The Increasing Scope of Lawyers in Healthcare

The Medical Technology Blog

In the third instalment of her guest blog, Louise Campbell, an undergraduate law student with the University of Southampton, examines the increasing scope of lawyers in healthcare

Nowadays, law firms have become as important partners to the medical industry as the scientists, sales executives, marketing managers and CEOs that are driving the company forwards.  This blog looks at some of these areas in more detail and illustrates that lawyers are as important in the work environment as are in the courtroom.

Commercial Agreements

Lawyers are often employed to aid the creation of commercial agreements between companies. They will assist in negotiating the terms of the contract and, once agreed, will draft and facilitate the signing and exchange of the relevant documents and contracts. The nature of the terms and of the agreement will naturally vary, but some of the most common used in the healthcare industry include:

  • Patent Licence agreements: key terms may include: the scope of the licence, its exclusivity and the territory it covers the licence, which often includes or excludes all countries that have granted patent protection to the invention. Others encompass remuneration, royalties and how such payment(s) are made; and duration, how long the agreement is to last
  • R&D collaboration: where two or more enterprises agree to collaborate developing new products or processes. To commercialise the results of the collaboration, the agreement often extends to the exploitation of the results. Collaboration can also extend to higher education institutions
  • Confidentiality agreements
  • Contract manufacture and supply agreements:  As a guide, key terms may include: interpretation; orders for products; manufacturer obligations; inspection and testing; delivery; rejection of products; warranty and indemnity; prices and payment;  how to vary the terms of the contract in the future if necessary; intellectual property;  confidentiality and; termination
  • Distribution and agency agreements: An Agency Agreement involves appointing a third party to act on its behalf, marketing and selling its products and services – often in exchange for commission. The distribution agreement transfers the ownership of goods to the distributor prior to their ultimate sale. Flexibility in such agreements allows for sales targets and territories to be negotiated
  • Co-marketing and co-promotion agreements: Co-marketing is where two companies cooperate with separate distribution channels. This sometimes includes profit sharing. Co-promotion on the other hand, is where two or more companies use each other’s salesforces as well as their own, to promote the same brand or range of brands

Corporate Services

Corporate compliance, in other words, meeting statutory obligations surrounding how a company operate, reporting and particularly directors’ duties towards shareholders are covered by legislation. Companies are regarded as legal persons and failure to meet the various requirements may result in fines and other punishments for directors and officers.
In the UK, the most recent updating of legislation governance is The Companies Act 2006 which supersedes previous regulations. It is the longest Act of Parliament in British history, containing 1,300 schedules in 15 sections. Given the considerable size of the legislation, lawyers are useful in determining which sections are relevant to the company and advising as appropriate.

Lawyers may also provide useful guidance in raising funds and the most suitable process in which to do this. Some examples of common practices are raising money through debt financing or equity financing. Debt financing is when a firm raises money for working capital or capital expenditures by selling bonds, bills, or notes to individual and/or institutional investors. In return for lending the money, the individuals or institutions become creditors and receive a promise that the principal and interest on the debt will be repaid. Equity financing is where shares are issued in a public offering. In return for the money paid, shareholders receive ownership interests in the corporation.  A recent example of this in action is Archimedes Pharma successfully raising £65 million round of new funding in 2010. That particular deal is believed to be Europe’s biggest single fund raising round for a bio-pharma company in 15 years.

Should a company wish to merge or acquire another company, a legal mergers and acquisitions team ensures that this is completed effectively. Lawyers are heavily involved in the due diligence side of this, analysing the target firm’s business history, its assets, its capital, and its organisational structure.  They will also negotiate, draft and facilitate the signing of contracts and help manage the integration process after the merger or acquisition is complete.

Intellectual Property and due diligence

Protecting and defending innovations in this sector is essential. Companies may call upon lawyers for help with applying for intellectual property rights, such as patents and trademarks, and perhaps identifying a particular strategy with regards to this.

Due diligence is a routine practice in the healthcare sector prior to investments and public offerings, mergers and acquisitions, private equity and venture capital transactions. These transactions involve providing capital to private businesses to speed up their development. The completion of a successful venture capital or private equity deal requires the deal to progress through a multistage process including due diligence. Due diligence is also a key element in licensing and collaboration agreements.

Dispute Resolution

For when it all goes wrong, lawyers are often the first port of call for resolving a dispute either through going to court or an out of court arbitration or mediation process.

In terms of IP disputes, often these centre on enforcement and/or infringement of IP rights and disputes over ownership. A recent example of this was the patent dispute between Ranbaxy (UK) Ltd and AstraZeneca AB in which Ranbaxy, the claimant, successfully achieved declaration of non-infringement and revocation of a European patent owned by AstraZeneca, the defendant pharmaceutical company.

For contract disputes, the most cost effective way of settling the disagreement is through out of court means as litigation costs can be huge.

Product liability is key area for disputes. Lawyers can be on hand to aid defence or settlement of product liability claims. Strategic advice and representation in multi-claimant litigation is also offered by many law firms as well as assistance with international coordination of product liability actions. They may also advise on what steps to take after realising any safety concerns or objections raised by regulatory authorities such as product recalls, additional safety instructions or temporary restrictions on use. The unmissable DePuy ASR hip replacement litigation is a prime example of this.

Regulatory and Competition compliance

The healthcare industry has been increasingly subject to regulatory and competition (antitrust) measures, including regulation of clinical trials, freedom of information and advertising.  Lawyers are often asked to take the hassle out of contacting the relevant regulatory authorities and advise on ensuring compliance with these regulations.

With regards to competition law, ultimately companies must not abuse their dominant market position should they be in such a position of strength. Co-marketing and promotion agreements, as an example, can be subject to intense scrutiny by the national and European competition authorities as can any mergers and acquisitions. Lawyers can help set up a compliance programme or advise on how to minimise and reduce any risk of violating competition laws. One example of this was when AstraZeneca lost a claim that false representations to the European Patent Office constituted an abuse of their dominant market position.

Infrastructure, Tax and Employment

Tax lawyers are useful in ensuring that the corporation is tax efficient and drafting documentation to allocate tax risks between parties in the agreed manner.

Lawyers are also involved in the transactions for the design, construction and maintenance of new and existing healthcare infrastructure.

Employment lawyers can aid in drafting employment contracts, tailored to the needs of the business, and consultancy agreements which strike the right balance between safeguarding your interests and commercial and economic flexibility. In some cases, healthcare corporations will need to place restrictive covenants on their employees to prevent them from exposing confidential information or intellectual property and lawyers can advise on the best ways to do this also.



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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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NICE Facing Challenges in the 21st Century

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Guest contributor, Louise Campbell, an undergraduate with the University of Southampton, examines the impact of the National Institute of Clinical Excellence and how judges remain reluctant to be seen as driving healthcare policy

Ageing population and lower healthcare costs leave regulatory authorities with a big headache. NICE faces up to the challenges of 21st Century healthcare

Ever since the NHS was created in the UK it has lurched from financial crisis to financial crisis and this year is no exception. Out of 137 NHS Foundation Trusts in the UK that submitted plans to the independent regulator, Monitor, this year, 11 listed themselves within the two highest financial risk ratings and a further ten say they will experience a high level of financial risk.   Consequently, the NHS ‘postcode lottery’ – where a patient’s location will have a bearing on the treatment they can receive – and its apparent inability to treat patients with the most effective and expensive drugs and treatments can only be expected to increase.

Before medical devices drugs are prescribed or given on the NHS they are scrutinised and recommended by the National Institute for Health and Clinical Excellence (NICE) which evaluates them for cost effectiveness. NICE has been blamed for the start of explicit, national “rationing” on the NHS, but it has also been faced the challenge of lowering the possibility of a ‘postcode lottery’ over the years through issuing uniform practice guidance, that, though not compulsory, drive the policies that Primary Care Trusts (PCT) should be following. This was  highlighted in a successful legal challenge in 2000 against North West Lancashire Health Authority, in which three transsexuals successfully challenged a decision to refuse funding for gender reassignment surgery. In this case, it was shown 34 out of 41 other authorities made some provision for funding such surgery and that a policy which effectively amounted to a ‘blanket ban’ in one locality would therefore recognise that treatment would depend upon where the patient lived.

Essentially, NICE is a non-governmental agency with a key role of evaluating the clinical effectiveness of treatments versus the associated cost burden.  The guidelines are passed onto the NHS with advice as to whether the technology is for routine or restricted use on the NHS. The NHS is constrained by a crippling budget, yet demand is always rising for its services, creating a climate for difficult and often unpopular decisions.

Ultimately, it will be the individual PCT that decides whether certain technology is used in treatment based on NICE’s recommendations. If a PCT refuses to treat a person with certain drugs or surgery, to challenge the decision involves a lengthy expensive, judicial review process. Case law also suggests that Judges are reluctant to get involved in the allocation of NHS resources as shown in a challenge against Cambridge Health Authority by a young girl and her father that attracted much media attention. In this case, potentially lifesaving treatment was refused to a ten year-old girl due to the success rate/cost ratio.

In another recent case, a 22st man lost his legal challenge against North Staffordshire PCT over its refusal to pay for gastric band surgery. Social factors do not have to be considered by PCTs in making their decision. Failure to consider such factors was ruled not to be in contravention of his human right to respect for private and family life under Article 8 of the European Convention of Human Rights. Some align the decision to an inherent prejudice against the obese. However, despite an envisaged long term saving by the claimant as the operation may cure his diabetes and related illness, the money is not always available in the short term. NICE recommendations suggest that people may be eligible for the surgery if they are morbidly obese which, for the purpose of the guidelines, means if they have a body mass index (BMI) of 40 or more or they have a BMI of between 35 and 40 and other significant disease (for example, diabetes, high blood pressure) that may be improved if they lose weight. Many PCTs chose to have the BMI threshold at above 50 as a way of controlling the cost-burden.

However, this is not to say that judges will not get involved should the situation demand as it was in case of a breast cancer sufferer who challenged her health authority and the Secretary of State for Health on their decision not to give her the drug Herceptin when they were giving it to others. The claimant proved the PCT’s decision process was “irrational” as the policy could not be rationally explained. The PCT would provide the drug in ‘exceptional circumstances’ but could not discern a threshold for what these circumstances were.

Over the past 18 months, two life-saving drugs have also been denied on the NHS after cost recommendations by NICE. In January 2010, lifesaving drugs Dasatinib and Nilotinib, which are supplied in Scotland and parts of Europe, were refused to cancer patients in England. Both drugs cost around £30,000 per year but could increase life expectancy by decades. At this time, NICE claimed the decision was based on a lack of robust evidence that the drugs are effective or more effective than those available, despite hearing evidence from clinical experts that the drugs are effective.

NICE also recently proposed not to recommend the drug Lucentis to treat the eye condition diabetic macular oedema (DMO) on the NHS, a decision which Diabetes UK and three other charities are challenging and campaigning against on the basis of a call for a proper consultation allowing stakeholders to submit their comments. The charities are also urging Novartis, the drug manufacturer, the Department of Health and NICE to reconsider the option of a Patient Access Scheme so that a maximum number of patients can benefit from this sight saving treatment.  The Lucentis injections have the potential to save the sight of thousands. Whilst the treatment is expensive, the Institute is accused of failing to consider the long-term effects of their decision. If people lose their sight, much of their independence is gone and costs for the NHS will ultimately rise despite a short-term saving.

Some think it ludicrous that potential life-saving treatment and treatment that enables a person to continue to live independently is denied when the NHS will offer cosmetic procedures such as Breast Enlargement surgery and Rhinoplasty. It’s a debate that is likely to increase in frequency over the next decade as the NHS grapples with an ageing population and a reduction in healthcare expenditure.



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The weekend’s nearly here and we finish off with an article from Orthopaedic Business News by Espicom’s medical news editor Sophie Bracken.

CellSonic Medical, an India and UK-based developer and manufacturer of machines and consumables for wound healing, orthopaedic, urology and skin care in the medical, veterinary and cosmetic markets, is looking for worldwide distributors for its products, which span the areas of lithotripsy, urology, surgery, laparoscopy and dermatology, and also include cosmetic creams and gels. All of CellSonic’s products possess CE mark approval.

The CellSonic medical device is a lithotripter with variable power for use in hospitals and clinics to treat bones, wounds and sports injuries. The device produces a shockwave that is focused by the parabola in the head. According to CellSonic, the company has miniaturised the lithotripter, making it “safe, reliable, easy to use and reduced to price to reach a worldwide market for wound healing”. Calcified shoulder is the most commonly treated condition with shockwaves. Tennis and golfer’s elbow are also commonly treated with the technique. A power boost can be provided for machines that require a bone-healing facility.

According to CellSonic, its system can cost half that of electro-magnetic machines and claims to be cheapest in the medical, veterinary and cosmetic markets. The distributor will exclusively offer CellSonic’s full range and undertake all sales functions.

Have a great weekend, thanks for reading, Paul.



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Therasense v Becton Dickinson – A case study in US litigation

The Medical Technology Blog

Guest contributor, Louise Campbell, takes a look at a recent patent dispute involving two of the biggest names in diabetes and explains why a legal ruling could have implications on challenging patents in the US.

On 25th May 2011, the US Court of Appeals for the Federal Circuit handed down their judgment from Therasense v Becton Dickinson, radically changing the way inequitable conduct (unfair or inappropriate conduct) is to be treated as a legal defence in a patent dispute, imposing much higher standards and essentially limiting a doctrine that some of the residing majority described as an “absolute plague”. A claim of inequitable conduct, if successful has harsh consequences and can result in the patent being unenforceable. When considering the gravity of this consequence, it may be suggested that a high standard of proof is necessary, which may have further adverse effects on quality and cost of US patents.

About the case:

The case largely revolved around two patents for Abbott’s disposable blood glucose test strip with an electrochemical sensor. The initial patent No. 4,545,382 (the ‘382 patent) for a sensor consisting of an electrode with an enzyme bound to its external surface included the following sentence, and the cause of the claim: “Optionally but preferably when being used on live blood, a protective membrane surrounds both the enzyme and the mediator layers, permeable to water and glucose levels.” It was later contended that someone skilled in the art would have known it was necessary to employ the protective membrane when used in whole blood and that the “Optionally but preferably” language was ‘patent phraseology’ and should not be considered a technical disclosure. However, it was this disclosure that prevented the issuing of a second patent (No. 5,820,551 – the ‘551 patent) for an extended period of time.

In securing a European equivalent to its ‘382 patent from the European Patent Office (EPO), Abbott, which bought TheraSense in 2004, overcame a German reference requiring the use of a diffusion-limiting membrane by stating that theirs was a protective rather than diffusion-limiting membrane and that the protective membrane was optional. However, following this, they did not submit this to the US PTO when applying for the ‘551 patent and this was the centre of the challenge. Becton Dickinson unsuccessfully sued Abbott in 2004 seeking a non-infringement judgment on two other patents that Abbott held. Abbott countersued and also sued Bayer, Roche, and one of its suppliers, Nova Biomedical, for infringement of the two other patents as well as the ‘551 patent. Roche settled on the eve of the trial but the other parties held out and were successful in the District Court after successfully highlighting Abbott’s failure to disclose EPO argument as inequitable conduct. The panel of Federal Circuit judges, however, departed from this, in a shake-up of the way inequitable conduct is to be viewed in patent cases.

Becton Dickinson has until 23rd August to file an appeal. Even if they do file for an appeal, this is unlikely to be considered until the Supreme Court’s next conference in late September.

Prior to the case:

Under the previous standard, in order to invalidate a patent, the party alleging inequitable conduct had to show “clear and convincing evidence” that the application misrepresented material fact, failed to disclose material information, or submitted false material information and intended to deceive the US PTO. Prior Federal Circuit case law had created and allowed the use of at least five different standards of materiality, creating inconsistency and uncertainty which indicates why a panel hearing was granted in this case. Furthermore, intent to deceive could be evidenced by negligence or gross negligence.

The changes:

With a minor exception, the ruling in the case introduces a two-part test to establish inequitable conduct in the US. Litigants must now persuade the Court that there is “specific intent to deceive and that the deception was material”. These are two separate elements; the majority forbade inferring intent solely from a high showing of materiality and vice versa. These ‘parts’ have been tightened and a higher standard of proof required from that described above. Consequently, specific intent to deceive cannot lightly be inferred merely because information was not disclosed, even if it is important to patentability.  Intent to deceive must be “the single most reasonable inference able to be drawn from the evidence.”

Furthermore, the patentee need not offer a good faith explanation unless the accused infringer first proves a threshold level of intent to deceive. Proof of negligence or gross negligence is no longer sufficient. In the case of nondisclosure, the evidence must show that the applicant “knew of the reference, knew that it was material, and made a deliberate decision to withhold it.” Materiality is to be decided on a “but-for” basis, meaning that the patent would not have been issued if the information had been known to the examiner. This change was arguably prompted by the fact that the prior tests were so easily satisfied.  – “but-for” is a test widely used across many jurisdictions and is notoriously hard to prove.

Impact of the ruling:

The dissenting judges argued that the ruling comes “close to abolishing” the inequitable conduct doctrine. They wished to maintain the US PTO rule 56 or “duty of candor” (duty to disclose material facts). Judge Kathleen O’Malley agreed that intent to deceive  should drive inequitable conduct cases but dissented from the “but-for” materiality standard arguing that the district courts should have more say in shaping inequitable conduct cases. Her judgment provides a critical analysis of this system. In consequence, the US PTO is to issue guidance in the near future regarding the materials that are required under their duty of disclosure. A US PTO press release on May 26th said this about the decision “The Court’s decision resolves uncertainties in many aspects of how district courts must apply the inequitable conduct doctrine. It also directly affects applicant behaviour in front of the US PTO and, in particular, their disclosure of information relevant to the patentability of their inventions.”

Conclusion:

As US patent law is one of the most expensive areas to litigate, for companies, this is a winning situation, inequitable conduct is harder to challenge and it could theoretically mean less litigation and lower legal fees. However, these new standards are now open to interpretation so it will be interesting to see how these doctrines will be shaped by the district courts.
This case is one of the reasons why fewer inequitable conduct suits are expected to be filed in future.  The America Invents Acts bill passed the Senate on 8th March and the House of Representatives on 22nd June and creates a new supplemental examination procedure. The new procedure allows patent owners to return to the patent office to cite previously undisclosed prior art or correct errors and omissions made during the original prosecution, thereby allowing companies to remedy acts or omissions that could be used as the basis for an inequitable conduct claim. However, the downside of this is that it may reduce opportunities for well-founded inequitable conduct claims. The Therasense v Becton Dickinson dispute has clarified the expectations for attorneys and applicants and provided them with more effective tools to address difficult situations.



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US regulatory bodies respond to rapid rise of modern wireless technology and apps for medical devices

Latest news from Medical Industry Week

The proliferation of broadband and wireless-enabled medical devices has prompted the FDA and US Federal Communications Commission (FCC) to issue a joint plan aimed at bringing clarity to the issue.

Although these devices represent the opportunity to enhance health and reduce the costs of healthcare, they aren’t without a few risks too. The devices, which include wireless sensors that remotely monitor heart rhythm and portable glucose monitoring systems, are increasingly playing a major role in treatments.

The US government agencies have come to the conclusion that clear guidelines are needed to make sure these devices are operated in a safe, reliable and secure manner. The FDA, in particular, is of the opinion that the industry, healthcare providers, patients, and other interested stakeholders in the medical environment should have clear regulatory pathways, processes and standards to bring the technology to market.

Although specific details are thin on the ground at the moment, the aim still pretty noble enough. “All Americans should be afforded the opportunity to benefit from medical technology advances with improved broadband and wireless technology” – the communiqué boldly claims.  At the end of the day though, by clarifying each agency’s scope of authority with respect to these devices, the hope is that interested parties will get a clearer picture of the regulatory process, streamline the application process, and make sure that innovation doesn’t get stifled through bureaucracy.
The move comes as the FDA grapples with even more complex issue of software applications (apps), the likes of which are increasingly been used in mobile medical technology, such as mobile phones, tablet computers and PDAs.

In general, the FDA’s position is that if a mobile app is intended for use in performing a medical device function it is a medical device, regardless of the platform on which it is run. This can range from mobile apps used on mobile phones to analyse glucose meter readings.

In consultation with the US public, the agency is looking to establish formal guidance that define a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. The offending apps could be used as an accessory to medical device already regulated by the FDA transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.

There’s an obvious need for some kind of monitoring in this area. Nowadays an app can be used by a healthcare professional to make a specific diagnosis by viewing a medical image on a mobile phone or tablet, whilst some apps can turn a smartphone into an ECG machine and be used to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack. Understandably, the FDA is of the opinion that these particular mobile apps pose the same or similar potential risk to the public health as currently regulated devices if they fail to function as intended.

The FDA has set a deadline for 19th October 2011 for interest parties – including manufacturers and app developers, to submit comments relating to the agency’s draft policy document, with a view to formulating clear guidance on the matter once and for all.  One thing is for sure, it’s a good idea to revise the present guidelines – the FDA’s last significant attempt to address the topic was made in 1989!

Thanks to Lawrence Miller for yet another great article, Lawrence is the Espicom’s editor for Medical Industry Week, and medical newsletter teamleader. For more articles like this, or to start your subscription please click on the link to Medical Industry Week

 



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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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HQ relocation brings Nuvilex closer to the action

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Nuvilex, a company that dedicates itself to the development of natural and biotechnology products, has made the canny decision to up sticks and move its corporate headquarters from Scottsdale, AZ, to Silver Spring, MD – only four miles from the FDA’s doorstep. Nuvilex is hoping that the move – which is in its final stages – will give the company immediate access to the FDA’s resources as the company pursues clinical development of its pancreatic cancer treatment technology, as well as other biotechnology developments in the future.

Not only is the company’s HQ in the FDA’s backyard, it is also only about ten miles away from the National Institutes of Health, and the National Cancer Institute – both major sources of funding grants and research collaborations. To explain the move, Nuvilex’ President and CEO, Dr Robert F Ryan, said the new location “..will facilitate our interactions with the FDA, an important part of our overall strategic planning, especially given our recent entry into biotechnology and our plans for expansion in this area”.

Nuvilex’ pancreatic cancer treatment is currently being geared-up for more clinical trials, and apparently, significant advances are in progress with the company’s live-cell encapsulation technology. Natural products in development include Gluten-Free Cinnergen and others to enhance a healthy lifestyle. The company is also developing products designed for cosmetic use, flu treatment and the use of heavy-metal-free tattoo inks. Future developments are planned for Citroxin and Oraphyte, Nuvilex’ antimicrobial and antinematodal agents.

This article was kindly provided by Sophie Bracken, editor of Drug Delivery Insight for Espicom.



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Results of a survey conducted at europacolon’s European CRC Patient Conference show that patients believe tests using blood samples would encourage more people to participate in regular screening for colorectal cancer.

The survey was jointly conducted by Epigenomics and europacolon, a European non-profit organisation dedicated to colorectal cancer. Of the participants in the survey, more than 50 per cent had previously heard of the possibility of colorectal cancer blood testing and more than 70 per cent thought that using a blood test would encourage more people to participate in regular screening for the condition. Some of the most often mentioned reasons that survey participants gave for preferring blood tests were ease-of-use and simplicity, not having to handle stool samples as necessary for conventional non-invasive testing, and overall fit with other routine blood tests.

In June, Quest Diagnostics, one of Epigenomics’ partners in the US, in collaboration with the non-profit organisation Colon Cancer Alliance, reported the results of a US national telephone survey of more than 1,300 men and women 50 years of age and older. In this survey, 31 per cent of the participants reported that they had never been screened for CRC. Of the respondents between 60 to 70 years of age that had previously participated in screening, 33 per cent stated that they had only been screened once in the past. These results highlight widespread lack of adherence to national guidelines in the US, which recommend regular screening by colonoscopy in combination with other tests for colorectal cancer for all men and women aged 50 and older. When asked about the option of a blood test, 78 per cent of the participants said that they were likely to take a blood test for colorectal cancer screening and 75 per cent said they were more likely to get screened more frequently if a blood test was offered to them.

According to Dr Jürgen Beck, Senior VP Medical Affairs of Epigenomics, the lack of widespread acceptance and regular use of conventional methods for the early detection of colorectal cancer, such as colonoscopy and stool tests, severely limits the potential of screening to reduce mortality from this common cancer. The two surveys in Europe and the US show the potential of blood-based screening as an approach to increase compliance. Epigenomics expects these findings to be substantiated further through studies into patient preferences and screening adherence that are ongoing at clinical centres in the US and Europe.

Epigenomics has developed an in vitro diagnostic blood test for the early detection of colorectal cancer, known as the Septin9 test. Alongside its partner, Abbott, the companies already market their respective first-generation CE-marked Septin9 tests in Europe, the Middle East, Asia/Pacific and further markets. Epigenomics is in the process of developing a second-generation Septin9 assay as a colorectal cancer screening test for the US and European markets. The company expects to submit this enhanced Septin9 colorectal cancer screening test, branded Epi proColon 2.0, to the FDA for regulatory review before the end of the year. Under licences from Epigenomics, Septin9 testing is currently offered in the US by Quest Diagnostics (ColoVantage) and ARUP Laboratories (Methylated Septin9 Test) as laboratory-developed tests aiding in the detection of colorectal cancer.

This article was provided by Sophie Sanderson, editor of Espicom’s newsletter Diagnostics Focus.



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A New Force in Medical Market Research!

Combining Espicom’s world class data with a state-of-the-art analysis tool, Medistat Interactive takes medical market research to a new level.

Dashboard driven and rich in graphics, you can now easily mobilise key data, immediately compare and contrast key health indicators, infrastructure and market data for multiple markets at the click of a button. Track changes to historical/forecast data, export the data to other programs or create pdfs of charts and tables for inclusion in plans and presentations.

Whether it’s fast access through one of the many pre-defined tabs or the easy-to-use custom report builder, you have complete control over the data, making fast and efficient for your medical market research.

For over 30 years, Espicom has been the leader in analysing medical device and equipment markets worldwide. Its reputation as a provider of reliable and thorough information is well founded and its services are used by leading healthcare companies in more than 50 markets.

Key benefits & features of Medistat Interactive

Compare Key Indicators
How does per capita health spend compare in BRIC countries? What is the forecast market growth in orthopaedics in Poland, Czech Republic and Hungary? With Medistat Interactive you can easily compare any statistics for any number of countries.
medistat interactive detailed country data snapshot

Strategic Insights
Medistat Interactive provides the strategic intelligence to support key investment, business planning and marketing decisions.

Market Snapshots
Easily review all statistics and forecasts for a particular market.

Medistat Interactive Market by Country Data Snapshot

Benchmarking
Assess your company’s performance against actual market figures or monitor regional/national sales offices and the work of specialist sales agents.

Medical Sector Analysis
With actual figures and reliable forecasts, use Medistat Interactive to view market data on specific medical technology areas in the context of other health indicators.

medistat interactive medical market by category data snapshot

Book a demonstration today for the ultimate in medical market research.
Contact

  • Telephone: +44 (0)1243 756011 to speak to a representative


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