Breast cancer diagnostic development stepped up
Ciphergen Biosystems, Inc. announced today that it is launching a formal breast cancer diagnostic development program based on a series of discoveries made using Ciphergen’s surface enhanced laser desorption/ionization (SELDI) technology and PatternTrack™ biomarker discovery process. Two prospective breast cancer biomarkers (namely, complement protein C3a and breast cancer marker one [BC1]) have been identified and validated by two studies published this month. Ciphergen plans to expand its breast cancer diagnostic development program based on these promising results; Ciphergen has recently collaborated with University College of London (UCL) and UCL BioMedica Plc., to carry out analysis of samples collected from 200,000 women for breast and ovarian cancer. This is expected to complement the existing collaboration with Johns Hopkins School of Medicine.
“Only 63% of breast cancers are localized at the time of diagnosis. Ideally, most women would prefer a simple blood test that would measure molecular markers for the presence of an early lesion. We are planning multisite studies to validate several candidate biomarkers that could form the basis of a multimarker assay to detect ductal carcinoma in situ, since the majority of women diagnosed at this stage can be cured. Our goal is to develop a blood test that can be used in combination with sophisticated imaging techniques to improve the diagnosis of breast cancer,” said Gail S Page, President and Chief Operating Officer of Ciphergen Biosystems, Inc.
Over the past few years, there have been notable studies utilizing SELDI time-of-flight mass spectrometry in diagnostic and prognostic areas of breast cancer research. While the development of biomarkers robust enough to meet the requirements for a diagnostic assay has driven extensive research over the past 20 years, recently, the repeated discovery (overlap) of candidate biomarkers from independent studies is leading Ciphergen and its collaborators to embark upon an expanded development program aimed at understanding the specific biologic pathways of early breast cancer and development of diagnostic and prognostic assays.
Real-time molecular flu assay completes validation
Prodesse have announced that Lahey Clinic (Burlington, MA) has completed validation of Prodesse’s ProFlu-1™ assay. Lahey Clinic plans to use ProFlu-1 instead of traditional culture techniques for detection of respiratory viruses. ProFlu-1 is a multiplex, real time PCR assay that, from a single sample, can simultaneously detect and differentiate three of the most important respiratory viruses (Influenza A, Influenza B and RSV) in less than 2 h. Released in August in a one-step reverse transcriptase reverse transcriptase-PCR format, ProFlu-1 requires minimal hands-on time, making it ideal for even the largest laboratories.
Steve Cook, Manager of the Molecular Diagnostics Laboratory, stated “We recently presented a poster at the 21st Clinical Virology Symposium, showing that ProFlu-1 is more sensitive and much more rapid than viral culture techniques. As a result, we plan to replace cell cultures with ProFlu-1 as our definitive influenza test during the upcoming Flu season. We are pleased that our clinicians and, ultimately, our patients will receive the benefit of much faster and more accurate test results.”
The traditional gold standard, culture, can take as long as 2 weeks and is less accurate. Many laboratories are considering switching from culture to molecular assays for infectious disease detection because molecular assays have been conclusively proven to be more sensitive and much faster. In addition, with concerns about avian influenza and the recent announcement by the Department of Health and Human Services that if avian influenza becomes pandemic then culturing for respiratory viruses will be highly restricted, molecular assays such as ProFlu-1 present the only alternative that offers sufficient accuracy.
Pap test given go-ahead in another UK region
TriPath Imaging, Inc. has announced that Medical Solutions plc, its licensed distributor in the UK, has been awarded a 5-year contract to supply the SurePath™ liquid-based Pap test to the South Yorkshire Cytology Trusts.
“We are very pleased that the UK continues to adopt the SurePath liquid- based Pap test,” said Ray Swanson, Senior Vice President of Commercial Operations of TriPath Imaging. “With this contract, we now have cumulative commitments that represent nearly 36% of the market in the UK, 38% in England and Wales. We expect to continue to grow our opportunity in the UK as other regions finalize their decisions.”
Renal cell carcinoma biomarker foray launched
FALCO biosystems Ltd. and PPD, Inc. today announced they have signed an agreement under which PPD’s biomarker discovery sciences group will seek to discover and validate biomarkers that may lead to the development of a diagnostic test for renal cell carcinoma.
Under the terms of the agreement, PPD will apply its proprietary, integrated platform for proteomics, peptidomics and metabolomics, using unique samples obtained from a clinical study designed to optimize discovery of useful biomarkers for renal cell carcinoma. PPD’s technology allows for the identification of biomarkers that may have a useful role in disease detection and in the evaluation of therapeutic response. PPD will own any intellectual property derived from these analyses, and FALCO will receive an exclusive license to use such intellectual property in specified countries.
Innovative new assays for measurement of in vivo cartilage dynamics
KineMed, Inc., a platform-based indications discovery and development drug company, have announced the presentation of two posters detailing results from a new product program. KineMed’s proprietary in vivo KineMarker™ assays provide new, sensitive and high-throughput measures of several key pathways involved in the pathogenesis and treatment of degenerative joint conditions. These assays can be used in clinical as well as preclinical settings.
KineMed’s Cartilage Matrix KineMarkers are much more sensitive, reproducible and high-throughput than traditional methods such as histologic staining.
Dubai regulations lead to visitor testing deal
Medical Services International Inc. is pleased to announce that it has received an order from a Dubai-based company for 1,000,000 VScan test kits to be delivered during 2006. This order will generate revenues for the Company in excess of US$2,900,000 during this period.
According to the Dubai company, based on anticipated changes to the regulations allowing visitors into the country, there is a possibility that this order will be increased significantly. Medical Services is confident that its production facilities can handle any increased volume. The majority of the kits ordered will be the VScan HIV kits; the ease of use and accuracy (especially with whole blood) were the reasons the company received the order. The VScan rapid test kit is a single-use, disposable, accurate, cost-effective and easy-to-use test for the screening of HIV1 and 2, Hepatitis B and C, Tuberculosis, Dengue fever, West Nile, syphilis, malaria and prostate cancer.
Improvements for point-of-use prion test performance
Genesis Bioventures, Inc. (GBI) has announced improved results of sample tests performed with the Prion Developmental Laboratories (PDL) mad cow diagnostic assay.
The PDL Rapid bovine spongiform encephalopathy (BSE) test was evaluated in the second round of the European Union Food Safety Commission’s validation series and was found to be 96% sensitive and 100% specific. Since this evaluation, recent improvements to the test increased the rapid assay sensitivity 100-fold. Further sample tests carried out at the Central Veterinary Laboratory in Weybridge, UK, show that the test can detect earlier infections in cattle by achieving a 1:128 fold dilution (compared to the previous 1:4 result).
“We are very pleased with the outstanding results of our proprietary mad cow disease assay on the severely deteriorated mad cow specimens we used to evaluate the new test. I expect our 20-min rapid mad cow disease test will perform even better with fresh specimens, such as those our customers will test to ensure no mad cow disease-infected meat gets into the human food supply,” commented Robert B Petersen, President of PDL. PDL developed a rapid point-of-use assay to ensure human food safety by diagnosing BSE before processing. “We are very excited with continued development of this ground-breaking test…the world’s only definitive assay that can be used to test each animal immediately before it is processed for human consumption,” said Douglas C Lane of Experigen. “This advantage will, for the first time, enable all cattle processors to test each animal without economic disadvantage and without changing their current meat processing methods.”
“Testing each animal today is impractical, with tests that take two or more hours to produce a result. Consequently, most animals are not being tested,” said, Greg McCartney, CEO of Genesis Bioventures. “We believe PDL’s BSE rapid assay advantage can improve the US$98 billion dollar US livestock industry’s economic outlook and possibly produce a positive effect on the current food embargoes of US beef exports by foreign governments.”
RNAi Global Initiative: first meeting report
Genome-Wide RNAi Global Initiative, pioneering the use of whole-genome RNAi screening, has announced results from its first meeting. The participating institutions are among the first laboratories in the world to have complete human genome-wide small interfereing RNA collections. The meeting focused on developing standardized procedures for data gathering, with the intention of accelerating the group’s progress. The team will identify standards that will facilitate generation of reproducible intralaboratory results. This effort, termed Minimal Information About RNAi Experiments (MIARE), will propose standards for sharing results across the wider biomedical research community. The team also agreed to solicit additional input from other external sources. The Genome-wide RNAi Global Initiative members plan to meet twice a year.