A Diagnostics & Imaging Week

Oxford Gene Technology (OGT; Oxford UK), St. George’s University of London and St. George’s Healthcare NHS Trust reported signing a collaboration to develop a single-platform microarray to diagnose multiple sexually transmitted infections (STIs).

The collaboration between OGT and St. George’s aims to develop a diagnostic with the capacity to detect the DNA of many sexually transmitted pathogens in one specimen from infected people.

The microarray test aims for more comprehensive and accurate diagnoses with accurate same-day results. The array technology lends itself to the development of point-of-care testing for multiple STIs combined with the highest standards of accuracy.

The parties said the STI diagnostic microarray is a “timely investment in new gene technologies that directly address the emerging crisis of STIs in the UK.”

Dr. Tariq Sadiq, senior lecturer and consultant genitourinary physician at St. George’s, said, “The incidence of STI continues to rise and is challenging our ability to provide care for our patients, directly costing the NHS in excess of 1 billion a year. As more responsibility for this care falls on settings such as GP practices, community-based sexual healthcare providers and even high street pharmacies, concern exists for the need to maintain high standards of diagnostic accuracy while also recognizing the increasing role of many infections not traditionally tested for.”

Diagnostic DNA microarrays, or “gene chips,” have been pioneered by the research team of Professor Philip Butcher, of St. George’s University of London, for bacterial and viral pathogen detection, exploiting expertise in bacterial microarrays built up by the Wellcome Trust (London).

In partnership with St. George’s clinical and microbiology expertise, OGT will design and develop the high-quality optimized 60 mer oligonucleotide microarray using its ink jet in situ synthesis platform and also will investigate the use of its Multi Sample Array format, enabling the parallel analysis of multiple samples. This will aim to reduce the cost per sample and provide a rapid diagnostic result, the company said.

Dr. John Anson, R&D director at OGT, said, “OGT’s microarray technologies will provide a nucleic acid-based tool which, coupled with PCR [polymerase chain reaction] amplification, is aimed at producing a diagnostic test to improve the detection range, accuracy and the speed of STI diagnosis to meet clinician’s needs.”

The project will be jointly funded by the Heptagon Proof of Concept Fund and OGT and will last a year in the first phase. By the end of this period, the team hopes to have a prototype which will then be validated using clinical samples.

Collaboration set on image analysis

Transinsight (Dresden, Germany) has entered into a three-year collaboration with the Max Planck Institute of Molecular Cell Biology and Genetics (MPI-CBG; also Dresden) in the area of knowledge-based image analysis.

Transinsight is a software company that provides products and solutions for knowledge-based technologies in the life sciences.

Its flagship product, GoPubMed, a biomedical search engine, will be extended towards biomedical image search and knowledge-based image recognition. Particle-tracking imagery produced by high-throughput microscopy will be a focus in the upcoming years.

“The extraordinary scientific work performed at the MPI-CBG by Dr. Yannis Kalaidzidis in the area of particle tracking is an ideal start for collaboration. The close-to-practice testing of our developments at the MPI-CBG is an invaluable advantage for us,” said Dr. Michael Alvers, co-founder and CEO of Transinsight.

Dr. Ivan Baines, who fostered the collaboration and outlined the three-year agreement, said, “This kind of research/industry collaboration allows us to influence developments towards our needs. With Transinsight, we will develop a far more flexible and powerful application that will help solve problems beyond that for which it was originally developed.

Verax in manufacturing pact with BBI

Verax Biomedical (Worcester, Massachusetts), a developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has signed a 10-year agreement with British Biocell International (BBI; Cardiff, UK) to manufacture the Verax Platelet PGD Test. British Biocell could produce as many as 50 million tests and will establish a second manufacturing facility to handle Verax production.

Verax said the agreement comes in anticipation of strong worldwide demand for the Platelet PGD (Pan Genera Detection) test and follows its recent unveiling of an exclusive worldwide distribution agreement with Abbott Diagnostics (Abbott Park, Illinois) to market and distribute the test, which is currently being evaluated in clinical trials.

The Platelet PGD Test is a disposable device designed to detect the presence of bacterial contaminants in platelets — which Verax said is the single greatest infectious risk in transfusion medicine — just prior to transfusion.

An estimated 10 million platelet units are transfused each year into patients in North America, Europe and Asia, and the company said experts estimate as many as 1 in every 2,000 units could be contaminated with bacteria. Current culture-testing methods, it said, miss as much as half of all bacterial contaminations and take up to three days before results are available.

In comparison, the Verax Platelet PGD Test is designed to produce results in less than 30 minutes, and targets all species of bacteria known to cause diseases in humans.

Clinical trials of the test are under way at University Hospitals Case Medical Center and the Cleveland Clinic (both Cleveland) and Dartmouth Hitchcock Medical Center (Lebanon, New Hampshire).

“We anticipate tremendous demand for our Platelet PGD Test because it cuts the detection time for bacterial contamination to just 30 minutes,” said Verax CEO Jim Lousararian. “This could be the key to detecting contaminated platelet units missed by current culture-based testing techniques.”

He said his company needed “a seasoned contract manufacturing partner” like British Bioicell that can meet this demand. “Because of its potential to reduce infection and fatalities after platelet transfusions, we believe the PGD Test will become an indispensable tool for hospitals around the world,” said Julian Baines, managing director of British Biocell. “We are so confident in the success of the Verax PGD Test we are adding a second manufacturing facility to meet demand.”

Affymetrix, Sysmex in distribution, other accords

Affymetrix (Santa Clara, California) said it has signed two agreements with Sysmex (Kobe, Japan) to distribute, develop and market in vitro diagnostic tests. Sysmex has exclusive rights to distribute Affymetrix’s diagnostic microarray products and instrumentation in Japan, with the opportunity to expand into certain Asia-Pacific countries.

In addition, a Powered by Affymetrix agreement gives Sysmex non-exclusive access to Affymetrix microarray technology to develop and market in vitro diagnostic tests on a worldwide basis.

Sysmex will carry out all registration, sales and customer support activities for the diagnostic instrumentation, array and reagent products as the Affymetrix distributor in Japan.

The Japanese company globally markets diagnostic systems for hematology, coagulation and immunochemistry testing and recently launched a system for detection of breast cancer lymph node metastasis.

The Powered by Affymetrix agreement enables Sysmex to incorporate Affymetrix arrays into its diagnostic products. The companies said that the resulting microarray-based tests will enable clinicians to provide more efficient and complete methods to diagnose, classify and manage these disorders.

The Affymetrix line of products includes the GeneChip System 3000Dx (GCS3000Dx), which it calls the first microarray instrumentation system for molecular diagnostic laboratories. The GCS3000Dx has been granted regulatory clearance by the FDA and is CE-marked for in vitro diagnostic use.

Affymetrix and its Powered by Affymetrix partners are developing array-based tests for use with this system.

Bruker sets AXS unit for Australia

Bruker Biosciences (Billerica, Massachusetts) said it was set to launch a new Bruker AXS (Madison, Wisconsin) business in Australia Jan. 1.

Bruker AXS is a developer and provider of life science, materials research and industrial X-ray analysis tools and has previously been represented in Australia by its longstanding distributor, Sietronics.

The company’s AXS business unit is being established with headquarters in Melbourne to take it forward in the Australian market with a large installed instrument base and the Bruker AXS brand name.

To ensure continuity for existing customers, Bruker AXS said it has secured business management and service resources from the former distributor. With trained personnel as a result of these recruitments, the company, based in Western Australia, Victoria and New South Wales, will deliver support to its existing customers and will grow its presence in the rapidly expanding X-ray diffraction, X-ray fluorescence and optical emission spectrometers markets.

“After many years of excellent representation by Sietronics, we are delighted to be able to expand our presence directly in the Australian market. We have ensured that our large range of innovative industrial and academic XRD, XRF and OES products are backed by first-class local service and application support and we believe that our direct commitment to the Australian market will yield increased customer satisfaction and market share,” said Bernd Masling, sales director of Bruker AXS.

Emergo Group to help Ciphergen in Europe

Ciphergen Biosystems (Fremont, California) said that it has engaged Emergo Group (Austin, Texas) to help gain regulatory clearance of Ciphergen’s ovarian tumor triage test in various European countries.

“Having obtained positive preclinical data in our ovarian cancer diagnostic program in studies performed with samples from European patients, we are seeking to rapidly pursue registration and commercialization of our ovarian tumor test in Europe,” said Gail Page, president and CEO of Ciphergen. “The Emergo Group has an outstanding reputation that fits our efforts to move quickly to commercialize this test in at least one European country in 2007.”

Emergo Europe (The Hague, the Netherlands), a medical device consulting firm, will register Ciphergen’s in vitro diagnostics through the regulatory agencies in each country and provide consulting support on product packaging and labeling. Emergo is an International Standards Organization.

Ciphergen has developed a panel of biomarkers that provides risk stratification information for ovarian cancer based on a series of studies involving more than 2,000 clinical samples from multiple sites. It is undertaking a prospective clinical trial to support submission to the FDA for clearance as an in vitro diagnostic.

The company, along with scientific collaborators from various institutions, has ongoing diagnostic programs in oncology, cardiology and women’s health, the latter with an initial focus in ovarian cancer.

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