A Diagnostics & Imaging Week

Orion Genomics (St. Louis) said it has initiated a collaboration with researchers at University of Glasgow (Glasgow, Scotland) to discover novel epigenetic biomarkers for the development of tests that screen for cancer at an early stage and provide personalized information about how tumors are most effectively treated.

Under the collaboration, scientists at Orion and the University of Glasgow will use the company's methylation technologies to identify biomarkers useful in the detection and treatment of cancers of the lung, breast and ovaries.

"DNA methylation-based diagnostics have the potential to substantially change the way physicians first diagnose and later treat cancer patients," said Professor Robert Brown, PhD, of the University of Glasgow. "We are excited to collaborate with Orion Genomics, whose microarray and PCR technologies are at the forefront for methylation analysis, both for marker discovery and for applying methylation diagnostics in a clinical setting."

The research will use Orion's DNA methylation technologies, including MethylScope microarrays and MethylScreen PCR assays. Methylation refers to naturally occurring chemical modifications of DNA that regulate gene function. Abnormal DNA methylation often is found on DNA from cancerous cells and is believed to impact a tumor's sensitivity to chemotherapeutic drugs.

The groups will compare patterns of DNA methylation from normal and tumor DNA to identify specific patterns of abnormal methylation that indicate the presence of cancer and provide information about its stage and type. Orion will develop diagnostics based on these patterns that detect trace amounts of methylated tumor DNA in easily accessed patient samples including blood serum, biopsies, and cell scrapes.

Nathan Lakey, CEO and president of Orion Genomics, said Brown is a leader in translation research. "Working together with clinical trial groups, ethics committees and with support from Cancer Research UK, [he] has carefully assembled tumor banks that will enable scientists in his lab, in collaboration with Orion, to find biomarkers for novel therapy selection and screening diagnostics and will expand Orion's exciting pipeline of diagnostic products."

Orion said its MethylScreen technology "leverages biomarkers discovered using [the] MethylScope technology to develop a new class of oncology diagnostic kits."

CE mark for CT/NG test

Abbott (Abbott Park, Illinois) said that its highly sensitive new test for the simultaneous detection of the sexually transmitted pathogens Chlamydia trachomatis (CT) and Neissera gonorrhoeae (NG) has received CE mark certification.

The test is designed for use on the Abbott m2000, an automated instrument using magnetic particle and real-time PCR (polymerase chain reaction) technology.

"Chlamydia and gonorrhea are the two most common sexually transmitted diseases in the world, and accurate detection of these infections is extremely important in order to avoid serious illness," said Edward Michael, president of Abbott Molecular. "The Abbott RealTime CT/NG assay combined with the automated Abbott m2000 system gives European laboratories an important new option for delivering highly reliable test results to patients quickly and efficiently."

Unlike conventional methods, amplified nucleic acid tests can be performed non-invasively on urine samples.

The Abbott RealTime CT/NG test will be offered in Europe by Abbott as part of its alliance with Celera Diagnostics (Foster City, California). The companies also will offer the Abbott RealTime CT assay, a real-time PCR test for the sole detection of Chlamydia trachomatis. Offered along with the tests will be the Abbott multi-Collect Specimen Collection Kit.

The Abbott m2000 system's test menu also includes real-time PCR tests for HIV-1 and hepatitis C virus. Abbott said additional tests are in development for the system, including methods for detecting hepatitis B virus. The company said it plans to submit the CT/NG test for U.S. regulatory approval this year.

Steen Solution gets CE mark

Vitrolife (Kungsbacka, Sweden) said it has obtained CE-mark approval for Steen Solution, a solution for functional testing and reconditioning of lungs outside the body before transplantation, which means that sales of the product in Europe can begin.

"The new method that has been developed means that the doctor can assess the suitability of the organ for donation after it has been taken from the donor in a way that was not possible previously. This in its turn means that the potential availability of organs that can be transplanted increases considerably," said CEO Magnus Nilsson.

Steen Solution enables heart-dead donors' lungs, or lungs from brain-dead patients that are initially assessed as "doubtful," to be tested outside the body for possible use.

The method was developed by Professor Stig Steen at University Hospital (Lund, Sweden) in collaboration with Vitrolife. "For people with severe lung disease, a group of patients that suffers greatly today, Steen Solution means a greater opportunity of receiving effective therapy," said Steen. Vitrolife said the new method for functional testing and preservation of lungs outside the body could in time lead to a five-fold to ten-fold increase in the number of lung transplantations carried out.

The company said it is the market leader within the area of lung preservation solutions with its Perfadex product, with more than 80% of all lung transplantations in the world performed using the product. Vitrolife has a U.S. subsidiary in Denver.

Anderson to head Vital Images Europe

Vital Images (Minneapolis), a provider of enterprise-wide advanced visualization and analysis solutions for use in clinical diagnosis and therapy planning, has named Stephen Andersen vice president of Vital Images Europe, effective March 1. He has served as vice president of engineering since January 2004.

Vital Images said it is in the process of selecting a site for its European office and expects to open the office by mid-year.

"Strong international sales growth, particularly through our distribution partnership with Toshiba Medical Systems, coupled with the opportunity to replicate the success we've had in selling and marketing throughout the healthcare enterprise in the U.S., are behind our decision to establish an office in Europe," said Jay Miller, president and CEO of Vital Images.

Through the first nine months of 2005, international sales contributed 17% of total company revenues, a 44% increase over the same year-earlier period.

"With more than 400 customers in Europe and a growing revenue stream, we have strong momentum in this market," said Andersen. "A European office will help us expand relationships with current customers and distribution partners, while establishing a direct sales presence for growing license and services revenue."

Andersen joined Vital Images in 1999 as an engineering program manager and has held positions of increasing responsibility. From January 2002 to January 2004, he served as senior director of quality and customer satisfaction.

Asian distribution accord for Ciphergen

Ciphergen Biosystems (Fremont, California) said it has signed an agreement for distribution of its products in China and other Asian markets.

The agreement with Techcomp (Holdings) Ltd. (Singapore) covers distribution of Ciphergen's ProteinChip family of products in China, Hong Kong, Singapore, Malaysia, Vietnam and Indonesia.

The two companies also have entered into a product development and manufacturing agreement for sample preparation technology and an associated device. The resulting product or products would be manufactured by Techcomp and sold by Ciphergen on a worldwide basis.

"We are delighted to be working with Techcomp to cover a market that clearly has significant potential for [us]," said Gail Page, Ciphergen's president and CEO. "Techcomp has a proven capability in these territories in distributing and servicing analytical instruments, life science instrumentation and laboratory equipment for other companies. In addition, they are a proven original design manufacturer for international companies and under their own brand for the Chinese market."

Richard Lo, president of Techcomp, said, "We believe that there is a significant market opportunity in China for the ProteinChip technology and with our wide coverage of the Chinese customer base we are confident we can contribute to the success of Ciphergen."

Ciphergen is focused on the discovery of protein biomarkers and panels of biomarkers and their development into protein molecular diagnostic tests, as well as on providing collaborative R&D services through its Biomarker Discovery Center laboratories for biomarker discovery and pharmacoproteomic services for improved drug toxicology, efficacy and theranostic assays.

Its ProteinChip systems enable protein discovery, validation, identification and assay development to provide researchers with predictive, multi-marker assay capabilities and a better understanding of biological function at the protein level.

Synova inks Israel supply accord

Synova Healthcare (Media, Pennsylvania), a subsidiary of Synova Healthcare Group, reported entering into an exclusive five-year distribution and supply agreement with Common Sense, an Israeli developer of diagnostic products for women's healthcare. Common Sense will supply Synova with products utilizing its technology, which will complement Synova's developing female healthcare lines.

Synova's current products, Menocheck and MenocheckPro, are over-the-counter and point-of-care/professional use non-invasive diagnostic tests used to detect the onset of menopause. In early 2006, Synova said it plans to utilize the Common Sense technology to introduce a non-invasive at-home test that will indicate whether users need to seek professional care for infections such as bacterial vaginosis or Trichomonas. Synova recently announced similar plans for the introduction of an infertility diagnostic, and also continues to develop a novel, non-invasive fetal monitor.

Synova CEO Stephen King said, "We look forward to continuing our commitment to our customers and shareholders, by delivering a portfolio of leading-edge products to both the retail and professional point-of-care marketplace, through collaboration with valued research and development partners like Common Sense."

Given gets reimbursement in Czech Republic

Given Imaging (Yokneam, Israel) said the Ministry of Health of the Czech Republic has issued a reimbursement policy for PillCam SB capsule endoscopy. The decision is effective immediately and provides reimbursement for some 7 million Czech citizens who are covered by the Vseobecna zdravotni pojistovna insurance company.

The policy covers reimbursement of PillCam SB for suspected small bowel disease, including bleeding, tumors and inflammatory bowel disease following a negative gastroscopy or colonoscopy. About 115 million Europeans now have access to PillCam SB capsule endoscopy.

"[This] reimbursement reflects growing recognition in European countries of the important role that PillCam SB plays in detecting and monitoring diseases of the small bowel," said Gavriel Meron, president and CEO of Given Imaging. "We continue to work closely with officials from the ministries of health in those countries where PillCam is not yet reimbursed and anticipate additional policies to be issued in 2006."

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