Current Biomarker Study Seeks More Accurate Diagnosis of ALS
The Amyotrophic Lateral Sclerosis Association (ALSA) is currently funding a year-long study to find a more rapid and accurate diagnostic test for amyotrophic lateral sclerosis (ALS) using biomarkers found in cerebrospinal fluid and blood.
The study, Identification of Diagnostic Biomarkers and Therapeutic Targets for ALS, is being conducted as a collaborative project by researchers from academic institutions and biotechnology sectors, such as Massachusetts General Hospital, the University of Pittsburgh School of Medicine, and Metabalon Inc. The organizations will spend 1 year working on the project with the potential for renewal after a presentation of the initial data to the ALSA.
“There is an urgent need to find a faster and more reliable diagnostic process that will enable earlier treatment and improve chances that therapy will alter the course of ALS,” says Lucie Bruijn, PhD, science director and vice president of the ALSA.
According to the association, patients are diagnosed with ALS primarily by a process of elimination, ruling out diseases in a lengthy and expensive process that is often uncomfortable for patients and allows for uncertainty in results.
In the new study, researchers will analyze blood and cerebrospinal fluid from a control group and from ALSA patients by using two different technologies that have the potential to strengthen and validate the findings.
Researchers believe that biomarkers for ALS are more likely to be detected in the cerebrospinal fluid that is contained in the central nervous system and bathes motor neurons in the spinal cord and brain. This fluid is in direct contact with cells that are dying in ALS progression. However, earlier diagnostic testing in patients could be achieved if the same markers are found in the blood.
The research currently being conducted may also yield new methods to determine the progress of the disease by comparing the amounts of biomarkers—small molecules associated with ALS—at early and late stages. This type of test also may make it possible to measure the effectiveness of different drug treatments in clinical trials.
A study conducted in 2003 by the University of Pittsburgh School of Medicine found several small proteins in the cerebrospinal fluid of ALS patients that are not present in the cerebrospinal fluid in control patients. These were sensitive diagnostic markers for ALS. In the new study, the Ciphergen Protein Chip mass spectrometry proteomic system will be used to confirm these initial findings in a larger sample pool of cerebrospinal fluid and blood taken from ALS and control patients.
Samples obtained from Massachusetts General Hospital and the University of Pittsburgh will include a variety of neurological disorders, including Alzheimer’s disease. The diversity of control samples is critical to ensure that markers identified are specific to ALS.
The same set of samples will be tested at Metabalon, where the company’s metabolomics platform will search for signatures of ALS by measuring the spectrum of biochemical changes and mapping these changes to metabolic pathways.
Contact: The Amyotrophic Lateral Sclerosis Association (818) 880-9007; www.als.org
| Thermo Electron and Dynal Biotech Collaborate on Innovative Automated Solution Thermo Electron Corp and Dynal Biotech have entered into a nonexclusive collaboration agreement to develop and comarket automated solutions within proteomics. As a result of the agreement, the two companies have announced the launch of a solution for the rapid and efficient isolation of histidine-tagged proteins, a solution that combines Thermo Electron’s KingFisher® technology and Dynal Biotech’s magnetic beads, the Dynabeads® TALON™ system. By combining the technologies for recombinant protein purification, users can perform automated, high-speed, reproducible, and efficient isolation of pure proteins. The beads disperse well in the solution and have a slow sedimentation rate. Their magnetic mobility is high and without remanence, making them ideal for use on automated platforms. Users can insert a deep-well plate containing the bacterial culture directly into the KingFisher 96. In one run, 96 samples can be purified in 30 minutes, enabling more than 1,000 samples to be processed daily. The purified proteins are suitable for a variety of downstream applications in drug and biomarker discovery, such as aptamer and phage-display screening, DNA-protein, or protein-protein interactions. The combination of KingFisher and the Dynabeads TALON system isolates fully functional and high-purity proteins, while providing higher throughput, increased sensitivity, and reproducibility. Contact: Thermo Electron Corp, (740) 373-4763; www.thermo.com |
 FDA Clears Pall Bacteria Detection SystemThe US Food and Drug Administration has granted clearance to market Pall Corp’s enhanced bacteria detection system (eBDS). The enhanced system is designed to make detecting bacteria in blood more efficient, and offers a more sensitive and easier method for detecting bacteria in blood platelets. The increased sensitivity of eBDS will improve patient safety by allowing blood banks to accurately detect the lowest levels of bacterial contamination without false-positive results so that viable platelets are not discarded and wasted. Currently, eBDS is the only system that can detect bacteria in all platelets whether derived from single donor (apheresis) or whole blood (random donor) collection procedures. The new system also reduces overall testing time by as much as 20%, which helps improve availability of blood for transfusion by allowing faster access to platelets found to be bacteria-free prior to becoming outdated. According to Pall, the FDA clearance of the enhanced system comes at a critical time. As of March 1, blood centers have begun testing all platelet components for the presence of bacteria. This is according to a new American Association of Blood Banks standard, which is the result of the transfusion community’s recognition of the severity of the problem associated with contaminated platelets and the availability of technology to address it. Bacterial contamination of platelets is the leading cause of transfusion-related patient fatalities. Contact: Pall Corp (516) 484-5400; www.pall.com |
Cytyc and Abbott Announce Collaboration
Cytyc Corp and Abbott Laboratories have entered into a collaboration and copromotion agreement for the development and marketing of the ThinPrep® UroCyte™ Slide Preparation System. The efforts of the collaboration will focus on modifying Cytyc’s proprietary ThinPrep sample preparation technology to be used in conjunction with UroVysion™, a DNA probe-based test for detection of bladder cancer recurrence. Both companies will promote this new system following completion and regulatory clearance of the codeveloped product.
According to the National Cancer Institute, bladder cancer is the fifth most common cancer in the United States, and it has the highest recurrence rate of any cancer. It is estimated that as many as 70% of cases will recur and, of those that do recur, as many as 30% become a dangerous tumor.
“Clearly, the need to detect recurrence is vital,” says Marek Skacel, MD, associate staff pathologist, Cleveland Clinic Foundation. “And the ThinPrep UroCyte Slide Preparation System is an important advance.”
The UroVysion Bladder Cancer Recurrence Kit is the first and only FDA-cleared molecular urine cytology test that uses DNA probes to identify chromosomal abnormalities in patients previously diagnosed with bladder cancer.
“With UroVysion, we get the best available method to detect recurrence because its reliability identifies those DNA cellular changes that other noninvasive methods simply can’t,” says Steve Jones, MD, Section of Urological Oncology, Cleveland Clinic Foundation.
“Cytyc’s ThinPrep technology is not only an improved method for cytology application but, importantly, has been shown to be an excellent platform for adjunctive testing, which we believe will help accelerate adoption of our UroVysion test and significantly improve medical care for patients with bladder cancer,” says Rollie Carlson, PhD, vice president and general manager, Vysis Products, Abbott Laboratories.
“This is an excellent fit for Cytyc,” adds Christopher Bleck, vice president of commercial operations for Cytyc. “Abbott is the industry leader in the development and the commercialization of diagnostic technologies and our ThinPrep sample preparation method offers opportunities for a variety of applications.”
Contact: Cytyc Corp (978) 266-3010; www.cytyc.com
Microgenics Added to Premier Offerings
Microgenics and Premier have entered into a purchasing agreement that allows Premier members the benefit of purchasing Microgenics reagents for drugs of abuse testing, therapeutic drug management and immunosuppressant drug monitoring, serum toxicology, and endocrine products.
According to Microgenics, there is an increasing need for diagnostic assays that offer precision and accuracy. The company states that it is meeting the challenge through multiple technologies that expand laboratory operations. Each of its technology portfolios is optimized to perform on a wide range of analyzers. Microgenics also brings new diagnostic assays to the market, such as heroin metabolite, ecstasy, methadone metabolite, and oxycodone.
Contact: Microgenics Corp (510) 979-5000; www.microgenics.com
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MacroPore Biosurgery Awarded Grant to Study Treatment of Heart Attack The National Institutes of Health has awarded MacroPore Biosurgery Inc a Fast Track Phase 1/11 Small Business Innovation Research (SBIR) grant to study the role of adipose-derived regenerative cells in treating myocardial infarction (heart attack). The research will be conducted in collaboration with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). MacroPore and its collaborators have shown that adipose tissue is a rich source of autologous regenerative cells, which contain adult stem cells. The SBIR studies are designated to evaluate the capacity of adipose-derived regenerative cells to improve revascularization and to regenerate damaged myocardial tissue following a heart attack. By using adipose tissue as a cell source, MacroPore intends to demonstrate that it can obtain therapeutically relevant quantities of regenerative-capable cells in real time. “The limited ability of the adult heart to regenerate itself after an injury, such as a heart attack, often leads to heart failure or other complications,” says Robb MacLellan, MD, David Geffen School of Medicine, UCLA. “The research performed at MacroPore suggests that regenerative cells purified from adipose tissue may represent a clinically useful source of cells to promote myocardial regeneration in patients immediately after a heart attack. This grant will allow us to continue our collaboration with MacroPore and further accelerate this research.” According to Christopher Calhoun, president and chief executive officer of MacroPore, the company has gained a significant understanding of the potential clinical applications for adipose-derived regenerative cells from preclinical studies. “The receipt of this grant will provide funding to help advance our development program,” Calhoun says. Contact: MacroPore Biosurgery (858) 458-0990; www.macropore.com |
Two Out of Three Biopsy Patients Report Stress, Pain, and Confusion
According to a consumer poll commissioned by Acupath Laboratories, more than 66% of patients who have had a biopsy report that the experience was stressful, the test was physically uncomfortable, and the process of receiving results was unsettling. Moveover, two out of three biopsy patients waited between 4 and 14 days to receive their test results. The same number of patients expected to receive their results directly from their physicians, but instead received their results from a nurse, physician’s assistant, or technician.
According to George Hollenberg, MD, Acupath’s founding director, the results of the survey indicate that the majority of patients face the test with little or no physical or mental preparation. He concedes that some of the anxiety patients feel as they prepare for a biopsy is natural. “A biopsy carries with it a certain level of concern,” explains Hollenberg. “We are conducting the test because there is some reason to believe something may be amiss.”
Hollenberg adds that patients can take action beforehand to reduce the stress, physical discomfort, and fear associated with a biopsy. The measures include choosing the lab, scheduling an informative meeting with the physician before the procedure to address any concerns, and staying positive.
Contact: Acupath (888) 228-7284; www.acupath.com
Globalization Strategies for the Medical Device Industry
According to TransPerfect Translations, the US medical-device industry generated total revenues in excess of $190 billion in 2003. Approximately 45% of this revenue was generated abroad. While many large medical device companies can capitalize on foreign opportunities, small- to medium-size organizations are often unable to participate due to limited finances. This is especially true when product development cycles are not sufficiently advanced to attract investors to make commitments in the face of the rapid regulatory changes in the medical-device market.
One of the most overlooked, yet significant expenses in the global product development process is translation. For large-scale rollouts, translation costs can often approach $1 million by the time a device reaches worldwide release. For the unprepared medical device executive, this can present significant hurdles to accessing a wider market for products.
“If you plan properly, translation can be any company’s trump card in effectively bringing a new medical device to market,” says Liz Elting, CEO and president of TransPerfect Translations. “If used correctly, translation can even the playing field, enabling small and midsize companies to compete against larger companies despite the fact that they have fewer resources.”
TransPerfect has three suggestions for minimizing investment risk:
1) Identify your target markets and understand the regional regulations that will affect your translation requirements. Often a medical device developer directs research to specific regions where an uncharacteristically high target population exists. In this scenario, it is important to identify the volume of research candidates you plan to include in your studies. You must also identify the type of documentation that might typically be included in this process in order to determine the volume of translation you may need for submissions to the local or regional authority.
2) Prioritize your specific translation needs. By the time you determine a favorable location for your research and submissions, you should develop a checklist of the required stages of the approval process, as well as the types of documentation that you will need to translate at each stage. The list should include study protocols, informed consent documentation, clinical research data, packaging and labeling, as well as user documentation.
3) Develop a plan to manage translations, including both operational and budgetary factors. Once you have assessed your translation needs and options, you should be ready to select the optimal resources for providing the specific translation services that you will require.
“The key to translation lies in identifying your requirements and selecting the solution that best meets your specific needs,” says Elting. “With some front-loading and planning, translation need not be a nightmare. It can even be a competitive advantage when you want to be the first to market.”
Contact: TransPerfect Translations (212) 689-5555; www.transperfect.com
Esoterix Uses New Web Site to Launch Product
The revamped Web site from Esoterix Inc now features the company’s Health Horizons™ educational program designed to support health care professionals and patients.
The new Web site provides comprehensive information for Esoterix products and services, including a test directory, access to Medtrax™, the company’s online test ordering and results reporting system, as well as Health Horizons.
Health Horizons consists of patient-oriented procedural guides, disease and test information reports, and frequently asked health care questions and answers.
According to William McDowell, corporate vice president of marketing for Esoterix, the new Web site design, combined with the availability of Health Horizons, will serve as important tools for clients and their patients. “Our new Web site is easy to navigate and provides a wide variety of applicable information about our products and services, test menu, and valuable educational materials through Health Horizons.”
Contact: Esoterix Inc (512) 225-1100; www.esoterix.com
Biosite Reveals Results of Heart Failure Study
Research conducted at University Hospital in Basel, Switzerland found that including rapidly obtained B-type natriuretic peptide (BNP) measurements in the diagnostic regimen used to evaluate emergency room patients with dyspnea can lead to improved treatment and reduced costs.
Dyspnea, or shortness of breath, is a primary symptom of heart failure and results in more than 4 million visits to US emergency rooms each year. The Triage® BNP test from Biosite® Inc was used in the study and is used in approximately 2,335 US hospitals located throughout Europe.
“Through this study we determined that rapid BNP testing, performed in the emergency room and used in conjunction with other clinical information, improves the evaluation and treatment of patients with shortness of breath, thus reducing the time to discharge and the total cost of treatment,” says Christian Mueller, MD, Department of Internal Medicine, University Hospital, Basel, Switzerland. “Clearly, rapid and accurate diagnosis is essential for cost-effective management.”
The BNP for acute shortness of breath evaluation consisted of a controlled study of 452 patients who visited emergency rooms because of acute dyspnea. Patients were randomly assigned to a control group that received either conventional diagnostic evaluation, such as a clinical exam, electrocardiography and chest radiography, or a diagnostic strategy combining conventional care with rapid point-of-care measurements of BNP levels.
According to the study, the use of BNP levels accelerated treatment, while reducing costs. The average time of treatment was 63 minutes for the patients in the group tested for BNP, compared to 90 minutes for the control group. Additionally, hospitalization levels were 10% lower among patients in the BNP group. Among all 452 patients, 24% of patients in the control group required intensive care, compared with 15% in the BNP group. The median time to discharge was 8 days in the BNP group and 11 days in the control group.
“Given the numbers, the rapid and accurate differentiation of heart failure from other causes of breathing difficulty is essential to maintaining efficiency in a busy emergency room,” says Frank Peacock, MD, department of emergency medicine and director of clinical operations at the Cleveland Clinic. “Although conducted in Europe, the Basel study presents clinical findings that are representative of the challenges faced in most US emergency departments.”
Contact: Biosite Inc (858) 455-4808; www.biosite.com
Web-Based Transactions Streamline VistaLab Services
VistaLab Technologies Inc has extended its service programs for MLA-brand and Ovation pipettes to include three distinct programs coupled with a new Web-based request process that will enable the company to offer fast turnaround and volume discounts for qualifying facilities. The company has streamlined its service in three effective areas.
“As required” services provide MLA-brand and Ovation pipette calibration and repairs on an as-needed basis. A prepaid plan eliminates the time and overhead costs of individual financial transactions. Tiered discounts are available, based on an organization’s annual needs for calibration and repair of all MLA-brand and Ovation fixed volume pipettes.
TotalCare™ extends the warranty coverage to a period of 3 years for Ovation adjustable pipettes. The program also provides two annual calibration or repair procedures, including electronic components and any needed parts.
Contact: VistaLab Technologies (888) 652-6520; www.vistalab.com
Closer Ties With Japan Allow for New Urine Chemistry Analyzer
International Remote Imaging Systems Inc has entered into a distribution relationship with Japan’s ARKRAY Inc for the AUTION JET AJ-4270, a new urine chemistry analyzer. The agreement also covers related products targeting decentralized locations around the hospital, including emergency rooms and satellite labs.
“The agreement represents another step forward in our relationship with ARKRAY, a manufacturer of urine chemistry analyzers and diagnostics equipment,” says Cesar Garcia, president and CEO of International Remote Imaging Systems. “We are pleased to add another urine chemistry analyzer and related components to our US product line at a time when we are in the final stages of negotiations with ARKRAY to distribute our new iQ® 200 product platform in Japan.”
The retail price for the AJ-4270 is $11,900, and includes a complete line of urinalysis instruments.
According to Garcia, the AJ-4270 is an ideal instrument for hospital emergency rooms, satellite laboratories, and for backing up larger units in a hospital’s main laboratory. “An emergency room technician with an AJ-4270 at hand can save critical time with an on-the-spot urinalysis test instead of sending the specimen off to a central laboratory.”
Contact: International Remote Imaging Systems Inc; (818) 709-1244; www.proiris.com
Study Reveals Effects of 2003 Recession on French Medical Research Industry
Paris-based CIFL (Comité Interprofessionnel des Fournisseurs du Laboratoire [Interprofessional Committee of Laboratory Suppliers]) reports that in 2003, laboratory suppliers suffered as a result of a difficult economy.
According to the CIFL, the principal reasons for the regression include the freezing of credits allocated to public laboratories in 2003, the current delocalization of numerous research centers in the pharmaceutical industry, and the fact that the biotechnology sector has cut its expenses by 5.2% in 2003 compared to 2002, despite announced political support.
The combination of these elements account for a decrease of 5.5% of investments linked to laboratory instrumentation in 2003. Over the same period, the purchase of supplies indispensable for the functioning of these laboratories dropped by 2%.
Contact: CIFL (33)-1-44-18-98-62; www.cifl.com
VersaTREK Receives Medical Design Award
The Medical Design Excellence Award (MDEA) was given this year to VersaTREK Automated Microbial Detection System. The MDEA recognizes design and engineering expertise in the creation of products that enhance market reach among health care industry professionals.
Manufactured by Plexus Technology Group, the VersaTREK System allows laboratories to conduct four tests on a single platform: blood culture, sterile body fluid culture, Mycobacteria detection, and M. tuberculosis susceptibility testing. VersaTREK offers VorTrexing™ agitation with enhanced ergonomics that utilize TREK’s concept of any bottle anywhere. The system also features Windows-based software with one-touch access to all patient information and records.
“We are pleased with the performance of the system and the early market acceptance,” says Mike Burke, president and CEO of TREK Diagnostic Systems. “The engineering done by Plexus and development by TREK validates how deserving this product is of the MDEA award.”
Contact: TREK Diagnostic Systems (800) 871- 8909; www.trekds.com
Millipore Receives CE Mark
The European Union’s Council of Ministers has granted a CE mark to Millipore’s clinical sample preparation devices, indicating that the products meet all essential requirements set forth by the new In-vitro Diagnostic Directive.
The primary aim of the In-vitro Diagnostic Directive is to remove technical barriers to trade and protect the health and environment of patients and third parties. The directive went into effect in June 2000. At this time products complying with the directive were entitled to bear the CE marking. Products given the CE marking will be granted free movement within the European Economic Area.
Millipore’s preparation devices that received the CE mark include Amicon® Ultra-4, Centriprep®, Centricon® and Centrifree® centrifugal filter units, and Minicon® and Miniplus® static concentrators.
These products are used to concentrate and purify macromolecules in human specimens (serum, urine, spinal fluid, and other biological fluids) prior to further analysis. The applications can be valued prognostic indicators of specific abnormalities, such as tumor cells.
Contact: Millipore (978) 715-4321; www.millipore.com
Trinity Biotech Acquires Adaltis US
The recent $3.5 million acquisition of Adaltis US by Trinity Biotech ensures that Trinity will have nonexclusive distribution of diagnostic instruments and reagents for the infectious disease market in the United States.
“The acquisition of Adaltis US is a strategic move for Trinity and is designed to enhance our infectious disease product offering,” says Ronan O’Caoimh, chief executive officer of Trinity Biotech. “The acquisition also gives Trinity access to the existing installed base of instruments in the United States, while providing an opportunity for our company to place its own reagents on this installed base of instruments.”
Contact: Trinity Biotech (800) 603-8076; www.trinitybiotech.com
Americans Save With Canadian Drug Calculator
According to the nonprofit organization, Results for America (RFA), more than 4,500 consumers used the Canadian drug savings calculator to calculate $20 million in total savings during the first 10 weeks the tool was available online.
Unveiled on November 25, 2003, the Canadian drug savings calculator enables Americans purchasing medications to calculate exactly how much they could save by buying medications in Canada. RFA is a project of the nonprofit Civil Society Institute, which is not involved in the health care industry or the recent lobbying on Medicare reform.
The RFA calculator allows consumers to gauge savings on nearly 50 of the most popular prescription medications by picking multiple drugs, different dosage settings, and time horizons ranging from 1 month to 20 years. For example, the calculator shows that an American consumer who buys a commonly prescribed osteoarthritis pain-relief medication, such as Vioxx, could spend $524.16 per year less at Canadian prices. Similarly, a person taking Lipitor for treatment of high cholesterol could save $338.52 per year in Canada, according to the calculator.
Prices reflected on the calculator’s Web site, www.drugsavingscalculator.com, were compiled from the list of prices of four different online pharmacy retailers from October 1–7, 2003. Certain price factors, such as inflation and competition-related adjustments in drug prices, are not reflected in the calculator’s multiyear results.
Contact: Visit Civil Society Institute (703) 276-3254; www.civilsocietyinstitute.org
