A Diagnostics & Imaging Week
Nanogen (San Diego) and Pathway Diagnostics (Malibu, California) said that they have entered into a non-exclusive, worldwide license agreement under which Nanogen will develop diagnostic products that detect genetic variations associated with responses to antidepressant and antipsychotic therapeutics.
The companies have begun work on developing a molecular diagnostic product that could be used to select the most appropriate drug and dosage for patients treated for psychiatric diseases. Specific financial terms of the agreement were not disclosed.
Although many therapeutic options are available for patients suffering from these conditions, for some patients the side effects of drug therapy can range from unpleasant to life-threatening, Nanogen said. Determining optimal drug regimens and dosing strategies are challenges that are currently addressed by trial-and-error prescribing practices.
Side effects may be caused by a variety of factors, including variations in genes that are targets of the drugs or are involved in drug response. In addition to the negative effect on an individual's health, the company said significant direct and indirect costs are associated with these adverse drug responses.
Howard Birndorf, Nanogen's chairman of the board and CEO, said, "Because our NanoChip platform can simultaneously analyze multiple genetic markers, we have the capability to develop a diagnostic panel to detect these newly licensed genetic variations, along with genes in the cytochrome P450 family that are related to drug metabolism, in order to allow the physician to prescribe the right drug at the right dosage."
Ciphergen Diagnostics, a division of Ciphergen Bio-systems (both Fremont, California), reported renewal of its multi-year accord with the Johns Hopkins University School of Medicine (Baltimore), aimed at the discovery of protein biomarkers in the field of cancer. The focus of the collaboration over the last five years has been to discover and validate new diagnostic biomarkers that may improve cancer detection, classify types of disease and provide disease monitoring.
This collaboration led to the publication, in August 2004 in Cancer Research, of a study describing the use of Ciphergen's PatternTrack approach to discover three protein biomarkers as the basis for a potential assay to detect early-stage ovarian cancer. The three biomarkers, when combined, were able to diagnose early stage (I/II) ovarian cancer with 74% sensitivity and 97% specificity.
Ciphergen will continue to provide financial support, technical assistance and access to advanced platforms through its Biomarker Discovery Center scientists. Johns Hopkins will continue to provide its resources, such as serum samples and its scientists' expertise.
Ciphergen said it would have access to the commercial rights of any discoveries made through the collaboration with Johns Hopkins.
Gail Page, president of Ciphergen's Diagnostics Division, said the partnership "will result in rigorously conducted research that can be translated into commercial products that will benefit patients and the healthcare system."
Ciphergen's Diagnostics Division is focused on discovering protein biomarkers and panels of biomarkers and their development into protein molecular diagnostic tests that improve patient care; and to providing R&D services through its Biomarker Discovery Center laboratories for new diagnostic tests and theranostic assays.
In other grants/contracts news:
Ikonisys (New Haven, Connecticut) reported the execution of two agreements that grant it license and supply rights to certain DNA probe technology for use with the proprietary Celloptics technology platform developed by Ikonisys.
The license agreement grants Ikonisys a worldwide license under Abbott (Abbott Park, Illinois) patents for the manufacture and sale of DNA probes in conjunction with Chromotest, a test for the prenatal diagnosis of chromosomal abnormalities using fetal cells from the maternal circulation.
The companies also signed a probe supply agreement granting Ikonisys rights to purchase from Abbott chromosome fluorescence in situ hybridization (FISH) probes in the fields of pre-implantation genetic diagnosis and automated detection in amniocytes of FISH signals of the most common chromosomal abnormalities.
Under the agreement, Ikonisys will pay Abbott an up-front, non-refundable license fee and royalties on commercialized kits. The supply agreement covers the terms under which Ikonisys will purchase probes from Abbott.
Ikonisys is developing products for diagnosing diseases early using chromosome FISH dot counting and rare-cell identification and analysis.
DMS Imaging (Minneapolis), a member of the DMS Health Group, said that it has signed a three-year agreement with VHA (Irving, Texas), which serves more than 2,200 healthcare organizations nationwide.
DMS Imaging will provide VHA members with mobile shared services imaging and interim rentals of mobile imaging products. The agreement, which took effect Feb. 15, includes MRI, computed tomography (CT), positron emission tomography (PET), PET/CT, nuclear medicine and ultrasound services.
DMS Interim Solutions places rental MRI, PET, CT and PET/CT systems on a short- or long-term basis during times of construction, scheduling backlog or other situations during which a temporary imaging system is needed.
DMS MedSource Partners provides an option for on-site permanently installed diagnostic imaging equipment. This agreement is for long-term services.
LifePoint (Ontario, California), a provider of non-invasive drug diagnostics and solutions, reported that the company would sub-license its exclusive rights to saliva-testing technology acquired from the U.S. Navy.
This strategy is in addition to completing "fixes" now under way with its current Impact system that are designed to enhance its marketplace capability, the company said.
LifePoint has developed an "on-site" diagnostic system using saliva rather than traditional blood or urine systems. LifePoint's system is based on a license of U.S. Navy patents for saliva-based "flow immunosensor" technology, providing it with exclusive rights to commercialize all saliva-based diagnostics using the technology.
"On the current product front, we intend to resolve the two or three most serious operational problems being experienced with the existing Impact system as quickly as possible," the company said. "Our goal is to provide existing customers and prospects with a testing system that provides more consistent and accurate results than the current product is providing ... [W]e are optimistic that satisfactory solutions will be found over the next few months. Beyond that, however, we intend to start leveraging our exclusive worldwide license rights to all saliva-based 'flow immunosensor' diagnostics."
ChondroGene (Toronto) reported receiving "a contribution" the amount not disclosed from the Canadian National Research Council's Industrial Research Assistance Program (NRC-IRAP) to support development of a blood-based molecular diagnostic assay able to detect early, asymptomatic osteoarthritis (OA), as well as stage its severity.
ChondroGene will use its Sentinel Principle to identify blood-based biomarkers that are associated with osteo-arthritis. Once validated, these biomarkers will form the basis of a diagnostic test.
Currently the treatments for osteoarthritis only target the symptoms of the disease, namely pain and inflammation, ChondroGene said. In the most severe cases, artificial joint replacement is the only treatment. Pharma companies are seeking to develop disease modifying osteoarthritis drugs (DMOADs) that will slow, stop the progression of disease or, ideally, reverse the process. These companies will require "a simple and effective way of detecting patients with early stage asymptomatic OA and monitoring the progress of disease during the development and clinical trials of DMOADs," the company said.
VirtualScopics (Rochester, New York), a provider of imaging solutions using biomarkers for pharmaceutical development, reported that it is providing analytical and imaging services to Wyeth Pharmaceuticals (Madison, New Jersey) for a Phase 1 clinical trial for a drug being studied as a potential treatment for muscle wasting.
VirtualScopics uses its suite of image analysis algorithms to detect and analyze biological structures from medical image data, such as computed tomography (CT) or MRI scans.
VirtualScopics' computer-assisted analysis technique is designed for faster, more reliable detection of disease progression or therapeutic benefit, accelerating the clinical trial process, and providing for future diagnostic applications, it said. Its algorithms process hundreds of medical images taken during an MRI or CT session into a single, anatomically accurate 3-D model, providing researchers a previously unobtainable source of reproducible data, including characterization of minute changes over time, according to the company.