A Medical Device Daily

InterGenetics (Oklahoma City), a predictive medicine company focused on molecular diagnostics and targeted therapy for cancer, reported the international release of OncoVue, which it said is “the first genetic-based, breast cancer risk test that incorporates both personal history and gene-based information to determine a woman’s future breast cancer risk.”

Opaldia, a genetic health service provider with a network of clinics, will release OncoVue in the UK and Ireland under an exclusive agreement with InterGenetics.

“OncoVue has undergone over seven years of research, and the genetic information for this test came from the testing of over 8,000 women with and without breast cancer from five geographic regions of the U.S., giving us the support to introduce the test to an international market,” said Dr. Craig Shimasaki, president/CEO of interGenetics.

The OncoVue test is easy for women to take. They first answer a simple medical history questionnaire, then swish a mouthwash and deposit the fluid into a tube. In the InterGenetics’ laboratories, DNA from the woman’s cheek cells in the mouthwash are analyzed using the OncoVue CombiSNP technology that looks at combinations of genes, rather than any single gene alone.

Research has shown such gene and personal history combinations have a “significant” relationship to women diagnosed with “sporadic” breast cancer; the type of breast cancer affecting 90% to 95% of all women, according to the company. The research also reveals a strong dependence on age for genetic contribution to breast cancer risk.

Elaine Warburton, CEO of Opaldia, said, “In the UK, we have a ‘one-size-fits-all’ national breast screening program which has the potential to miss cancers in women under 50.”

She said her company is “the UK’s premier private provider of genetic health services,” and that OncoVue is “a perfect fit for Opaldia’s unique Breast Care program, since the test can now identify those women at greater risk of developing sporadic breast cancer and who would therefore benefit from a carefully managed screening program at various stages in their lives.”

Saying that OncoVue “gives a woman a better assessment of her future risk of breast cancer to guide her in deciding on surveillance and preventative options based on a comprehensive risk assessment,” Warburton said that the OncoVue report shows a woman her risk assessment in three stages of her life: pre-menopause, peri-menopause and post-menopause.

The test has been developed even for women who do not have a strong family history of cancer, or about 85% of the women who get breast cancer. Opaldia will promote OncoVue in the UK and provide genetic counseling and other breast surveillance services in tandem with the testing.

InterGenetics and Opaldia will jointly participate in the development and sharing of best practice protocols for OncoVue in the UK and Irish markets.

The OncoVue test has been released in the U.S. under an FDA-approved investigational device exemption (IDE) study conducted by InterGenetics at 12 “comprehensive” breast centers and individual physicians’ practices in 10 states.

The strategic partnership between InterGenetics and Opaldia also will expand the borders applying this science,” Shimasaki said. “Opaldia is implementing medical programs in South Africa, the Middle East, Australia and in the Far East, opening up potential future commercial markets for OncoVue.”

Cell-cultivation systems agreement in works

Cinvention (Wiesbaden, Germany) and Instrumentation Laboratory (Lexington, Massachusetts) said they plan to enter into a distribution and marketing partnership to market Cinvention’s nano-structured bioactive carrier systems for cell cultivation in biomanufacturing and tissue engineering. The products are known under the brand names CarboScale and CarboSeed.

Formerly known as Blue Membranes, Cinvention has developed a portfolio of products for cultivating mammalian cells on bio-mimicking nano-structured carbon moulds used in conventional bio-reactor systems. These carrier systems provide tissue-like surfaces attracting cells to attach and proliferate on the bioactive surfaces.

Compared to conventional cultivation systems, Cinvention said its products allow increasing yields up to 8.000%. The materials for attaching cells are disposables and available both as beads and structured packings. The increase of surfaces by nano-structuring and embedding flow-channels into the structured packings allows increasing the overall surface area of up to 10,000 square meters per 100 ml of cell cultivation volume.

Cinvention has two business units: medical device coatings – including the development of drug-eluting stent technology — and bioprocessing. The company has launched nano-composite carbon-coatings for drug-eluting stents that are expected potentially to overcome the current issues surrounding polymer-coated stents, namely late thrombosis.

Instrumentation Laboratory, which is part of the CH-Werfen Group, is a manufacturer of in vitro diagnostic instruments, reagents, controls, consumables and services for use primarily in hospitals and clinical laboratories.

U.S. distribution accord for Dutch firm

King Pharmaceuticals (Bristol, Tennessee) and Gelita Medical (Amsterdam, the Netherlands) have entered into an agreement under which King received an exclusive license to distribute Gelita’s absorbable gelatin sponge in the U.S. Gelita will manufacture and supply the hemostatic product to King.

King’s Thrombin-JMI, a topical active hemostatic agent, is used by surgeons together with a variety of passive hemostatic agents, including absorbable gelatin sponges.

Absorbing 50 times their own weight, Gelita’s hemostatic products stop bleeding fast, generally within two minutes.

Brian Markison, president/CEO of King, said, “This transaction further enhances the wide array of hemostatic options that our hospital sales team of over 110 professionals can offer physicians for the purpose of controlling bleeding during surgery.”

King said it plans to begin marketing Gelita’s absorbable gelatin sponge in the U.S. after the product receives FDA approval for use during surgery. The license also provides King an exclusive option to acquire U.S. commercialization rights to any new hemostatic products developed by Gelita.