A Diagnostics & Imaging Week

Affymetrix (Santa Clara, California) and Vanderbilt-Ingram Cancer Center (Nashville, Tennessee) reported that they have entered into a three-year translational research collaboration to analyze genomic information across a large number of patient samples.

Researchers at Vanderbilt-Ingram and Vanderbilt University Medical Center will use Affymetrix GeneChip microarray technology to develop new applications for translational research projects, focusing on disease areas such as cancer and HIV/AIDS.

“Cancer is a genetic disease. The technological capabilities that Affymetrix provides in gene expression and genotyping provides an important set of tools to examine the molecular and genetic basis of cancer,” said Shawn Levy, PhD, assistant professor of biomedical informatics and director of the Vanderbilt Microarray Shared Resource. “This partnership provides a mechanism to bring these technologies to the forefront of translational research in helping Vanderbilt understand not only the molecular basis for the disease but also the genetic disparities in various cancers and responses to therapy.”

The HIV/AIDS translational research project will aim to help clinicians avoid the often irreversible and costly complications of therapy. The Affymetrix Human Mitochondrial Resequencing Array 2.0 will be used as a research tool to identify genetic variants that may make some patients more susceptible to adverse effects of certain drugs.

Affymetrix collaborates with academic institutions, advocacy groups and the pharmaceutical and diagnostics community through its Translational Medicine Program to develop molecular signatures for improving patient care.

In other agreement news:

• Roche Diagnostics (Indianapolis) and Protedyne (Windsor, Connecticut), a company offering industrial robotic solutions, said they have integrated their technologies to provide a rapid, completely automated solution for high-throughput quantitative PCR applications.

Roche’s LightCycler 480 Instrument is a 96- or 384-well, plate-based quantitative polymerase chain reaction (PCR) instrument. The LightCycler 480 is a platform for gene-expression and mutation analysis. The LightCycler 480 Instrument builds upon the sensitivity and accuracy of the well established LightCycler System, and now enables rapid high throughput quantitative PCR.

Protedyne’s Radius is a new benchtop robotic system using the principles of industrial automation designed to offer flexibility, reproducibility, and process control for today’s laboratories, the companies said. Its radial design and vertical construction provide maximum functionality that can access areas of the bench top beyond its own footprint for simple and cost-effective device integration. The Radius system uses Protedyne’s software that easily adapts to multiple protocols — and SmartTools, easily interchangeable tools with built-in microprocessors that store tool calibration information and track performance data.

• Novadaq Technologies (Toronto), a developer of imaging systems for the operating room, said that it has ended its distribution partnership with CarboMedics (Austin, Texas), a member of the Sorin Group (Milan, Italy). The action became effective Dec. 31, 2006, representing the final step in Novadaq’s strategy to establish a dedicated direct sales organization, it said.

The termination of these arrangements will not require any significant net payment from one party to the other, Novadaq said.

In December, Novadaq hired 12 sales representatives to represent the SPY Intra-operative Imaging System (SPY system) throughout the U.S. The newly hired sales team will partner with Novadaq’s 12 existing clinical educators to drive SPY system sales and product adoption across the U.S. Both companies are currently working together to achieve a smooth transition of sales responsibility for current and future SPY customers from the CarboMedics sales organization to the Novadaq direct sales team.

Novadaq said that in December it also secured 12 additional purchase orders for SPY systems, which are being installed during the month of January bringing the number of systems installed in the U.S. to 67. Additional purchase orders have been received in January and will be reported later as part of the 1Q07 results.

• Sequenom (San Diego) and Lenetix Medical Screening Laboratory (Mineola, New York), a provider of genetic screening and diagnostic testing for clinicians worldwide, reported that they have entered into a collaboration-and-license agreement to develop and commercialize a non-invasive prenatal Rhesus D (RhD) incompatibility test based on Sequenom patent rights and RT polymerase chain reaction methodology.

Financial terms of the agreement were not disclosed.

The RhD test, Sequenom’s first non-invasive prenatal test, is expected to be marketed as a “home brew” test in the U.S. in the first half of this year.

“The non-invasive characterization of fetal Rh genotype and other fetal genetic information has the potential to transform the practice of prenatal risk assessment,” said Leonard Kellner, president of Lenetix. “This new approach to non-invasive evaluation of a baby in utero is a very exciting scientific and commercial development, and may significantly reduce the need for invasive fetal diagnostic tests such as amniocentesis or chorionic villus sampling.”

RhD blood group incompatibility between a pregnant woman and her fetus is a significant health problem due to the possibility of maternal alloimmunization and consequent hemolytic disease of newborns. Although the pregnancy in which alloimmunization first occurs in an unaffected child, future children are at substantial risk of anemia and, in the worst cases, fetal death. In the U.S. alone, RhD incompatibility occurs in more than 10% of all pregnancies, translating into more than 400,000 cases of RhD incompatibility annually.

“This collaboration marks a significant milestone in our strategy to commercialize non-invasive prenatal diagnostic tests and we believe Lenetix’s quality reputation and established position in prenatal testing will provide a solid foundation for our market entry,” said Harry Stylli, PhD, president/CEO of Sequenom. “We expect physician and patient adoption of the RhD test could pave the way for greater acceptance of our broader portfolio of non-invasive prenatal diagnostic tests in development.”

• iCardiac Technologies (Rochester, New York) said it has entered into a multi-year research alliance with Pfizer (New York) to develop and validate advanced ECG-based cardiac safety biomarkers using the COMPAS technology platform.

iCardiac will receive an equity investment and technology license payment, plus research and development funding over the term of the alliance. The company will retain commercial rights to the validated technology platform and new biomarkers for future application in cardiac safety clinical trials and technologies.

The COMPAS technology was developed within the University of Rochester’s Heart Research Follow-Up Program — a group of electrocardiology researchers focused on the ventricular repolarization process of the heart — and exclusively licensed to iCardiac.

The aim of the research alliance is the further development of iCardiac’s COMPAS platform and advanced ECG markers for use in the safety testing of in-development and on-market drugs, and includes a cross-licensing arrangement by which iCardiac will receive rights to ECG analysis technologies developed within Pfizer.

Under the terms of the agreement, iCardiac and Pfizer will collaborate on a research program comprised of a series of studies, including retrospective and prospective ECG data analyses.