News Story #16445

Calypte Biomedical launches U.S. urine-based testing service for HIV and STD exposure
Calypte Biomedical Corp. of Alameda, Calif., said that its Sentinel testing service, a urine-based testing service dedicated exclusively to the detection of HIV-1, chlamydia and gonorrhea, is now available throughout the United States.
    Three tests comprise the Sentinel testing service: HIV-1 antibody, chlamydia DNA and gonorrhea DNA. All can be performed on a single urine specimen. The process requires that a patient urine specimen be sent to a central testing laboratory. Generally, results are reported three days after the sample is received by the lab. Currently, many clinics without in-house laboratories send samples to state public health labs for analysis. This can slow the process and forces patients to wait weeks for their results.
    For healthcare providers, a major upside of urine testing is the reduced risk of accidental needle sticks. Patients also avoid the discomfort associated with blood draws, pelvic exams and urethral swabs.
    To further facilitate testing, Calypte is developing a Sentinel testing service web site that will enable medical professionals and authorized institutions to order testing services directly over the Internet. The testing service, jointly marketed by Calypte Biomedical and Wampole Laboratories, offers multiple combinations of HIV-1 antibody, chlamydia DNA, and gonorrhea DNA testing services. Anonymous HIV-1 antibody testing is available through the Sentinel testing service where permitted by local regulations. The HIV-1 urine antibody tests used in the service are manufactured by Calypte and the testing services are provided by Clinical Reference Laboratory in Lenexa, Kan.

FDA clears new test for underlying cause of ulcers
A new test to diagnose active H. pylori infection, one of the leading causes of peptic ulcer disease, was recently cleared by the FDA.
Ez-HBTTM is a diagnostic tool that can accurately detect active H. pylori infection by means of a simple blood test administered in a doctor’s office. Current blood tests, which rely on antibody detection, cannot distinguish between active and past infection.
    Ez-HBTTM is part of a new generation of medical diagnostic tests that interact with a pathogen or an enzyme to produce compounds that can be detected in breath or blood samples. These tests can alert physicians to the presence of disease or allow them to monitor the health of an organ. Currently, this technology is being used to develop other tests to assess liver and pancreas function, determine the gastric emptying rate, and detect bacterial overgrowth in the small intestine.
    To use the test, a small oral dose of 13C-urea (non-radioactive label) is ingested by the patient. In the presence of H. pylori, the bacterial enzyme urease converts urea to 13CO2, a labeled carbon dioxide, and ammonia. The 13CO2 is absorbed into the bloodstream and 30 minutes after administering the dose, a single blood sample is drawn in a standard blood collection tube. This tube is sent to a lab where the carbon dioxide is extracted from the blood and analyzed using an isotope ratio mass spectrometer to detect the presence of 13C. The presence of 13C indicates active infection.
    Developed by Boston University’s Stable Isotope Laboratory, the technology was exclusively licensed by the Boston University Technology Fund to Metabolic Solutions, Inc. of Nashua, N.H. The company will market the test under the name Ez-HBTTM. Scientists at the University of California at San Francisco, and the Veterans Administration Medical Center in Palo Alto also participated in the development of the underlying technology.
    The test was licensed exclusively to MSI by Boston University’s Community Technology Fund, and it was supported in part by the Small Business Innovative Research program of the National Institutes of Health.

BD names John Considine executive VP and CFO
BD (Becton, Dickinson and Company) of Raritan, N.J. announced that John R. Considine has been named executive vice president and chief financial officer. The appointment follows an external search by the company to replace Kenneth R. Weisshaar, former senior vice president and chief financial officer.
    Considine, 50, comes to BD from American Home Products where he was senior vice president of finance. Considine will be responsible for executive management and oversight of BD’s global financial operations, reporting directly to Edward J. Ludwig, BD president and chief executive officer.

Boston Marathon uses Nova Biomed analyzers to evaluate physiological changes
Nova Biomedical, Waltham, Mass., Stat Profile M Critical Care Analyzers were used at the 104th running of the Boston Marathon as part of a study intended to evaluate the physiological changes associated with the 26.2 mile race.
    A team consisting of physicians and nurses from the Boston Marathon Medical Team plus Nova volunteers participated in the controlled study involving runners who provided blood samples before and after the race. Tests that were evaluated included blood gases, electrolytes, metabolites and hematocrit. In addition, the Nova analyzers were available for stat analysis of samples from runners who were adversely affected during the race. The results of this study will be published following comprehensive analysis.

Test for detecting malaria in disease-carrying mosquitoes developed by Medical Analysis
Medical Analysis Systems, Inc. of Camarillo, Calif., has completed development and preliminary field testing of VecTest, a rapid assay for detecting malaria parasites in infected mosquitoes.
    According to the company, the U.S. military, researchers and public health teams from around the world are evaluating this test, which can be used in the field to continuously monitor mosquito vectors for Plasmodium falciparum and Plasmodium vivax, the two most serious species of malaria. VecTest was developed at Navix Inc., a subsidiary of Medical Analysis, with funding provided by the Walter Reed Army Institute of Research through the federal government’s Small Business Innovative Research program.
The U.S. Armed Forces requested that the test be developed for them because malaria remains a major concern for Department of Defense personnel, whom often deploy to malarious areas, MAS said.
    Dr. Kirti Dave, team leader of the VecTest project said the device is especially useful in pointing out which is the primary vector in any given area. This is important because each species of anopheline can have a different biology. Dave also said there are implications for prophylaxis depending on which species of malaria parasite is encountered.
    It is anticipated that the VecTest Malaria Panel Assay will contribute to efforts aimed at rolling back malaria, such as the World Health Organization’s Roll Back Malaria summit, which focuses on the problem as well as seeking funding and solutions. The assay detects the primary disease-causing agents in field populations of mosquitoes, making it possible to identify malarious foci, monitor the spread of the disease and effectively target control measures.
    Dr. Dennis Chenoweth, Ph.D., M.D., the chief innovation officer at Medical Analysis Systems, said since the test was originally designed to meet the criteria of the U.S. Army, it is cost effective, can be performed by untrained personnel in the field, and results are provided in 15 minutes.

ECRI conference to highlight safety in healthcare technology
ECRI, a non-profit international health services research agency, will host its eight annual Health Technology Assessment Information Service (HTAIS) Conference on October 26 and 27, 2000 at the organization’s research campus in Plymouth Meeting, Pa., a suburb of Philadelphia.
     The theme of this year’s conference is "Beyond Medical Error: How the Healthcare Community Accepts New Technology as ‘Safe.’" The conference will be preceded on Wednesday, October 25, by a technology assessment methodology preconference workshop.
     ECRI’s HTAIS 2000 conference will offer clinical, regulatory, coverage, reimbursement, and legal perspectives on the contentious and critical relationship between safety and the introduction and management of new technology. Scheduled topics include medical error, government regulation, off-label uses of drugs and devices, the safety of new clinical procedures, payers’ vigilance regarding safety, and what patients should know about safety risks. Speakers also will examine safety loopholes in healthcare Web sites, dietary supplements and alternative medicines, and direct-to-consumer advertising.
     Conference speakers include government officials, American Medical Association members, Medicare experts, representatives from medical device and pharmaceutical companies, and executives from insurance firms and healthcare plans. The conference is targeted to health plan and hospital executives, medical directors, benefit providers, pharmaceutical and medical device manufacturers, attorneys, risk managers, state and federal legislators and patient advocacy organizations.

Leica DM E microscope receives the Worlddidac Award
The Leica DM E microscope recently received the Worlddidac Award 2000 for its innovation, excellence and performance-to-cost value. This international education award was presented at a ceremony at the Worlddidac 2000 Conference on March 29, 2000 in Zurich, Switzerland.
     An international panel of judges examined 52 products from 13 countries over four days and chose the Leica microscope as a university level, optical instrument winner.
     According to Leica, the microscope was designed with input from educational instructors worldwide. It allows viewing in a variety of applications including brightfield, darkfield, polarization, phase contrast and photomicrography. The focus system provides self-adjusting tension to prevent stage drift for the life of the microscope.
     Worlddidac stands for the world association of publishers, manufacturers and distributors of educational materials. Founded in 1952, this independent international organization has members in 48 countries and is a member of UNESCO. It also maintains close cooperative relationships with the World Bank, ILO and UNDP.

Diagnostic Deals Healthcare information technology vendor Cerner Corp., of Kansas City, Mo., has signed a definitive agreement to acquire Citation Computer Systems Inc., of St. Louis, a clinical laboratory system provider for small to mid-size hospitals. Cerner will pay an effective cash price of $5.10 per share for each of Cerner’s 598,000 shares. The transaction is expected to close in the third quarter of 2000, pending Citation shareholder and regulatory approval. Citation provides clinical laboratory systems to approximately 300 national and international clients through its distribution partners. The majority of the company’s clients use its C-LAB laboratory system product. The effort to develop standards for the rapidly growing point-of-care testing field has taken on a new face. The Connectivity Industry Consortium (CIC), a non-profit, industry-sponsored consortium has been chartered to address problems with POC device connectivity. The group’s senior executives, comprised of more than 32 member companies and healthcare providers, agreed to an organizational structure, technical plan and timeline to develop a standard connectivity solution. Agilent Laboratories of Palo Alto, Calif., spearheaded the CIC organization at the request of the American Association of Clinical Chemistry’s point of care testing division. Cepheid of Sunnyvale, Calif., has acquired a license from PE Biosystems Group of Norwalk, Conn., to manufacture and sell thermal cyclers for use in the PCR process. The agreement grants rights under both the PCR process patents and PE’s amplification system patent regarding thermal cyclers and applies to Cepheid’s family of I-CORE based systems. Vysis Inc. of Downers Grove, Ill., developer of genomic disease management clinical products, has signed a collaborative agreement with Genentech Inc., of South San Francisco, Calif. Genentech is the developer of the Herceptin monoclonal antibody treatment for metastatic breast cancer. The agreement extends the use of Vysis’ FDA-cleared PathVysion HER-2 breast cancer test kit as an aid in the assessment of patients for whom Herceptin treatment is being considered. The collaboration extends to future clinical studies involving other cancers. The PathVysion assay is based on Vysis’ proprietary FISH DNA probe technology. Abgenix Inc. of Fremont, Calif., will use its XenoMouse technology to generate fully human antibodies to several disease targets for Abbott Laboratories’ Hospital Products Division. Under the collaboration and license agreement, Abgenix could receive royalty payments on future product sales by Abbott, of Abbott Park, Ill., which will manufacture and market any products developed through the collaboration. The Abbott collaboration is further evidence of the growing interest by large healthcare companies in generating antibody product candidates using XenoMouse technology, said R. Scott Greer, president and CEO of Abgenix. Abbott is Abgenix’s 20th XenoMouse partner, and the eighth in the last four months. The Med-Design Corp., of Ventura, Calif., has signed a final agreement granting BD (Becton Dickinson) of Franklin Lakes, N.J., a worldwide exclusive license to use its patent rights and know-how in the manufacture and sale of safety syringe products. Med-Design will receive an up-front payment of $4 million this year. In addition to royalty payments from the first five products licensed to BD, the company will receive continuous royalty payments on any and all spring-based retracting hypodermic syringes sold worldwide by BD for a period equal to the life of the company’s principal syringe patent. Digene Corp. of Gaithersburg, Md., announced that reimbursement coverage for its Hybrid Capture II HPV Test has been expanded by U.S. health plans to include 125 million people. Increased reimbursement is critical to commercializing the test, according to Digene’s Chairman and CEO Evan Jones. Digene also announced that Physicians for Women’s Health has adopted a revised guideline making its Hybrid Capture II HPV Test the preferred method of evaluating Pap smear patients with Atypical Squamous Cells of Undetermined Significance. The 140-physician group, which serves more than 350,000 patients, has recommended that Digene’s advanced Hybrid Capture II technology be used in all its ASCUS patients to detect high-risk HPV. A blood test that detects up to 13 early-stage human cancers hit U.S. markets in May under an FDA research exemption. Clinical trials of the DR-70 test have been successful in five countries, according to AMDL, Inc. of Tustin, Calif., which developed the test. Until a general FDA approval, initial U.S. sales of the test are restricted to hospitals and commercial and research labs. However, those institutions can purchase the test, and make it available to physicians and other medical institutions under the exemption. Gary L. Dreher, AMDL chief executive, said DR-70 took 11 years and $10 million to develop. The test lets a person know with a high degree of specificity if they have one or more of the 13 most serious and most common cancers. If positive, other standard tests are used to determine the specific cancer. The non-invasive test costs no more than $100 a test per patient, Dreher said, and it can be completed within a matter of hours. LabCorp of Burlington, N.C., will offer South San Francisco, Calif.-based ViroLogic’s phenotypic HIV drug susceptibility assay, PhotoSense HIV, through its national laboratory services network. This agreement adds PhotoSense HIV to LabCorp’s existing phenotyping and genotyping test menu. The use of phenotypic HIV resistance testing in making treatment choices has been shown to significantly improve outcomes of patients who had failed previous therapy. LabCorp began offering HIV viral load testing in 1993, and later introduced HIV resistance testing. LabCorp will offer its customers the choice of ViroLogic’s assay or the currently offered phenotypic method for HIV drug resistance. Medical Analysis Systems, Inc. of Camarillo, Calif., has signed a contract with Consorta Catholic Resource Partners to provide its complete Dade TQC line of quality control products for clinical diagnostic testing and its LabLink Quality Assurance Programs to Consorta’s membership. The Rolling Meadows, Ill.-based Consorta is the group purchasing organization for more than 900 healthcare organizations. Third Wave Technologies of Madison, Wis., announced that reference lab Specialty Laboratories of Santa Monica, Calif., has adopted its proprietary Invader operating system for use in routine clinical applications. Third Wave currently markets three sets of Invader technology-based analyte-specific reagents and assay controls for use in the clinical setting. Reagents specific for mutations in the factor V (Leiden), factor II (prothrombin), and methylene tetrahydrofolate reductase (MTHFR) genes are available. Initially, Specialty Laboratories will use Invader technology for its hypercoagulation tests. Bio-Rad Laboratories, Hercules, Calif., said that it has successfully achieved its goals in the first phase of integrating the recently acquired Pasteur Sanofi Diagnostics businesses. Bio-Rad acquired the French PSD, Marnes-La-Coquette, in the fourth quarter of 1999. The planned reorganization of the ex-Sanofi business has been ahead of schedule, and the business is now organized into vertically integrated units focused on sales and profitability within specific market segments. A new management team has been created and placed, and negotiations with the French labor unions were concluded successfully in May, according to Bio-Rad. Infectious disease testing manufacturer Hemagen Diagnostics announced it would close its Waltham, Mass., facility, relocating portions of its manufacturing to its underutilized facility in Columbia, Md. This closing will further reduce the company’s annual expenses, according to a Hemagen spokesperson. The company has completed its previously announced private placement, raising $6.3 million. Proceeds of the private placement were used to re-finance its $3.8 million bank debt and private working capital. Bayer Diagnostics of Tarrytown, N.Y., has joined the Global Health Care Exchange, LLC, which is being formed by five large healthcare companies to streamline the hospital-supply business. The announcement marks the company’s first entry into an e-Business enterprise and follows the recent formation of its e-Business group.

FDA clears Cytyc’s ThinPrep 3000 Processor for Pap smears
Cytyc Corp. of Boxborough, Mass., has received FDA clearance for its ThinPrep 3000 Processor, an automated system capable of unattended batch processing of ThinPrep Pap Test samples. Designed for implementation in large volume laboratories, the processor complements the ThinPrep 2000 Processor, which can process the ThinPrep Pap Test as well as non-gynecological specimens.

Quest Diagnostics appoints business development leader
Quest Diagnostics Inc., of Teterboro, N. J., has appointed Kenneth R. Finnegan to lead its business development efforts.
     In the newly created position of Corporate Vice President, Business Development, Finnegan will be responsible for building on Quest Diagnostics’ market leadership position and accelerating profitable growth. According to Quest, Finnegan will focus on identifying, assessing and executing strategic transactions with a particular emphasis on targeted growth areas including esoteric and genetic testing, medical information and direct-to-consumer services. Finnegan will report to Kenneth W. Freeman, chairman and chief executive officer.
     Finnegan joined Quest as vice president, treasurer in 1997, and he will retain responsibility for investor relations until a successor is named.