Tissue-Processing Workshop Planned for February
Milestone Medical will host a free workshop on automated microwave accelerated tissue processing and its impact on future diagnostic pathology and lean laboratory practices. The workshop will take place Febuary 14 from 5:30 pm to 7:30 pm during the 2006 United States and Canada Association of Pathology exhibition in Atlanta.
Technological advances in providing rapid, fully automated microwave histoprocessing is revolutionizing diagnostic histopathology, enabling the provision of routine, same-day turnaround times for diagnostic results. The benefits of a balanced workload throughout the working day will not only benefit the patient, but will also significantly improve the working conditions for both pathologists and laboratory staff in an environment where being “lean” in working practices is gradually becoming the norm in the competitive world of pathology services.
The workshop will be led by renowned pathologist Carlos Ghimenton, MD, author of numerous papers on the use of microwaves in routine pathology; and Donna Willis, who spent 13 years running the Histology Lab at Harris Methodist Hospital and brings firsthand experience on how microwave technology is used in real-world situations.
Contact: Milestone Medical (866) 995-5300; www.milestonemed.com
FDA Approves Plavix-Response Test
The US Food and Drug Administration (FDA) has recently approved the VerifyNow P2Y12 test to measure the effects of Plavix (Clopidogrel), a commonly prescribed drug in the United States, to confirm whether or not a patient is responding adequately to the drug.
Almost 10 million Americans take the drug to help prevent a potentially life-threatening heart attack or stroke. Studies show, however, that up to 30% of patients do not respond adequately to it and are at a much higher risk for cardiovascular events, such as heart attack, stroke, and blockage of coronary stents. Monitoring Plavix also has economic implications as a 1 month’s supply of the drug can cost more than $100.
“We’re now developing an understanding that, as for every other medicine, not all patients respond equally well to Plavix,” says Daniel Simon, MD, associate director of interventional cardiology at Boston’s Brigham and Women’s Hospital. “We don’t prescribe other drugs and just assume they’re working. We test for the effects of cholesterol drugs and blood-pressure drugs, and we monitor response to the anticoagulant Warfarin. We need to start adopting a similar paradigm for antiplatelet therapies such as aspirin and Plavix.”
The approval of the VerifyNow P2Y12 test allows Plavix response to be tested simply and reliably—for the first time. The blood test is a fast and easy way to measure the effects of Plavix on platelets, the blood cells primarily responsible for clotting. In less than 15 minutes, VerifyNow provides a result indicating whether a person is responding effectively to Plavix. The test is cost-efficient and covered by Medicare and many insurance providers.
“Plavix is a very effective medication for preventing strokes and heart attacks,” notes Mark Alberts, MD, professor of neurology at Northwestern University Feinberg School of Medicine and director of the stroke program at Northwestern Memorial Hospital in Chicago. “However, in a certain percentage of patients, the blood-thinning effects of Plavix may not be optimal. The VerifyNow test provides physicians with an important tool to help identify these patients and plan appropriate therapy.”
VerifyNow P2Y12 has implications in other areas of medicine as well. For example, the test can help physicians determine whether a patient can safely undergo surgery. Medical guidelines recommend that a person stop taking Plavix for 5 days prior to an operation to enable clotting function to return to normal and to reduce the risk of excessive bleeding during or after the procedure. However, this means that surgery often must be delayed. Furthermore, withholding Plavix can put patients at increased risk for a heart attack or stroke while they are waiting to undergo their operation.
Such a situation occurred recently when former President Bill Clinton needed heart surgery. His doctors waited several days before performing the bypass operation to ensure that the antiplatelet drugs he had been taking were cleared from his system.
“The Plavix test removes the guesswork about whether it’s safe to go to surgery,” says Christopher Cannon, MD, associate physician in the cardiovascular division of Brigham and Women’s Hospital and a leading cardiovascular researcher. “Having information about clotting status allows us to proceed with the operation the day that function returns to normal, rather than routinely waiting 5 days in every case. This could dramatically reduce surgical delays for patients taking Plavix.”
Contact: Accumetrics Inc (518) 393-2200; www.accumetrics.com
|CDC Issues New Tuberculosis-Detection Guidelines|
|The Centers for Disease Control and Prevention (CDC) has published new M tuberculosis (TB) detection guidelines, advising that the QuantiFERON®-TB GOLD blood test can be used in all circumstances under which the traditional tuberculin skin test (TST) is currently used.
“QuantiFERON-TB GOLD represents a breakthrough in TB diagnosis and control and offers several important advantages, including the fact that it is more accurate than the TST and only requires one visit,” says David DeBiasi, RN, director of community health and tuberculosis services for the American Lung Association of Virginia. “New diagnostics such as QuantiFERON-TB GOLD are the key to the future success of eliminating TB, which continues to ravage the globe, causing nearly 2 million deaths a year.”
The guidelines, published in the CDC’s December 16 Morbidity and Mortality Weekly Report, affirm that QuantiFERON-TB GOLD can be administered in place of the 100-year-old TST, which, despite widespread use, can be unreliable because of false-positive and false-negative results. Typical, and often mandatory, TB tests include contact investigations, evaluations of recent immigrants, and infection-control surveillance programs, such as yearly testing for health care workers. Details of the CDC’s recommendations on how to use the test can be found at www.cdc.gov/mmwr/.
“One of the greatest problems in combating this disease has been the reliance on an antiquated detection method,” says Tony Radford, MD, managing director of Cellestis Inc, maker of QuantiFERON-TB GOLD. “These guidelines represent a significant advancement in the detection and potential elimination of TB in the United States.”
QuantiFERON-TB GOLD is also able to detect latent or nonsymptomatic TB in individuals while eliminating candidates who have had BCG vaccinations for TB, a common cause for false-positive readings with the TST. The blood test is highly specific because it measures immune responses to peptides that simulate M tuberculosis proteins not present in the BCG vaccine. Thus, a positive QuantiFERON-TB GOLD test result is a strong predictor of TB infection, eliminating subjective interpretations of test results.
As a blood test, QuantiFERON-TB GOLD eliminates the need for patients to visit their physician a second time so that the results can be read. Currently, as many as 30% of people tested using the TST do not return for the second requested screening, during which a medical professional examines a patient’s skin for reactions, a possible indicator of TB infection.
Contact: Cellestis Inc (800) 519-4627; www.cellestis.com
West Nile Virus Assay Receives FDA Approval
The USA Food and Drug Administration (FDA) has recently approved Chiron Corp’s PROCLEIX West Nile Virus (WNV) Assay to screen whole-blood donations for use on the PROCLEIX System. The assay, developed in collaboration with Gen-Probe Inc, has been used to screen more than 29 million units of blood on an investigational-use-only basis since June 2003 and has intercepted more than 1,450 WNV-positive donations.
“The approval of the PROCLEIX WNV Assay extends Chiron’s leadership in the field of blood safety,” says Gene Walther, president, Chiron Blood Testing. “We are committed to helping our customers safeguard the blood supply against emerging pathogens, such as West Nile Virus. We continue to work in collaboration with our customers to meet the urgent need to provide a safe blood supply.”
“The safety of the blood supply is a critical concern of the American Red Cross,” says Jack McGuire, executive vicepresident of American Red Cross Biomedical Services. “Being able to screen blood donations for West Nile Virus provides an additional layer of safety and reduces the risk of transmission of a potentially deadly virus.”
WNV is a mosquito-borne virus associated with a human form of the disease ranging from mild, flu-like symptoms to severe neurological disease. The first confirmed US death resulting from transmission through donated blood was reported in 2002. In the fall of 2002, the FDA challenged the blood-safety industry to develop a test to directly detect the virus in donated blood by the summer of 2003. Within 9 months, Gen-Probe and Chiron had developed the PROCLEIX WNV Assay and brought it to market on an investigational-use-only basis.
Contact: Chiron (510) 655-8730; www.chiron.com
Abbott Submits PMA Applications for Hepatitis Assays
Abbott has submitted premarket approval (PMA) applications with the US Food and Drug Administration (FDA), seeking approval of a hepatitis anti-HBs test for use on its ARCHITECT® instrument and a hepatitis HBsAg/Confirmatory test for use on its AxSYM® instrument.
Additionally, the company announced it had filed a PMA seeking FDA approval of a hepatitis anti-HCV test for use on its ARCHITECT automated immunoassay instrument system. It said it plans to submit additional PMAs soon.
“We are glad to have completed this important step in advancing hepatitis assay development for our ARCHITECT and AxSYM instruments,” says William Brown, PhD, vice president, diagnostic assays and system development, for Abbot Diagnostics.
Contact: Abbott Diagnostics (800) 323-9100; www.abbottdiagnostics.com
Battelle Acquires CareStat Inc
CareStat Inc has been renamed BattelleCRO Inc as part of an ownership agreement with Battelle. Terms of the agreement were not disclosed.
“This acquisition allows us to expand our existing capabilities in the pharmaceutical, biotech, and medical device industries,” says Steven McLaughlin, senior vice president and general manager of Battelle’s health and life sciences division. “By combining the strengths of CareStat’s clinical trial excellence with Battelle’s resources, we can now provide the full range of drug-discovery and development services to support our government and industrial clients.”
Services provided throughout the product development include life-cycle of discovery, early preclinical development, premarket regulatory submissions, clinical trials, FDA approval, and postmarketing surveillance.
Battelle’s health and life sciences division currently has an annual business volume of about $150 million. It hopes to double that number over the next 5 years.
“We’re excited about the opportunities this acquisition affords us,” says Howard Golub, president of CareStat. “We can now offer our customers one-stop shopping from a menu of options for health care product development.”
BattelleCRO will retain the CareStat management team and operations center in the Boston area. McLaughlin will become chairman of its five-member board of directors.
Contact: Battelle (614) 424-5544; www.battelle.org
Sigma-Aldrich Offers Online Stain Information
Sigma-Aldrich has launched the STAIN EXPERT, a Web-based application specifically developed to assist customers with the retrieval of stain and dye information.
The new application, located on the Sigma-Aldrich Hematology and Histology Web site, provides an intuitive interface for navigating staining procedures, catalog information, product specifications, material safety data sheets, certificates of analysis, and technical bulletins.
The Web site uses Flash software to guide customers through a wide range of staining procedures while reducing the complexity of multistep processes. Reagent preparation and staining results are extensively covered. The integration of the Sigma-Aldrich Web search engine with recommended chemicals ensures quick retrieval of information.
“This application provides an engaging and innovative user experience for retrieving stain-related content and offers a dynamic online experience worth returning to,” says Mark Frei, technical marketing specialist at Sigma-Aldrich.
Contact: Sigma-Aldrich Corp (800) 325-5052; www.sigma-aldrich.com/stainexpert
|CeMines Announces Intent to Sell Research Tools Business
CeMines Inc has announced it has been soliciting offers to purchase its research tools business and related inventory of polyclonal antibodies, cDNA, and mRNA. The business also includes associated trademarks and an elite multinational customer base that includes some of the world’s most prestigious research institutions.
“CeMines entered the research-tools business in 2001 to advance our strategic cancer-diagnostic product-development and drug-discovery research initiatives, using a capitalization model that would be minimally dilutive,” says Roger Attick, president and CEO of CeMines. “In my opinion, current industry dynamics are already forcing a substantial amount of consolidation.”
Additionally, the company has stated that it has received multiple offers since it began to notify prospective buyers several months ago. CeMines is actively reviewing pro forma bids, some of which it says are quite interesting propositions for extended business partnerships.
Contact: CeMines Inc (303) 526-3700; www.cemines.com
|Beckman Coulter Introduces Systems for Automated Sample Handling, Testing, and Postanalytical Processes|
|Beckman Coulter Inc has released 12 standard configurations of its LH 1500 series hematology automation systems.
Previously available only as a custom system, the LH 1500 series helps high-volume laboratories manage all hematology-testing processes, including preanalytical sorting, testing, and analysis of results, and postanalytical storage. The standard configurations simplify system ordering, delivery, and installation for laboratories.
Each of the 12 systems includes an automation track line in various combinations to link up for COULTER® LH 750 hematology analyzers or COULTER LH 755 work cells, which feature integrated SlideMaker and SlideStainer modules.
All configurations include sample tracking, sorting, automated cassette loading and unloading, and automatic repeat and reflex testing capabilities. The systems manage rerun and reflex testing requirements without operator intervention based on programmable decision rules such as age, gender, physician, location, and other criteria.
Technologists place samples directly in the inlet module when using an LH 1500 series. The tubes are then routed automatically to a connected hematology analyzer via a track system and robotics.
After analysis, the tubes are moved from the analyzer and sorted into either an outlet for additional testing or stored in a stockyard module, where they may be recalled in response to add-on test requests from physicians.
The LH 1500 will continue to be available in custom configurations based on specific laboratory needs.
In addition, Beckman Coulter’s automation family includes the scalable Power Processor, the most widely used clinical lab automation system in the world. The Power Processor performs sample login, cap removal, and centrifugation. Also, it features optional modules such as the Intelligent Aliquotter; a recapper; various instrument connectors; a large-capacity refrigerated stockyard, which accommodates up to 3,060 samples; and a non-refrigerated model, which holds 1,020 samples.
Contact: Beckman Coulter (800) 352-3433; www.beckmancoulter.com
|Tm Bioscience To Supply PathGroup With Reagents
Tm Bioscience Corp has announced an agreement with PathGroup to supply it with its Tag-It™ analyte-specific reagents for use in PathGroup’s cystic fibrosis gene assay.
“We are committed to providing the highest-quality medical diagnostic services available, serving patients across Tennessee, Kentucky, Indiana, Illinois, North Carolina, and Georgia,” says Safedin Beqaj, MD, laboratory director of microbiology and molecular diagnostics at PathGroup Labs. “Using the reagents from Tm Bioscience, we have developed an upgraded CF assay that performs to our high standards and reduces operator time significantly, which will enable PathGroup to address the growing demand for cystic fibrosis screening and best serve our customers.”
“We are pleased that PathGroup has selected products from Tm Bioscience and adopted our standardized Tag-It approach,” says Greg Hines, president and CEO of Tm Bioscience. “We look forward to working with Dr Beqaj to evaluate additional products from our menu.”
Contact: Tm Bioscience (416) 593-4323; www.tmbioscience.com
|Beckman Coulter Releases Software Updates for Automation Line
Beckman Coulter Inc has released updated software that allows clinical laboratories to connect the UniCel DxC 600 and DxC 800 Synchron® chemistry systems to the company’s open-architecture Power Processor sample processor.
Using the new DxC 600 or 800 software as well as updated Power Processor line-controller software, the DxC 600 or 800, connected to the Power Processor, enables laboratories to automate the entire preanalytical sample-preparation process, from sample sorting to transportation of those samples directly to the chemistry instruments for analysis.
The DxC 800 features a throughput of up to 1,440 tests per hour and an onboard capacity of 70 reagents. The DxC 600 features an onboard capacity of 65 reagents and a throughput of up to 990 tests per hour.
More than 100 liquid, ready-to-use reagents are available for use on the DxC 600 and 800, including general chemistries, critical care chemistries, proteins, serologies, and esoteric chemistries, as well as therapeutic drug monitoring and drugs-of-abuse tests.
The scalable Power Processor is a widely used clinical lab automation system, and it performs sample login, cap removal, and centrifugation.
Additional components include the LH 1500 series hematology automation system, intelligent aliquotter, recapper, stockyards, the SYNCHRON LX® connection module, and the UniCel DxI™ connection module.
Contact: Beckman Coulter (800) 526-3821; www.beckmancoulter.com
Nanogen Begins Shipping NanoChip 400 Systems
Nanogen Inc has begun shipping the NanoChip® 400 system to the United States and to Europe. The general laboratory system for molecular biology applications uses the company’s improved NanoChip 400-site electronic microarray, upon which homebrew molecular assays can be developed in clinical and research laboratories.
The new multipurpose system builds on features from the first-generation NanoChip molecular biology workstation and 100-site chip, and combines sample- and reagent-handling robotics with detection in an instrument half the size of its predecessor. The open platform creates the opportunity for laboratories to use one system for multiple molecular applications, including the detection of single nucleotide polymorphisms (SNPs) and multi-gene targets, such as those tested for pharmacogenetics.
The NanoChip 400 cartridge used with the system is a blank microarray template that constructs the user-defined panel of genetic markers on one chip at the time of sample testing. The cartridge has 400 test sites that can be used for any combination of multiple genes and multiple samples. It can be employed multiple times until the 400 test sites are utilized. This cartridge reusability makes the NanoChip 400 system easier and more cost-efficient to use than research-grade thousand-gene chip arrays, and more suitable than polymerase chain reaction (PCR) when multi-allele or multi-gene assays are of interest. The system is ideal for mid- to high-volume laboratories where the need to streamline testing and workflow is a high priority.
“I am very excited about the new instrument,” says Steve Cook, manager of molecular diagnostics at Lahey Clinic in Boston. “I think it is going to be great for us as a customer and great for Nanogen as a vendor. The walkaway capability will be a valuable improvement over the molecular biology workstation and will allow us to consolidate and streamline our workflow. This capability may open up the instrument for us to do more homebrew designs.”
“Our first deliveries of the NanoChip 400 system mark a significant milestone in the development of our company,” says Howard C. Birndorf, Nanogen chairman and CEO. “Moving products out of development and into our commercial product portfolio will contribute significantly to our revenue in the coming quarters. We’re delighted to be able to offer new tools that facilitate the understanding of disease and can ultimately be used to improve the health of patients.”
Contact: Nanogen Inc (877) NANOGEN; www.nanogen.com
Catholic Healthcare West Deploys Medication Information Solution
Catholic Healthcare West (CHW) has implemented Thomson Micromedex’s comprehensive medication information suite throughout its 40-hospital system.
CHW serves 22 million people in California, Arizona, and Nevada. Physicians, pharmacists, nurses, and other caregivers will have access to Micromedex® Healthcare Series via the provider’s secure system-wide Intranet connection at all facilities. The easy Web-enabled navigation reduces clinicians’ search times—giving them quick access to the latest answers to disease, drug, and toxicology questions.
“Micromedex Healthcare Series was selected as one of our medication-information resources because of the depth, breadth, and quality of its evidence-based clinical content,” says Dan Ross, director of pharmacy integration at CHW. “We at CHW are committed to ensuring all clinicians have access to the highest caliber of clinical information that supports and confirms treatment decisions.”
At CHW, Micromedex will implement the following Healthcare Series drug-content solutions: DRUGDEX®, AltMedDex®, DRUG-REAX®, IV INDEX®, and Formulary Advisor®.
“Micromedex is excited to provide Catholic Healthcare West clinicians with accurate and consistent clinical decision support research to help them deliver better patient care, faster,” says Jay Katzen, vice president of marketing and product development at Thomson Micromedex. “The Healthcare Series fosters evidence-based practices in clinical operations to promote enhanced health and disease management, and potentially reduces medication errors.”
Contact: Catholic Healthcare West (415) 438-5500; www.chwhealth.org or Thompson Micromedex (203) 539-8000; www.thompson.com
Psyche Partners With Labtest Systems for Outreach Programs
Psyche Systems Corp has announced an alliance with Labtest Systems for an outreach suite. Labtest specializes in providing remote order-entry and results-reporting solutions for clinical and anatomic pathology laboratories across the United States and Canada. Psyche offers the outreach suite as a module for its LabWeb® laboratory information systems (LIS) and WindoPath® anatomic pathology system, or as an enhancement to the laboratory’s existing LIS via e.lixa®. With e.orders and e.reports for clinical and anatomic pathology, laboratories of all sizes and types can cost-efficiently implement a hosted outreach system that meets their needs.
e.reports gives clinicians immediate access to critical patient-care information while helping the laboratory streamline its report distribution to improve efficiency and turnaround time. Physicians can also access historic patient results, view cumulative graphs, and use data-mining tools for in-depth analysis. With e.orders, physicians can quickly and easily place test orders online through a secure laboratory-branded Web page from any PC. It also features ABN generation with NCD/LMRP checking, an intuitive online test catalog, automatic courier packing lists, and “just-in-time” automatic accessioning. The laboratories receive great benefit from receiving clean orders, thereby reducing clinical and billing errors.
“For nearly 30 years, Psyche Systems has focused on delivering high-quality laboratory information systems,” says Bob Sage, president of Psych Systems. “I believe that to really do something well, you need to focus on that one thing. Our partnership with Labtest allows us to combine their expertise in Web-based outreach with our own deep experience in the laboratory. That is a powerful combination that will serve our customers well.”
“The combined suite of products will enable our clients to grow their business, reduce processing inefficiencies, and enhance patient care,” says Jack Redding, vice president of Labtest Systems. “Having a strong IT solution, from the inception of the order to the final report, will enable our clients to flourish in today’s competitive market.”
Laboratories have the option of choosing the full Laboratory Outreach suite, or selecting only the result-reporting or order-entry module for either the clinical laboratory or the anatomic pathology laboratory. Psyche Systems’ Outreach package extends its LabWeb LIS and WindoPath anatomic pathology system, which, with the company’s SBB blood-bank software, offer an end-to-end laboratory suite.
e.orders and e.reports are also featured components of Psyche’s e.lixa, a suite of hosted applications designed to give new life to hospitals’ and clinics’ current LIS. e.lixa enables the laboratory to maximize its current information-systems investments, including legacy software, by seamlessly adding on advanced functionality. With e.lixa, hospitals and private laboratories are able to realize a high return on investment by enhancing their services and improving reimbursement rates, while maximizing their existing IT resources through Psyche’s eXerva® application-hosting services.
Contact: Psyche Systems Corp (508) 473-1500; www.psychesystems.com
New Study Demonstrates Way to Use Cancer Gene to Trigger Death of Breast-Cancer Cells
The National Surgical Adjuvant Breast and Bowel Project (NSABP) has announced the results of a groundbreaking laboratory study performed on human breast cancer specimens collected as part of a clinical trial evaluating the breast cancer drug Herceptin™. The results suggest that a cancer-causing gene, called cMYC, can be triggered to cause the death of breast cancer cells.
The study, led by Soonmyung Paik, MD, director of the NSABP Institute of Molecular Pathology, evaluated the breast cancers of more than 3,000 patients treated on two large adjuvant breast cancer clinical trials conducted by the NSABP. The results of the study were presented December 8 at the San Antonio Breast Cancer Symposium, led by Paik.
This finding is the end result of a 3-year-long project that required the screening of more than 51,000 individual test samples. The research team began by searching for cancer-chromosomal abnormalities called gene amplifications, which were thought to influence the behavior of breast cancer. All people are born with two sets of all genes, one copy from each parent. For some unknown reason, over time, some genes increase their copy number, resulting in normal cells becoming cancerous. After screening for gene amplifications in 1,900 cases of breast cancer treated with chemotherapy as part of the NSABP B-28 trial, amplification of three genes (HER2, cMYC, and HTPAP) was found to lead to a poorer prognosis even after standard chemotherapy is used.
In May 2005, the NSABP and the North Central Cancer Treatment Group, which, along with the NSABP, is funded by the National Cancer Institute (NCI), announced the results from a joint analysis of data from the two similar clinical trials (NSABP B-31 and NCCTG N9831) conducted by the groups. The analysis showed significant clinical benefit by adding Herceptin, a monoclonal antibody that targets the HER2 protein, to standard chemotherapy in patients diagnosed with breast cancer with increased copies (amplification) of the HER2 gene. Adding Herceptin resulted in a 53% reduction in the recurrence rate—a result hailed by one expert as “revolutionary rather than evolutionary.”
Since cMYC was frequently amplified together with the HER2 gene in the initial study of the cancers from patients in the B-28 study, Paik’s team examined cMYC amplification in the tumor specimens collected in the NSABP B-31 Herceptin study. They examined the benefit of adding Herceptin to chemotherapy in these patients whose tumors had amplification of the HER2 gene according to the presence or absence of cMYC amplification. Those with cMYC amplification had achieved a much larger reduction in recurrence rate (76%), compared to those without cMYC amplification (37%).
Out of the 237 patients with cMYC-amplified cancers who received Herceptin along with chemotherapy, only .5% had developed recurrent breast cancer within 4 years after beginning treatment, and .3% of these patients died within 4 years of their diagnosis. In contrast, of the 234 patients with cMYC-amplified cancers treated only with standard chemotherapy, four times as many recurred and three times as many patients died within 4 years of starting therapy. Additionally, there were no recurrences after 2 years in cMYC-amplified Herceptin-treated patients. These results suggest that the potential impact of Herceptin on survival in patients with coamplification of HER2 and cMYC will be very substantial. “Since patients with cMYC-amplified tumors start with a worse prognosis, it is remarkable that their fortune is essentially reversed due to the addition of Herceptin to chemotherapy,” Paik noted.
Paik describes this finding as not completely surprising given the body of laboratory evidence collected over the years regarding the apparent dual role of cancer-causing genes such as cMYC. Notably, this is the first time that this concept has been demonstrated in a large study conducted in breast cancer patients. Normally, the activity of the cMYC gene is tightly controlled because gene activity causes cells to rapidly divide and increase in number. Uncontrolled growth caused by unregulated activity of genes such as cMYC plays an important role in the development of breast cancer and other cancers.
As a natural defense against cancer, potentially cancer-causing genes such as cMYC, which play important roles in normal cells, are equipped with a capability to not only stimulate cell proliferation, but also to trigger the death of the cell (a process called apoptosis). When cMYC becomes expressed in an unregulated manner, cMYC triggers cell death instead of continuing cell proliferation, so the cell will not develop into cancer.
The existence of this natural defense mechanism explains why cancer does not develop in the majority of people. However, if there is activation of other genes, such as HER2, that suppress the cell death pathway while cMYC is stimulating cell proliferation, an aggressive cancer may eventually develop. The results of this study suggest that when HER2 activity is inhibited by the antibody Herceptin, cMYC regains its ability to trigger cellular death. “This probably explains why Herceptin added to chemotherapy worked so well in cMYC-amplified tumors,” Paik said.
Paik believes that this finding has important potential applicability in other cancers, including breast cancers without HER2 amplification. About 30% or more of all human cancers have problems of abnormal expression of cMYC. Such tumors tend to have a worse prognosis compared to the cancers without cMYC abnormalities. The data from Paik’s lab suggests that these aggressive tumors could be triggered to die if active coconspiring cancer genes could be identified and effectively blocked, as Herceptin does by blocking the activity of HER2.
“The possibility that a cancer gene can be manipulated to trigger the death of cancer cells themselves is a fascinating one and may potentially lead to the development of substantially more effective treatment strategies for many kinds of cancer with fewer side effects,” Paik said. Dr. Paik and his colleagues at the NSABP are actively searching for other cancer genes that interact with cMYC.
These important molecular NSABP studies were made possible through the commitment of the NSABP scientific leadership and member institutions to the development of the NSABP Tumor Bank, which is funded mainly by grants from the NCI and is one of the largest annotated breast and colorectal cancer tissue banks in the world. It contains more than 65,000 specimens, which have all been donated by patients who participated in clinical trials conducted by the NSABP during the past 40 years. Each year, about 3,000–4,000 specimens are added.
The Tumor Bank has contributed significantly over the years to the clarification of the importance of various tumor molecular markers and the development of practical prognostic tests. Its notable contributions include: 1) the demonstration that HER2 is an important prognostic factor for breast cancer; 2) the demonstration that HER2-positive tumors respond better to doxorubicin containing chemotherapy regimens; 3) the importance of quality control for lab tests for HER2 and estrogen receptor; 4) the development of the first multigene prognostic test, which can be performed on breast cancer specimens that were processed for pathologic evaluation in the standard manner (Oncotype Dx™); and 5) the role of cMYC as a predictor of response to Herceptin.
Contact: NSABP (412) 330-4600; www.nsabp.pitt.edu
Gen-Probe Collaborates with Molecular Profiling Institute
Gen-Probe Inc has announced a nonexclusive collaboration with the Molecular Profiling Institute Inc (Molecular Profiling), a private, specialty reference laboratory, to accelerate the market development of Gen-Probe’s pipeline of novel cancer diagnostics. Molecular Profiling is the for-profit reference laboratory of the Translational Genomics Research Institute (TGen), a nonprofit biomedical research institute whose mission is to make and translate genomic discoveries into advances in human health.
Under the terms of the agreement, Molecular Profiling will validate, commercialize, and undertake market-development activities for up to four Gen-Probe products, starting with the company’s investigational PCA3 assay, which is intended as an aid in the diagnosis of prostate cancer. Gen-Probe will have a 5-year “right of first refusal” should Molecular Profiling seek a partner to develop nontissue-based diagnostic products based on cancer and predictive medicine markers discovered or acquired by Molecular Profiling. Molecular Profiling has exclusive rights to TGen’s markers. In addition, Molecular Profiling will provide Gen-Probe certain clinical-contract research services associated with the PCA3 development program.
As part of the collaboration, Gen-Probe has acquired a minority interest in Molecular Profiling. Financial terms were not disclosed, but the transaction is expected to have no effect on Gen-Probe’s income statement, and an immaterial effect on the company’s cash position.
“Oncology remains an important driver of long-term growth for Gen-Probe,” said Hank Nordhoff, Gen-Probe’s chairman, president, and CEO. “This agreement adds another dimension to our oncology strategy. We based our strategy on core Gen-Probe technologies such as transcription mediated amplification, then added exclusive rights to novel cancer markers from companies like DiagnoCure and Corixa. Now, by collaborating with Molecular Profiling and its network of partners, we intend to strengthen our ability to build markets for these markers and accelerate the adoption of our innovative diagnostic tests, starting with our investigational PCA3 assay.”
Molecular Profiling’s mission is to introduce discoveries made in the research lab to clinical patient care. Molecular Profiling offers tests to help oncologists better understand and treat cancer patients with personalized treatment plans based on the molecular characteristics of their tumors. Additionally, Molecular Profiling participates in biospecimen analysis and storage for research, product development, and clinical trials. Molecular Profiling has access to more than 20% of the nation’s patients through its partnerships and relationships with nationwide physician organizations.
Contact: Gen-Probe (858) 410-8000; www.gen-probe.com
Olympus Increases Worldwide Reagent Production Capacity with Irish Manufacturing Facility
Olympus has vastly expanded its worldwide capability to manufacture reagents by expanding and redesigning its production, research, and development facility in County Clare, Ireland, near Shannon Airport. The facility will handle R, verification and optimization for the full line of Olympus assays sold globally. In addition, it will be the international reagent production center for the company’s chemistry analyzers, and for its forthcoming immunoassay systems. (The AU3000i, the first immunoassay analyzer developed by Olympus for use in the US market, is presently under review by the US Food and Drug Administration; it is not currently available in the United States.)
The new 102,000-square-foot facility, which represents an investment of $6.2 million by Olympus Life and Material Science Europa-Ireland, includes an R area with extensive, modern wet-chemistry laboratories and instrument rooms, along with a single-story manufacturing center, a high-bay warehouse, and administrative offices. Its modern design also incorporates the latest robotic manufacturing capabilities for accuracy and reliability. The facility represents a complete renovation and major expansion of a facility that has stood on the premises since 1987. The project took a little more than 1 year to complete.
“The Olympus diagnostics business worldwide has enjoyed double-digit growth each year over the past number of years,” said Piers Devereux, CEO of Olympus Life and Material Science Europa-Ireland. “To meet the growing demand, and to prepare for Olympus’ anticipated future immunoassay business, we decided to enhance and enlarge our facility. We expect continued rapid expansion for at least the next 5 to 10 years.”
“With our market-share growth in North America, we needed expanded manufacturing capability,” said Stephen Wasserman, group vice president, Diagnostic Systems Group, Olympus America Inc. “Not only will we be better able to supply our growing client base in the United States and Canada, we’ll also be able to expand our reagent-product offering and provide a variety of enhanced reagent-management benefits.”
Contact: Olympus Diagnostic Systems Group (800) 223-0125; www.olympus-diagnostica.com
Aspyra Previews AccessNET PACS at RSNA
Aspyra Inc previewed AccessNET version 6.0, the company’s highly scalable and flexible picture archiving and communication system (PACS) solution, at the RSNA 2005 annual meeting, held November 2005 at McCormick Place in Chicago.
The AccessNET 6.0 continues the tradition of fast product development from CCA, a provider of clinical information systems (CIS) for hospital and clinic-based laboratories, pharmacies, and medical imaging departments, and StorCOMM Inc, a provider of PACS and clinical image-management systems for the medical imaging market, from which Aspyra was formed.
AccessNET, a system used to manage clinical images and reports, provides basic PACS functionality as well as management of clinical workflow. AccessNET version 6.0 is a major upgrade from AccessNET version 5.6.1, with many functional enhancements. The most significant enhancements in version 6.0 include improved transcription work flow, enhanced report creation, automated report distribution, report verification, improved support for import/export of DICOM studies, and integration with the company’s CyberRAD RIS product.
“Conference attendees, members of the press, and industry consultants alike praised the robust functionality and improved work-flow features included in AccessNET version 6.0,” said Douglas Collie, Aspyra’s diagnostic solutions product manager.
Improved transcription work flow includes the addition of customizable work lists for Report Transcribe and Report Sign functions, along with a streamlined functionality within the MedVIEW viewing workstation to quickly sign reports. The new version also provides support for the IHE Portable Media Profile, export of structured report documents and/or reports to portable media (DICOM Interchange CD), and the option to include or exclude the MedVIEW Express DICOM viewer on portable media.
Contact: Aspyra Inc (818) 880-6700; www.aspyra.com