A Medical Device Daily

Cepheid (Sunnyvale, California) has reported the release of its Xpert C. difficile test as a European IVD product.

The company said that for the first time, European hospitals "will have access to a reliable, rapid test for Clostridium difficile, which simultaneously detects and identifies the commonly occurring strains and specifically identifies the more virulent Type 027 strain."

The new 50-minute test runs on Cepheid's GeneXpert System, which the company calls "the world's leading HAI molecular testing platform, and eliminates the need for multiple tests using less reliable methods."

Based on published incidence rates, Cepheid said there are roughly 58,000 annual cases of C. difficile-associated disease in the UK. A recent health statistics report on deaths involving C. difficile in England and Wales showed the annual number of deaths rising by about 55% to nearly 8,500 in 2007.

"C. difficile is a horrific infection for a patient to deal with, especially as it is most common amongst the elderly and infirm, or those who are already seriously ill and have a weakened immune system," said Professor Richard James, director of the Center for Healthcare Associated Infections at the University of Nottingham. "C. difficile-infected patients are a source of transmission to other patients, therefore it is important that infected patients are detected as early as possible in order to minimize the impact of the outbreak."

He added, "When combined with isolation of infected patients, rapid molecular testing, providing wholly accurate results in less than an hour, provides an important new weapon in our battle against healthcare-associated infections."

The more virulent C. difficile Type 027 strain has been reported in 16 European countries through June of this year, responsible for outbreaks in Belgium, Germany, Finland, France, Ireland, Luxembourg, the Netherlands, Switzerland and the UK.

C. difficile infections are estimated to cost the UK's National Health Service up to £8,000 per patient and more than £200 million in total each year.

Dr. David Persing, Cepheid executive VP and chief medical/technology officer, said, "The ability to specifically identify the 027 strain will enable tracking of local hospital outbreaks of this strain, which is likely to be of significant value to infection control professionals in curbing the spread of C. difficile."

He said, "Xpert C. difficile comprises the attributes of high accuracy and rapid, on-demand results that are of the greatest importance in controlling transmission of this emerging pathogen."

The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that combines onboard sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis.

NovaMesh to be introduced at MEDICA

Nicast (Lod, Israel), developer of medical devices made of electrospun nanofabric, said that it will introduce NovaMesh for the treatment of ventral hernias at MEDICA 2008, which will be held in Dusseldorf, Germany, Nov. 19-22.

"NovaMesh is the first hernia mesh to exploit the unique properties of electrospun nanofabric. It offers improved resistance to tissue adhesion on the visceral-facing surface and promotes excellent tissue ingrowth on the fascial surface," said CEO Benjamin Eliason.

Nicast also will exhibit the AVflo vascular access graft for hemodialysis, its flagship product, which received CE-mark certification in October. AVflo, a self-sealing vascular access graft, offers a prime alternative to current products, as it enables unobstructed blood flow, allows for dialysis within 24 to 48 hours after implantation and self-seals within less than five minutes following withdrawal of the dialysis needles.

The company said the device "is simple to implant and to suture to blood vessels; the needle punctures and suture holes seal rapidly. AVflo is also strong enough to withstand the pressure of blood flow, yet thin enough for blood flow to be easily felt through it."

Nicast said it is in discussions with distributors from the EU and Asian countries regarding first distribution agreements for the device.

New Eastern European distributor for Nanogen

Nanogen (San Diego) said it has entered into an agreement with A. Menarini Diagnostics Srl, a division of The Menarini Group (Florence, Italy) to commercialize CE-marked in vitro diagnostics (IVD) infectious disease kits based on Nanogen's proprietary MGB technology.

The U.S. firm said the arrangement combines its strength in real-time PCR IVD product development with Menarini's "significant market presence in the major EU countries and their rapidly expanding reach into the developing Eastern European markets."

Under the terms of the agreement the kits will be manufactured by Nanogen and branded as Menarini products. The first products are expected to be introduced to the market in 2009 and will target infectious disease diagnostics.

"Molecular diagnostics is a high-growth segment of the global IVD market and real-time PCR has become a 'gold standard' diagnostic technology," said Nanogen CEO Howard Birndorf. "We are pleased to have a partner like Menarini that can help bring our innovative technology to the $1 billion European market."

We believe our strong technology and product capabilities together with Menarini's local sales strength will open a new market and revenue stream for Nanogen and will make a highly competitive offering in Europe."

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