A Diagnostics & Imaging Week
Illumina (San Diego) and Mayo Clinic (Rochester, Minnesota) reported signing an agreement for the co-development of molecular diagnostic tests for the study of complex diseases.
Illumina will contribute its VeraCode technology and development expertise for the BeadArray and BeadXpress instrument platforms. Mayo will provide its knowledge in clinical practice and patient outcome management, along with proficiency in establishing clinical utility of new diagnostic technologies. In addition, Mayo’s ability to discover and validate biomarkers offers the potential for both parties to implement important new clinical tests, the organizations said.
Terms of the agreement enable the implementation of new clinical tests within Mayo’s clinical practice and Mayo Medical Laboratories. Additionally, Illumina will manufacture and market tests worldwide on its BeadArray and upcoming BeadXpress Reader.
In other agreements news:
• diaDexus (South San Francisco), a privately held biotechnology company, reported a collaboration with Mayo Validation Support Services of the Mayo Clinic (Rochester, Minnesota) to investigate a test featuring a select panel of tumor-specific genes to aid in patient risk stratification and assist in chemotherapy treatment decisions for breast cancer patients. The test uses gene expression profiling to predict recurrence of malignancy in patients diagnosed with primary invasive early stage breast cancer.
Previous study data presented by diaDexus at the 2005 San Antonio Breast Cancer Symposium demonstrated that a set of eight genes were differentially expressed in patients who presented with progressive disease, compared with those who were disease-free after a median follow-up of 70 months, suggesting that the PCR-based test involving these genes warrants additional investigation into its utility in identifying patients at higher risk for recurrence.
The Mayo collaboration is part of diaDexus’ molecular diagnostics program focused on developing tests to aid in the prognosis and staging of breast, colorectal, and prostate cancers.
• eGene (Irvine, California), developer of a genetic analysis technology, reported that it has entered into a distribution agreement with Fisher Scientific, Canada, part of Thermo Fisher Scientific (Waltham, Massachusetts), to promote and sell eGene’s HDA-GT12 system in Canada.
Thermo Fisher focuses on providing analytical instruments, equipment, reagents and consumables, software and services for research, analysis, discovery and diagnostics.
eGene focuses its core technologies of capillary electrophoresis, microfluidics, liquid handling and automation to develop and manufacture low-cost microfluidic, miniaturized digital genetic analyzer systems, software and consumables for biological materials testing applications.
The products are designed to detect, quantify, identify and characterize DNA and RNA at high rates of specificity and sensitivity while automating routine and non-routine laboratory and industrial procedures critical to product safety, development quality and productivity, the company said.
• Arrhythmia Research Technology (ART; Fitchburg, Massachusetts) reported that its wholly owned subsidiary, Micron Products, has entered into a three-year supply agreement with the Molecular Diagnostics division of Osmetech (Atlanta). Micron, through its New England Molders division, will provide manufacturing services for consumables components used in Osmetech’s Opti Tube and Opti Gene product lines.
The Opti Tube product line consists of patented plastic tubes with ergonomic sealing caps and carousel which have been designed as a replacement for the glass capillaries which are used in the Roche LightCycler. Opti Tube is an robust alternative solution designed to eliminate the dangers of glass breakage and minimizes the risk of laboratory personnel exposure to potentially dangerous samples and glass shards.
Osmetech’s Opti Gene instrument is specifically designed to meet the requirements of the molecular diagnostic market in the small to medium sized hospital. This product is designed to enable simple and more complex molecular diagnostic tests to be performed accurately in a cost effective and easy to use format and meet the increasing demand for genetic tests to improve disease management.
ART, through Micron, makes silver plated and non-silver plated conductive resin sensors and distributes metal snaps used in the manufacture of disposable ECG, EEG, EMS and TENS electrodes. Micron’s NEM division manufactures custom injection molded products for medical, electronic, industrial and consumer applications. Micron’s MIT division provides end- to- end product life cycle management through a comprehensive portfolio of value-added services such as design, engineering, prototyping, manufacturing, machining, assembly and packaging.
Osmetech is an international diagnostics business with operations in Atlanta, Boston and Pasadena, serving the near-patient testing market and targeting small to medium sized hospitals. Osmetech has launched eSensor, an FDA-cleared electrochemistry-based array system, for Cystic fibrosis carrier detection and it said it will launch a number of pharmacogenomic assays utilizing proprietary technology in the near future.