A Medical Device Daily

Covidien (Mansfield, Massachusetts) said that its Surgical Devices business unit, located in North Haven, Connecticut, has launched three new access products in Europe, VersaStep Plus 15 mm, Visiport Plus with fixation and Versaport Plus RPF 15 mm with fixation.

The European launch follows the U.S. introduction of all three products in March.

The VersaStep Plus 15 mm is a bladeless laparoscopic access system with a radially expandable sleeve that, according to the company, "minimizes the fascial defect and reduces the downward insertion forces associated with normal trocar insertion."

Covidien said its Proven Step technology "is designed to enhance patient safety, save time in surgery and reduce the likelihood of complications, including vascular and visceral injuries."

The company said the VersaStep Plus 15 mm "complements the existing VersaStep Plus line and offers all of the benefits of Covidien's Step technology."

Scott Flora, president of the Surgical Devices unit, said, "Step was the first non-bladed technology in the marketplace and set the standard for safety in laparoscopic entry. The VersaSte Plus15 mm will be used in advanced, minimally invasive abdominal surgeries such as gastric banding and gastric bypass that require the use of larger sized instruments."

The Visiport Plus with fixation supplies a Versaport Plus fixation cannula, an enhanced cannula with integrated fixation ribs for port stability, and a Visiport Plus optical trocar that provides direct visualization of tissue layers during primary port insertion and allows a combination of controlled blunt and sharp dissection during entry, the company said.

The Versaport Plus RPF 15 mm with fixation is used in advanced laparoscopic procedures, as it accommodates larger instrumentation. The Versaport Plus RPF 15 mm also is supplied with an enhanced cannula with integrated fixation ribs for port stability.

LabCorp licenses MGMT testing technology

OncoMethylome Sciences (Liege, Belgium) and Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) said that the Belgian company has granted LabCorp an exclusive license on certain IP technology to perform commercial MGMT methylation laboratory testing services in the U.S. and Canada, subject to limited exceptions.

LabCorp's Esoterix Clinical Trials Services Division also was selected by OncoMethylome as one of its preferred sub-contractors of MGMT methylation testing services for clinical trials.

OncoMethylome will receive an up-front fee, milestone payments and royalties from LabCorp. Other terms were not disclosed.

The companies said MGMT methylation has been shown to be a common event in many cancers and predictive of response to some cancer therapies. For example, they said, "MGMT methylation status has been shown to be a promising potential predictor of response to alkylating agent-based chemotherapies used to treat patients with malignant brain tumors, and therefore is of interest to oncologists who treat such patients."

LabCorp said it plans to determine MGMT methylation status using methylation-specific polymerase chain reaction (PCR) technology licensed from OncoMethylome Sciences.

Because of the potential for broader applications of the oncology marker, the evaluation of MGMT methylation is being integrated into numerous international clinical trials for patients with brain cancer and other cancers.

Biovator developing allergenicity test

In less than a year, animal allergenicity testing for the production of cosmetics in the European Union will be banned, leaving only a limited time to find alternative methods to avoid further exemptions. Biovator (Stockholm, Sweden) said it is developing a solution to part of the problem with its test tube-based technology the in vitro CPA test.

Government investment agency ALMI Företagspartner, in conjunction with Biovator owner LinkMed, has decided to provide funding to further develop the procedure, which uses human tissue to identify substances that cause allergic reactions.

Biovator said the technology, which could replace some of the animal testing currently done in the development of medicines, cosmetics, foods and in the chemical industry, will enable the identification of allergens.

Currently, animal testing is used to trace allergens.

Other investors include IBL Hamburg, a German immunobiological diagnostics company; Medicago, a Swedish biochemical firm, Linköping University and AstraZeneca.

Biovator said development work on the test is proceeding on schedule, and with the help of an industry partner, it plans to have the method ready for commercial use in the first half of 2009.

The company's test is based on work carried out by Professor Birger Andersson in the early 1990s at Stockholm's Karolinska Institute. Andersson was one of the first in the field and his method for in vitro testing became known as the Cytokine Profile Assay (CPA).

"Our test will be more reliable than current methods because tests on animals can only be used to identify Type 4 allergies skin conditions. At present, there is no test for Type 1 allergic reactions airborne allergies an area where there is a proven medical need," said Biovator CEO Stan Mikulowski.

In vitro testing also is quicker and less expensive than animal testing.

CE-mark approvals for China Medical

China Medical Technologies (Beijing) a developer of in vitro diagnostic (IVD) products and high-intensity focused ultrasound tumor therapy systems, said it has received the CE mark for its two semi-automatic ECLIA analyzers and 15 reagents.

Under the In-Vitro Diagnostic Directive of the European Union (EU), products must meet regulatory requirements in order to qualify for sales and distributions in the EU. The CE mark indicates that a product complies with the EU regulatory requirements.

Xiaodong Wu, chairman/CEO, said, "It [the CE mark not only allows us access to new markets, but also strengthens our leading position in the advanced IVD market in China."

The ECLIA system is a closed IVD system including an analyzer and reagents that are used to detect and quantify particular antibodies or antigens for the diagnosis and analysis of various diseases and disorders. The company said it would continue to work on receiving CE-mark approval for its other ECLIA reagents.