Diagnostics & Imaging Week Associate Managing Editors

GE Healthcare (Waukesha, Wisconsin) and St. Jude Medical (St. Paul, Minnesota) reported that they have entered a "significant development and collaboration agreement" that is intended to bring an integrated imaging and monitoring capability to cardiac catheterization labs around the world.

The companies said they will co-develop a state-of-the-art cardiovascular ultrasound imaging system with fully integrated intracardiac echocardiography (ICE) imaging capabilities, intended for use in treating patients suffering from heart disease.

Mark Langer, the global general manager for invasive cardiology at GE Healthcare told Diagnostics & Imaging Week that the two companies have had "a rather quiet NIH-funded collaboration" to develop "some pretty innovative imaging catheter designs."

According to Langer, the companies have finally come up with a device that they believe is best-in-class and are ready to begin the process of bringing it to market. "I guess you could say our relationship is at a place where it's becoming public."

The device is specifically designed to treat heart rhythm disease, which affects more than 8 million people globally. It is a dysfunction in the electrical workings of a patient's heart, disturbing the heart's ability to beat normally and pump blood efficiently. The irregular electrical pulses pose significant risks such as heart muscle damage and stroke.

The most common heart rhythm disorder, atrial fibrillation (AF), is an irregular and rapid rhythm where the heart's atria quiver instead of pumping efficiently. Each year, more than 380,000 new cases of AF are diagnosed worldwide and according to Langer, there are more than 5 million people around the world who suffer from this condition.

For many AF patients, existing therapies including medications are ineffective or cause significant side effects, such as severe reduction in stamina. Ablation, in which an electrophysiologist eliminates the tissues in the heart that contribute to the disturbance of electrical flow, is an effective treatment with a success rate of 84% to 87%.

Langer noted that medication is only about 29% effective compared to the much higher success rate of ablation in the treatment of AF and wonders why ablation hasn't become the standard-of-care.

He noted that currently, because of its complexity and procedure time, ablation is performed less often than indicated, but better visualization technology is expected to make ablation procedures more accessible to patients.

"There's just a handful of physicians that can do the [AF ablation] procedure," he said, with only about 500 around the world at this time. He said this represents a vastly under penetrated market. "There's probably only 10,000 of these AF ablations performed every year, and that's too bad because it's such an effective therapy and I think we can do things to improve it."

Through the collaboration, GE's ultrasound technology will be integrated with St. Jude's catheter technology to provide physicians with real-time ultrasound imaging inside the heart, with direct visualization of both blood flow and other catheters used during cardiac procedures. The combined imaging technology is expected to give physicians high-quality diagnostic images of cardiac structures and blood flow throughout the entire heart, enhancing visibility and enabling more successful procedures.

"These new visualization tools are like having eyes inside the patient's heart, without actually having to open the chest," said Laurence Epstein, MD, chief of the Cardiac Arrhythmia Service at Brigham and Women's Hospital (Boston). "The development of ICE technology has changed how we approach ablation procedures. We can visualize, in real time, the actual anatomic structures that we are targeting."

"GE Healthcare technologies are utilized in 112 of the 120 electrophysiology teaching institutions today. This latest agreement with St. Jude Medical is a natural extension of our commitment to delivering state-of-the-art tools and technologies to the electrophysiologist," said Laura King, global vice president, interventional, cardiology and surgery, of GE Healthcare. "We are excited about bringing together the expertise from two innovative companies to enable effective, minimally invasive therapies."

"Atrial fibrillation is one of the largest unmet clinical needs in cardiovascular medicine today," said Dr. Peter Chen, president of St. Jude's organization that is developing the ICE catheter. "By working with GE Healthcare, we are enhancing our ongoing efforts to improve treatment options for AF patients and their physicians."

Beyond all the technology being utilized in the new system, Langer noted one other important aspect to the potential adoption of the new device once it is approved, and that is the excellent physician programs that both companies have.

"By providing a lot more [physician] training than they've ever had before," he said, "we think we can improve [ICE] use and adoption."

In other agreements news:

• deCODE genetics (Reykjavik, Iceland) and Ilumina (San Diego) reported the formation of an alliance under which the companies plan to co-develop and commercialize DNA-based diagnostic tests in several major disease areas.

The alliance will employ Illumina's platform for high-multiplex single- nucleotide polymorphism (SNP) genotyping to develop tests for gene variants deCODE has previously shown to have impact on the risk of a growing number of common diseases with major public health impact.

Under the terms of the agreement, Illumina will gain access to disease- related biomarkers for joint validation as diagnostic panels to be marketed and sold by Illumina on its forthcoming BeadXpress platform. The companies will share development costs and split the profits from sales of the diagnostics tests.

The alliance will initially focus on the development, validation and commercialization of specific diagnostic tests for variants in genes involved in three disease-related pathways:

• The gene-encoding leukotriene A4 hydrolase, linked to heart attacks.
• The gene-encoding transcription factor 7-like 2 (TCF7L2), linked to Type 2 diabetes.
• The gene-encoding BARD1, linked to breast cancer.

As part of the agreement, Illumina will install its SNP genotyping platform at deCODE, enabling deCODE to expand its contract genotyping business to offer Illumina platform and assay technologies together with deCODE's proprietary analytical services for customers.

deCODE will use the Illumina platform to carry out high-density, whole-genome studies utilizing its comprehensive population genetics resources in Iceland, including more than 100,000 participants in some 50 common diseases.

• SurModics (Eden Prairie, Minnesota), a provider of surface modification technologies in the areas of biocompatibility, site-specific drug delivery, biological cell encapsulation, and medical diagnostics, and Donaldson (Minneapolis), a provider of filtration systems and replacement parts, reported a strategic marketing and distribution agreement with Corning.

Through Corning Life Sciences, that company will provide worldwide marketing and distribution of nanofiber cell culture products for in vitro (laboratory based) cell culture research and drug discovery applications.

The distribution agreement is intended to bring the SurModics-Donaldson jointly developed nanofiber products to customers more quickly by taking advantage of Corning Life Sciences' market position in plastic and glass labware for use in cell culture and drug discovery applications.

Evaluations by multiple customers have demonstrated that the Ultra-Web Synthetic ECM (extracellular matrix) products mimic cell growth conditions that more closely resemble those found in the body, leading to improved outcomes in cell culture, cell-based bioassays and other in vitro cell-related applications.

Donaldson and SurModics formed a joint development relationship in May 2005, combining Donaldson's nanofiber technology and SurModics' surface modification technology to create synthetic nanofibrillar cell culture products. Donaldson and SurModics recently introduced the first jointly developed product as a cell culture insert based on the Ultra-Web Synthetic ECM technology. Moving forward, all three companies will continue to jointly develop a platform of products based on the technology.

SurModics, Donaldson, and Corning Life Sciences will target both basic cell biology research and cell-based high throughput screening applications for drug discovery and development.