A Medical Device Daily

LETI (Grenoble, France), a global research center directed toward creating and commercializing innovation in micro- and nanotechnologies, said it has launched a new company, Fluoptics, whose focus is to improve surgery of some types of cancers.

LETI, the Laboratory for Electronics & Information Technology, is a unit of CEA, the French public research and technology organization. LETI is focused on micro and nanotechnologies and their applications, from wireless devices and systems to biology and healthcare or photonics.

Combining technologies developed by Leti and Université Joseph Fourier (also Grenoble), Fluoptics has developed an innovative approach of fluorescence imaging for cancer targeting. This new real-time, imaging technique improves detection of tumors and helps surgeons to delineate it for removal.

Fluoptics, the 30th start-up launched by LETI, expects to commercialize its FluoBeam instrument in 2010 for pre-clinical research and begin the regulatory for its first fluorescent marker.

"Fluoptics not only exemplifies LETI's mission of creating innovation and transferring it to industry, but it also is our first start-up in the growing field of biomedicine," said Laurent Malier, CEO of LETI. "The company has great potential to improve the detection and treatment of cancer, and to have a real impact on the lives of cancer patients."

"It is very difficult to distinguish between cancerous and healthy tissue, and our technology is the only intra-operative technique available to help surgeons precisely locate and delineate tumors," said Odile Allard, CEO of Fluoptics. "Our incubation in Leti enabled the finalization of the laboratory prototype and its preclinical validation by surgeons specialized in cancer."

Fluoptics, one of the four start-ups launched by LETI in the past year, will be based in Minatec (Grenoble, France) which LETI terms "Europe's leading center of excellence in micro- and nanotechnologies."

CE mark for Cepheid Xpert test

Cepheid (Sunnyvale, California) reported the release of its improved Xpert BCR-ABL Monitor test to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. With improved time to results, the test now detects the BCR-ABL chromosomal translocation in about 2 hours as compared to 2.5 hours for the original product release.

The test is intended to aid European clinicians in the monitoring of patients with chronic myelogenous leukemia (CML). The test runs on Cepheid's GeneXpert System, which it terms "the world's leading on-demand molecular diagnostic platform."

"The GeneXpert System is capable of producing unheard of sensitivity levels for a molecular system - a potential key benefit in monitoring minimal residual disease," said CEO John Bishop. "Similar to our recently announced test for Mycobacterium tuberculosis, Xpert BCR-ABL Monitor uses nested PCR, a critical amplification process possible only within a fully closed integrated molecular sample prep/test system. We will continue to extend the many unique benefits of the GeneXpert System across multiple markets and testing applications."

Worldwide, CML affects one to two people per 100,000 annually. The Europe Against Cancer Program practice guidelines, for management of patients with CML, call for use of quantitative reverse transcription polymerase chain reaction (RT-PCR) assays during the initial workup of patients with chronic phase CML, and in monitoring for minimal residual disease. Patients may have their blood tested as often as four times a year.

"Cepheid's ... test is a powerful tool for monitoring patients being treated for chronic myelogenous leukemia," said Ellie Nacheva, MD, PhD, head of lab-leukemia cytogenetics at the Royal Free and University College School of Medicine (London). "The ... sensitivity of the GeneXpert System enables clinicians to process molecular tests in their own facilities instead of sending patient samples to a central lab and waiting for results."

Siemens installs S2000 systems

Siemens Healthcare (Erlangen, Germany) reported the installation of three Acuson S2000 ultrasound systems at Bradford Royal Infirmary (Bradford, UK).

One S2000 has been installed into the radiology department for use in general radiology, musculoskeletal and paediatric work. The remaining two systems are being used in the maternity department's fetal abnormality clinic for scanning fetal hearts and abnormalities, nuchal translucency (NT) scans on twins, and for improved visualization of the female pelvis in transvaginal (TV) scans.

The S2000 ultrasound systems were ordered as a result of the updated antenatal guidelines published last year by the UK's National Institute for Health and Clinical Excellence and were selected due to the excellent quality image resolution and highly ergonomic use.

"Our department deals with a lot of high-risk pregnancies, so being able to achieve high quality fetal scans is an important service that we can now confidently offer," said Virginia Lodge, principal superintendent for ultrasound at Bradford Royal Infirmary. "The color Doppler imaging is superb, providing us with clear, detailed images of any abnormalities so that the next diagnostic steps can quickly be taken."

Bernadette Leonard, regional sales manager for ultrasound products at Siemens Healthcare, said, "The S2000 ultrasound systems will significantly enhance the in-house service available to patients at Bradford Royal Infirmary, providing a clear insight during fetal scans and gynecology examinations. This will enable the early detection and identification of any risks or abnormalities during pregnancy, allowing patients to receive the required level of care and attention."