COLA Announces New QMS Accreditation Program
COLA has launched a quality management systems (QMS) accreditation program to assist laboratories faced with the challenge of maintaining a culture of quality. The program is a systems-based management approach for testing quality, patient safety, and the overall efficiency of laboratory service that combines quality management and business process techniques with traditional laboratory assessment. The program will provide results and benefits for laboratories that participate in the ongoing process approach.
According to the association, laboratories that take part in the QMS accreditation program will experience higher quality and improved patient safety through prevention of errors, improved risk management in laboratories, more efficient and productive operations, improved integration and data sharing, and increased employee involvement and satisfaction.
“COLA’s QMS approach to laboratory accreditation is the first critical step in creating that culture of quality,” says Doug Beigel, CEO of COLA. He believes that the use of a QMS approach will make it difficult for serious problems to go undetected by lab staff or management. The organization believes this core foundation of encouraging the reporting of errors and problems is what will make this approach successful and result in safety and efficiency.
Contact: COLA (800) 981-9883; www.cola.org
|Scott Specialty Gases Develops Calibration Products for Homeland Security Applications
At the request of the US military, calibration gases for instruments used to detect chemical warfare agents (CWAs) have been included in Scott Specialty Gases’ product line. The company supplies pure and mixed gases for applications that are used in environmental processes, laboratories, and medical simiconductor applications. Scott Specialty Gases’ increasing involvement in homeland security also is a result of requests from other companies that are developing specialized instruments and detectors to identify CWAs. Some of the products being developed by Scott are standard mixtures, such as cyanogen chloride, phosgene, and hydrogen cyanide.
Scott currently is partnered with INFICON, which provides vital chemical identification systems for immediate, on-site detection and analysis of volatile organic compounds, such as toxic industrial chemicals and chemical warfare agents in air, water, and soil. INFICON’s HAPSITE® Smart Chemical ID system is used in the United States and overseas to provide fast, on-site detection, identification, and quantification of toxic industrial chemicals and CWAs. Scott’s products are an integral feature of the HAPSITE Smart’s portability and ease-of-use.
Contact: Scott Specialty Gases (800) 217-2688; www.scottgas.com
|Fujirebio Ventures Into the Outback
MESOMARK™, an in-vitro diagnostic test for patients with mesothelioma, is the subject of a recent distribution agreement between producer Fujirebio Diagnostics Inc (FDI) and Australia-based Vital Diagnostics. FDI has selected Vital Diagnostics to be the Australian distributor of MESOMARK. The agreement marks the beginning of FDI’s commercial rollout of the test, which is now available for the first time in Australia.
“The launch of MESOMARK is a significant event for FDI and greatly enhances our product portfolio, underscoring our commitment to commercialize high-quality diagnostic tools that improve cancer patient care,” says Jeffrey Allard, MD, vice president and chief scientific officer at FDI. “MESOMARK is the first in-vitro diagnostic test for patients with mesothelioma, and it has the potential to improve survival rates and quality of life for patients with this aggressive and often fatal disease.”
Mesothelioma, a rare form of cancer in which fluid accumulates between the lining of the lungs and chest cavity, is primarily caused by work-related asbestos exposure and has a latency period of up to 75 years. It is estimated that 10,000 new cases are diagnosed each year in industrialized countries.
MESOMARK is a manual enzyme-linked immunosorbent assay (ELISA) for managing mesothelioma. It works by identifying a group of molecular markers called soluble mesothelin-related proteins (SMRPs), which are released into the bloodstream by mesothelioma cells.
Because SMRPs can be elevated for several years before an actual diagnosis of mesothelioma can be made, MESOMARK will help in the routine monitoring of asbestos-exposed individuals who are at greatest risk for developing mesothelioma.
Contact: Fujirebio Diagnostics Inc (610) 240-3800; www.fdi.com
|TREK Celebrates National Medical Laboratory Week
National Medical Laboratory Week (NMLW) is April 24–30, and this year’s theme is “Laboratory Professionals—The Heart of the Medical Investigation Team.” To celebrate the event, TREK Diagnostic Systems is inviting laboratory professionals to register to win a special commendation for his or her microbiology laboratory. Visitors to the company Web site, www.trekds.com, can click on the NMLW link to complete a brief qualifying form. At the end of NMLW, one entry will be randomly selected as a winner. Visitors to the site also can request the TREK promotional bug “TREK Gets the Tough Bugs.”
Contact: TREK Diagnostic Systems (800) 871-8909; www.trekds.com
TotalLab Software Suite Compatible With Mac
Nonlinear Dynamics Ltd, a provider of bioinformatics solutions, recently announced that its TotalLab general image analysis software solution is now compatible with the Apple Macintosh operating system by using Virtual PC for Mac v7.0.
TotalLab provides automated and quantitative analysis of images from a wide range of biological samples. The core component is the comprehensive 1D analysis module, which is simple to use and allows a fast and consistent analysis of 1D gel electrophoresis images in a few clicks. Sophisticated algorithms enable single-click identification of lanes and bands, followed by accurate calculation of molecular weights and band quantities from 1D images that are difficult to analyze.
“By using the Virtual PC tool, [TotalLab] is accessible to the many scientists worldwide who use the Apple Mac platform,” says John Spreadbury, CEO of Nonlinear USA Inc. “This enlarges the group of researchers who can benefit from this versatile lab tool, particularly within US academia, where the Mac has a strong user base.”
Contact: Nonlinear Dynamics Ltd (919) 313-4556; www.nonlinear.com
Wide-Reaching Health Care IT System Developed
GE Healthcare and Intermountain Health Care (IHC) recently announced a collaboration to create a best-practices-based clinical software program that will enhance the patient care process and accelerate the adoption of electronic health records (EHRs) among health systems in the United States.
“The collaboration between GE and IHC is intended to spur the development of a comprehensive way to manage the explosion of data that has emerged from the health care industry,” says Vishal Wanchoo, president and CEO of GE Healthcare Information Technologies. “Our work together has the potential to do for health care what the Internet did for research. Information will no longer be tied to a physical location, but will be available in seconds on a computer, to anyone anywhere.”
It is expected that GE and IHC team members will work together from Salt Lake City to research and develop significant advances to GE’s Centricity software IT platform. The new best-practices-based clinical software system will include IHC’s clinical decision-making abilities and will be based on current and emerging open health care standards.
GE also intends to provide Centricity technologies for departments, including pharmacy, computerized physician order entry, and cardiology, across institutions within IHC’s network, which includes 92 clinics/physician offices and 21 hospitals in Utah and Idaho. These installations, which will facilitate the sharing of patient information throughout IHC’s network, will continue over the next 5 years.
“GE and IHC will work together to develop an IT system that simplifies health care’s current approach to clinical information systems by ensuring all facilities, regardless of where they are located, have the most comprehensive and coordinated access to clinical data, resulting in faster diagnosis and more effective patient care,” says Greg Poulsen, IHC’s senior vice president.
According to Poulsen, the collaboration between GE and IHC is intended to enhance and equalize patient care.
“Through improved access to EHRs and decision support, local hospitals in rural areas have the same access to patient information, best-practice models, and research as larger hospitals in urban areas,” says Poulsen. “For example, the EHRs of a child treated at a local hospital in a small town in Utah can be accessed by experts at the Primary Children’s Medical Center in Salt Lake City, who can provide counsel on the best course of treatment after viewing the medical history and test results via IHC’s software program. In health care, timely access to information is the great equalizer. GE and IHC want to make the most progressive research and modern tools of diagnosis and treatment available to everyone.”
According to Poulsen, the evolution of clinical information technologies in health care is just beginning, which makes it an opportune time for this kind of collaboration.
“Less that 15 percent of the health care providers in developed countries have adopted clinical IT systems,” says Poulsen.
“Because of such a low level of penetration, GE and IHC view this as an opportunity to set the standard for the industry to follow.”
Contact: GE Healthcare (732) 547-8000; www.gehealthcare.com
|Thermo Electron Acquires License to Produce and Supply LNA
Thermo Electron Corp has acquired a nonexclusive license to produce and supply locked nucleic acids (LNAs) to the worldwide scientific research community from the Danish company, Exiqon A/S. According to the agreement, Exiqon will allow Thermo to produce all types of high-quality LNA oligonocleotides and assist customers with questions regarding the design and application of LNA molecules.
Due to the enhanced stability of LNA-DNA hybrids, LNA probes can improve nearly all types of basic genomic research, such as FISH and microarray analysis, as well as antisense applications. The ability to tailor the melting temperature of an LNA molecule allows customers to optimize all experiments—such as PCR, SNP detection, and expression profiling—with Tm as a critical parameter.
Contact: Thermo Electron Corp (866) 984-3766; www.thermo.com
|Franek Offers Power Support
Franek Technologies Inc continues to provide power support to critical laboratories across the country, before the threat of power loss becomes a reality.
The company has installed more than 50 certified, instrumentation-specific power-protection systems at City of Hope National Medical Center (Duarte, Calif) and Beckman Research Institute (Champagne, Ill) to protect critical research and patient care instrumentation valued at more than $25 million.
As research institutes and treatment centers, City of Hope and Beckman Research Institute rely on sophisticated instrumentation to conduct cancer, diabetes, HIV/AIDS, and other life-threatening disease research. Such instrumentation is highly sensitive to uncontrolled environmental conditions, such as power fluctuations or interruptions. Failure to provide adequate power protection can result in costly damage to the instrumentation, irreplaceable sample loss, and lost production time.
Contact: Franek Technologies Inc (800) 326-6480; www.franek-tech.com
|Gen-Probe Receives FDA Marketing Clearance for Neisseria Gonorrhoeae Test
Gen-Probe’s APTIMA® assay for Neisseria gonorrhoeae (GC), an amplified nucleic acid test that detects, on a stand-alone basis, the bacterium that causes GC, has been granted marketing clearance by the FDA.
Gen-Probe’s primary amplified STD test is the APTIMA GC® assay, which simultaneously detects chlamydia trachomatis and GC. Like the APTIMA Combo 2 assay, the APTIMA GC assay was cleared to detect GC from the widest variety of sample types: clinician-collected endocervical, vaginal, and urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The APTIMA GC assay can be run on Gen-Probe’s semi-automated DTS instruments.
Contact: Gen-Probe (800) 523-5001; www.gen-probe.com
Battelle and C-PERL Form Alliance to Streamline Development Cycle
Battelle and Chesapeake PERL Inc (C-PERL) recently announced the formation of an alliance to provide the clinical diagnostic industry with support and service. The two companies will offer clients seamless and integrated solutions that range from protein processing and purification to preclinical animal studies.
“Our alliance with C-PERL allows us to offer protein manufacturing, in addition to the full scope of product characterizations, toxicology, clinical, and medical device development services we already provide,” says Bark Gritz, vice president of the Health and Life Sciences Division of Battelle. “Jointly, we can enhance our customers’ ability to rapidly progress their products from discovery to development to commercialization.”
The high cost of risk associated with developing new drugs and biological products highlights the need for pharmaceutical and biotechnology industries to reduce product development cycle times. The combination of Battelle and C-PERL capabilities enables clients to move their recombinant protein products from discovery to rapid production of milligram quantities to the commercial market more quickly and effectively. As a result, companies can concentrate on their core competencies and sharply focus their spending plans.
“There’s a substantial unmet market need for rapid and scalable recombinant protein production to address the complex needs of the marketplace,” says Terry Chase, president of C-PERL. “We’re excited to expand our product capabilities with a company such as Battelle to address these market needs and to deliver an integrated offering to our combined client list.”
Contact: Battelle (614) 424-5544; www.battelle.org
|FlowMedica Announces Involvement in Renal Insufficiency Study
FlowMedica Inc is taking part in a clinical study being conducted by the Scripps Clinic of La Jolla, Calif. The physician-sponsored study is using FlowMedica’s Benephit infusion system in patients with compromised kidney function who are undergoing coronary procedures. The Benephit infusion system is a proprietary catheter-based infusion system for targeted renal therapy that delivers therapeutic agents to the kidneys via the renal arteries.
The multi-center, randomized, placebo-controlled study is under the direction of principal investigator Paul Teirstein, MD, FACC, director of interventional cardiology at Scripps Clinic. The study monitors 64 diabetic patients with compromised kidney function. These patients are at high risk of developing acute kidney failure due to their inability to process the contrast agents used during coronary interventional or diagnostic procedures, a condition known as radiocontrast nephropathy (RCN).
The study is being conducted to evaluate the ability of the Benephit infusion system to deliver fenoldopam selectively to the kidneys to preserve renal function as measured by serum creatinine levels, a direct indication of kidney function. Although fenoldopam can increase blood flow to the kidneys and improve kidney function, its systemic use to prevent RCN is limited since doses high enough to be effective are associated with significant lowering of blood pressure or hypotension.
The study is designed to assess the effectiveness of escalating doses of fenoldopam delivered intra-renally by the Benephit system.
“This study builds on the success of an initial trial of the Benephit system in patients who have a lesser risk for developing RCN,” says Teirstein. “In this case we will be evaluating high-risk patients to confirm that targeted intra-renal drug delivery can maximize the beneficial effects of drugs while minimizing systemic side effects.”
According to a previous study conducted at Scripps Clinic and St Joseph’s Medical Center in Stockton, Calif, the intra-renal delivery of fenoldopam via the Benephit infusion system improved kidney function significantly; the intravenous administration of fenoldopam at the same dose improved kidney function only minimally. The study also showed that systemic drug levels were significantly less following intra-renal delivery of fenoldopam vs intravenous treatment, leading to less blood pressure reduction.
Contact: FlowMedica (866) 671-9500; www.flowmedica.com
Quest Announces New Blood Tests for Leukemia and Lymphoma Patients
The University of Texas MD Anderson Cancer Center in Houston has granted Quest Diagnostics Inc exclusive use of five proprietary blood-testing methods that, once available in the form of laboratory diagnostic tests, may eliminate the need for painful and expensive bone marrow and other tissue extractions, according to Quest Diagnostics. The methods are the subject of two United States patent applications. The tests are intended to provide a safer, less painful tool for the diagnosis, treatment, and monitoring of leukemia and lymphoma in cancer patients. The initial tests are expected to be available following validation, which could be as early as the end of 2005. Additional terms of the licensing transaction were not disclosed.
Current diagnostic and monitoring tests for leukemia and lymphoma patients often require patients to undergo painful procedures such as bone marrow biopsies, which require extraction of tissue with a bone-piercing, large-gauge needle. The new tests are in development at Quest Diagnostics’ research and development center, Nichols Institute in San Juan Capistrano, Calif. They have the potential to provide a more clinically useful assessment of prognosis, disease progression, and therapeutic success, which could enable oncologists to advance the efficacy of therapies.
“Our research has shown that testing for tumor constituents in the blood provides a more clinically useful assessment of a patient’s disease status because it shows what is happening in the entire body, compared with biopsies where a tissue sample only provides information about a specific area,” says Michael J. Keating, MD, professor of medicine and deputy department chairman for the department of leukemia at MD Anderson Cancer Center. “It also offers a less painful and more cost-effective way to monitor patients. As a result, the new blood tests may allow oncologists to assess patients more frequently and thus provide more clinically relevant monitoring of their progress.”
Quest Diagnostics is developing new tests, based on the MD Anderson technology, that are designed to detect certain proteins that are expressed on the surface of tumor cells, as well as molecular targets from the tumor cells. The assays will look for the proteins and tumor-specific DNA and RNA in blood plasma. The tests are intended to help doctors diagnose lymphoma and leukemia, assess patient response to cancer treatment, and monitor the patient post-treatment. By measuring tumor constituents in the blood, as opposed to assessing a tissue sample, physicians might one day replace the current bone marrow biopsies that are painful for patients to endure.
“We are very excited about this opportunity to develop new tests to help patients with lymphoma and leukemia,” says Surya N. Mohapatra, PhD, chairman and CEO of Quest Diagnostics. “We hope to provide physicians with tests that avoid the pain associated with bone marrow biopsies.”
Contact: Quest Diagnostics Inc (703) 802-6900; www.questdiagnostics.com
Industry Partnership Addresses Laboratory Needs
In an effort to expand its laboratory-automation capabilities, Abbott Laboratories has entered into an agreement with Inpeco SpA, a provider of automation solutions. Through the agreement, Abbott will offer a suite of automation solutions that can be customized to address needs within the laboratory while enhancing the consistency and efficiency of the diagnostic-testing process.
“Laboratories are looking at automation to help them address labor shortages, improve safety, and reduce errors,” says Douglas Bryant, vice president, Global Commercial Operations of Abbott Diagnostics Division. “Many of Abbott’s diagnostic instruments and software already address some of these challenges. However, this agreement allows Abbott to offer a broader range of automation solutions that can be customized to support the lab’s workflow needs.”
Abbott and Inpeco will partner to design, develop, and commercialize interfaces between Abbott’s ARCHITECT® and CELL-DYN® family of analyzers, and Inpeco’s suite of modular, laboratory automation components, to create an enhanced preanalytical/postanalytical work cell, an immunochemistry track work cell, a hematology track work cell, or a customized combination of the three. Abbott also will offer laboratories additional flexibility by utilizing an open architecture. The open-system approach allows laboratories to customize a system that best meets their needs.
In addition to Abbott obtaining nonexclusive rights to distribute and market Inpeco’s automation equipment, the agreement also states that the company will have access to new lab-automation technologies developed by Inpeco. This gives Abbott the ability to incorporate technological advancements such as information technology and robotics into future Abbott automation solutions.
Contact: Abbott Laboratories (800) 323-9100; www.abbottdiagnostics.com
|Adeza Supports March of Dimes
To raise public awareness of the growing rate of premature births, Adeza, a manufacturer of women’s health products, has signed on as a corporate supporter of the March of Dimes multimillion-dollar national campaign.
“We are proud to work with the March of Dimes on this vital public health issue,” says Emory Anderson, president and chief executive officer of Adeza. “Raising public awareness to the burden prematurity places on families and the health care system may help Americans find additional answers to this heartbreaking problem. Early detection, coupled with risk assessments, education, and prescribed interventions, can produce the outcomes Adeza and the March of Dimes are striving to achieve.”
Adeza will provide support to many local March of Dimes Chapters to assist in their statewide prematurity campaign efforts. Adeza and the March of Dimes will be cobranding two brochures to help raise awareness: “Preventing Preterm Birth” and “The Cost of Prematurity for Businesses.” The brochures will be distributed nationwide this year.
Contact: Adeza (888) 773-8376; www.adeza.com
Gen-Probe Signs Purchase Agreement
Gen-Probe has signed a supply and purchase agreement with Roche Ltd and its affiliate, Roche Molecular Systems Inc. According to the agreement, Gen-Probe will purchase products from Roche for use in molecular diagnostic assays for human papillomavirus (HPV). Gen-Probe plans to use the HPV probes supplied by Roche in APTIMA® format HPV test kits to detect high-risk subtypes of HPV.
“Developing an HPV test is an important part of Gen-Probe’s long-term strategy to enter new markets where there are important medical needs and attractive commercial opportunities,” says Henry Nordhoff, chairman, president, and chief executive officer of Gen-Probe.
Contact: Gen-Probe (800) 523-5001; www.gen-probe.com
In-Office Test to Confirm Aspirin’s Effectiveness Granted CLIA Waiver
The FDA has granted Accumetrics a CLIA waiver for its VerifyNow™ aspirin test, which helps identify patients who are not experiencing aspirin’s protective effects against heart attack and stroke. The test provides rapid results that reveal whether a patient is responding to aspirin and is adequately protected. If a person is found to be nonresponsive, a number of options are available to increase the level of protection, including increasing the dose of aspirin, modifying the use of other drugs that can interfere with aspirin’s effect, or switching to another type of antiplatelet agent.
“With this one test, patients can leave the doctor’s [office] knowing that the aspirin they are taking is working for them in the way that it should,” says Marc Ladenheim, MD, cardiologist at Providence Saint Joseph Hospital in Los Angeles. “For those patients who aren’t responding, [the test results] give them the opportunity to work with their physician to modify treatment before it’s too late.”
Contact: Accumetrics; www.accumetrics.com
Per-Se Provides New Outsourcing Solution
Per-Se Technologies recently announced it will provide an outsourcing solution to improve reimbursement and business intelligence for clinical laboratories. Per-Se has teamed with XIFIN Inc to use the company’s revenue cycle-management applications specific to clinical labs to complete the new service offering.
XIFIN develops Web-based applications that improve cash collections and deliver financial information to help clinical labs operate more efficiently. Per-Se’s two decades of reimbursement experience, combined with XIFIN’s clinical lab application technology, will enable labs to achieve their income potential.
Executive chairman and founder of XIFIN, Lâle White, states that laboratories now can realize an immediate and dramatic impact on cash collections with the new revenue cycle-management solution. “Per-Se and XIFIN offer laboratories a comprehensive outsourcing solution to help reduce the process errors that have plagued the laboratory industry—errors that have resulted in laboratory debt, rework, and compliance liabilities,” says White.
Contact: Per-Se Technologies (770) 237-4300; www.per-se.com
|Ventana Obtains Judgment in Biogenex Case
The US District Court for the Northern District of California, San Jose Division, has issued a summary judgment in favor of Ventana Medical Systems Inc in the BioGenex v Ventana case. Ventana, a manufacturer of instrument and reagent systems that automate slide preparation and staining in clinical histology and drug-discovery laboratories, was successful in obtaining a judgment of noninfringement of BioGenex’ US Patent No 6,451,551. With regard to BioGenex’ US Patent No 5,578,452, the court ruled the patent was invalid in the context of this litigation. The court also denied BioGenex’s motion to add its US Patent No 6,632,598 to this litigation.
Contact: Ventana Medical Systems (800) 227-2155; www.ventanamed.com
|Nanogen Issues Patent for Electronic MICROArray
Diagnostics product developer Nanogen Inc recently received US Patent No 6,867,048, “Multiplexed Active Biologic Array,” from the US Patent and Trademark Office. The patent relates to a method of addressing one or more electrodes (test sites) across multiple rows and columns of a microarray. The patent also covers a method for storing the voltage value associated with each electrode in a local memory.
The company’s smart chip technology is a key feature of its NanoChip® 400 electronic microarray, Nanogen’s second-generation multipurpose system for developing and performing molecular-diagnostic tests. Utilizing local memory circuits enables precise control of currents delivered to individual electrodes on the array, while minimizing the utilization of off-chip circuitry and overall system costs.
According to sources at Nanogen, storing critical voltage information allows for precise control of the biological molecules during analysis and increases data-management efficiency by tracking test-site activation and array usage directly on the electronic microarray cartridge.
Contact: Nanogen Inc (877) 626-6436; www.nanogen.com