A Medical Device Daily

iCAD (Nashua, New Hampshire), a provider of advanced image analysis and workflow solutions for the early identification of cancer, reported the completion of a six-system sale to the Osakidetza Regional Health Care Service in the Basque region of Spain. To date, the systems have been installed with GE's Essential platform and placed in the Hospital de Galdakao (Bilbao), the Hospital de Basurto (Bilabao), the Hospital de Deonostia (San Sebastian) and the Hospital Santiago Apostol (Vitoria)

SecondLook Digital is designed to assist the radiologist in distinguishing cancers from other anomalies in the breast. It is optimized for digital mammography systems. In addition, iCAD's SecondLook Digital provides digital imaging and communications in medicine connectivity enabling universal compatibility with leading picture archiving communication system and review workstations.

"We are honored to provide Osakidetza Regional Health Care Service with SecondLook CAD to highlight suspicious areas on their digital mammograms where further attention by a radiologist is warranted," said Ken Ferry, president/CEO of iCAD. "We look forward to continued adoption of our CAD solutions in Europe and to a continued strong partnership with GE Healthcare that benefits patients worldwide."

DxS/AstraZeneca to make companion diagnostic

DxS (Manchester, UK), a personalized medicine company and makers of companion diagnostics, reported that it is working closely with AstraZeneca to make available a companion diagnostic for use with Iressa (gefitinib), AstraZeneca's (London) treatment for non small cell lung cancer (NSCLC).

DxS' clinical diagnostic, the TheraScreen: EGFR29 Mutation Kit will be used to test the mutation status of a patient's EGFR oncogene to identify their eligibility for treatment with Iressa. The TheraScreen: EGFR29 Mutation Kit, is the only CE-marked kit currently available and is based on DxS' real-time PCR technology ARMS and Scorpions which allows for a highly sensitive and selective test which can detect low levels of mutant in a background of wild type genomic DNA in a tumor with time to result in less than three hours.

The collaboration follows the granting of marketing authorization for Iressa in the EU for the treatment of adults with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK across all lines of therapy. Iressa acts by inhibiting the tyrosine kinase enzyme in the epidermal growth factor receptor (EGFR), thus blocking the transmission of signals involved in the growth and spread of tumors. In around 10%-15% of NSCLC cases in Caucasians, a mutation in the EGFR pathway causes tumors to be particularly susceptible to treatment with Iressa, making the use of a companion diagnostic to identify those most suitable for treatment extremely important. The EU authorization is based on a submission package including two pivotal Phase III studies, IPASS and INTEREST.

TDCA BioMed files for CE certification

TDCA BioMed (San Diego), formerly known as Tulip BioMed, a developer of disposable medical devices for plastic, cosmetic, orthopedic surgeries, and veterinarian procedures, reported that it has submitted its completed technical file required to secure CE certification for products sold by the company.

Based on discussions with the group working with the company on this process, TDCA BioMed said it anticipates obtaining CE certification in 3Q09, with sales expected to begin in Europe within4Q09/1Q10 timeframe.