A Diagnostics & Imaging Week

Dade Behring (Deerfield, Illinois) reported the launch in Europe of the N Latex CDT (carbohydrate deficient transferring) assay for use with its BNII and BN ProSpec systems.

The company said the assay is the first fully automated and direct CDT immunoassay method to identify chronic alcohol abuse.

The isoforms disialo-, monosialo-, and asialotransferrin collectively are named carbohydrate deficient transferrin. CDT is regarded as the most specific marker for the detection and monitoring of chronic alcohol abuse, Dade Behring said. Heavy drinkers show higher CDT concentrations due to a changed glycosylation pattern of transferrin.

The company said CDT testing is effective for early identification of alcohol abuse and the differential diagnosis of alcohol and non-alcohol induced liver diseases.

About 20% of patients seen in clinical practice present with indications of underlying alcohol misuse, Dade Behring said in a news release. It said high alcohol consumption increases the risk of health problems such as liver diseases, hypertension, stroke/cardiovascular disease, cancer in the airway and digestive tract, chronic gastritis, and overall mortality.

CDT is a specific marker for the determination of chronic alcohol abuse — greater than 60 g alcohol/day for a minimum of two weeks — and also is an accurate indicator of a relapse to drinking, the company said. "In combination with N Antiserum to human transferrin, the N Latex CDT assay offers a fully automated result available in less than 20 minutes, and an automatic calculation of CDT percentage on BN systems."

Jim Reid-Anderson, chairman, president and CEO of Dade Behring, said the introduction of the first fully automated and highly specific immunoassay for the detection of high alcohol consumption is in keeping with his company's commitment to "relevant, life-saving innovation. Having the ability to identify liver damage caused by high alcohol consumption will better enable physicians to quickly determine and implement the proper treatment for their patients, thus saving or enhancing the quality of life for many individuals."

Dade Behring refers to itself as the world's largest company dedicated solely to clinical diagnostics. It had 2004 revenues of nearly $1.6 billion.

Positive opinion issued on Vasovist

Epix Pharmaceuticals (Cambridge, Massachusetts) said the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Schering AG's (Berlin) marketing authorization application for Vasovist (gadofosveset trisodium) for contrast-enhanced magnetic resonance angiography for visualization of abdominal or limb vessels in patients with suspected or known vascular disease.

The EU marketing application for Epix's MS-325 product, trade-named Vasovist, was submitted in June 2004 by Schering, which is the company's worldwide development and marketing partner.

CHMP is the scientific committee of the European Medicines Agency (EMEA). Its opinions generally serve as the basis for approval by the European Commission.

If granted, the marketing authorization for Vasovist will be valid in all 25 member states of the European Union, Epix said. It added that Vasovist is anticipated to be the first in a new class of MRI contrast agents with an extended imaging window particularly suitable for magnetic resonance angiography (MRA).

Michael Webb, CEO of Epix, said, "We expect that the European marketing authorization for Vasovist will be granted later this year. In anticipation of approval, Schering has been preparing for a 2006 launch in Europe, where an estimated 4 million patients a year undergo invasive, catheter-based X-ray angiography for the diagnosis of vascular disease."

He said that if approved, MRA with Vasovist "will provide clinicians with a robust and flexible tool to perform a vascular diagnostic work-up with a single injection."

Epix uses its Target Visualization Technology to create imaging agents targeted at the molecular level, designed to enable physicians to use MRI to obtain detailed information about specific disease processes. It said its lead product candidate, MS-325 or Vasovist, is the first imaging pharmaceutical specifically designed for MRA.

In January, Epix received an "approvable" letter from the FDA for the company's new drug application for Vasovist, requesting additional clinical studies. The company submitted what it said it considers "a complete response" to the FDA last month.

Epix also is collaborating with Schering in the development of a second drug candidate, EP-2104R, for imaging blood clots using MRI, as well as in a research partnership to discover novel compounds for MRI.

1st European Panorama 1.0T installation

The University of Cologne's (Cologne, Germany) medical center has opened its new MRI suite, which features Europe's first installation of the Philips Medical Systems (Best, the Netherlands) Panorama 1.0T open MRI system.

Philips said the Panorama 1.0T has a "truly open design" and a 160 cm wide opening, "making it possible for medical professionals to image any and all patients who need an MRI." These properties, it said, "make the system ideal for imaging claustrophobic and larger patients."

The company said that about one-third of patients undergoing a MRI procedure for the first time "experience severe anxiety due to claustrophobia." The company added that healthcare providers are unable to perform MRI procedures on about 10% of their patients due to claustrophobia and obesity.

University of Cologne is Philips' first installation of the Panorama 1.0T in Europe and the second globally after its installation at the Nevada Imaging Center (Las Vegas) in March.

The University of Cologne MRI suite also will host the company's new Achieva 1.5T and Philips Achieva 3.0T systems.