AmeriNet Inc. of St. Louis has signed a six-year agreement with Dade Behring for several product lines and services. The agreement is expected to produce more than $750 million in purchases of instruments, reagents and supplies for Dade Behring, according to AmeriNet. It becomes effective March 1, 2000.
    The contract spans numerous Dade Behring product lines, including cardiac, chemistry/
immunochemistry, Syva drug monitoring, plasma protein, hemostasis and microbiology. In 1999, AmeriNet initiated its Clinical Services Program to provide capital equipment, supplies and pharmaceutical contracting for the entire continuum of care for cardiovascular patients. This agreement represents the largest purchasing agreement for the program since its inception.
     In addition, AmeriNet and B. Braun Medical Inc. of Bethlehem, Pa., an IV therapy, anesthesia and critical care supplier, have signed a three-year agreement. The contract became effective Jan. 1, 2000.
B. Braun will continue to provide anesthesia trays, pharmacy admixture products, IV administration systems, needle-free IV systems including Safsite, Ultrasite and Clave, vascular access products and wound care products.

Premier adds Roche’s Elecsys immunodiagnostics to its existing strategic partnership
Premier’s group purchasing arm, Purchasing Partners of Chicago, has contracted with Roche Diagnostics of Indianapolis to supply Elecsys immunoassay instrumentation, reagents and services to its members. The agreement expands the corporate partnership between Premier and Roche, which began in 1997.
Analyzers covered in the agreement include the Elecsys 1010 for rapid response testing and lower volume facilities, and the Elecsys 2010 disk and rack systems for consolidated high-volume testing. The Roche/Hitachi Modular Systems E170, for high throughput or integrated immunoassay and chemistry testing, will be added when available. The Elecsys menu currently includes assays for acute care, cardiac diagnostics, thyroid function, tumor markers, fertility, anemia and bone metabolism.
Elecsys systems, available in a range of configurations, give Premier member hospitals access to common immunoassay technology. This can make it easier to compare results, share reagents and supplies, and standardize training, quality control and maintenance. Elecsys electrochemiluminescent systems are used in the detection of disease markers including Roche’s Cardiac T assay for the detection of troponin T, an indicator of myocardial damage.

nd01.jpg (7420 bytes)SIMS Deltec, Inc. introduces peripheral access system
SIMS Deltec, Inc. of St. Paul, Minn., has announced the availability of a new peripherally inserted central venous access system for delivery of chemotherapeutic drugs, antibiotics, pain medications, nutritional solutions and other intravenous therapies.
     The P.A.S. PORT Elite implantable access system is a small, low profile portal designed for comfortable arm placement. The portal consists of a lightweight plastic exterior and a titanium interior floor for gouge-resistance and long term durability. The large silicone septum allows for easy needle access due to its large needle puncture area. Implantation of the system can be performed in an outpatient procedure room, which eliminates in-patient, OR and other charges.
     The system expands the peripheral product line available from Deltec that includes the P.A.S. PORT and P.A.S. PORT T2 systems.

Qiagen and Zeptosens partner to develop nucleic acid micro-array detection technology
Qiagen N.V., Venlo, Netherlands, and Zeptosens AG, Witterswil, Switzerland, have inked a worldwide, multi-year agreement to collaborate on the development of integrated, multi-analyte detection systems that are speedier, more cost effective and more sensitive for applications such as functional genomics, toxicology and pharmacogenomics.
     The alliance will build on Zeptosen’s proprietary planar waveguide (PWG) platform detection technology, Zeptosen’s surface chemistry and assay architecture experience and Qiagen’s proprietary instrumentation and consumable technologies for nucleic acid handling, purification and preparation. The significant increases in detection sensitivity of the PWG technology can expand the potential of microarrays.
     In 1999, Qiagen was a founding investor in Zeptosens and now holds a minority position in the company. In addition to the equity contribution, Qiagen has agreed to fund product development relating to nucleic acid detection and analysis. Qiagen expects to commercialize products based on these technologies to academic, clinical and industrial research markets. The alliance is targeting a product introduction, which will include instrumentation and consumables, in 2001.
     Recently Qiagen has also acquired Rapigene, Inc., of Bothell, Wash., an indirect wholly- owned subsidiary of Celltech Group PLC. Rapigene develops enabling technologies and services for single nucleotide polymorphism (SNP) analyses as well as other genomic applications.
     Under agreement terms, Qiagen will issue approximately 154,000 shares of its common stock (approximately $12,000,000) in exchange for 100 percent of the outstanding equity in Rapigene. The transaction will be accounted for as a purchase. Qiagen will record a charge of approximately $4.5 million after tax, or $0.13 per share in its fourth quarter 1999 financials. It will amortize the remaining goodwill and intangibles of approximately $4.5 million over 10 years. The transaction is expected to dilute Qiagen’s earning per share in 2000 by approximately $0.02.
      Rapigene’s core competencies include its Masscode Cleavable Mass Spec Tag technology. Unlike fluorescence, which is limited to four to eight analyses at a time, Masscode tags are capable of providing hundreds of simultaneous measurements. Masscode technology, coupled with a mass spectroscopy unit, enables a genomic analyst to obtain more than 40,000 measurements per day per instrument. Rapigene already offers the technology worldwide as a service to pharmaceutical, agricultural and genomics companies and academic centers.

nd02.jpg (8039 bytes)Data Innovations opens subsidiary in Brussels, Belgium
Laboratory information system provider Data Innovations, Inc. of S. Burlington, Vt., has announced the opening of a European subsidiary, Data Innovations Europe. Bob Rothstein has been named managing director for the subsidiary, which is based in Brussels, Belgium.
Data Innovations Europe will handle sales, marketing, distribution, installation and support of the company’s Data Instrument Manager product. In November 1999, Data Innovations celebrated its 10-year anniversary. Greg Vail, president, and David Potter, vice president founded the company.

nd03.jpg (6832 bytes)24-hour prenatal chromosome test rules out fetal abnormalities
Vysis, Inc. of Downers Grove, Ill., is receiving positive feedback from expectant mothers taking its prenatal chromosome test, AneuVysion. A growing number of women are using the test in conjunction with amniocentesis to rule out possible fetal abnormalities in less than half the time of a traditional Karyotype analysis.
     The assay, an FDA-cleared FISH (Fluorescence In Situ Hybridization) test, provides analysis of common chromosome anomalies indicated by abnormal triple screen or ultrasound results. The analysis is performed on cells obtained from the amniotic fluid as early as 14 weeks and provides answers within 24 to 48 hours after the amniocentesis is performed.
(top) Direct (uncultured) amniocyte hybridized with the AneuVysion 18/X/Y probe. Three aqua signals indicate three copies of chromosome 18, one green signal indicates one copy of chromosome X and one orange/pink signal indicates one copy of chromosome Y. (bottom) Direct uncultured amniocyte hybridized with the AneuVysion 13/21 probe. Three orange/pink signals indicate three copies of chromosome 21 (trisomy 21), two green signals indicate two copies of chromosome 13.

NIH funds breeding of mice with human-like gene variants
In an effort to learn more about the way human bodies repair their environment-damaged DNA and control their cells’ lifecycles, the National Institute of Environmental Health Sciences, part of the National Institutes of Health, Bethesda, Md., will fund the breeding of mice with human-like genetic variations at up to five research centers.
     The centers will provide the special mutant mice for scientists throughout the NIH and to other research programs. The study of mice with similar genes and variations could help scientists better predict human risks. The resulting information would help businesses, workers and local, state and federal regulators fine-tune environmental policies to protect the most susceptible subpopulations at low cost. Today, policy makers may over-regulate to protect these people, according to a NIEHS spokesperson. The mouse centers will help in the study of human susceptibility to natural and manmade substances. The animals and the data on them will be made widely available to the scientific commnuity.
    On Oct. 5., 1999, the National Institutes of Health announced a $21 million NIH-wide effort to map the genes of the mouse via a Mouse Genome Sequencing Network. Up to $5 million a year in grants may be available to create the centers and carry out the work.

Patent infringement filed against Waters Corp.
On Nov. 5, 1999 a patent infringement was filed against Waters Corp. and Waters Technology Corp. (“Waters”) by Viscotek Corp. The allegedly infringing product is the “patented multi-capillary viscometer” contained in the Alliance System 2000 Chromatograph for high temperature Gel Permeation Chromatography, which Waters has sold in the United States and other countries during the past two years. The suit alleges that this viscometer infringes on viscometer patents owned by DuPont and exclusively licensed to Viscotek. The suit seeks an injunction restraining Waters from further production and sale of this viscometer, and monetary damages as compensation to Viscotek for past infringement.

Schering-Plough submits U.S. application to clear Peg-Intron for chronic Hepatitis C patients
Schering-Plough Corp. of Madison, N.J., has submitted a Biologics License Application to the U.S. Food and Drug Administration seeking marketing approval for Peg-Intron (peginterferon alfa-2b) injection powder for the treatment of chronic Hepatitis C in adult patients with compensated liver disease. The application proposes administration of Peg-Intron subcutaneously once weekly for one year.
      Schering-Plough previously submitted a centralized Marketing Authorization Application for Peg-Intron to the European Union’s European Agency for the Evaluation of Medicinal Products (EMEA). Approval by the European agency would result in unified labeling for Peg-Intron that would be valid in all 15 EU-member states.
     Peg-Intron is a modified form of the company’s Intron A (interferon alfa 2-b, recombinant) Injection that uses proprietary PEG technology developed by Enzon, Inc., Piscataway, N.J. Schering-Plough holds an exclusive worldwide license to Peg-Intron. Intron A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert antiviral and immunomodulatory effects.

FDA clears blood glucose sample-drawing alternative
The U.S. Food and Drug Administration has cleared FreeStyle, a product that allows diabetics to obtain a blood sample from places other than fingertips. It was developed by TheraSense Inc. of Alameda, Calif., a medical device manufacturing firm.
The company’s purpose in developing the FreeStyle was to improve diabetes management by reducing pain, one of the biggest barriers to testing, according to Mark Lortz, president and CEO of TheraSense. The product quickly and accurately provides a blood glucose value using a fraction of the blood sample currently required by other products on the market, Lortz said.

nd04.jpg (8764 bytes)Matritech’s gets FDA OK for bladder cancer screening
Matritech Inc. of Newton, Mass., said the Food and Drug Administration has cleared its NMP22 Test Kit for expanded use as an aid in testing previously undiagnosed individuals who have symptoms of or are at risk for bladder cancer. NMP22 is already cleared by the FDA for monitoring the recurrence of bladder cancer, and it has been approved for screening in Japan and China. The test is also in use in Europe.
     On Dec. 14, 1999, an FDA advisory panel unanimously recommended approval of this expanded use of the NMP22Test kit with two conditions. The FDA has notified Matritech that these conditions have been satisfied, and that the company may proceed with marketing the kit for previously undiagnosed individuals.
David L. Corbet, president and CEO at Matritech, said the company plans to begin marketing NMP22 for this use in the United States during the first half of this year. Matritech’s nuclear matrix protein core technology correlates levels of NMPs in body fluids to the presence of cancer. The company is using its NMP technology to develop and commercialize serum-, cell-, and urine-based NMP diagnostics that enable physicians to reliably detect and monitor the presence of bladder, cervical, colon, breast and prostate cancers. The technology was discovered at the Massachusetts Institute of Technology in Cambridge, Mass., and is licensed exclusively to Matritech.

nd05.jpg (9159 bytes)LabCorp to offer Digene’s Hybrid Capture II HPV Test
Digene Corp. of Gaithersburg, Md., and Laboratory Corp. of America of Burlington, N.C., have entered into an agreement whereby LabCorp will use the Digene Hybrid Capture II HPV test for women with ASCUS (atypical squamous cells of undetermined significance), or borderline Pap smear results. LabCorp will use Digene’s advanced DNA-based technology to detect the human papillomavirus (HPV), a major cause of cervical cancer.
     The Digene Hybrid Capture HPV Test is an FDA-cleared test for HPV. There are more than 70 types of HPV, one of the most common sexually transmitted infections. Of these 70, 23 affect the genital tract and 13 types cause cervical cancer. The Digene test, which can detect these 13 key cancer-causing types of HPV, is used in the United States as an adjunct to the Pap smear for cervical cancer screening. It is also being marketed in select countries as a primary cervical cancer screen either in conjunction with or separate from the Pap smear.
     LabCorp is a national clinical laboratory with clients including physicians, state and federal government, managed care organizations, hospitals, clinics, pharmaceutical and Fortune 100 companies. Digene develops, manufactures and markets proprietary DNA and RNA testing systems to aid in the diagnosis of human diseases.
     Quest Diagnostics Inc., Teterboro, N.J., has also begun to offer the Digene Hybrid Capture II HPV Test to physicians whose patients have equivocal Pap smear results.

Dade Behring awarded federal government contract for lab instruments and supplies
Dade Behring Inc. of Deerfield, Ill., has been awarded a five-year multi-award contract with the U.S. Department of Veteran Affairs, National Acquisition Center in Hines, Ill. The contract, started in January, is effective through September 2004. It encompasses instrumentation, supplies and service for the cardiac, chemistry/immunochemistry, plasma protein, hemostasis and microbiology disciplines of laboratory diagnostics.
     The contract pricing may be accessed by the Department of Defense, the Indian Health Services and any federal healthcare agencies. The VA group represents more than 300 clinics and hospitals nationwide. The contract provides federal government laboratories with discounted pricing structures across almost all areas of the clinical laboratory. Dade Behring has signed agreements with 17 Veterans Integrated Service Networks and Tri-Care Regions. Through the five-year extension of the relationship, the company gains the potential to serve each of the 22 individual VISNs and 12 Tri-Care Regions.

Scientists gain clues to how polio virus enters cells
A research group from Purdue University in West Lafayette, Ind., and the State University of New York at Stony Brook has analyzed in molecular detail how the polio virus interacts with a cell to gain entry. They compared the virus’ methods to those of human rhinoviruses and common cold viruses that are similar in size and structure.
     Although these two virus types use different receptors to enter a cell, their receptors have a similar footprint and interact with the virus at similar sites on the virus shell, according to Michael Rossmann, the Hanley Distinguished Professor of Biological Sciences at Purdue.
     The shells of rhinoviruses and polio viruses contain deep crevices or canyons, which is the site where binding occurs. This site may be a trigger for initiation of the subsequent uncoating step required for viral infection.
     By comparing the processes used by rhinoviruses and polio viruses, scientists can describe in molecular detail the process by which a virus selectively attaches to its particular receptor. The findings provide insight on what differentiates one virus from another, and they may suggest ways for developing drugs that prevent illnesses caused by viral pathogens.
     Details of the study are in the January 4th issue of the Journal Proceedings of the National Academy of Sciences. Appearing in the same issue of the journal are similar results found by another team of researchers from the National Institutes of Health, Columbia University and Harvard Medical School.
     Polio viruses cause poliomyelitis, and though effective vaccines have been developed against polio viruses, scientists did not have a clear understanding of how these viruses attached to cell receptor molecules to initiate infection. Using high-resolution cryo-electron microscopy and 3D image reconstruction techniques, the researchers were able to obtain a 3D image of how polio virus 1, one of the three types of polio viruses, binds to a receptor, a molecule called CD155, on the cell.
    CD155 is one of hundreds of types of receptors found on a cell. Each cell may contain thousands of these receptors on its membrane. Though cellular receptors are designed to carry out specific chemical processes for the cell, viruses have developed ways to use them for entering into cells. The CD155 receptor is a single protein composed of three sections called domains.
    The protein penetrates the cellular membrane. The virus attaches to a receptor at the foot end of the molecule. The footprint is then compared to that of the ICAM-1 receptor, which is used by a number of rhinoviruses to infect human cells. As the receptors lock into their specific binding sites, the viruses bind with the receptor to form a single complex.

nd06.jpg (10232 bytes)ABgene opens first U.S. office
ABgene has opened its first U.S. office in Rochester, N.Y. The company, which manufactures PCR reagents, specialized plastic consumables and restriction enzymes, is headquartered in the United Kingdom.
ABgene offers custom made PCR Master Mixes, which includes licensed Taq polymerase, dNTPs, MgCl2, and reaction buffer in one solution; and one-step RT-PCR kits that can maintain sensitivity with RNA samples in the order of femtograms. The company also offers a pre-aliquoted PCR Master Mix in thin-walled plastic consumables. These are produced in a Class 100,000 clean room according to ISO9000 standards.

Genzyme and Alexion partner to develop recombinant proteins with transgenic system
Genzyme Transgenics Corp. of Framingham, Mass., and Alexion Pharmaceuticals Inc. of New Haven, Conn., have signed an agreement to produce a recombinant protein using GTC’s transgenic manufacturing system. Genzyme will work with Alexion to develop a large-scale manufacturing approach for one of Alexion’s recombinant protein products.
     In the first phase, Genzyme will develop transgenic animals that produce the recombinant protein in their milk. For that Genzyme will receive development and milestone fees from Alexion. Depending on the results of the development and clinical programs, it is expected that the companies would enter into supply agreements for clinical and commercial production.
     GTC has produced more than 60 human proteins in animals’ milk, including monoclonal antibodies, immunoglobulin fusion proteins, hard-to-express proteins and plasma proteins, achieving higher expression and greater volume than alternate production systems. Genzyme is working with biotechnology and pharmaceutical companies to produce transgenic proteins as potential treatments for a variety of diseases, such as autoimmune and inflammatory disorders, cardiovascular diseases and HIV/AIDS.
     Genzyme applies transgenic technology to enable the development and production of recombinant proteins and monoclonal antibodies for medical uses. Primedica Corp., GTC’s contract research organization, provides preclinical development and testing services to pharmaceutical, biotechnology and medical device companies. GTC also is developing idiotypic vaccines in collaboration with the National Cancer Institute.
Alexion is engaged in the development of products for the treatment of cardiovascular, autoimmune and neurologic diseases caused by undesired effects of the human immune system. Alexion’s two lead product candidates are currently in six clinical development programs; 5G1.1-SC, in a Phase IIb cardiopulmonary bypass efficacy trial, and two Phase II myocardial infarction efficacy trials in collaboration with Proctor & Gamble; and 5G1.1, in Phase II efficacy trials for the chronic treatment of rheumatoid arthritis and membranous nephritis.

Coley Pharmaceutical and SmithKline collaborate to develop immunotherapeutics
SmithKline Beecham of Philadelphia and Coley Pharmaceutical Group of Wellesley, Mass., (formerly CpG ImmunoPharmaceuticals) have entered into a co-exclusive licensing agreement to develop immunotherapeutic products based on CpG DNA, a broad enabling technology for immune system stimulation.
The agreement provides SmithKline with a worldwide co-exclusive license to proprietary CpG DNA-based compounds including CpG 7909 and Coley’s lead immune stimulant for use in certain therapeutic and prophylactic vaccines for infectious diseases. In exchange, Coley could receive up to $72 million in license fees, research funding and milestone payments from SmithKline.
     Under terms of the agreement, Coley will grant SmithKline co-exclusive licenses to CpG 7909 and other CpG-based immune stimulants for a number of therapeutic and prophylactic infectious disease indications. In return for commercial rights to Coley’s proprietary immune stimulants, it will receive $8 million in upfront payments, license fees and guaranteed research and development funding from SmithKline. Coley also could receive up to $64 million in future milestone payments and royalties on sales of products developed through the collaboration.
     CpG DNA encompasses a family of molecules for naturally stimulating and modulating the human immune system. CPG’s two lead products, CpG 7909 and CpG 8916, consist of proprietary synthetic DNA sequences that rapidly induce comprehensive and balanced immune responses, providing therapeutic and prophylactic activity in cancer, infectious disease and allergy/asthma models. In preclinical studies, CpG DNA was active when used alone or in combination with disease-associated antigens or antibodies. Subtle variations in CpG DNA sequences can alter immune responses, which provides the potential to create highly specific therapies. These fundamental discoveries in DNA-based immune stimulation are protected by Coley’s patent portfolio.

Esperion Therapeutics builds peptides to remove excess cellular cholesterol
Biotechnology company Esperion Therapeutics of Ann Arbor, Mich., has obtained the worldwide rights and intellectual property to a series of novel peptides. It plans to create a new peptide program to promote HDL-cholesterol elevation and enhance reverse lipid transport. Esperion obtained the rights to these peptides when it hired Dr. Jean-Louis Dasseux, the lead scientist who discovered them.
     The peptide program includes three new series of small amphipathic peptides, which mimic the functional properties of the apoA-I protein. Esperion’s peptides interact with phospholipids to form new HDL-like particles that are recognized to be effective particles for removing excess cellular cholesterol. These new peptides stereospecifically activate the enzyme responsible for cholesterol esterification in the blood, a key factor in the reverse lipid transport pathway. Additionally, these peptides are very small, consisting of 18 to 22 amino acids, compared with the apoA-I, which consists of 273 amino acids, thereby offering the opportunity for exploring alternative delivery methods and use as a chronic therapy.
     The company’s lead peptide, ESP 24218, has been proven to be stable and non-immunogenic. In preclinical testing it was shown to increase HDL cholesterol levels. ESP24218 is expected to enter Phase I clinical trials for acute treatment in the fourth quarter of 2000. Esperion will conduct preclinical studies on optimal delivery methods, including oral and inhaled administration.
     There are approximately 20 patents filed, issued and allowed for Esperion’s new peptide program.

Abbott Laboratories and American Biogenetic Sciences sign agreement to license new neuroscience compound
Abbott Laboratories of Abbott Park, Ill., recently signed a licensing agreement with American Biogenetic Sciences of Copiague, N.Y., for its new neurological compound, ABS-103.
     The agreement gives Abbott exclusive rights to develop and market the compound worldwide. As a result of the agreement, Abbott will make upfront investments including taking an equity position in ABS and making additional milestone payments. Studies were expected to start in February 2000. Terms of the agreement were not disclosed.

nd07.jpg (9202 bytes)ViTechnology names Holly Roche as sales coordinator
ViTechnology, LLC, Haverhill, Mass., has named Holly Roche as Sales Coordinator for its automated optical inspection (AOI) systems. For the past several years, Roche has been employed by Speedline Technologies/CAM/A LOT, Haverhill, Mass., as both Sales Systems Manager and Sales Coordinator for automated dispensing systems. Roche began her career as an inside sales coordinator for a contract manufacturer.
     Roche is primarily responsible for inside sales and marketing support for the AOI product line, and communications between ViTechnology’s American sales representative and customers.

nd08.jpg (8307 bytes)Olympus America announces top management changes
Olympus America Inc. of Melville, N.Y., has announced the retirement of President Sidney Braginsky. In addition, Tsuyoshi Kikukawa, chairman and C.E.O. of Olympus America, said the board of directors of Olympus Optical Co., Ltd., Tokyo, has elected F. Mark Gumz to succeed Braginsky as president and C.E.O.
Kikukawa said Braginsky was the first American to hold the post of president in the company’s 31-year history. Braginsky will be a consultant to Gumz for special projects through the end of 2000.
     Most recently, Gumz has been a consultant to Olympus’ Digital Imaging Systems Group, the consumer products division. His initial relationship with the company stems from 1977 to 1983, when he was vice president of Olympus Camera Corp., a corporate entity that pre-dates Olympus America Inc.
     Gumz currently heads the Gumz Group, Inc., Bethlehem, Pa., an international trading company. Working as a consultant with Olympus since May 1999, Gumz has been involved with analyzing the opportunities of electronic business while at the same time focusing on new business development.

Hemagen Diagnostics signs long term supply agreement with Roche Diagnostics Corp.
Hemagen Diagnostics, Inc. of Waltham, Mass., has signed a long-term agreement to provide reagents and diagnostic kits to Roche Diagnostics Corp. of Indianapolis. The extent of the agreement encompasses 30 products manufactured by Hemagen’s Raichem division, which is expected to generate in excess of $7 million in sales during the next three years.
     In addition to the 30 products covered by this agreement, Roche has indicated a desire for additional products that are not presently offered by Hemagen. As part of the agreement, the companies will work together to expand the offering further.
     Hemagen develops, manufactures and markets more than 148 FDA-cleared proprietary medical diagnostic test kits for use in the diagnosis of autoimmune and infectious diseases. The company also manufactures and sells the Analyst, a clinical chemistry analyzer used to measure constituents in human and animal blood.

Serotec announces strategic partnership with Oxford Bio-Innovations Ltd.
Serotec Inc., a biomedical research product company with U.S. headquarters in Raleigh, N.C., has announced a strategic partnership with Oxford Bio-Innovation Ltd., Oxford, U.K. Oxford Bio-Innovation supplies antibodies and ELISAs for inhibins and activins. Serotec will distribute these products to researchers in North America.

nd09.jpg (8716 bytes)J. Stephen Kroger, M.D.,is appointed to panel charged with examining Medicare Part B payment methods
J. Stephen Kroger, M.D., F.A.C.P., has been appointed to the Institute of Medicine’s Committee on Medicare Payment Methodology for Clinical Laboratory Services. The institute, which is part of the National Academy of Sciences, has been given a grant from the Health Care Financing Administration to evaluate new methods for reimbursement of Medicare Part B clinical laboratory services for the new millennium.
     The 12-person committee is charged with documenting recent trends in laboratory technology and anticipating new trends. It will assess the strengths and weaknesses of the current Medicare payment methodology for outpatient laboratory tests and look at alternative Medicare payment methodologies. As it works toward its recommendations, the committee will consider the history of the clinical laboratory industry and how it has changed since the early 1980s. It will also consider the cost of performing testing, the effects of laboratory size, specialty and site of service and the needs of the patients to access testing.
     Kroger has written and lectured on the subject of physician office laboratories at numerous regional and national healthcare conferences. Currently, he serves as the chief executive officer of COLA of Columbia, Md., a national healthcare organization.
     Kroger also has consulted with the Centers for Disease Control and Prevention regarding the Clinical Laboratory Improvement Amendments (CLIA) regulations and was appointed to the CLIA Advisory committee by the Secretary of Health and Human Services.

PE Biosystems buys Third Wave Technologies for more than $300 million
Biotech company PE Biosystems (Foster City, Calif.), a division of publicly held Perkin Elmer Corp., has acquired Third Wave Technologies, Madison, Wis., for more than $300 million. A definitive merger agreement was signed under which PE Biosystems will acquire Third Wave in a stock-for-stock transaction.
     The transaction was approved by the boards of directors of both companies, and is structured as a tax-free pooling of interests. All of the equity of Third Wave will be exchanged for an aggregate of approximately 1,972,000 shares of PE Biosystems’ common stock, before giving effect to the 2-for-1 stock dividend declared Jan. 20, 2000. The transaction is subject to customary closing conditions and regulatory approvals.
     Third Wave has developed the Invader nucleic acid (DNA and RNA) detection technology. The Invader assays can rapidly detect differences among genetic sequences important for the analysis of single nucleotide polymorphisms (SNPs). The assay technology is expected to accelerate the understanding, diagnosis and treatment of disease by enabling rapid, large-scale testing of SNPs. It will be used with PE Biosystem’s Sequence Detection Systems (SDS), a proprietary technology for real-time analysis of genetic information.
     In a statement released by PE Biosystems, Lance Fors, Ph.D., founder and CEO of Third Wave, said the company believes the merger with PE Biosystems will provide the opportunity to make the Invader technology the methodology of choice for the detection of genetic variations in research and clinical variations.

Novation signs sole-source lab distribution agreement with Allegiance, contract expected to generate $700 million in sales
Supply company Novation of Irving, Texas, has signed a new three-year sole-source distribution agreement with Allegiance Healthcare Corp., McGaw Park, Ill., for laboratory products and lab related capital equipment.
     The agreement, which went into effect Feb. 1, 2000 and runs through Jan. 31, 2003, covers more than 40,000 general lab products and capital equipment. The agreement includes two one-year renewal options, exercisable by Novation. Allegiance was selected through a public competitive bid process that included input from VHA Inc. and University HealthSystem Consortium members, through the Novation national laboratory leadership council. Novation is the supply company of VHA Inc., and UHC.
     The new distribution contract is expected to save VHA and UHC members more than $3.77 million over the course of the agreement, compared to previous pricing with another distributor. Both companies estimate the agreement could generate more than $700 million in sales for Allegiance. The new agreement extends to healthcare organizations that purchase supplies through HealthCare Purchasing Partners International, a company that markets Novation contracts to organizations that do not belong to VHA or UHC. Novation and HPPI serve approximately 6,500 healthcare organizations nationwide. These organizations house or are affiliated with 1,250 medical labs.
     Allegiance distributes thousands of medical, surgical and laboratory products from 2,800 suppliers through 48 distribution centers in the United States. Novation was established in 1998 through the combination of the supply programs of VHA and UHC, two national healthcare alliances. VHA, also based in Irving, Texas, is a nationwide network of more than 1,850 community-owned healthcare organizations and their physicians. UHC of Oak Brook, Ill., is an alliance of 81 academic medical centers and 73 associate members.