Laboratory-Standardization Program Developed to Detect Kidney Disease
The DigitalPT standardization program developed by AccuTest Proficiency Testing Services and HealthMetrx Canada enables clinical laboratories to implement a key National Institutes of Health (NIH) recommendation aimed at detecting kidney disease in its earlier stages, when treatment can slow the progression of the disease.
The National Kidney Disease Education Plan (NKDEP) of the NIH recommends that laboratories report an estimated glomerular filtration rate (eGFR) with every adult serum creatinine test. The eGFR is calculated with the modification of diet in renal disease (MDRD) prediction equation that uses the patient’s serum creatinine value, age, gender, and ethnicity.
While accurate eGFR requires accurate creatinine, studies indicate that creatinine measurements are not standardized and vary significantly between laboratories and different analytical instruments. Nonstandardized testing may result in misclassification of patients and missed opportunities for prevention and intervention. NKDEP efforts are under way at the national level with instrument manufacturers to correct for calibration biases, with full implementation targeted for 2009. The DigitalPT standardization program provides an immediate solution for calibration bias while manufacturers work toward recalibrating their platforms.
“The DigitalPT Standardization Program enables labs and managed care organizations to more effectively detect early kidney disease,” says Bill Donohue, president of AccuTest. “More than 20 million adult Americans have undetected kidney disease, and 20 million more are at risk. Without greater intervention efforts, treatment costs are projected to hit almost $40 billion by the end of this decade. Effective screening can save health care providers billions of dollars and spare many patients from a life dependent upon dialysis or organ transplantation.”
Program participants are provided a blind set of human serum test samples that challenge at critical decision levels for early-stage kidney disease. Samples have target values assigned by the ID|GC|MS reference method approved by the IFCC Joint Committee on Traceability in Laboratory Medicine (JCTLM). Replicate testing over several days generates a comprehensive assessment of total error, calibration bias, and imprecision against reference-method targets. Laboratory participants also receive a custom bias-correction formula that they use postanalytically, and the corrected creatinine result is then used to calculate an eGFR.
Contact: AccuTest Proficiency Testing Services (800) 665-2575; www.accutest.org
High-Capacity Human Protein Removal System Developed
Agilent Technologies Inc has introduced a high-capacity version of its human protein multiple affinity removal system, which removes as much as 99% of the six most common proteins from human blood serum. The new system allows researchers to facilitate the detection and identification of low-abundance proteins that may serve as markers for a wide range of diseases.
Proteins that are representative of disease processes are typically present in small amounts in human serum, and may be difficult to isolate amid high-abundance proteins such as albumin. By doubling the throughput of protein removal, the new Agilent high-capacity multiple affinity removal system makes it easier for researchers to eliminate high-abundance proteins from larger sample volumes.
“This high-capacity system will help to improve the speed, efficiency, and productivity of human biomarker research,” says Mary Pat Knauss, bioreagents business manager at Agilent. “Along with our ongoing efforts to develop methods for removing an even greater number of high-abundance proteins from serum or plasma, the new system enhances a scientist’s ability to delve into the human proteome and advance the progress of proteomic research.”
The new high-capacity affinity removal system is available in both high-performance liquid chromatography column and spin cartridge formats, facilitating protein removal through liquid chromatography (LC) or centrifugation techniques. The products can be reused for more than 200 runs and are compatible with most standard LC instruments and benchtop centrifuges.
Contact: Agilent Technologies Inc (800) 227-9770; www.agilent.com
Laboratory and Hospital Safety Meeting Scheduled for Lake Tahoe
The University of Pittsburgh School of Medicine will host the “Improving Hospital and Laboratory Safety” meeting August 22–23 at the Granlibakken Resort and Conference Center in Tahoe City, Calif, near Lake Tahoe. The meeting, which is designed for pathologists, laboratory administrators, quality assurance/patient safety officers, and nonpathologist physicians, will provide current patient safety improvement information from health services researchers, health care administrators, and quality-improvement practitioners.
The meeting also will promote awareness, education, research, and clinical applications development in the areas of pathology, laboratory quality improvement, and patient safety. It is designed to provide a forum for pathology laboratory practitioners and other stakeholders in hospital and laboratory quality improvement to network and to form collaborations for patient safety-related research or other quality-improvement initiatives. John D. Banja, PhD, author of The Narcissistic Allure and Pitfalls of the Health Professions, will serve as the meeting’s keynote speaker.
For more information, visit [removed]http://path.upmc.edu/pqps/default.htm[/removed]
 Trestle Expands Internet-Microscopy Offerings to MexicoTrestle Holdings Inc recently announced that the American British Cowdray (ABC) Medical Center, one of the largest private hospitals in Mexico, has installed Trestle’s Internet-microscopy solution in its facilities as part of the organization’s expansion to new locations.Founded in 1941 by the merger of two large hospitals in Mexico, the nonprofit ABC Medical Center expanded in late 2004 to a new campus in the suburban area of Santa Fe. The center is heralded as the most advanced medical facility in Latin America. After reviewing several digital-imaging solutions for its laboratories, ABC Medical Center chose Trestle’s MedMicro. The Web-based slide-viewing system enables medical personnel to view high-quality digital images of patient specimens from anywhere, via the Internet, using a standard PC. Physicians in different locations can view a patient’s slide simultaneously and collaborate in real time. According to Carlos Ortiz, MD, director of pathology at the ABC Hospital, “The Trestle MedMicro system will provide immediate interactive consultation regarding surgical pathology specimens. This will result in more efficient collaboration between the hospitals and improved health care for patients.” Contact: Trestle Holdings Inc (800) 823-3203; www.trestlecorp.com |
SurgiLance Prevails in Patent-Infringement Case
The 4-year dispute between competitors SurgiLance Inc and Owen Mumford Inc (OM) has come to an end by way of a decision made by the United States Court of Appeals for the Federal Circuit.
The dispute was initiated by OM against SurgiLance Inc and its Singapore parent, SurgiLance Pte Ltd. OM claimed that the design of the SurgiLance One-Step safety lancet was in violation of a paper patent held by OM. On June 22, 2004, the Federal District Court in Atlanta ruled that the One-Step safety lancet infringed OM’s patent but granted SurgiLance the right to an immediate appeal. On June 7, 2005, the Court of Appeals reversed the District Court’s judgment of infringement and directed the District Court to enter a judgment of noninfringement.
“[The Court’s decision] vindicates the position that we have held all along—that we invented our own product,” says Patrick Yi, founder and CEO of SurgiLance. “We researched the market responsibly and thoroughly, resulting in the development of our own unique design.”
Contact: SurgiLance Inc (888) 808-6494; www.surgilance.com
| FDA Clears Laboratory-Control Solution Roche Diagnostics has received clearance from the US Food and Drug Administration for its Elecsys PreciControl tumor-marker control solution, which provides laboratory professionals with the same control for six different tumor-marker tests.Because one control can be used with all of the tests, laboratory professionals experience an increase in efficiency and productivity. There is no need to switch controls to run different tests. Contact: Roche Diagnostics (317) 845-2000; www.roche-diagnostics.com |
Beckman Coulter Signs Licensing Agreement to Develop Preeclampsia Laboratory Tests
Beckman Coulter Inc has signed a licensing agreement with Nephromics LLC that will provide the company with access to all Nephromics’ patents, patent applications, and biologics related to the detection, monitoring, and risk-assessment of preeclampsia, which is the second leading cause of maternal deaths in the developed world.
According to the World Health Organization, preeclampsia is responsible for 18% of all maternal deaths, 80,000 premature births, and numerous neonatal complications in the United States. The condition costs the country more than $7 billion annually.
“Currently, there are no specific in vitro diagnostic tests for preeclampsia, even though the disease threatens the lives of thousands of women and their babies, and places a significant burden on health care systems worldwide,” says Mike Whelan, vice president of Beckman Coulter’s immunoassays and nucleic acid testing business center. “Through this licensing agreement, we plan to develop new immunoassay tests designed to improve the outcomes in certain at-risk pregnancies.”
Preeclampsia, characterized by hypertension and protein in the urine, occurs in as many as 10% of all pregnancies in the developed world. During preeclampsia, the fetus is at risk from reduced placental blood circulation and function. The condition may result in premature birth, low birth weight, and respiratory distress syndrome. For the mother, preeclampsia can cause seizures; brain, liver, and other organ damage; and even death.
The Nephromics technology is based, in part, on reagents supplied by R&D Systems. In 2003, Beckman Coulter entered into an agreement with R&D Systems for the development and manufacture of automated cytokine assays and assay components designed for Beckman Coulter’s Access® family of immunoassay systems. The new tests are being designed for use on the immunoassay systems, including the UniCel® DxI 800 analyzer and the SYNCHRON LX®i 725 chemistry-immunoassay system.
Contact: Beckman Coulter Inc (800) 526-3821; www.beckmancoulter.com
REAL 2005 Offers Answers to Regulatory and Compliance Challenges
The Clinical Laboratory Management Association’s annual regulatory and compliance workshop, Reimbursement Education and Learning (REAL) 2005, will be held September 8–10 in New Orleans.
REAL 2005 is designed to provide laboratory professionals with the latest information needed to ensure maximum reimbursement. Participants will have a chance to gather resources, tips, and suggestions on ways to solve reimbursement challenges.
Program leaders will combine case studies, on-site coaching, question-and-answer periods, and expert lectures on a number of regulatory topics.
For a course agenda and registration information, call (610) 995-9580, or visit www.clma.org
A Growing Number of Americans are Turning to the Internet for Medical Answers
A recent Harris Interactive poll conducted earlier this year has revealed that an increasing number of US residents are going online to find health or medical information.
According to the poll results, 90% of respondents who have researched health information online said they believe the information is reliable. Additionally, 57% of respondents who have used the Internet to find health information said they have discussed this information with their physician at least once. Also, 52% of respondents said they had searched for health information online based on a discussion with their physician.
Contact: Harris Interactive (877) 919-4765; www.harrisinteractive.com
| FDA Approves PCR-Based Tests for HIV-1 and Hepatitis C Roche Diagnostics has received US Food and Drug Administration (FDA) approval for its COBAS AmpliPrep/COBAS AMPLICOR HIV-1 monitor test version 1.5. The new HIV-1 molecular diagnostic test system is a polymerase chain reaction (PCR)-based test that offers fully automated specimen preparation followed by fully automated amplification and quantification of the HIV-1 RNA for viral load monitoring. The key innovation in the upgraded products is the automation of specimen preparation using the COBAS AmpliPrep instrument, which is designed to provide consistent specimen preparation for nucleic acid tests. The power of automation for the specimen-preparation process yields enhanced operational efficiencies for laboratories that use PCR-based diagnostic tests for the quantification of HIV RNA and the detection of HCV RNA. Roche previously had received approval for the COBAS AmpliPrep/COBAS AMPLICOR HCV test version 2.0, which also features fully automated specimen preparation and automated amplification and detection of the HCV viral RNA, allowing physicians to assess whether treatment is appropriate. Contact: Roche Diagnostics (317) 845-2000; www.roche-diagnostics.com |
GE and Gen-Probe Form Alliance
GE Infrastructure, Water & Process Technologies—a unit of General Electric Company—and Gen-Probe have joined forces on an exclusive basis to develop, manufacture, and commercialize nucleic acid testing (NAT) technologies that are designed to detect the genetic sequences of microorganisms in selected water applications.
“In today’s day and age, we must do everything we can to ensure the safety of our water resources,” says George Oliver, president and CEO of GE Infrastructure, Water & Process Technologies. “The GE and Gen-Probe alliance will explore pioneering technologies that help prevent the spread of illness and disease throughout the world.”
According to Gen-Probe, 1.2 billion people worldwide do not have access to safe, usable water, and 5 million people die each year from waterborne diseases. The most common and pervasive water risks are caused by infectious diseases such as pathogenic bacteria, viruses, and protozoan parasites. People are introduced to these microorganisms through contaminated drinking water, irrigation, aerosols, and washing or bathing.
The companies estimate that more than 1 billion industrial microbiology tests are conducted annually around the world. Roughly three quarters of these tests are conducted using culture methods that cannot deliver results as rapidly as NAT technologies.
Contact: Gen-Probe (800) 523-5001; www.gen-probe.com
| AMETEK Acquires SPECTRO Analytical Instruments In a transaction valued at approximately $80 million, AMETEK Inc has acquired SPECTRO Beteiligungs GmbH, the holding company of SPECTRO Analytical Instruments GmbH & Co KG and its affiliates. SPECTRO—a supplier of atomic spectroscopy analytical instrumentation—designs, manufactures, and services spectroscopic instrumentation used to analyze the elemental composition of solids and liquids. “We are very excited about the acquisition of SPECTRO,” says Frank S. Hermance, chairman and CEO of AMETEK. “SPECTRO is a differentiated business, which significantly expands our elemental analysis capabilities, bringing new technologies and market opportunities to AMETEK.” SPECTRO joins AMETEK as part of its Electronic Instruments Group (EIG)—a provider of monitoring, testing, calibrating, and display instruments. Contact: AMETEK Inc (610) 647-2121; www.ametek.com |
AcroMetrix Receives 510(k) Clearance for Blood-Screening Controls
AcroMetrix Corp recently received 510(k) clearance from the US Food and Drug Administration (FDA) for its VeriSure Pro external quality controls. The controls are used on Chiron’s Procleix® blood-testing system that is approved by the FDA for the testing of HIV-1 and HCV using nucleic acid amplification. The clearance from the FDA allows the controls to be marketed and sold in the United States for in vitro diagnostic use.
“Customers who use the Procleix assay now have a choice of external quality controls to use in blood testing,” says Michael Eck, CEO of AcroMetrix.
The VeriSure Pro external quality controls are intended to provide a means to estimate accuracy, and then have the potential to detect systematic deviations of nucleic acid test procedures for the qualitative determination of HIV-1 RNA and HCV RNA.
Currently, more than 50 million units of blood are tested by nucleic acid testing (NAT) technologies worldwide, and the Chiron NAT assays currently approved for use in the screening of blood and plasma samples in the United States are for the detection of HIV-1 and HCV. AcroMetrix also is the only Chiron-approved provider of WNV RNA controls for the Chiron WNV NAT test that is currently in clinical trials.
Contact: AcroMetrix Corp (888) 746-7921; www.acrometrix.com
CeMines Receives Notice of Grant for New Class of Oncology Targets
CeMines Inc has received a Notice of Allowance from the US Patent and Trademark Office related to a patent application for claims directed to Mammalian Neuralized Family transcriptional regulators.
The patent claims that polynucleotides that encode transcriptional suppressors characterized by the presence of a neuralized homology repeat domain and a C3HC4 RING-zinc finger domain have been discovered. The biological functions of the Neuralized Family are wide-ranging, and they include regulation of muscle and neural development. Equally important, members of the Neuralized Family have been associated with neural and neuroendocrine cancer types, including glioma and nonsmall-cell lung cancer.
“Obviously, we’re very pleased that the US Patent Office has recognized the novelty and significance of our discovery of the Neuralized Family of transcription factors,” says Roger Attick, president and CEO of CeMines. “Over and above the persuasive clinical data contained in our patent application, we continue to generate additional convincing clinical data from our ongoing international studies validating these molecules as a significant new class of oncology targets,” says Toomas Neuman, MD, chief scientific officer for CeMines. “It is important to note that CeMines is now reaping the benefits of our early work in biomarker discovery, validation, diagnostic arrays, and theranostics.”
Earlier this year, CeMines filed an application with the US Food and Drug Administration seeking clearance for clinical use of CeMines CellCorrect Lab, the first minimally invasive cancer-detection kit.
Contact: CeMines Inc (858) 964-2200; www.cemines.com
| Global Med Signs Contract With Nigeria Working closely with Safe Blood for Africa™ Foundation (SBFA), Wyndgate Technologies®—a division of Global Med Technologies Inc—has signed a nationwide contract with the Nigerian government in which the company will provide the country with SafeTrace donor-management systems and SafeTrace Tx advanced transfusion-management systems. The technology will enable the SBFA to establish, upgrade, and operate the Nigeria National Blood Transfusion Service in collaboration with the Federal Ministry of Health. The agreement will provide for the installation of Global Med’s blood bank information systems in each blood center operated by the SBFA. “Blood centers in underdeveloped countries face challenges beyond those in technologically advanced countries,” says Stephen Field, MD, medical director for the SBFA. “Blood shortages are a concern, and the blood supply is at risk of possible contamination with blood-borne diseases, such as HIV, hepatitis, and syphilis. Replacing Nigeria’s blood centers’ manual processes and manual records with automated solutions can help to manage Nigeria’s donor testing and help to ensure the safe release of blood and blood products for transfusion.” According to Field, an estimated six additional centers are interested in installing Global Med’s software in 2005. “This nationwide contract and implementation of Global Med’s donor and hospital transfusion systems via satellite throughout the country of Nigeria is an indication of Global Med’s ability to provide its software to entire countries—not only in Africa, but throughout the world,” says Will Willman, senior vice president of international business development for Global Med. Contact: Global Med Technologies Inc (800) 996-34283; www.globalmedtech.com |
