Leica Technology Makes Hollywood DebutIB
An episode of “CSI: NY” recently aired in which the Leica AS LMD laser microdissection system played a major role in the development and conclusion of the story’s plot.
The Leica AS LMD is used to separate specific cell types from sexual assault evidence for DNA analysis. Cells of interest are circumscribed on a computer monitor so that spermatozoa or epithelial cells can be isolated for DNA analysis. The system also is used for separating other epithelial transfer evidence, isolating single hair follicles, and analyzing parentage from fetal tissue.
“CSI: NY” writers developed a plot that was well-suited for Leica’s AS LMD technology.
“What excited ‘CSI: NY’ writers and producers about the AS LMD was the capability to use the instrument live on the set with actor Gary Sinise,” says Deb Cole, the show’s associate producer.
Representing new technology in forensic science, the “CSI: NY” characters used the AS LMD for separating specific epithelial cells from a blood-splatter mixture in an out-of-the-ordinary “CSI: NY” case.
Contact: Leica Microsystems (800) 248-0123; www.leica-microsystems.com
Scientific Software and Labtronics Collaborate to Develop Laboratory Software
Scientific Software Inc (SSI), a provider of software solutions to the scientific community, and Labtronics Inc have announced the development of LimsLink for OpenLAB, a connectivity module integrating OpenLAB with LimsLink. LimsLink for OpenLAB provides an off-the-shelf solution for integrating third-party LIMS systems to SSI’s OpenLAB laboratory software framework. In this way, more than 30 different commercial LIMS systems from different LIMS vendors can be integrated into the OpenLAB framework.
“The OpenLAB laboratory software framework provides laboratories with a strategic platform to address their instrument, lab information, and other electronic content,” says Edward Long, vice president of marketing at Scientific Software. “We are very pleased to see technology partners such as Labtronics develop complementary solutions to integrate OpenLAB with other laboratory software such as commercial LIMS packages.”
LimsLink for OpenLAB provides extraction and transfer of sample data from LIMS to instruments, transfer of data from OpenLAB to third-party LIMS, viewing of OpenLAB reports from within third-party LIMS packages, and transfer of LIMS data to OpenLAB to make future searches easier. LimsLink for OpenLAB is available from Labtronics Inc. It can be added to any OpenLAB laboratory software framework, version 2.0 or greater.
Contact: Labtronics Inc (519) 767-1061; www.labtronics.com
|CeMines Seeks FDA Clearance for Cancer-Detection Kit
CeMines Inc has filed a 510(k) application with the Food and Drug Administration (FDA) seeking clearance for clinical use of the company’s first minimally invasive cancer-detection kit, CeMines CellCorrect™ Lab.
The test detects altered autoimmunity and associated patterns of disease-related autoantibodies in the bloodstream. According to sources from CeMines, the company has conducted extensive clinical studies that demonstrate that specific and consistent patterns of certain antibodies regularly prove their utility as composite biomarkers to characterize cancer, and can therefore be used as diagnostic tests for cancer. The company used a proprietary bioinformatics-based statistical pattern-recognition application, CeMines Molecular FingerPrinting™, that evaluates patterns of certain antibodies and the profiles of cancer patients. This data is then presented to help physicians diagnose cancer.
“We believe our approach to diagnostic testing is the only practical approach to achieving an accurate determination of clinical prognosis, as well as precise measurement of a patient’s response to treatment,” says Roger Attick, CEO of CeMines. “Too many cancer patients lose their will to survive, especially when their hope and desire to live also fall victim to the disease. The team at CeMines is dedicated to achieving advancements in research and technology that we hope will forever change cancer’s sad legacy, so that the victims of this disease will never again have to say, ‘If only we’d caught it sooner.’ ”
Contact: CeMines (303) 526-3700; www.cemines.com
Genome Analysis Technology Aids in Fight Against Mesothelioma
A breakthrough human genome CGH microarray technology from Agilent Technologies Inc is being used by researchers at Peter MacCallum Cancer Centre in Melbourne, Australia, to better understand mesothelioma, a cancer found in the lining of the chest, the abdominal cavity, and in areas around the heart.
The cancer usually is caused by exposure to asbestos. Due to the country’s aggressive mining and manufacturing of asbestos in the mid-1900s, Australia has the highest incidence of mesothelioma in the world. Rates of the disease have tripled in the past 20 years, and they are expected to peak by 2010. Diagnosis of this type of cancer is difficult, and patients often are not identified until the condition is advanced.
Agilent’s microarray techniques in comparative genomic hybridization (CGH) will allow researchers to rapidly and reliably identify genetic changes in tumorous cells. It is believed that specific genetic changes may accompany the onset and progression of the disease.
Andrew Holloway, MD, from the Peter MacCallum Cancer Centre, says his team will work in conjunction with colleagues at the University of Western Australia, using Agilent’s CGH microarray to provide a more thorough understanding of the genetic makeup of mesothelioma cells, which may lead to increased knowledge of the origin and development of this and other cancers.
“Agilent’s CGH technology will allow us to study the entire genome in a manner that hasn’t been possible in previous genomics research,” says Holloway. “Upon completion, this project will produce the largest data set of its kind on mesothelioma in the world. We are very optimistic that it will give us a much clearer understanding and interpretation of this devastating disease.”
Contact: Agilent Technologies Inc (877) 424-4536; www.agilent.com
|bioMérieux Launches ‘Innovation-in-Motion’ Bus Tour
In May, bioMérieux Inc took to the road—literally—in an effort to reach out and educate customers. The company launched Innovation-in-Motion, a high-tech bus-board presentation theater and mobile laboratory that is crisscrossing the country on a 50-city tour. The full-size luxury bus is equipped with the bioMérieux Integrated Solution, including BacT/ALERT® 3D, VITEK® 2 compact, and STELLARA™, as well as diagnostic and information technology equipment. The tour provides an up-close demonstration of the latest diagnostic technologies to hospital laboratory technicians, pharmacists, and physicians across the country.
“This is a unique effort in the diagnostics industry and will provide us the opportunity to demonstrate our technology firsthand with health care innovators across the United States,” says Eric Bouvier, president of bioMérieux North America. “Our mission for the tour is to spread awareness about how the collective benefits of integrating diagnostics with clinical decision support software and other information systems can have a positive impact on improving patient care and lowering administrative costs, while streamlining the flow of diagnostic information to clinicians.”
The tour began in St Louis and will end September 20 in New Orleans. The theme, “Innovation-in-Motion,” is designed to illustrate rapid results, increased productivity, automated bacterial identification, extensive clinical intervention, and improved safety. The focus of the tour will be to visit innovative, small- to midsize hospitals in 50 towns and cities that may not have access to demonstrations of this sort. bioMérieux also plans to offer special promotions and discounts during the 4-month road show.
Contact: bioMérieux Inc (919) 620-2000; www.biomerieux-usa.com
Trestle Expands Internet-Microscopy Offerings to Mexico
Trestle 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 a new location.
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
Test Monitors Anti-Rejection Drug Levels for Kidney-Transplant Patients
Axis-Shield, the manufacturing partner of Abbott Laboratories, has received 510(k) clearance from the Food and Drug Administration (FDA) for its automated sirolimus test that monitors the therapeutic levels of Wyeth Pharmaceutical’s anti-rejection drug RAPAMUNE® in whole blood. The assay uses Abbott’s IMx® System, an automated immunoassay analyzer used in hospital laboratories throughout the world.
The IMx Sirolimus assay enables laboratories and transplant physicians to measure sirolimus levels in patients. Last year, Abbott introduced the test in other major markets around the world, and the company expects to start distributing the product in the United States within a few weeks.
“To help reduce the risk of organ rejection, transplant patients are given a regimen of immunosuppressant agents that require ongoing therapeutic drug monitoring. Since drugs that require management work best within a specific range, monitoring blood levels is an important part of treatment,” says Douglas C. Bryant, vice president, Global Commercial Operations, Abbott Diagnostics Division. “With this assay, many hospital laboratories now will be able to process patient samples in-house and provide results to doctors within hours, improving patient care.”
The IMx Sirolimus assay uses microparticle enzyme immunoassay technology to measure and quantify the amount of sirolimus in a patient’s blood sample. The assay is used on the IMx analyzer, a benchtop system that can process multiple samples using different testing methodologies.
“Sirolimus has become an important therapeutic choice for doctors performing renal transplants. Having this new sensitive and reliable assay for sirolimus will make it easier for doctors caring for transplant patients to help optimize the patient’s therapy,” says Joseph S. Camardo, MD, senior vice president, Global Medical Affairs, Wyeth Pharmaceuticals.
According to the Organ Procurement and Transplantation Network, more than 15,000 kidney transplants were performed last year in the United States. More than 7 million adults have chronic kidney disease, which may eventually lead to kidney failure.
Contact: Abbott Laboratories (800) 323-9100; www.abbottdiagnostics.com
Troemner Receives NVLAP Accreditation
Troemner Pressure Calibration Service recently was awarded accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) in the field of pressure calibration. The company’s pressure-calibration laboratory uses calibration equipment with reference standards directly traceable to the National Institute of Standards and Technology (NIST).
Environmental conditions in the Troemner laboratory are strictly monitored and controlled. Calibration equipment used in the company’s laboratories includes a piston gage similar to those used in national laboratories as a primary pressure standard. Laboratory capabilities are 0 to 1,000 psi with accuracy as low as 0.005% of reading.
In addition to pressure, Troemner has NVLAP accreditation for mass, mass magnetic susceptibility determination, mass density determination, temperature, humidity, and pipettes calibration services.
Contact: Troemner Pressure Calibration Service (800) 352-7718; www.troemner.com
Technology Adopted for Improved Osmometer Accuracy
Altoona Hospital (Altoona, Penn) has selected the Renol™ urine reference control from Advanced Instruments to calibrate the osmometer in its diagnostic laboratory.
“When Advanced Instruments’ Renol urine-control material became available, we tried it on our osmometer to determine if it would achieve better results,” says Doug Decker, assistant lab supervisor, Altoona Hospital. “In our trials, we found that Renol’s ranges are more in line with what we would find from our patient samples. The normal range of the constituents in human urine is very wide. And the Renol controls better reflect the normal ranges for osmolality that we expect to see in our patient population.”
“We received a lot of feedback that osmometer users were looking for a better material than the multi-analyte controls presently on the market,” says Ken Micciche, director of marketing, Advanced Instruments. “Our goal was to design a reference solution that goes beyond quality control compliance and helps laboratories, such as Altoona Hospital, maximize the accuracy and precision of their instruments.”
Micciche explains that the wider tolerances in multi-analyte controls can mask variations in osmometer performance while maintaining Clinical Laboratories Improvement Act (CLIA) compliance. Renol offered additional benefits to the Altoona Hospital lab. “While the material’s chemical makeup simulates urine, it is not a biological fluid and is safe for laboratory personnel to handle. These concentrations are very close to medical decision levels where performance is critical for the use and interpretation of the test,” says Micciche.
Contact: Advanced Instruments Inc (800) 225-4034; www.aircompanies.com
David B. Pall Award Established for Research in Transfusion Medicine
Pall Corp and the National Blood Foundation (NBF), a program of the American Association of Blood Banks, have established the David B. Pall prize for innovative research in transfusion medicine. The $10,000 annual award recognizes individuals for innovation and creativity in research that may ultimately lead to improving transfusion medicine outcomes.
David B. Pall, MD, was awarded the National Medal of Technology in 1990, the highest honor in technology in the United States.
The award pays tribute to Pall’s contributions in transfusion medicine and cellular therapy. Candidates to be considered for the prize have completed their research under the NBF Scientific Research Grants Program within 12 months prior to the granting of the award. Research is evaluated with regard to the innovation and creativity exhibited, and the practical impact it will have on patient outcomes in transfusion medicine.
Contact: American Association of Blood Banks (301) 907-6977; www.aabb.org
DCL Receives FDA Clearance for Plasma Testing
Diagnostic Chemicals Limited (DCL) has received 510(k) clearance from the Food and Drug Administration for its enzymatic, liquid-stable Acetominophen-SL assay for the quantitative determination of the drug in human plasma. According to the company, the assay’s ability to now test both serum and plasma clinical specimens will benefit physician offices, hospitals, and reference laboratories.
The assay is suited for use with fully automated testing procedures, with an extensive listing of applications readily available. Configured in three packaging formats, the test kit is able to provide clinical laboratories with an assay that best fits their existing instrumentation and testing volume.
Contact: Diagnostic Chemicals Limited (800) 565-0265; www.dclchem.com
|Greiner Bio-One Preanalytics Partners with Novation
A 3-year contract has been signed between Greiner Bio-One Preanalytics and Novation, the supply company of VHA Inc and the University HealthSystem Consortium (UHC). Throughout the duration of the contract, Greiner Bio-One will provide UHC members access to its VACUETTE® venous blood-collection tubes. The company’s line of plastic blood-collection tubes offer the industry a safe alternative to glass tubes.
Contact: Greiner Bio-One Preanalyticcs (704) 261-7800; www.gbo.com
Centura Health Assumes Management of Its Lab Operations
Due to the expiration of a 5-year contract between Centura Health and Quest Diagnostics, six clinical laboratories operated by Quest and located in Centura facilities will be managed by Centura Health.
“Quest Diagnostics has done an admirable job of running our hospital labs since we outsourced the work almost five years ago,” says Matt Fulton, senior vice president of business development for Centura Health. “However, we now feel that the laboratory should again be directly under our control.”
Centura has contracted with Health Care Solutions, a division of Roche Diagnostics, to perform a current assessment of the labs. The Roche team will work with Centura and Quest to determine an effective transition plan and to design the future organizational structure of the labs. The transition is scheduled to be complete by January 2006.
Contact: Centura Health (303) 290-6500; www.centura.org
Carl Zeiss Relaunches e-Commerce Site
Carl Zeiss MicroImaging Inc has redesigned and relaunched its e-commerce site, www.ShopZeiss.com. The latest information on the site features more than 800 products, including accessories and consumables.
Microscopes for biological and industrial applications also are available on the site and are displayed in preconfigured packages based on a specific application. In addition, catalogs for consumable items such as bulbs, immersion oil, dust covers, and incubation and PALM laser microdissection accessories have been expanded to include items for recently introduced products.
The site also features a new digital camera configurator feature that helps visitors identify the right camera adaptors required for integration of consumer cameras with the Zeiss microscopes.
Contact: Carl Zeiss MicroImaging Inc (800) 233-2343; www.zeiss.com/micro
Panbio Teams with Trinity Biotech
West Nile Enzyme-Linked Immunosorbent Assay products manufactured by Australian-based Panbio Limited are now available in the United States via a distribution agreement with Trinity Biotech. The agreement provides Panbio access to Trinity’s distribution network and an installed instrument base of more than 100 analyzers.
In 2003, Panbio became the first company to obtain Food and Drug Administration clearance in the United States for an immunoassay diagnostic kit to test for suspected West Nile infection.
Contact: Trinity Biotech USA (800) 325-3424; www.trinitybiotech.com
InterGenetics and ideas Partner to Develop Interactive Genetic Testing Technology
In an effort to advance the fight against cancer, ideas—an Orlando-based creative content studio—and InterGenetics have partnered to combine scientific and digital storytelling technologies. The two companies are developing the InterGenetics product suite, an interactive education program aimed at helping women better understand the importance and procedures of genetic testing. To introduce the product suite, the ideas team will use entertainment technologies to create education and communication tools for patients and health care providers.
“We are working with a health care model that screens for illnesses and provides the education paramount to managing risks and prevention,” says Bob Allen, principal executive and chief storytelling officer at ideas. “The interactive patient-education program we are designing will guide each patient through the process—from taking the test to understanding the results—helping the clinicians explain to patients what to do next. We want to help patients retake responsibility and control of their health.”
The initial product offering from InterGenetics and ideas, OncoVue®, is a genetic-based, risk-predictive test for breast cancer that provides a numeric risk score to the patient and her physician for use in managing her risk level. By identifying women at risk for breast cancer, and initiating preventive and disease-management protocols, OncoVue can help physicians influence a patient’s genetic future.
“We now have a tool to better identify the high-risk population for breast cancer in the general population,” says Craig D. Shimasaki, MD, president and CEO, InterGenetics. “With more women being identified as high-risk patients, there will be less time for medical personnel to fully explain potential risks to patients. Additionally, short doctor’s visits, which are becoming more frequent, reduce the opportunity to apply preventive measures. This is where ideas’ expertise and ability to engage people through innovative learning environments come into play. We are thrilled to have a strong partner creating patient learning environments where comfort, knowledge, and training are equally dispensed.”
Managing the OncoVue education component and planning for future product rollouts, Duncan Kennedy, director of creative development at ideas, explains the long-range goals. “We’re creating an integrated suite of multimedia, print, and Web-based content for release when OncoVue rolls out this fall.” As new testing products become available for diseases beyond breast cancer, ideas will develop, with content help from oncologists and genetic counselors, materials to explain the different prevention and care protocols.
“It is important that patients easily understand the genetics, what the test results mean, and what can be done after receiving the results,” adds Kennedy. “We want the entire experience to be a positive opportunity for education and action that translates into long and healthy lives.”
Contact: InterGenetics Inc (866) 662-6883; www.intergenetics.com
NIH Awards Cancer Research Grant
The National Institutes of Health (NIH) has awarded a small business technology transfer grant worth $587,000 to Immunicon Corp and Fox Chase Cancer Center. The grant will fund the development of a new strategy to actively monitor the effectiveness of cancer drugs in clinical trials.
In recent years, patients have been able to benefit from drugs that specifically target tumor cells. These new targeted drugs often prolong life without the serious side effects typical of some traditional treatments. Scientists are now exploring new ways to expedite this process of researching and developing targeted therapies, which often takes a decade or more.
“The development of new treatments for cancer would be greatly facilitated if we could sample a person’s tumor multiple times during treatment,” explains Louis M. Weiner, MD, vice president of translation research and chairman of medical oncology at Fox Chase Cancer Center. “However, it isn’t always possible or appropriate to perform repeat biopsies that are invasive and sometimes uncomfortable.”
To remedy these perceived shortcomings in cancer-treatment development, researchers at Immunicon and Fox Chase are pursuing ways to investigate the pharmacodynamics, or the drug-tumor interaction, by examining a patient’s blood for the presence of tumor cells and tumor cell material.
“We now know that even early cancers can shed tumor cells into the bloodstream that then circulate throughout the body,” says Weiner. “The overall goal of our research is to investigate the circulating tumor cells in a patient’s blood to see if those cells can tell us what effect, if any, a drug is having on the tumor. In the future, we may be able to know within the first few weeks, or even sooner, whether a drug is working for a patient. If it is working, therapy can be changed without loss of additional time.”
The current way of tracking the progress of treatment is to wait approximately 3 months or more to see if a computed tomography scan or magnetic resonance imaging can detect tumor changes related to treatment.
“Another benefit of analyzing the drug-tumor interaction is determining the right drug dose,” adds Weiner. “In many cases, the appropriate drug dose isn’t what can be maximally tolerated, but rather the lowest dose found to selectively and thoroughly inhibit the function of the tumor.”
In addition to counting circulating tumor cells (CTCs) in samples of the patient’s blood, researchers will analyze gene expression in such CTCs using microarray analysis. Earlier studies have shown that microarray analysis of gene expression conducted on CTCs corresponds to gene expression patterns seen at tumor sites. Now, the work will be extended to determine the feasibility of using CTCs to monitor the effects of investigational therapy in clinical trials.
Contact: Immunicon Corp (215) 830-0777; www.immunicon.com
FDA Clears Breast Cancer Assessment Test
Applied Imaging has received 510(k)-clearance from the FDA to market its Ariol® Her-2/neu FISH application, which is designed to detect Her-2/neu gene amplification in breast cancer biopsy samples via fluorescence in situ hybridization (FISH).
The application complements and completes the breast cancer panel on the company’s Ariol system, which now includes assays for Her-2/neu immunohistochemistry (IHC), Her-2/neu FISH, estrogen receptor, and progesterone receptor. The Ariol Her-2/neu FISH application assists in the analysis of a complex test that is an important factor in the evaluation and selection of certain breast cancer patients for Genentech’s Herceptin (Trastuzumab) therapy. Herceptin is the first humanized antibody approved for the treatment of Her-2 positive metastatic breast cancer. The antibody targets and blocks the overexpression of Her-2 protein. Research indicates that women with Her-2 positive metastatic breast cancer have a more aggressive disease, greater likelihood of recurrence, poorer prognosis, and approximately half the life expectancy of women with Her-2 negative breast cancer.
“This FDA clearance is consistent with our plan to enhance the menu and add value to our Ariol pathology workstation for both clinical and research applications,” says Robin Stracey, president and CEO of Applied Imaging Corp. “The addition of this application to the existing Ariol breast cancer panel provides an important diagnostic tool for identifying breast cancer patients who are most appropriate for Herceptin therapy.”
Ariol is an automated scanning microscope and image analysis system that is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and quantification of cells of interest based on color, intensity, size, pattern, and shape.
Contact: Applied Imaging Corp (408) 719-6400; www.aicorp.com
|Misys Enhances Radiology Information System
Misys Healthcare Systems recently released its Misys Radiology™ 4.3, an enhanced version of its radiology information system. The new system features software refinements, such as enhanced turnaround time report; multi-facility enhancements promoting data exchange between inpatient and outpatient sites; two-way messaging between transcriptionists and radiologists using electronic notes; instant notification of duplicate and sequencing errors via rules for incorrectly delivered exam orders and schedules; and better manageability of patient tracking and pending orders.
The navigational layouts of the new release’s enhanced patient tracking screens are facilitating better workflow processes, including fewer keystrokes. “Any modification that reduces keystrokes when entering orders is a benefit when you have to touch 210,000 diagnostic exams annually,” says Lesley Brooks, manager of clinical information systems at Covenant Health System, Lubbock, Tex. Covenant Health System is one of the first facilities to utilize the upgraded Radiology 4.3 system from Misys.
Contact: Misys Healthcare Systems (866) 647-9787; www.misyshealthcare.com
CeMines Announces New Findings, Therapeutic Patents
Earlier this month, CeMines released updated data that demonstrated the high sensitivity and specificity of its CellCorrect™ LAb detection kit, which aids in the diagnosis of lung cancer. In addition, the new data demonstrated the presence of diagnostically informative autoantibodies in breast, colon, and stomach cancer in a patient’s blood.
“We have evaluated the theranostic potential of the CeMines CellCorrect technology platform, and concluded that systemic changes, as detected by the CellCorrect LAb kit, potentially could be used in future individualized medicine applications,” says Roger Attick, CEO of CeMines.
The company also announced that it has filed two patents with the FDA, claiming specific design and delivery of molecules that interfere with transcriptional mechanisms. This intellectual property will play a key role in the company’s development of drugs to treat different types of cancer.
Additionally, CeMines filed a 510(k) application seeking clearance for clinical use of CellCorrect LAb. The minimally invasive cancer test detects altered autoimmunity and associated patterns of disease-related autoantibodies in the bloodstream. Clinical studies conducted by CeMines demonstrate that specific and consistent patterns of certain antibodies have regularly proven their utility as composite biomarkers to characterize cancer, and can therefore be used as diagnostic tests for cancer. The company uses the proprietary bioinformatics-based statistical pattern recognition application, CeMines Molecular FingerPrinting™, to evaluate patterns of certain antibodies and the profiles of cancer patients.
Contact: CeMines Inc (303) 526-3700; www.cemines.com