A Diagnostics & Imaging Week

The development of new medical technologies such as hip and knee replacements, pacemakers and coronary stents got a boost in the UK last week, as a new agreement was reported that makes it easier to get approved trials in patients under way.

Launched jointly by the UK Department of Health and the Association of the British Healthcare Industries (ABHI), the model Clinical Investigation Agreement (mCIA) was welcomed by the medical technology industry as timely and helpful.

The mCIA covers all medical technology trials involving patients in National Health Service (NHS) hospitals that are funded by industry.

According to the Department of Health, "it removes much of the previous bureaucracy, which was a significant barrier to the efficient start-up of such trials in the UK."

Previously it was necessary for site-by-site reviews and local legal agreements to be drawn up before industry-sponsored trials could begin. The announcement of the new accord said the mCIA meets the UK government's requirements for transparency about research involving NHS patients, "and ensures that all medical technology industry-sponsored clinical trials are registered and published."

Experience with use of the new agreement will be reviewed after one year.

The agreement is "closely aligned," the Department of Health said, with the revised model Clinical Trial Agreement (mCTA) for pharmaceutical and biopharmaceutical industry-sponsored research in NHS hospitals that was published in 2006, and the Tripartite clinical trial agreement for pharmaceutical and biopharmaceutical industry-sponsored research in NHS hospitals, managed by contract research organizations (CRO-mCTA) published last year.

Peter Ellingworth, chief executive of ABHI, said the association "welcomes the launch of the model Clinical Investigation Agreement which has been the result of a great deal of work by the Department of Health, the medical devices industry and NHS stakeholders. The new agreement for both regulatory and post-market medical device studies will fulfill the need for a document that has the confidence of all parties in order to streamline the administrative process of getting approval for clinical investigations underway at NHS sites."

He added that the agreement "should ... help with the goal of making the UK a world-class environment in which to conduct clinical research on innovative medical technologies."

Public Health Minister Dawn Primarolo said, "The model Clinical Investigation Agreement is the first time that all UK health departments, the NHS and representatives from industry have agreed [to] standard contract requirements for medical technology industry-funded clinical trials."

She added that the mCIA was developed "to enhance the UK clinical research environment for the benefit of NHS patients."

John Jeans, industry co-chair of the Ministerial Medical Technology Strategy Group, said the group "fully supports the principle of the model Clinical Investigation Agreement for medical device companies carrying out clinical investigations in collaboration with the NHS. This document should serve as another step [toward] enhancing the UK environment for medical device research and development."

The mCIA agreement is the latest is a series of initiatives that have already been introduced to improve the clinical research environment in the UK, including:

• The Medicines and Healthcare products Regulatory Agency's introduction of new services that speed-up the assessment of clinical investigations for regulatory purposes and an industry-focused advice service.

• The National Research Ethics Service's introduction of a speedy and streamlined process using device-flagged committees that have expertise in device studies, as well as guidance on the ethical review of device studies.

• The Integrated Research Application System, which provides an electronic portal for the single submission of data required for the regulatory research permissions and approvals needed to initiate a clinical research study.

Virtual modeling of patients from EHR data

Even as the EU struggles to get ahead of the curve on telemedicine, another wing of the DG InfoSoc delivered at the World of Health IT congress in Copenhagen, Denmark, a view of the ultimate potential the EC sees in e-health and where it believes European universitis and companies can gain a competitive edge.

Ilias Iakovidis, deputy director of the ICT for Health Unit responsible for research, described a three-stage development of e-health in Europe over the next 30 years. First as a tool for assisting the delivery of health services, then to nurture good health among citizens, and finally to manage endogenous determinants of health, or the ability of advanced IT applications to identify genetic, environmental and lifestyle profiles for each citizen and then anticipate appropriate care practices.

In the context of the current challenges faced by the EU in healthcare, Iakovidis said he realized his discussion sounded like he was from a different planet and in his presentation took the audience on a mission to Mars.

The electronic health record today is filled with the observations of doctors, he said, but in the future the record will progressively become populated with a richer set of highly personal data that today is ethically and legally difficult to record.

Capturing and modeling this data will enable future physicians to view a kind of Google Body, not unlike the now-familiar imaging of Google Earth.

The zoom into a patient's health status will be to the power of 10-minus-nine, the equivalent of moving from a whole view of the earth down to the button on a person's shirt.

On a human scale it mean moving from a view of the entire body to the level of organs and then closer to the tissue of a specific organ, then even closer to cells in the tissue, to the 200 proteins in the cells and finally to the genetic level with 23,000 variables.

Combining in vivo digital images with in silico models, new computing tools would enable the visualization of actual, or probable, tumor evolution to quantify a diagnosis and optimize therapies.

The work already is under way, he said.

Under the EU's innovation funding for Framework Seven (FP7), Philips (Eindhoven, the Netherlands) is leading the euHeart project with the University of Oxford and 17 other partners to create the European Heart model that will dynamically display physical structures, such as tissue and vessels, along with blood flow and electrical charges.

Using data inputs from a patient's record, the virtual model will become a representation of a specific individual's heart condition for diagnosis.

Iakovidis said the European Heart model was selected by a Japanese team building a new peta-scale supercomputer to optimize computer processing and problem-solving.

He said in September that the Osteoporotic Virtual Physiological Human project, with €9 million ($11.5 million) of FP7 funding, will create a multi-scale predictive model for diagnosis and treatment of osteoporosis.

In an upcoming call for proposals the EU will be seeking companies and universities from anywhere in the world to partner on the development of a virtual physiological human to create multi-scale models and simulations of organs and the development of IT tools for biomedical research.

DxS in agreement on assays for studies

DxS Ltd. (Manchester, UK), a personalized medicine company focused on the development of companion diagnostics, has reported an agreement with AltheaDx (San Diego), which will provide U.S. study centers with access to K-RAS mutation detection assays from DxS.

The deal will see AltheaDx, an oncology diagnostic and biopharmaceutical services company, use the British firm's K-RAS mutation test kit to support clinical research where cancer patients are assessed for their K-RAS mutation status.

The DxS K-RAS mutation test kit allows clinicians to screen patients for mutations in the K-RAS gene, which is mutated in roughly 35% to 45% of metastatic colorectal cancer, as well as a variety of other cancers. Patients carrying mutations in the K-RAS gene do not respond to a class of drugs known as EGFR inhibitors – such as Vectibix and Erbitux.

DxS said the agreement builds on its continued expansion, including an exclusive global distribution agreement with Roche (Basel, Switzerland) earlier this year.

For the U.S. company, the agreement also builds on its biomarker development collaboration with BiPar Sciences and Poniard Pharmaceuticals.

AltheaDx said the accord "reinforces the position of AltheaDx as the premier biopharma partner for signature discovery and companion diagnostic development."

Dr. Stephen Little, CEO of DxS, said, "[This] deal with AltheaDx, a leading provider of biopharma testing services and cancer diagnostics, confirms once again that the K-RAS test is now the gold standard' assay of choice for detecting mutations in K-RAS."

He added, "We look forward to working with AltheaDx and expanding our reach in the U.S. clinical trial market."

AltheaDx CEO David Macdonald said, "Our agreement with DxS expands our capability to market-leading technology in genetic cancer testing. The DxS kit will enable [us] to offer K-RAS analysis for future clinical trials, in order to further advance the developments that have seen patients being prescribed the appropriate targeted [therapeutic] based on their genetic profile."

DxS has a range of products, including cancer mutation assays and kits, molecular diagnostic technologies and genetic analysis services. Its TheraScreen line of CE-marked kits can identify genetic tumor mutations affecting how patients respond to cancer therapies, enabling doctors and drug companies to provide the treatment most likely to benefit patients.

FDA okays Austrian firm's product

CNSystems Medizintechnik (Graz, Austria) said it has received FDA clearance for CNSystem's CNAP Monitor 500, permitting the sale of the product in the U.S. The CNAP Monitor 500 measures non-invasive and continuous blood pressure in real-time and can predict responsiveness to fluid administration.

In the perioperative setting, detecting blood pressure drops and their cause in time is crucial for peri- and postoperative outcome. However, until recently only invasive methods provided quality information to the clinician.

CNSystems said CNAP provides reliable blood pressure monitoring comparable to invasive techniques and adds valuable information about fluid responsiveness of the patient non-invasively. It said this allows spreading the highest level of blood pressure monitoring to all perioperative settings where close blood pressure monitoring is indicated, but the risk and discomfort of invasive measurement is not justified.