A Medical Device Daily

A new report from a group of leading Swedish researchers says the "fragmented organization and management" of lung cancer diagnosis and care in many European countries are exacerbating already poor survival rates among patients with the disease.

"There is a real need to improve survival and outcomes for people with lung cancer," said clinical oncologist Nils Wilking of the Karolinska Institute (Stockholm, Sweden), primary author of the "Benchmarking Report of Lung Cancer Care in Selected European Countries" report. He said, "We hope that this report will help both stimulate and measure the success of developments and changes in lung cancer services and ultimately improve patient outcomes."

The report says there is "a great need to improve outcomes for patients with lung cancer," the most lethal form of cancer in Europe, causing between 15% and 28% of all cancer deaths.

Key findings in the report include:

• Late diagnosis of lung cancer is the most important factor explaining low survival rates. Almost 90% of those diagnosed with lung cancer die within five years.

• Once diagnosed, the fragmented organization and management of lung cancer care in many countries are affecting timely access for patients to the most appropriate treatment.

• The countries in which survival is best tend to have better provision of radiotherapy equipment, as well as better patient access to modern lung cancer drugs.

• Lung cancer takes a relatively large share of overall healthcare spending for cancer, ranging from 6.6% in Finland to 9.9% in Hungary. Of this, hospital care uses a relatively large share of the direct costs, for example, 93% in Germany; 86% in Sweden and 77% in the Netherlands.

The report says the amount spent on ambulatory care — mainly outpatient care — is much smaller, 4%, 13% and 9% for the same countries, respectively, and drug costs account for the least amount of spending 3%, 1% and 3.5%, respectively.

• Apart from improving access to modern cancer drugs, it is important to introduce effective measures in prevention and early detection through well-structured and administered cancer registries to track any changes that these and other organizational changes may make.

The report includes data from 20 countries: Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland and the UK.

The report was undertaken through collaboration of Wilking, Daniel Hogberg of i3 Innovus, and Professor Bengt J nsson of the Stockholm School of Economics. Funding was provided to i3 Innovus by F. Hoffmann-La Roche (Basel, Switzerland).

Aptima HPV assay in European launch

Gen-Probe (San Diego) said it has launched its Aptima HPV Assay — a highly specific molecular diagnostic test to detect high-risk strains of the human papillomavirus (HPV) — in Europe.

The Aptima HPV Assay has been CE-marked and is available for sale in 13 European countries.

"The CE marking and launch of our Aptima HPV Assay in Europe reflects Gen-Probe's commitment to the development of novel, more accurate molecular diagnostic tests to detect life-threatening infectious diseases such as cervical cancer," said Carl Hull, president/COO. "We are hopeful that, over time, our HPV test will become an important long-term financial growth driver on both our current and future automated instrument platforms."

The Aptima HPV Assay is an amplified nucleic acid test that detects 14 high-risk HPV types that are associated with cervical cancer, including two messenger RNAs (mRNAs), E6 and E7, which are made in higher amounts when HPV infections progress toward cervical cancer.

"By targeting two HPV genes that are associated with progression to cervical cancer, the Aptima HPV assay may increase the specificity of cancer detection," said Jack Cuzick, professor of epidemiology at Cancer Research UK's Center for Epidemiology, Mathematics and Statistics. Cuzick is leading the 953-woman "Predictors" study, a head-to-head comparison of various HPV assays.

Ipsogen test powered by Affymetrix

Affymetrix (Santa Clara, California) said its technology is powering the Ipsogen (Marseille, France) MapQuant Dx Genomic Grade, the first genomic test designed to provide a more precise measurement of tumor grade than previous techniques. Ipsogen has just launched the test, which resulted from the Powered by Affymetrix (PbA) agreement signed in August 2007.

Affymetrix partners with diagnostic companies such as Ipsogen through its PbA program. The company said there are more than 20 different molecular assay tests based on the Affymetrix platform under development by Affymetrix and its 11 PbA partners.

"The Affymetrix technology enables us to address clinicians' needs by translating the genomic profile of each tumor into reliable, intelligible and decisive information for pathologists, oncologists and patients," said Vincent Fert, president/CEO of Ipsogen. "Extracting the grade from the confusing field of prognostic factors gives us a much better chance of offering timely treatment to women suffering from breast cancer."

The MapQuant Dx Genomic Grade is the first diagnostic test resulting from Affymetrix's PbA agreement with Ipsogen.

Italian center okays PLC study

PLC Systems (Franklin, Massachusetts) said the ethics committee of the Centro Cardiologico Monzino (CCM-University of Milan; Milan, Italy) has approved the planned randomized clinical trial to evaluate the use of PLC's RenalGuard in the prevention of contrast-induced nephropathy (CIN) in high-risk patients undergoing catheterization procedures at its institution.

The investigators for the trial are Antonio Bartorelli, MD, director, interventional cardiology, and Giancarlo Marenzi, MD, chief of the intensive cardiac care unit.

PLC President/CEO Mark Tauscher said, "We anticipate that this study will greatly increase the visibility of our RenalGuard System in Europe, and that the data gathered from the study will enable us to seek expanded claims in order to market RenalGuard as a CIN prevention device throughout the European Union."