UK healthcare sector investment

The Medical Technology Blog

Investment in nanoscience set to benefit UK healthcare sector

Grant funding totalling over £6.5 million has been awarded for seven business-led projects that will focus on developing therapeutic agents and diagnostics where nanoscale technologies are the focus of innovation. The funding will be provided by the UK Engineering and Physical Sciences Research Council (EPSRC) and the Technology Strategy Board, and the projects will be led by Critical Pharmaceuticals, Johnson Matthey, Mologic, Nanomerics, OJ-Bio, Renishaw Diagnostics and Sharp Laboratories of Europe.

The aim of the investment is to help ensure that the UK can become an early competitive adopter of these technologies and rapidly meet the urgent and difficult challenges posed within the worldwide healthcare sector, by translating early-stage ideas from academia and commercialising them through the building supply chains with businesses. This investment is part of a two-stage initiative under the Nanoscience through Engineering to Application Grand Challenge for Healthcare. The university partners on two of the funded projects had initially received three years of funding from EPSRC and these projects will follow onto scale-up the technologies developed in the first stage.

The proposed R&D projects will seek to develop closer links between the healthcare community and the emerging nanoscale technologies community, in order to rapidly develop and commercialise early-stage nanoscale technologies. Key challenge areas include the earlier and better detection and diagnosis of disease, leading to marked improvements in patient outcomes, and effective treatments that are tailored to patients’ needs, and which either modify the underlying disease or offer potential cures.

£1 million UK government funding

Separately, a group of projects are to receive over £1 million of UK government funding to enable them to develop new and improved “health-economics” tools or products that will assist and improve the design and evaluation of clinical trials for infectious agents. The funding, from the Technology Strategy Board, in partnership with the Department of Health, UK and with additional contributions from EPSRC to fund academic social science components, has been awarded for three development contracts. These will be undertaken by Diagnostics for the Real World (Europe), Integrated Medicines and the Health Protection Agency.

The funding award follows the organisations’ participation in the “Assessing the Impact of Near-Patient Testing” competition for development contracts managed by the Technology Strategy Board and developed in discussion with the National Institute for Health and Clinical Excellence (NICE) and the British In Vitro Diagnostics Association. The competition was run under the Technology Strategy Board’s infectious disease programme that aims to reduce the economic burden, death and illness of such diseases.

Two of the projects, to be undertaken by Diagnostics for the Real World and the Health Protection Agency, will focus on sexually transmitted infections, while the remaining Integrated Medicines project will focus on sepsis.

Article source: Kindly provided by Sophie Bracken, editor of Espicom’s business publication Diagnostics Focus




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Pathwork tissue of origin test confirms clinical validity

The Medical Technology Blog

Independent study of Pathwork tissue of origin test confirms clinical validity; “cost-effective for increasing cancer patient survival”

Results of a study conducted at Virginia Commonwealth University of the Pathwork Diagnostics’ Pathwork tissue of origin test have been published online in the American Journal of Clinical Pathology, in a paper entitled “Clinical verification of the performance of the Pathwork tissue of origin test: utility and limitations”. The Pathwork tissue of origin test is an FDA-cleared, Medicare-covered molecular diagnostic for identifying tissue of origin. It uses a tumour’s own genomic information to help pathologists and oncologists in the diagnosis of challenging cancer cases such as those that are metastatic or that have a complex clinical history.

In the study, the analytic and clinical performance of the tissue of origin test was examined in 43 poorly differentiated and undifferentiated tumour samples. Results showed 97 per cent (95 per cent confidence interval, 80.4 to 99.8 per cent) agreement between the tissue of origin test result and the reference diagnosis, which was determined on the basis of clinical correlations and immunohistochemical findings and was among the 15 tumour tissue types covered by the tissue of origin test.

The Pathwork tissue of origin test measures gene expression levels of 2,000 genes and uses algorithms to compare the tumour’s gene expression pattern with that of 15 tumour types, representing 58 morphologies and 90 per cent of all solid tumours. The test provides objective genomic information to help the physician diagnose what type of cancer the patient has. An accurate diagnosis allows oncologists to match therapy to the cancer.

In a related development, results from a study involving the Pathwork tissue of origin test have been presented at the American Association for Cancer Research – International Association for the Study of Lung Cancer joint conference on The Molecular Origins of Lung Cancer: Biology, Therapy and Personalised Medicine in San Diego, CA. The study, “Cost-effectiveness of gene-expression profiling for tumour-site origin”, was authored by John Hornberger, Irina Degtiar, Hialy Gutierrez, Ashwini Shewade, W David Henner, Shawn Becker and Stephen Raab.

The retrospective, observational study examined treatment changes made in patients by physicians who received tissue of origin test results. Changes in planned chemotherapy, surgery, radiation therapy, blood tests, imaging and referral to hospice care before and after test results were recorded. Estimates of the effect of changes in chemotherapy on survival were based on National Comprehensive Cancer Network (NCCN) and other treatment guidelines. Costs were estimated based on data from NCCN and Centers for Medicare and Medicaid Services fee schedules. Changes in overall survival, costs and cost per quality-adjusted life year (QALY) gained were estimated. In the study, use of chemotherapy regimens consistent with guidelines for the final tumour-site diagnosis increased from 42 per cent to 65 per cent. Overall survival was projected to increase from 15.9 months to 19.5 months, a mean gain of 3.6 months. The average increase in survival adjusted for quality of life was 2.7 months and the average cost per QALY gained was US$46,858.

Article source; Diagnostics Focus, edited by Sophie Bracken, medical news editor at Espicom Business Intelligence.

 


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Will Axis-Shield give into rising pressure of takeover offer from Alere?

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Alere, a key player in the rapid point-of-care and laboratory diagnostics market with products that focus on infectious disease, cardiology, oncology, drug abuse and women’s health, has brushed aside negative feedback from Axis-Shield and pushed ahead with a cash offer for the UK-based company.

As part of the offer, Axis-Shield’s shareholders will be offered £4.60 (or approximately US$7.51) for each Axis-Shield share held by them, valuing the transaction at approximately £230 million (or approximately US$375 million). The offer will be conditional upon Alere receiving valid acceptances in respect of not less than 90 per cent of Axis-Shield shares to which the offer relates and not less than 90 per cent of the voting rights carried by those shares.

In June, Alere had made an indicative non-binding proposal to acquire Axis-Shield, however, the latter rejected the proposal and also turned down an offer to conduct further discussions with Alere. At the time, Alere revealed that it was keen to work towards a recommended takeover offer for Axis-Shield and that it would welcome the opportunity to discuss a possible transaction in a constructive manner. The company said its proposal was “a means to facilitate discussions” with Axis-Shield and its shareholders. Now, in a move that adds further pressure on its target, Alere has made an additional open market purchase of approximately 6.4 per cent of Axis-Shield’s share capital.

Axis-Shield is an international in vitro diagnostics company, headquartered in Dundee, UK, with R&D and manufacturing bases in Dundee and Oslo. The group specialises in the supply of instruments and tests for the rapidly growing physician’s office testing market and the development, manufacture and marketing of diagnostic kits in areas of clinical need, including cardiovascular and neurological diseases, rheumatoid arthritis, and diabetes. During 2010, the company made significant advances with the continued growth of its international in vitro diagnostics business and revenues exceeded £100 million for the first time.

Alere believes it’s all cash offer is highly attractive for Axis-Shield shareholders, representing a ‘compelling value proposition’ with a high degree of certainty at a substantial premium to the undisturbed share price. In addition, the company expects Axis-Shield will be complementary to its existing businesses and that it can help develop and grow the Axis-Shield product portfolio to be a clear leader worldwide in its core markets.

Over the forthcoming weeks, the question remains as to whether Axis-Shield will succumb to the pressure to reach an agreement Alere, and whether the latter, with revenues of over US$2.1 billion behind it for 2010, has done enough to win over the UK-based company.



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Diagnostics Focus in The Medical Technology Blog this week – Scientists call for UK medical centres to adopt pulse oximetry test for identifying heart defects in newborns

The largest UK investigation into screening newborns for congenital heart defects has found that pulse oximetry is able to identify babies with life-threatening congenital heart defects, a major cause of infant mortality in the developed world. Researchers from the University of Birmingham and Birmingham Women’s Hospital have published data from the study, called PulseOx, in The Lancet medical journal.

More than 20,000 mothers and babies from throughout the West Midlands took part in the trial. Midwives used pulse oximetry to measure oxygen levels in newborns’ blood via a small sensor placed on the skin of hands or feet. Babies with low oxygen levels soon after birth may be at increased risk of heart defects. Current screening for heart defects involves ultrasound before delivery and routinely examining all newborns in the first 24 hours after birth. However, these examinations often miss babies with serious heart defects. PulseOx is carried out as an additional test on the postnatal ward, before discharge from hospital.

In six maternity units in the UK, asymptomatic newborn babies (gestation >34 weeks) were screened with pulse oximetry before discharge. Infants who did not achieve predetermined oxygen saturation thresholds underwent echocardiography. All other infants were followed up to 12 months of age by use of regional and national registries and clinical follow-up. The main outcome was the sensitivity and specificity of pulse oximetry for detection of critical congenital heart defects (causing death or requiring invasive intervention before 28 days) or major congenital heart disease (causing death or requiring invasive intervention within 12 months of age).

Out of the 20,055 newborn babies that were screened, 53 had major congenital heart disease (24 critical), a prevalence of 2·6 per 1,000 live births. Analyses were done on all babies for whom a pulse oximetry reading was obtained. Babies who failed the PulseOx test were given a heart ultrasound. Of 195 babies with an abnormal result following the test, 26 had a major congenital heart defect and a further 46 had other important problems which required urgent treatment brought to attention by the test.

Lead investigator Dr Andrew Ewer says that sufficient evidence exists for all babies to be routinely tested using pulse oximetry and, in conjunction with other tests, could help identify cases of critical congenital heart defects that go undetected with antenatal ultrasonography. Funding for the UK study was provided by the National Institute for Health Research Health Technology Assessment programme.

Thanks to Sophie Sanderson, editor of Diagnostics Focus for providing this article.



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Welcome back to The Medical Technology Blog, todays article is taken from Espicom’s business publication Diagnostics Focus, please read on…

Johns Hopkins University (JHU) scientists have developed a gene-based test to distinguish harmless from precancerous pancreatic cysts, and which could eventually help some patients avoid needless surgery to remove the harmless variety. The investigators estimate that fluid-filled cysts are identified in more than a million patients each year, most of whom have undergone CT or MRI scans to evaluate non-specific symptoms, such as abdominal pain and swelling.

Dr Bert Vogelstein, co-director of the Ludwig Center at JHU and a Howard Hughes Medical Institute investigator, and his colleagues analysed precancerous cysts from 19 patients and searched for mutations in 169 cancer-causing genes. They found mutations in the KRAS gene, known for its prevalence in pancreatic cancers, and the GNAS gene, which had not previously been associated with pancreatic cancer. In both KRAS and GNAS, the mutations occur at a single coding spot in the DNA, the equivalent of a typo in a word within an entire encyclopaedia. KRAS and GNAS genes produce signalling proteins, relaying signals from the cell surface to areas within the cell.

The researchers then tested a total of 132 precancerous pancreatic cysts for mutations in KRAS and GNAS. The latter were found in more than half of the samples (87 of them), and KRAS mutations occurred in 107 samples. Nearly all (127) had mutations in GNAS, KRAS or both. The mutations occurred in large and small, high- and low-grade cysts, and in all major types of the most common precancerous pancreatic cysts. There were no major differences in age, gender or smoking history for people with GNAS or KRAS mutations in their cysts’ cells. Finally, the investigators tested tissue from pancreatic cancers that had developed in eight people with GNAS-mutated cysts. Seven of the eight had GNAS mutations in their cancer, as well as cells in the cysts.

GNAS and KRAS mutations were not found in benign cysts, although KRAS mutations did appear occasionally in a rare type of cyst with a relatively low potential to become cancerous. These rare, mostly benign cysts are less challenging to diagnose because of their location within the pancreas and type of patient, according to the investigators. Genetic analysis of the kind reported in the new study offers a new way to sort the potential of these cysts to cause malignant trouble.

The investigators caution that cyst fluid removal, an invasive procedure, also has its drawbacks and can cause bleeding, infection and inflammation in a very small percentage of patients. Further studies on a larger number of patients are expected to be done before the gene-based test can be widely offered. However, Vogelstein says that the technology for developing a gene-based test in this case is relatively straightforward because “the mutation occurs at one spot in both of the genes.”

Major funding for the study was provided by the Lustgarten Foundation, a private foundation that provides to funding pancreatic cancer research. Other funding was provided by the Virginia and D K Ludwig Fund for Cancer Research, the Sol Goldman Center for Pancreatic Cancer Research, the Joseph L Rabinowitz Fund, the Michael Rolfe Foundation, the Indiana Genomics Initiative of Indiana University, which is supported in part by Lilly Endowment., the J.C. Monastra Foundation, Swim Across America and the National Institutes of Health. JHU has filed a patent application on inventions described in the study.

Thanks to Lawrence Miller for this post, if you woul like more information like this, or to start your subscription please click on the link  Diagnostics Focus Newsletter



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Hello and welcome back once more to The Medical Technology Blog.

The European Union has applied EUR 1.67 million from its Sixth Framework Programme (6th FWP) for research programme to help develop an instrument that more quickly identifies the harmful bacteria or fungus that may be lurking in the wounds of burn victims and causing an infection. Such a device would help to speed up the diagnostic and healing process by days.

At present, doctors have had to rely on microbiological tests that take several days to identify which bacteria are responsible for the infection. In contrast, researchers from Germany, Italy, Lithuania and the UK have been working on a small prototype electronic device, known as the Woundmonitor, which can pinpoint the type of bacteria within a few minutes, by identifying the minute amounts of gas the bacteria are producing. The quicker infections can be diagnosed, the faster patients can be treated, which can in turn lower the cost of lengthy hospital stays.

Most burn injuries occur at home or at work and are more predominant among vulnerable groups such as the elderly or young children. Early diagnosis and treatment of infection in burn patients is critical. However, despite advances in modern medicine, it still takes up to three days for microbiological tests to identify the bacteria present in the wound. Traditionally, medical students were taught to recognise bacterial infections by their characteristic odour. Clinicians and researchers from Germany, Italy, Lithuania and the UK in the Woundmonitor project used the same approach, but were assisted by the latest information and communication technologies.

The researchers developed an instrument that can identify types of bacteria from the small amount of volatile gases, recognisable by smell, that they emit. The experts first identified the three major types of bacteria: staphylococcus, streptococcus and pseudomonas, which account for about 80 per cent of the bacterial infections found in burns. They then identified the volatile chemicals spread by the bacteria when they multiply. With this information, the team designed an instrument containing eight gas sensors. The pattern of the responses from the sensors represents the characteristics of the chemicals present, by which the bacteria are identified.

This complex , but nimble, instrument has already been tested in a hospital in Manchester, UK, and at a Kaunas regional hospital (Lithuania). Results are said to have been very satisfactory and the researchers have positively assessed the instrument’s risk level. Several commercial companies have also indicated an interest in the instrument and discussions are underway to develop the instrument for commercial use.

The University of Manchester in the UK s co-ordinating the EUR 2.2 million programme, which commenced in January 2006. Other partners in the project include Puslaidininkiu Fizikos Institutas and Kaunas Medical University Hospital (both in Lithuania), CNR-Istituto Nazionale per la Fisica della Materia and Biodiversity (both Italy-based), Umwelt-Systemtechnik (Germany) and the Department of Burns and Plastic Surgery at South Manchester University Hospitals Trust.

Thanks to Lawrence Miller for this post, Lawrence is Espicom‘s medical newsletters team leader, and the managing editor of Medical Industry Week and Diagnostics Focus



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