A Diagnostics & Imaging Week

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.”

Canadian license for portable scanner

NeuroLogica (Danvers, Massachusetts), a neuroscience-based medical imaging company, said that its CereTom portable computed tomography (CT) scanner has received the Canadian Medical License. The approval will allow entry of the cordless scanner into hospitals, walk-in clinics and private-practice medical offices throughout that country.

“This is a major accomplishment for our company, and it will allow us to further our mission of bringing greater access globally to quality, mobile neuro-imaging,” said Eric Bailey, president and co-founder of NeuroLogica. “Hospitals in Canada will have access to more rapid scans for critical patients as [our] portable CT scanner will ultimately improve patient care.”

The CereTom is now installed at 30 hospitals and medical centers across the U.S. and Europe, and NeuroLogica said it will next apply for the appropriate certification required for global distribution, including Japan, China, Hong Kong, South Korea and India.

Singapore distributor buys Biofield systems

Biofield (Philadelphia) said that a Singapore distributor has ordered the Biofield Diagnostic Electropotentials System and three cases of sensors, representing enough complete sets for 600 exams. The company said the distributor — not named — is an industry leader in biomedical engineering and serves all the major medical centers and hospitals in Singapore.

Biofield said it believes that other orders will follow from this and other purchasers in Asia, Latin America and other parts of the world, based on existing marketing efforts. Biofield also will provide training and other services.

Each case contains sensors for tests on 200 female patients. Each test requires a set of 18 individual single-use sensors. Depending on the test results, a female patient may need to undergo several tests a year.

Biofield said there are “great opportunities” for its technology in Singapore, which has 1.75 million women ages 15-64.

Biofield is focused on the development of noninvasive diagnostic medical devices to assist in detecting breast cancer. The Biofield Diagnostic System employs single-use sensors to measure and analyze changes in cellular electrical charge distributions associated with the development of epithelial cancers, such as breast, ovaries, skin, prostate and colon cancers. The device is intended to diagnose palpable breast lesions in women under 55.

Accord signed on fluorescent reagents

AbD Serotec, a division of MorphoSys (Munich, Germany), and Thermo Fisher Scientific (Waltham, Massachusetts) have signed an agreement covering the use of Thermo Scientific’s DyLight Dyes in combination with AbD Serotec’s research antibodies to prepare a series of fluorescent reagents.

The resulting products will be available through the AbD Serotec sales catalog. Financial details of the accord were not disclosed.

“Fluorescent antibodies are particularly suited for detection of specific antigens in tissues or on cells and have become an indispensable tool for scientists worldwide,” said Dr. Achim Knappik, senior director of R&D at AbD Serotec.