidien, GE Healthcare and Johnson & Johnson entering the fold, who may be in a position to submit higher bids.

Thanks to Lawrence Miller for this article, Lawrence is editor of Medical Industry Week, Espicom’s weekly industry newsletter.

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