A recent study found that introducing a comprehensive safety and education program at a community hospital led to a significant and sustained decrease in the overall injury rate of its personnel. The study appeared in the December 1999 issue of Infection Control and Hospital Epidemiology published by the Vanderbilt University School of Medicine in Nashville, Tenn.
     According to lead author Robyn R.M. Gershon, Ph.D., associate scientist, Environmental Health Sciences, The Johns Hopkins School of Public Health in Baltimore, a multifaceted approach incorporating training and safety devices was found to be beneficial in reducing the overall number of injuries from sharps. The training component is important, according to Gershon, since it sends a message to employees that management is serious about their safety and health.
     Injury data were collected over a nine-year period from 1990 to 1998 at a mid-sized acute-care community hospital. In 1991, hospital administrators created an Anti-Needlestick and Sharps Injuries Task Force to develop and implement an intervention program. The program included the introduction of a needleless intravenous catheter, and a comprehensive sharps disposal system. It also featured extensive safety training for hospital employees. Workers experiencing sharps injuries were asked to complete a detailed exposure questionnaire as soon as possible after an incident.
     The researchers evaluated the program’s effectiveness by analyzing the pre- and post-intervention sharps injury rates. They found that following implementation of the program, the overall rate of sharps injuries decreased by 70 percent from 1990 to 1998. Data were obtained on a total of 633 injuries for an average population of 2,300 employees. Registered nurses and licensed practical nurses most frequently reported injuries, followed by technicians and support staff.

Nikon International Small World Competition winners display excellence in photography through the microscope
nd01.jpg (8680 bytes)A photograph of a newt lung cell in the process of dividing, shot by New York State Department of Health research scientist Alexey Khodjakov, has been awarded first prize in the 1999 Nikon International Small World Competition.
     The annual competition, founded in 1975, recognizes excellence in photography through the microscope. Over the years, winning images have depicted items from common household objects to foods and medications, dinosaur bones, and disease states like osteoporosis and cancer.
     Photos in this year’s competition were judged on the basis of originality, informational content, technical proficiency and visual impact. Khodjakov received Nikon photo equipment valued at $4,000. To create the winning image, Khodjakov used five different dyes. Since conventional fluorescence filters allow for only three different colors, he first stained for kineochores and centrosomes, then extracted the antibodies by low-pH treatment and restained for microtubules, keratin and chromosomes. All five data sets were collected as 3D volumes covering the entire cells. These original data sets were assembled with a computer and then mathematically deconvolved to reduce out-of-focus light. The image was shot at 240X.
nd02.jpg (8587 bytes)Lars Bech, of Naarden, the Netherlands, won second prize. He used polarized light to shoot Viagra dissolved in ammonia, at 50X. Daphne Zbaeren-Colburn of Bern, Switzerland was awarded third place for her photo of a mangrove leaf ( Rhizophora mangle), which was shot using fluorescent light at 40X.

CompuCyte and Genetics
Institute collaborate on test
CompuCyte Corp. and Genetics Institute Inc., both of Cambridge, Mass., have entered into a ‘theranostic’ collaboration. Theranostic refers to a diagnostic test that aids in the selection of patients and has the ability to rapidly monitor the biological effects of a drug therapy at the point of care. GI is a unit of Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corp.
     Under the agreement, CompuCyte will develop cell-based assays to be performed on the company’s OnCyte diagnostic system for rapid monitoring of the effects of GI’s cell adhesion inhibitors currently in clinical development. Cell adhesion inhibitors act to reduce leukocyte/platelet and leukocyte/endothelial interactions that mediate the primary and secondary pathology of vascular and inflammatory disease.

nd03.jpg (8291 bytes)American Bioproducts
Company changes name to Diagnostica Stago, Inc.
On Jan. 1, 2000, American Bioproducts Co., Parsippany, N.J., underwent a name change to Diagnostica Stago, Inc.
     ABC was founded in 1985 as the U.S. subsidiary of Diagnostica Stago, SA, Asnieres, France. Diagnostica Stago features a full line of reagents and instrumentation for the coagulation and hemostasis markets. "We are very pleased to begin the new millennium with our unified name," said Philippe Gadal, Ph.D., general manager and head of U.S. operations. "This name change reinforces our goal to be the premier organization as one company with one focus — coagulation."
     Diagnostica Stago manufactures the STA line of instrumentation, which includes the STA-R, STA and STA Compact. Stago also produces a full range of routine and specialty reagents, including an automated D-Dimer assay that is available for use on any of the STA instrumentation.

Radiometer awarded Consorta contract for blood gas systems
GPO Consorta, Inc. of Rolling Meadows, Ill., has chosen Radiometer of Denmark to supply its blood gas systems, related supplies and transcutaneous monitors for the next three years. This is Radiometer’s fifth contract award since the introduction of its new product generation.
     Thirteen leading Catholic healthcare delivery systems comprise Consorta. It serves approximately 250 acute care hospitals and 138 extended care sites in 35 states. Consorta’s annual purchase volume is approximately $1.4 billion.
     Last year, Radiometer introduced the ABL 700 and ABL70 Series blood gas analyzers, and the IT-solution Radiance, for laboratory and point-of-care testing in the market. Recently, the company introduced quantitative whole-blood measurement of bilirubin and fetal hemoglobin. These parameters are available on the ABL700 Series and the AutoCheck module, an automatic quality control system integrated into a blood gas analyzer.

nd04.jpg (11429 bytes)U.S. Navy reports positive results with needleless device
At the annual meeting of the American Society of Tropical Medicine and Hygiene, the Oregon-based Bioject Medical Technologies Inc. and the U.S. Naval Research Center, Silver Spring, Md., presented preliminary results of a Phase I human trial of a malaria DNA vaccine started in April.
     Preliminary data indicate that vaccine delivered with Bioject’s Biojector 2000 jet injector elicits cellular immune responses in the volunteers.
     The study is being conducted under the direction of principal investigators LCDR Judy Epstein, MC, USNR; Dr. Ruobing Wang; and Capt. Stephen L. Hoffman, MC, USNR, from the Malaria Program, Naval Medical Research Center. The clinical trial center for the study is the U.S. Army Medical Research Institute of Infectious Diseases in Fort Detrick, Md.
     Hoffman, director of the Navy Malaria Program, said they intend to continue the clinical research with the Biojector 2000. The system injects medication without a needle. It employs compressed gas as a power source to force medication at high speeds through a tiny orifice, penetrating the skin and delivering medication to either the subcutaneous or intramuscular level. Using needle-free technology to administer injections can eliminate the risk of contaminated needlestick injury and resulting blood-borne pathogen transmission.

Two BD systems help reduce medication and specimen errors
BD (Becton Dickinson and Co.) of Franklin Lakes, N.J., has developed two new systems that could reduce medication and specimen errors by up to two-thirds.
    The systems, the BD Rx System and the BD Dx System, combine handheld data terminals and barcode technology.
    The BD Rx System addresses errors in ordering, transcribing and dispensing, and allows healthcare providers automatic verification of the five “rights” of medication delivery — right patient, right time, right drug, right dose and right administration route. It also provides critical information about medication dosage and potential drug interactions before administration. Built-in reporting tools track missed doses and misidentifications for continuous process improvement.
     The BD Dx System reduces specimen collection erross by positively identifying the patient and the person collecting the specimen. It confirms that tests have been ordered for the correct patient, and verifies correct specimen container, correct order of draw and correct time of collection. The system then prints the correct bar code specimen label at point of collection and links all information back to the patient.

Gene mutations affect cell’s role in DNA damage, cancer
Researchers at the University of Wisconsin have found that gene mutations can cause ataxia-telangiectasia or A-T. The affected gene may play a crucial role in controlling how cells respond to DNA damage that can lead to cancer.
     The Dec. 10, 1999 report in Cell, says A-T is a genetic disorder that produces progressive nerve and muscle loss. Those affected may be susceptible to cancer and become severely ill when undergoing radiation therapy. Some may even be harmed by exposure to low levels of radiation associated with mammography.
     On the cellular level, genetic defects related to A-T can produce DNA instability and damage. DNA repair mechanisms in A-T patients do not work properly, which can send cells into serious disarray resulting in cancer.
     Scientists had previously identified mutations in a single gene, called ATM, as the cause of A-T, however the UW team, led by associate professor of genetics John Petrini, reports that mutations in a closely linked neighboring gene, Mre11, can also independently produce A-T. Cooperation between Mre11 and ATM compromises a critical part of the regulatory network that cells activate in response to DNA damage.

FDA OKs Celebrex as adjunct FAP treatment
The U.S. Food and Drug Administration cleared Celebrex (celecoxib capsules) as an oral adjunct to usual care for patients with familial adenomatous polyposis (FAP), a rare hereditary disease that when left untreated usually leads to colorectal cancer. Pharmacological agent Celebrex can reduce the number of edenomatous colorectal polyps in patients with FAP.
     FAP is characterized by the development of hundreds of potentially pre-cancerous polyps in the colon and rectum. Left untreated, virtually all FAP patients develop colorectal cancer by age 40 to 50. Previously, no drugs were approved for the care of patients with FAP.
     Celebrex is co-promoted by Searle, Skokie, Ill. A six-month, 83-patient clinical trial, sponsored by the National Cancer Institute and Searle, demonstrated that an oral dose of Celebrex reduced the number of adenomatous colorectal polyps by an average of 28 percent, compared to a five percent reduction with a placebo.

Abbott receives FDA clearance for ICU sedative injection
Abbott Laboratories of Abbott Park, Ill., has received clearance from the U.S. Food and Drug Administration to market Precedex (Dexmedetomidine Hydrochloride injection), a sedative for intensive care patients.
     Precedex provides sedation effects with a reduced need for pain medications such as morphine, without affecting a patient’s respiratory state, according to Abbott’s senior vice president, hospital products, Richard A. Gonzalez. Precedex, which is delivered by continuous infusion to the patient, selectively activates the alpha-2 adrenergic receptors that are found throughout the nervous system, blood vessels and in organs including the heart and intestines. Activating these receptors in the central nervous system can inhibit stress response, moderate blood pressure and heart rate, reduce anxiety and induce sedation.
     In clinical trials, Precedex was well tolerated, according to Gonzalez. The five most common side effects reported included atrial fibrillation, hypoxia, hypotension, nausea and decreased heart rate. In a study of healthy volunteers, respiratory rate and oxygen saturation remained within normal limits, and there was no evidence of respiratory depression when Precedex was infused within the recommended dose range.
     Precedex will be available in the United States in the first quarter of 2000. Regulatory applications for the product are pending in a number of markets including Europe and Canada.

Bladder cancer test gets FDA nod for undiagnosed patients
Matritech, Inc., Newton, Mass., announced that a Food and Drug Administration advisory panel has unanimously recommended clearance, with two conditions, of its NMP22 test kit. The clearance is for the expanded claim of testing previously undiagnosed individuals who have symptoms or are at risk for bladder cancer. NMP22 is already FDA cleared for monitoring the recurrence of bladder cancer in the United States. The test is also cleared for screening in Japan and China, and is in use in Europe.
     The FDA advisory panel’s recommendation for the expanded use of the test kit is contingent on the following two conditions being met — an increase in the "cut-off" value; and that the labeling claim includes language suggesting the test be used in conjunction with the current standard of care.
     Matritech’s core technology is based on the level of nuclear matrix proteins (NMPs) that are detected in body fluids. These levels are correlated to the presence of early-stage cancerous abnormalities that have been validated in multiple clinical studies. Discovered at the Massachusetts Institute of Technology and licensed exclusively to Matritech, the company is developing and commercializing serum-, cell-, and urine-based NMP diagnostics that enable physicians to detect and monitor the presence of bladder, cervical, colon, breast and prostate cancers.

nd05.jpg (7891 bytes)Abgenix becomes sole owner of XenoMouse fully human antibody technology that can be used in treating many diseases
Biopharmaceutical company Abgenix, Inc. of Fremont, Calif., will become the sole owner of XenoMouse technology by acquiring all of the interest in the technology owned by JT America Inc. XenoMouse was developed to generate fully-human antibody drugs that can be used in treating a range of disease.
     Under the agreements, Abgenix will pay $47 million to JT America for a 50 percent interest in Xenotech Inc., and Xenotech L.P., an equally owned limited partnership between the two companies that created the XenoMouse. Abgenix also will pay $10 million as compensation to Japan Tobacco, Inc. (JT) to relinquish certain option and license rights it is currently entitled to. The acquisition is contingent upon approval under antitrust regulations.
     Also under the agreement, JT will have a research license to use XenoMouse technology and options to license the technology for a small number of antigen targets each year. Abgenix will provide JT with licenses to related technology, and in return for these licenses, JT will pay Abgenix $10 million. JT also retains options to, or licenses on, several antigen targets it has previously nominated under the Xenotech structure. For antibody products generated using XenoMouse technology and developed by JT, JT will make license fee payments to Abgenix as well as royalty payments on any product sales.
     In 1991, a former subsidiary of JT America and Cell Genesys formed Xenotech, an equally owned limited partnership. When Cell Genesys created Abgenix in 1996 as a wholly owned subsidiary, Cell Genesys assigned its interest in Xenotech to Abgenix. JT and its subsidiaries invested more than an estimated $40 million in the creation of XenoMouse technology.
     Abgenix developed XenoMouse technology to enable the rapid generation of high-affinity, fully-human antibody product candidates to basically any disease target appropriate for antibody therapy. Abgenix has collaborative arrangements with multiple pharmaceutical and biotechnology companies involving its XenoMouse technology. Additionally, Abgenix has multiple proprietary antibody product candidates under development internally. Three of these are in human clinical trials for graft-versus-host disease, psoriasis, rheumatoid arthritis and cancer.

Beckman Coulter inks three new contracts with GPOs
Beckman Coulter Inc., Brea, Calif., has signed an exclusive agreement to provide clinical diagnostics instrumentation for two more of the 22 Veterans Integrated Service Network laboratory networks across the country.
VISN 21, located in the San Francisco Bay area, wanted to standardize its eight hospitals on a single platform for chemistry, hematology and flow cytometry.
     VISN 3, headquartered in New York, signed a similar agreement making the company the exclusive provider of hematology and chemistry systems for the network’s seven hospitals and outpatient clinics. Fifteen of the 22 VISN laboratory networks have contracts for one or more of the company’s product disciplines, and 10 are 100 percent compliant, said a BC spokesman.
Also renewed and expanded was a contract to provide clinical diagnostics instrumentation for the MHA (MedEcon) GPO in Florham Park, N.J., representing more than 700 member hospitals.
     The five-year contract with MHA represents an estimated $70 million in revenue. Under the agreement, the company will provide instrumentation and supplies for hematology, coagulation, centrifugation, flow cytometry, automation, protein chemistries, immunodiagnostics, electrophoresis, reagents and supplies.
     In addition, Beckman Coulter has announced it will be providing clinical diagnostics instrumentation for seven hospital systems within the Spectrum Laboratory Network of Greensboro, N.C., an organization owned by Triad Health Alliance. The five-year contract represents more than $12 million in revenue, according to Beckman Coulter.
     Under this agreement, Beckman Coulter is installing three Synchron LX 4201 clinical chemistry systems, one Synchron LX20 clinical chemistry system, eight Access Immunoassay Systems, one Array Protein System, one Synchron EL-ISE electrolyte system, 10 Spinchron centrifuges along with reagents and supplies.
     Recipients of the equipment are the core laboratory at Spectrum Lab Network, Forsyth, Moses Cone, Wesley Long, High Point, Women’s Hospital and six physician’s office labs in the Piedmont Triad area of North Carolina.

nd06.jpg (15776 bytes)Scientists find cancer marker in particular benign breast disease
A. Cytoplasm of epithelial cells of normal lobular units is positive for TGF-RII. The myoepithelial cell (arrows) are negative. B. More than 75% of EHLA cells stained for TGR-RII. C. Hyperplastic 75% positive cells with heterogenous staining pattern. Note the homgenous expression in the adjacent normal lobular unit (arrows). D. Less than 25% of epithelial cells of this EHLA are positive for TGF-RII.
   Researchers at Vanderbilt-Ingram Cancer Center in Nashville, have found that women with a benign breast disease whose cells lose the ability pick up signals instructing them not to divide are at increased risk of later developing breast cancer.
     In a recent issue of the Journal of the National Cancer Institute, scientists reported that a reduction in expression of a receptor for transforming growth factor beta (TGFb) occurs early in the progression from hyperplasia to malignancy in some women. TGFb is a regulator of cell growth that instructs cells not to divide; the cells hear this signal through the TGFb type II receptor, into which TGFb locks itself before sending its instructions to the cell nucleus.
     A laboratory test to determine levels of expression of this receptor might be used in the future to reassure women at no increased risk or to guide decisions about screening and preventative measures in women with an elevated risk, according to William Dupont, Ph.D., professor of preventative medicine at Vanderbilt.
     This research builds on more than two decades of work by Dupont, Dr. David Page, and colleagues with a group of close to 10,000 women who underwent biopsies revealing benign breast disease at three Nashville hospitals during a 30-year period.
     Dupont’s research has found that there are different types of benign breast disease with different levels of risk. So far, indicators of breast cancer risk identified through this work have been based on histology; how the cells look under the microscope in terms of shape, size, distribution, etc. A few molecular markers, abnormal expression of particular cancer-related genes like p53 or HER-2/neu, for example, have been identified. These can help predict prognosis in patients with well-established breast disease.
     The most recent work focuses on differences in risk among women with the same diagnosis of benign breast disease based on histology. The scientists identified 54 women in this cohort whose biopsies, conducted between 1965-1978, revealed a diagnosis of epithelial hyperplasia lacking atypia, and who subsequently developed invasive breast cancer. Each was matched to two control women with the same diagnosis, of similar age and whose diagnostic biopsy was done at approximately the same time. The women in the control group did not develop breast cancer during subsequent follow-up.
     The researchers tested tissue removed at the time of each woman’s initial with antibodies to the TGFb type II receptor. This test produces a brown stain in cells in which this receptor is expressed.
     By analyzing expression of the TGFb receptor and subsequent development of invasive breast cancer, the researchers discovered the fewer the cells able to pick up TGFb’s signals, the greater the risk of cancer. When the receptor was expressed in less than 25 percent of the cells, the women had more than three times the risk of subsequent invasive breast cancer, as compared to women who had receptor expression in more than 75 percent of their cells.
     The work was supported by the National Cancer Institute and the Vanderbilt-Ingram Cancer Center.