May 2010: Volume 36, Number 5

DNA microarrays produced by Agilent Technologies now meet the international quality management system requirements, ISO 13485. The microarrays are used to study gene expression and copy number variations, and to perform comparative genomic hybridization analyses. “Agilent has always emphasized quality in the manufacture of microarrays, and we’re very pleased to be adding the validation of an ISO 13485-registerd QMS on top of our existing ISO 9001 standard,” said Robert Schueren, Agilent vice president and general manager of Genomics and Life Sciences Reagents. The certification will help the company pursue FDA clearance for a cytogenetic device based on the microarray platform.

The PROOF Centre of Excellence, a Canadian not-for-profit organization, has joined forces with Luminex to create tests using biomarkers that will help gauge immune system rejection of kidneys and hearts in transplant patients. Composed of stakeholders from industry, academia, healthcare, government, and the public, the Centre has discovered and internally validated blood-based proteomic and genomic biomarker tests to diagnose and predict allograft immune rejection in heart and kidney transplantation. In the collaboration, Luminex will further develop these tests and clinically validate them on the xMAP technology platform. The new tests could help reduce the need for expensive and invasive post-surgery biopsies and reduce the burden of transplantation costs on the healthcare system by enabling earlier intervention and by personalizing patients’ immunosuppressant therapies.

“By guiding the need for biopsy tests with a reliable, quantitative blood biomarker test that measures proteins or genes in the blood, we can provide less expensive, better care while gaining insights into the biology of rejection or immune accommodation,” said Bruce McManus, director of the Proof Centre of Excellence.

CancerGuide Diagnostics now has exclusive commercial rights to validated molecular signatures that predict patient response to different therapeutics under a multi-year license and research collaboration with Duke University. The company intends to use these technologies with its pharmaceutical clients to improve the efficiency of the drug development process and to develop and commercialize novel clinical diagnostics with LabCorp.

“CancerGuide has begun building a well-characterized genomic knowledge database compiled from years of clinical studies,” said Geoffrey Ginsburg MD, PhD, director of the Center for Genomic Medicine in the Duke Institute for Genome Sciences & Policy. “This tool, coupled with expert consultation by two of the foremost, pioneering scientists in the cancer genomic field, will give drug developers the highest level of actionable data and precision to enhance the likelihood of clinical success of their targeted therapeutic.”

Founded in 2006, CancerGuide has focused on developing and commercializing novel molecular diagnostic assays for personalized medicine. Earlier this year, the company completed a strategic license and commercialization agreement with LabCorp to develop molecular oncology assays. “CancerGuide now has access to a suite of compelling technologies and knowhow that has potential to guide therapy selection decisions for clinicians and provide highly needed predictive tools for drug developers in the coming years,” said Myla Lai-Goldman, MD, CancerGuide CEO.

Gen-Probe filed a lawsuit against Becton-Dickson for patent infringement regarding the BD MAX nucleic acid testing system, previously known as the HandyLab Jaguar system. The suit, filed on March 23rd in the U.S. District Court for the Southern District of California, alleges that BD, which purchased HandyLab, Inc. in 2008, was aware of the patents, yet “manufactured, distributed, and sold those nucleic testing systems and companion assays specifically for uses that practice” the patents. The BD Max system is a single automated system that includes sample preparation, nucleic acid extraction, microfluidic real-time PCR amplification, and detection. A separate patent-infringement lawsuit filed by Gen-Probe against BD in October of 2009 similarly asserted that BD knowingly infringed on Gen-Probe’s patents for its Viper with XTR technology and ProbeTec molecular diagnostic systems used for STD testing. Gen-Probe is seeking damages.

Northrop Grumman and Luminex have teamed up to create a fully autonomous biological detection system that will monitor the air for potentially hazardous biological agents. The new system will use Luminex’s xMap Technology, which allows simultaneous testing for multiple agents in a single sample. “Luminex’s xMAP Technology gives us a cost-effective, flexible capability that can quickly and accurately detect multiple biohazards at once,” said David Tilles, vice president of CBRNE Defense at Northrop Grumman's Advanced Concepts & Technologies Division. “This flexibility allows us to meet today's requirements and to adapt to future threats that may emerge.”

The companies intend for the biological detection system to act as an alert to authorities. When completed, it will be reviewed by the U.S. government. “We are delighted to be collaborating with Northrop Grumman, a leader and innovator in the global security market,” said Patrick J. Balthrop, president and CEO of Luminex Corporation. “The capabilities of our xMAP Technology are highly suited to applications such as monitoring for harmful pathogens where speed, accuracy and definitive, actionable answers are paramount.”

Prometheus Laboratories, a specialty pharmaceutical and diagnostic company, and Bayer Schering Pharma AG will collaborate on a proprietary oncology diagnostic platform that will help select appropriate drug candidates for patients. Using Prometheus’s diagnostic platform, Bayer Schering Pharma will analyze the expression level and activation status of tumor targets serving as biomarkers in both preclinical and clinical studies for patient stratification. “A functional pathway analysis based on Prometheus’s oncology diagnostic platform could allow a comprehensive analysis of the tumor, patient stratification, and the efficacy predictability of not only individual targeted cancer therapeutics, but also of most effective treatment combinations,” said Andreas Busch, head of Global Drug Discovery and member of the Board of Management at Bayer Schering Pharma. “Developing such a diagnostic tool constitutes a significant step toward personalized medicine in cancer treatment, and we are convinced that this will increasingly become the standard of clinical care in oncology.”

Under the terms of the agreement, Prometheus will receive an upfront payment, research and development support, and testing fees, as well as potential additional payments if certain development milestones are reached. Prometheus will be eligible for milestone payments of up to $160 million depending on the number of drug candidates successfully developed.