photo Bio-Rad Laboratories, Inc. of Hercules, Calif., has been selected by France’s Commissariat a l’energie atomique or CEA, to produce and market a diagnostic test for BSE, Bovine Spongiform Encephalopathy, or Mad Cow disease.
   Of four tests investigated by the European Commission, the Bio-Rad/CEA test was determined to be the most sensitive. Working in collaboration with the CEA, the company plans to commercialize this immunoassay that uses brain stem samples from cattle. Industrialization of the product is underway, with epidemiological studies to begin soon, according to the French Health Authority.
   Bio-Rad has a worldwide exclusive option right on the test’s intellectual property, which is owned by the CEA. The primary objective of the test is to determine if the disease can be detected before the animal shows symptoms. Further epidemiological studies will be needed to determine if there is a connection between BSE and the human form of the disease, new variant Creutzfeld-Jakob Disease (Nv CJD). Although no direct evidence exists, it is feared that people who eat meat from BSE-exposed cattle could contract Nv CJD from it.

Customer survey finds Ortho-Clinical Diagnostics leading industry in customer service
ServiceTrak, a customer survey that evaluates clinical chemistry systems service and support, has found that Ortho-Clinical Diagnostics ranks at the top. This is the 15th consecutive year the Johnson & Johnson company has been rated highest in “overall service satisfaction.”
   The survey, an independent study by IMV Ltd., ranks clinical laboratory vendors in 30 categories including competence of field personnel, timeliness of on-site service, rapid response by hotline staff, whether equipment meets customer expectations and whether the hotline fulfills its commitments. In each of these categories, Ortho-Clinical outranked other vendors for its support of the company’s Vitros Clinical Chemistry Systems.
   These results come after another customer support achievement by Ortho-Clinical; an FDA study assessing Y2K compliance of medical devices gave the highest possible ratings to the company for Y2K preparedness. The CDRH Year 2000 Medical Device Assessment study concluded that the company’s Y2K program was well implemented and focused on maintaining levels of quality and service for customers.

HIMA outlines plan for fixing Medicare’s laboratory test
payment program
The Health Industry Manufacturers Association (HIMA), Washington, DC, has a plan to fix problems it sees in Medicare’s diagnostic test payment program. HIMA believes the current payment program prevents beneficiaries from receiving innovative tests even though they are covered by Medicare.
   In a presentation to the Institute of Medicine’s (IOM) Committee on Medicare Payment Methodology for Clinical Laboratory Services, Greg Raab, HIMA’s senior health affairs advisor, outlined problems with the current diagnostic test payment program that can cause reimbursement rates to be set too low. This can discourage use of the tests and makes it more difficult for patients to get them.
   Raab proposed the implementation of several steps that would help ensure that payment rates for diagnostic tests are set realistically. Among them are the establishment of an open, predictable processes for making coding and payment decisions, a mechanism for public appeal of reimbursement decisions and objective methods for setting payment rates for new technologies. Payment rates for new technology are often set through gap-filling and cross-walking techniques. Raab also proposed a mechanism for reviewing the adequacy of payment levels and introducing the use of market-based data in setting reimbursement rates.
   A position paper detailing HIMA’s plan was delivered to the IOM committee. It cites several cases where Medicare payment problems created access hurdles for innovative diagnostics. In one case, reimbursement for a breakthrough pre-term labor test was linked to an unrelated and more basic test, resulting in too low a payment rate. The reimbursement inequities can create access problems for women in Medicare and for those enrolled in private insurance plans that often follow HCFA’s lead in reimbursement.
   The time and expense required to correct such problems is high because Medicare has no procedures to allow for public appeal of inappropriate rates once they are set or for public input into the initial setting of payment rates.

photoTeen has cholesterol level reduced through LDL apheresis
A teenager at Cedars-Sinai Medical Center in Los Angeles, has had his ‘bad’ cholesterol level reduced through LDL apheresis. The patient, who was born with a genetic defect that caused very high levels of LDL cholesterol, had already undergone two heart surgeries to clean out and bypass some of the major blood vessels in and around the heart.
   Cedars-Sinai developed the procedure for patients who have dangerously high levels of LDL cholesterol that do not respond to diet and drug treatment. Patients who need this therapy have genetic abnormalities that cause their LDL cholesterol to be several times that of normal patients.
   LDL apheresis, which has been tested in the United States and other countries, has been found to dramatically reduce levels of LDL, the type of cholesterol that increases the risk of heart disease. During apheresis treatment, blood is continuously removed from a patient’s vein and passed through a machine that separates red blood cells from plasma. The red blood cells are returned immediately to the bloodstream through a different vein while the plasma enters a column that captures most of the LDL cholesterol. The plasma is then returned to the patient without the bad cholesterol. HDL or good cholesterol and other vital chemicals remain intact.
   The procedure takes about two to four hours, and must be repeated every one to three weeks depending on the patient’s LDL level, according to Dennis Goldfinger, M.D., director of the Cedars-Sinai Transfusion Center, where it is performed.
   A formal screening process is in place to review medical records and perform physical assessments of potential candidates to determine whether LDL apheresis may be helpful and appropriate.

photoi-STAT receives FDA 510(k) clearance for coagulation test
i-STAT Corp., manufacturer of point-of-care diagnostic systems for whole blood analysis, has received clearance from the Food and Drug Administration to market its celiteACT activated clotting time test. The test is used in cardiovascular surgery, cardiac catheterization labs (angiography and angioplasty), and other critical care settings to monitor patients on heparin therapy.
   i-STAT, based in East Windsor, N.J., develops, manufactures and markets diagnostic products that provide healthcare professionals diagnostic information at the point of patient care. The i-STAT system can test electrolytes, metabolites, blood gases and coagulation in a single instrument, combining an array of critical care tests into a handheld format for testing at the patient’s bedside.

Human data on combination monoclonal antibody therapeutic for Hepatitis B reported
According to XTL Biopharmaceuticals, Ltd., New Ipswich, N.H., the first human data from a Phase I clinical trial of XTL-001 was presented at the BIO CEO and Investor Conference in New York City in February 2000.
   The ongoing study will evaluate the safety, pharmacokinetics, and antiviral effects of two monoclonal antibodies in patients chronically infected with the Hepatitis B virus.
   XTL-001 is a combination therapy consisting of two fully human MAb drugs, developed by XTL (HBV-Ab(XTL) 17 and HBV-AB(XTL)19), that target different sites on the HBV surface to reduce the likelihood of acquired resistance. Preclinical studies in XTL’s proprietary Trimera(XTL) system, a small animal model of human hepatitis, have shown that the combination is an inhibitor of HBV infection in human liver tissue, and expresses a synergistic effect when used with a third antiviral drug.

photoFDA clears Digene’s chlamydia/gonorrhea combination test
Digene Corp. of Gaithersburg, Md., has received FDA clearance to market its Hybrid Capture II Chlamydia/Gonorrhea Test for the simultaneous detection of Chlamydia trachomatis (CT) DNA and Neisseria gonorrhea (GC) DNA in cervical specimens.
   Indicated for use in women with or without symptoms, the test identifies or confirms the presence of Chlamydia and/or gonorrhea. Abbott Laboratories, Abbott Park, Ill., will distribute the test in the United States.
   This signal amplified nucleic acid hybridization assay uses the company’s Hybrid Capture II technology. A common specimen collection device allows the three tests to be performed from a single patient specimen. A herpes test is in development.

Bayer Diagnostics and PharmaNetics to co-fund platelet function theranostic test
Bayer Diagnostics of Tarrytown, N.Y., and PharmaNetics Inc. of Raleigh, N.C., are co-funding a a research project that looks into the feasibility of developing a platelet function test that can monitor the effect of platelet inhibitors.
   The agreement calls for Bayer to provide $850,000 for the Phase I feasibility studies, which are projected to take six to eight months. If feasibility is demonstrated, the companies will enter into a development and commercialization agreement that will establish the milestones for additional funding.
   PharmaNetics believes that by modifying its dry chemistry technology, the new platelet function test can be performed on Bayer’s existing whole-blood, RapidPoint Coag platform. If successful, the addition of the platelet function test would enable healthcare providers to monitor the effect of platelet inhibitors, in addition to other anticoagulants, on a single, point-of-care instrument.
   The platelet function test will be developed specifically to assess GPIIb/IIIa platelet inhibition in response to drugs like Eli Lilly’s Reopro (abciximab), and COR Therapeutics’ Integrilin (eptifibatide). These GPIIb/IIIa antiplatelet agents have demonstrated benefit in treating patients undergoing coronary interventions such as angioplasty, stent placement and unstable angina. PharmaNetics, a manufacturer of rapid-turnaround diagnostics for assessing blood clot formation and dissolution, estimates that approximately 2.5 million patients are candidates for intravenous antiplatelet therapy.

photoPatented GenoSensor Microarray System lets researchers rapidly identify key genomic correlations
Genomic disease management company Vysis, Inc. of Downers Grove, Ill., has initiated customer shipments of its GenoSensor Microarray System. Initial placements have been made at customer sites in North America, Europe and Asia through the company’s direct sales efforts and a distribution network in 59 countries.
   The system, which is designed to simultaneously detect chromosomal amplifications or deletions of multiple genes in various human cancers, will enable researchers to rapidly identify and discover key genomic correlations in disease occurrence and outcome.
   The GenoSensor Microarray System uses patented technology and includes genomic microarrays, reagents, instrumentation and analysis software. Used in conjunction with expression microarrays, GenoSensor genomic microarrays can help researchers determine if a gene is present, whether the gene is found in abnormally high numbers, and if abnormal gene amplification is correlated with overexpression of an important protein.
   The first commercially available microarray for the system, the AmpliOnc I, simultaneously detects abnormal increases in gene copy number from 58 different genes.

Diagnostic Deals
St. Louis-based AmeriNet, Inc. has renewed and widened the scope of its agreement with Fisher HealthCare of Houston, a distributor of clinical-laboratory and rapid diagnostic products and a unit of Fisher Scientific L.L.C. The four-year agreement became effective Jan. 1, 2000.
   The agreement covers Fisher HealthCare’s 1st Choice product portfolio, which is comprised of Fisherbrand commodity plastics, private label diagnostics and exclusive vendor products.
   Fisher Scientific is supplying products to AmeriNet members through its Fisher Hamilton, Fisher Safety and Fisher Services units.
   Items from Fisher Hamilton, which manufactures laboratory workstations, include SafeAire fume hoods, safety cabinets, blood-drawing chairs and other laboratory furniture products. AmeriNet members can access the complete Fisher Safety product line, which covers items for respiratory, gas and personal protection, controlled environments, industrial protection, health, hygiene, ergonomics, fire fighting, rescue and hazardous material storage, handling and response.
   In other news, HSCA (Health Services Corp. of America) has signed a five-year agreement with Fisher HealthCare, for clinical laboratory products and consultative services on cost saving. The agreement, which has an estimated total contract potential of $240 million, became effective March 1.
   HSCA members can participate in one of three pricing tiers. Consultative services on cost savings, which are available depending on level of commitment to the agreement, can include guidance on cost containment through new laboratory methodologies, better product utilization and standardization, supply-chain management and electronic commerce. Additional benefits include cost-reduction opportunities through electronic ordering, early payment and ordering efficiency.
   UK-based Drew Scientific Group PLC, has signed an exclusive distribution contract with Fisher Healthcare to market its DS30 Homocysteine Testing System for cardiovascular disease in the United States. Drew is a manufacturer and supplier of diagnostics systems and related consumables for cardiovascular, diabetes and blood components testing.
  Bioject Medical Technologies, Inc. of Portland, Ore., developer and manufacturer of injection systems for needle-free drug delivery, has entered into a development and clinical supply agreement with biotechnology company Amgen Inc. of Thousand Oaks, Calif., for delivery of an Amgen product with Bioject’s Iject needle-free injection system.
   In connection with the agreement, Amgen will purchase $1.5 million in Bioject’s common stock. Amgen will receive an exclusive license to the Iject technology for the delivery of Amgen products for two indications. Amgen also received options to further license the technology for delivery of other Amgen products for other indications.
   The agreement includes up to $3.1 million in future payments to Bioject. These include licensing payments linked to developmental milestones, option payments that include other Amgen drugs in the current agreement and payments to support ongoing product development, clinical supplies and tooling expenses. The agreement also outlines a potential commercial supply agreement under which Bioject would provide Amgen with customized Iject systems.
   Myriad Genetics, Inc. of Salt Lake City has signed a multi-year agreement with Kaiser Permanente of Oakland, Calif., to provide its Bracanalysis breast and ovarian cancer susceptibility test to the healthcare provider’s patients. Under the agreement, Kaiser will offer Bracanalysis testing to patients who have an inherited risk of breast or ovarian cancer.
  Beckman Coulter of Fullerton, Calif., will be providing clinical diagnostics instrumentation to four hospital systems within the Baptist/St. Vincent Health Care System in the Jacksonville, Fla., area. The contract represents more than $6 million in new business over the next five years, according to the company. Systems to be installed include: one Synchron LX 4201 clinical chemistry system, one Synchron LX 20 system, two Synchron CX 9 ALX clinical chemistry systems, four Access immunoassay systems, one Paragon CZE capillary electrophoresis system, one Array protein system, one Synchron EL-ISE system, four Spinchron DLX centrifuges, one Synchron CX 3 clinical chemistry system as well as reagents and supplies across the four hospital system.
   Recipients of the equipment are Baptist Medical Center, St. Vincent Medical Center and Baptist Medical Center Beaches in Jacksonville, Fla., and Baptist Medical Center Nassau in Fernandina Beach, Fla.
   Amplistar Inc. of Winston-Salem, N.C., a Wake Forest University School of Medicine spin-off company that is developing cancer screening products, received $2.6 million in financing from Eno River Capital, manager of the $26 million N.C. Bioscience Investment Fund. Amplistar, which focuses on ovarian cancer screening, is developing an ultrasensitive, early-warning method for detecting immunological attacks on the cancer by the immune system. Venture Capital Solutions of Winston-Salem also participated in the financing.
   Sunquest Information Systems Inc. of Tucson, Ariz., has signed a value added reseller (VAR) agreement with Axolotl Corp. of Mountain View, Calif. Under the agreement, Sunquest will remarket, co-label, implement and support Axolotl’s Elysium Access and Elysium Intelligent Ordering products. The products add a set of web-based results-delivery and lab-ordering capabilities to Sunquest’s FlexiLab laboratory information system. The Sunquest solution FlexiLab system combines Internet, e-mail and automation tools to link physicians, clinics and hospitals to clinical information. The software allows clinicians to access test results, place orders, print specimen labels, process authorizations and deliver discharge summaries using common browser software over secure Internet and intranet connections. The first customer implementation is expected in the first quarter of 2000.
  InServe Support Solutions, Corte Madera, Calif., has completed a nationwide rollout of its InServe On Call rapid-deployment customer action team for Becton Dickinson and Co. BD will use InServe for outsourced customer support needs for BD’s safety-engineered products nationwide.
   InServe trains hospital workers in the use of medical devices, through its InServe On Call Program, a nationwide customer action team for biomedical suppliers. InServe employs more than 600 clinical professionals, who work on behalf of medical device manufacturers, to train nurses and other clinicians to work with new medical products. In Serve was also retained by BD in April 1999 to assist in converting BD’s California accounts by the July deadline imposed by California’s new needle-safety law.
   Members of the military and their families residing in the Tricare Mid-Atlantic and Tricare Heartland regions can expect to pay at least 5 percent on their lab co-pays. Anthem Alliance Health Insurance of Indianapolis and LabCorp. of Burlington, N.C., have announced that LabCorp will serve as a preferred provider for laboratory services in the Tricare Heartland region. LabCorp continues to be a preferred provider for lab services in the Tricare Mid-Atlantic region. The terms were not disclosed.
   Tricare, which is the health plan for the U.S. Department of Defense, offers military families a choice of three options; Tricare Prime, Tricare Extra and Tricare Standard. Anthem Alliance administers the managed care contract for the Tricare Heartland and Tricare Mid-Atlantic Regions. Tricare Heartland comprises Illinois, Indiana, Kentucky, Michigan, Ohio, West Virginia, Wisconsin, St. Louis and the Fort Campbell area of Tennessee. Tricare Mid-Atlantic comprises North Carolina and a large part of Virginia, exclusive of the Capital area.
   National laboratory company LabOne Inc. of Lenexa, Kan., announced that Kaiser Permanente of Kansas City has outsourced its lab testing to LabOne for its members throughout the Kansas City metropolitan area. The program will cover approximately 61,000 members.
   Abbott Laboratories of Abbott Park, Ill., has signed an agreement with Japan’s Takeda Chemical Industries, Ltd. giving Abbott exclusive rights to market Takeda’s new oral diabetes drug, Actos (pioglitazone hydrochloride) in nine Latin American countries including Argentina, Brazil, Chile, Columbia, Ecuador, Paraguay, Peru, Uruguay and Venezuela. Financial terms were not disclosed.
   Actos belongs to the class of oral diabetes drugs known as thiazolidinediones or TZDs, which are insulin-sensitizing diabetes agents that help reduce the target organ’s resistance to insulin and enhance the target organ’s use of its own insulin. This mechanism can help reduce and control blood glucose levels in diabetics. Actos was FDA-cleared in July 1999. Regulatory filings for the drug in Latin America will be made by Abbott and are planned for the first quarter of 2000. Actos is indicated in the United States for once-daily dosing as monotherapy and in combination with sulfonylureas, metformin or insulin for the treatment of hyperglycemia associated with type 2 diabetes.

MAbs may offer magic bullet for cancer
New developments in monoclonal antibody (MAb) technology suggest that they may turn out to be a magic bullet for cancer treatment. MAbs target specific parts of the immune response and selectively interfere with cancer cells, leaving non-cancerous cells untouched.
   The first two monoclonal antibodies for cancer, Hoffman-LaRoche/Genetech’s Rituxan for relapsed indolent non-Hodgkin’s lymphoma and Genetech’s Herceptin for HER2/neu-positive breast cancer, entered the market in 1997 and 1998.
   Current major targets for monoclonal antibodies include breast and ovarian cancer, non-small-cell lung cancer, small-cell lung cancer, prostate cancer, acute leukemias, colorectal cancer and non-Hodgkin’s lymphoma. The market for agents to treat leukemia and solid tumors remains open, except for breast cancer, where Herceptin is positioned to dominate, according to Decision Resources, Inc., Waltham, Mass.
   Therapeutic and Diagnostic Monoclonal Antibodies for Cancer, a study published by Decision Resources, reviews the cancers where monoclonal antibodies are likely to play a significant role.
   It expects therapeutic monoclonal antibody revenues for the seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, the United Kingdom and Japan) to expand to $4.4 billion by 2008.

photoSensIR Technologies’ Dr. John Reffner receives spectroscopy industry award at 2000 conference
John A. Reffner, Ph.D., technical director of SensIR Technologies in Danbury, Conn., was honored with the 2000 Williams-Wright Award for significant contributions to vibrational spectroscopy at the 2000 Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, held March 15, 2000, in New Orleans.
   Dr. Reffner will receive the award, presented since 1978 by the Coblentz Society to deserving industrial spectroscopists, for his work in the development of infrared microspectroscopy (IMS).
   In collaboration with colleagues, Dr. Reffner worked towards raising the standards for FT-IR microscopes and expanded the applications of IMS. This led to the development of new infrared microscopes and rapid advances in infrared microanalysis, spectral mapping and quantitative microspectroscopy