Medical Device Daily s

In August Roche Diagnostics (Basel, Switzerland) will distribute and support sales of the TheraScreen: K-RAS Mutation diagnostic kit in Canada to test patients' suitability for treatment with Amgen's (Thousand Oaks, California) colorectal cancer therapy, Vectibix.

Developed and manufactured by DxS (Manchester, UK), the TheraScreen assay tests for patients presenting with a non-mutated K-RAS gene, which studies have shown may respond well to treatment with Vectibix.

About 60% of metastatic colorectal cancer patients have a non-mutated K-RAS gene.

Approval of the TheraScreen kit for use in Canada advances the concept of personalized medicine in cancer treatment where a companion diagnostic is used to screen ptient populations for likely efficacy of a targeted therapeutic.

"This is extremely good news that we now have a registered method for K-RAS testing with a simple to use, highly sensitive diagnostic, said Kenneth Pritzker, MD, at Mount Sinai Services (Toronto), one of the centers carrying out K-RAS testing in Canada.

Colorectal cancer is the third-leading cause of cancer death in Canada, with around 22,000 diagnosed each year, causing 9,100 deaths.

The DxS TheraScreen diagnostic is currently being reviewed by the FDA (Medical Device Daily, April 23, 2009).

Boston Sci's Latitude gets CE mark

Boston Scientific (Natick, Massachusetts) reported receiving the CE mark for its Latitude patient management system. The system remotely monitors patients with implantable cardiac devices, gathering information on both the device and a patient's heart health status. The system can also detect clinical events between scheduled physician visits and send relevant data directly to a patient's physician. It will be launched in Europe in a phased approach beginning this week.

'Boston Scientific has enrolled more than 130,000 patients on the Latitude system since its introduction in the U.S. in 2006, making it the most rapidly adopted remote cardiac device monitoring system in the industry," said Fred Colen, president, Boston Scientific Cardiac Rhythm Management. "We expect continued success as we introduce the demonstrated benefits of our Latitude system to patients and physicians in Europe. Remote monitoring technology provides a significant opportunity to further improve patient care."

The system provides physicians actionable information that enables them to see changes in their patients' cardiac health sooner than regularly scheduled follow-up visits. The international version of the system is compatible with the company's wireless Teligen ICD and Cognis CRT.

The first enrollments of European patients onto the Latitude system were performed by J.H. Ruiter, MD, Medisch Centrum Alkmaar (Alkmaar, the Netherlands), and Peter Mortensen, MD, Chief Physician, Skejby University Hospital (Aarhus, Denmark).

Nanobiotix: Data claims nanoparticles are safe

Nanobiotix (Paris), an emerging nanomedicine company, reported that preclinical follow-up data regarding long-term toxicity evaluation suggests that its patented NBTXR3 nanoparticles are designed to be a safe and effective treatment for radiosensitive and radioresistant tumors. The preclinical studies were performed at NAMSA Biomatech (Lyon, France). NAMSA is registered with the CDER and CBER divisions of the FDA.

Nanobiotix is using technology that it calls 'nanoXray therapeutics' to resolve radiation therapy's biggest drawback: destruction of healthy tissue and its subsequent deleterious side effects when a high dose of xray is necessary. The company believes that nanoXray therapeutics offer a dramatic innovation in cancer therapy, based on a technology that is designed to allow destruction of cancer cells only-a new treatment weapon that could be used alone, or in concert with existing anticancer protocols: chemotherapy, surgery, and immunotherapy. Because NBTXR3 is comprised of crystalline nanoparticles, it does not have deleterious effects on healthy cells, unlike chemotherapy or other systemic anticancer agents.

"Our nanotechnology is designed to allow for the precise destruction of cancer cells via the controlled application of an outside-the-body energy source-in this case, an X-ray. We have aggressively worked to achieve our goal of completing this preclinical program in order for Nanobiotix to be able to start the first-in-man clinical trial by the end of this year. We are highly encouraged by these latest results, with confirmation of good tolerance and negligible toxicity observed in animals," said Laurent L vy, PhD, president/CEO of Nanobiotix.

Unisense devices okayed for use in IVF

Unisense FertiliTech (Aarhus, Denmark) reported that the EmbryoScope embryo monitoring system and EmbryoSlide tray have received CE approval as class IIa medical devices for use during in vitro fertilization (IVF) procedures. Unisense said it also received the DS/EN ISO13485:2003 and AC:2007 quality system certificate for production, installation and servicing of IVF incubators and related accessories.

Francesca Bahr, sales manager at Unisense FertiliTech said, "the CE mark will allow us to market the instrument to assisted reproduction clinics across Europe, with the goal of improving embryo assessment and to facilitate the goal of elective single embryo transfer."

During IVF treatment, multiple oocytes are removed from the patient and fertilized in vitro. The resulting fertilized eggs are cultured for a period of 2 to 5 days, before the embryologist must select the best potential embryo or embryos to transfer to the patient. Ideally, a single embryo resulting in a single pregnancy is optimal as multiple pregnancies present risks to maternal and fetal health.

A major challenge for the embryologist is determining which embryos have the best potential to create a single healthy baby.

The EmbryoScope is designed to allow uninterrupted observation of embryo development in a stable environment. Embryo quality parameters can be assessed and reviewed without the potentially damaging effects of removing the embryo from a controlled incubation environment, the company said. Retrospective analysis of development will allow embryologists to identify potentially new parameters for embryo analysis.