Abbott signs with Quest, Quest offers H. pylori breath test
Abbott Laboratories of Abbott Park, Ill., has signed a two-year, $60 million supply agreement with Quest Diagnostics Inc. of Teterboro, N.J.
      Abbott will provide Quest with immunoassay tests and systems for hepatitis, cancer, cardiac conditions and therapeutic drug monitoring, PSA and homocysteine assays.
     Quest has begun to offer a breath test for the detection of ulcer causing bacterium, Helicobacter pylori, in Texas and Seattle. The 35-minute test, made by Meretek, Inc. of Nashville, has been FDA cleared for the diagnosis and post-treatment monitoring of H. pylori using patented non-radioactive technology.

photoHome use of HbA1c POC test granted to Metrika device
Metrika Inc. of Sunnyvale, Calif., a developer of point-of-care monitoring devices for diabetes patients, has received CLIA waiver and 510(k) marketing clearance from the FDA for prescription home use of its DRx HbA1c Patient Monitor. The product is a single-use, quantitative test for long-term glucose monitoring for diabetics. While already cleared for professional in-office use, Metrika said the addition of the CLIA waiver enables a greater number of physicians to use the DRx HbA1c monitor to perform a key test once available only in clinical labs, and to obtain quantitative lab-equivalent results in eight minutes. The product is also cleared for patient use, allowing HbA1c testing to be done at home with a doctor’s prescription, Metrika said. The company plans to market the device for home testing in mid-2001.

Jewett acquired by Revco
GS Laboratory Equipment of Asheville, N.C., changed its name to Revco Technologies, Inc. on September 12 and acquired refrigeration and pathology equipment provider, Jewett Inc. of Buffalo, N.Y., on September 18. Jewett annual revenues are approximately $13 million.
     A unit of SPX Corp. of Muskegon, Mich., the new Revco Technologies will continue to manufacture and market its ultra-low and cryogenic freezers, lab refrigerators and freezers, CO2 incubators, lab furnaces, ovens, water baths and associated products for clinical markets worldwide. The company will continue to market its brands, Revco, Harris, Puffer-Hubbard, Queue and Lindberg/BlueM, through current sales channels.

Letters to the Editor
Clot wave form analysis benefits from
better computing power of today
I found it amusing that the clot wave form analysis is being viewed as new technology [Product Development, October]. Bio/Data had Coagulation Profilers CP-7 and CP-8 on the market in the 1970s with this capability. Due to the lack of PC processing, it was only accepted by the investigative market sector. We still include several of the wave form analysis in our present analyzer software to verify clot reaction and ensure results. These also are included in our patented fibrinogen measurement method (KFA) which has been studied and published on its equivalance to the von Clauss and WHO methods in many disease states. A second paper is soon to be released on the KFA and fibrinogen degregation products.

William Coville
Bio/Data Corp.

photoOlympic athletes tested for EPO on Bayer system
After the announcement by the International Olympic Committee regarding implementation of blood doping testing at the 2000 Olympic Games in Sydney, Australia, Bayer Diagnostics of Tarrytown, N.Y., installed two new Advia 120 Hematology Systems at the Australian Sports Drug Testing Laboratory. The systems were used as part of the new test protocol implemented at the 2000 games to detect the use of erythropoietin by competing athletes. The testing consisted of a recently developed method that uses a combination of blood and urine tests to assess EPO use.
     The Advia 120 was used to assess abnormally high levels of EPO, which makes new red blood cells, in connection with the random EPO testing in urine. Researchers at the Australian Institute for Sport, in collaboration with sports medicine experts from several other countries, tailored the output from the Advia 120 to develop the blood testing parameters for this application.

Pap test may miss one type of cervical cancer
New research from the University of New Mexico Health Sciences Center in Albuquerque, N.M., suggests that the Pap smear may not pick up one particular type of cervical cancer.
      The research, by Dr. Harriet O. Smith and colleagues, found that since 1973, the incidence of adenocarcinoma of the cervix has increased 30 percent, despite a noticeable decline in squamous cell carcinoma, a more common form of cervical cancer. In the August Gynecologic Oncology, the researchers report that while squamous cell cancer arises from the lining of the cervix, adenocarcinoma forms in cervical glands, making it more difficult to detect. The fact that adenocarcinoma is becoming more common, suggests that the current screening for cervical cancer may be insufficient.
       Examining federal cancer statistics, Smith’s team found that the incidence of all cervical cancers fell 37 percent between 1973 and 1996. The incidence of squamous cell cancer fell 42 percent, and in contrast, adenocarcinoma rose 30 percent. This shows that available screening methods may be insufficient to detect a number of lesions that are precursors to invasive cervical adenocarcinoma. The Smith team concluded that better methods, designed to target cervical glands, are needed.
       Smith said additional techniques need to be investigated to improve the sensitivity and specificity of the Pap smear, such as liquid-based cytology, which may be more accurate than the traditional Pap smear in detecting endocervical cells.
     The team of researchers noted that in the past, adenocarcinoma of the cervix was thought to affect older women, but the data shows the numbers growing among younger women.

Diagnostic Deals

photoMeridian Diagnostics of Cincinnati, Ohio, has acquired Viral Antigens, Inc. of Memphis, a manufacturer of specialty viral reagents for infectious disease. The purchase price includes $9 million in cash and earnout opportunities over six years. VAI’s current management will remain intact. The acquisition is part of Meridian’s expansion into services that will discover new pharmaceuticals, vaccines and diagnostics.

Beckman Coulter, Inc. of Fullerton, Calif., and Bio-Rad Laboratories, Inc. of Hercules, Calif., are not renewing their distribution contract for the Access Immunoassay System in 90 markets throughout Europe, Africa and the Pacific Rim. Beckman Coulter assumed sales responsibility in September.

POC Assays, Inc. of Tewksbury, Mass., has completed its seed stage corporate milestones aimed at developing a second-generation point-of-care testing platform for critical care blood diagnostics. The wireless technology automates data management and is designed to reduce the cost of stat blood testing outside the central lab.

A rapid test for Prostate Specific Antigen from MedMira Laboratories of Toronto is ready for clinical trials, first in Europe and then in Canada. The MedMira Rapid PSA Test is capable of detecting above-normal levels of free PSA in two drops of whole blood in a few minutes.

Triple G Systems Group of Markham, Canada, and Minneapolis-based Allina Health System have signed a contract for Triple G’s Ultra software to integrate lab processing functions across Allina’s network of 18 hospitals, 48 clinics and its million-plus member health plan, Medica. Allina, a non-profit, integrated system serves communities throughout Minnesota, western Wisconsin and eastern North and South Dakota.

National healthcare accreditation organization COLA has announced the election of four board officers and the appointment of three new board members. Margaret S. Skinner, MD, a pathologist at Palm Beach Pathology Group in West Palm Beach, Fla., was elected chair. Verlin K. Janzen, MD, FAAFP, a family physician with the Hutchinson Clinic in Hutchinson, Kan., was elected vice chair. Cyril M. Hetsko, MD, an internist and infectious disease specialist at the Dean Clinic S.C., Madison, Wis., was elected board secretary. Timothy T. Flaherty, MD, chair of the AMA Board of Trustees and a board-certified radiologist in Neenah, Wis., was elected treasurer. Isabel V. Hoverman, MD, Thomas Sodeman, MD, and Amelia G. Tunanidas, DO, were appointed board members.

After entering a licensing agreement in June, Invirion Inc. of Frankfort, Mich., has delivered its initial probe for human papilloma virus detection to Ampersand Medical Corp. of Chicago. Ampersand, which begins human clinical studies on the probe by the end of the year, plans to use the HPV probe in conjunction with its biomolecular markers. The oncogenic probes screen for HPV using a fluorescence detection platform and genomic data from the Human Genome Project. The probe identifies E6/E7 genes which may have a role in causing cervical cancer.

Nymox Pharmaceutical Corp. of Maywood, N.J., maker of the 7C Gold test, a urine test that measures neural thread protein to aid in the diagnosis or exclusion of Alzheimer’s disease or dementia, hired 35 sales reps and appointed Charles Collins, of Orlando, Fla., as National Sales Executive.

On October 1, Caprius, Inc. of Fort Lee, N.J., a wholly owned subsidiary of Opus Diagnostics, Inc., entered into an exclusive distribution agreement with Polymedco, Inc. of Cortlandt Manor, N.Y. Polymedco’s sales force will exclusively market the Opus line of InnoFluor TDM assays in the United States. Polymedco will stock and distribute Opus’ products from its Cortlandt Manor facility and will offer a range of complementary products.

B. Braun Medical, Inc. of Bethlehem, Pa., has contracted with Novation of Irving, Texas to be one of two companies providing large-volume infusion pumps and needle-free devices to UHC members. The agreement, which runs through May 31, 2005, was based on the results of Novation’s public competitive bid process.

B. Braun also has been awarded a contract to provide safety IV catheters to HealthTrust Purchasing Group, LP of Nashville, which has a membership in excess of 550 facilities. B. Braun will be a dual-source provider of safety IV catheters. The new contract became effective September 15, 2000.

Wireless communication provider Data Critical Corp. of Bothell, Wash., and LabCorp of Burlington, N.C., have entered an agreement under which physicians will be able to order lab tests and receive results through the MobileLab service component of unwiredDr, Data Critical’s wireless web services for physicians.

Lab equipment manufacturer DiaSys Corp. of Waterbury, Conn., has acquired Intersep Ltd., a UK-based manufacturer of lab consumables, reagents and test kits.

LabDat, Inc. of Burbank, Calif., will provide its package of Internet services to Millennium Clinical Laboratories, also in Burbank. The proprietary system enables secure reporting of clinical lab data to physician-clients coupled with systems that allow physicians to pass results on to patients.

Organon Teknika of Durham, N.C., has inked a four-year agreement with Premier for automated microbiology instrumentation and reagents. The contract provides access to BacT/Alert products for all Premier member institutions.

photoTed Pella gets new general manager
Lab equipment and chemical provider Ted Pella Inc. of Reading, Calif., has promoted Tom Pella (left) to vice president and general manager.
     After working for six years in General Dynamics’ computer system department, Pella joined Computer Sciences Corp., where he advanced to computer systems architect for highly specialized computer systems designs and installations. As manager of information for Ted Pella, Inc., he has modernized the company’s computer systems and ensured its Y2K compliance.

photoMedical Analysis Systems promotes new operations VP
Medical Analysis Systems Inc. of Camarillo, Calif., has promoted Scot Kinghorn (left) from vice president of quality and regulatory affairs to vice president of operations.
     Kinghorn will oversee the daily manufacturing operations for MAS’s worldwide clinical diagnostics business and report directly to the company’s president, Marty Solberg.
     Kinghorn has an extensive background in quality and operations within the diagnostics industry. In addition to his recent standing as head of the department of Quality and Regulatory Affairs, Kinghorn’s roles at MAS also include manager of the compounding and quality control departments. Prior to joining MAS, Kinghorn was employed at E. Merck’s EM Science division, where he served as quality control manager and manager of process development.

New CEO and CFO at Dade-Behring
The Dade Behring Board of Directors has selected James Reid-Anderson, currently president and chief operating officer, to become president and chief executive officer and a member of the board of directors.
      Reid-Anderson, 41, will succeed Steven W. Barnes, who has served as Dade’s CEO for three years. Barnes will co-chair the company while transitioning to lead the Bain Capital portfolio group.
     Reid-Anderson has more than 20 years of global management experience. He joined the company in 1996 as chief financial officer and was subsequently promoted to chief administrative officer, then to president and COO. Prior to joining Dade, Reid-Anderson served as chief operating officer and chief administrative officer for Wilson Sporting Goods.
      Dade also has asked Jeffrey G. Naylor to be the company’s senior vice president, finance, and chief financial officer. Naylor, also 41, will be responsible for worldwide finance activities including treasury, corporate control, and financial planning, reporting and financial operations. Naylor will report to Reid-Anderson. He joins Dade from The Limited Inc., where he was vice president and controller.

photoSigma-Aldrich board member named National Science Board director
The U.S. Senate has confirmed President Clinton’s nomination, Dr. Nina Fedoroff (left), as director of the 24-member National Science Board. This group guides the activities of the National Science Foundation, the core of one of the country’s most important science and engineering programs.
     For the past four years, Fedoroff has served on the Sigma-Aldrich Board of Directors. Fedoroff is director of the Biotechnology Institute and director of the Life Science Consortium at Pennsylvania State University in State College, Pa., where she is a Willaman Professor of Life Sciences.
     Fedoroff’s research has focused on unraveling the genetic secrets of the maize plant. Her studies have centered around further understanding the transposable elements (transposons) of genetic material in this plant. Fedoroff and her group also are making inroads into understanding transposon mutagenesis and building DNA microchips for analyzing gene expression patterns.

photoFormer Abbott exec joins SpectRx board
SpectRx, Inc. of Norcross, Ga., appointed to its board of directors, Chris Monahan (left), former divisional vice president and general manager with Abbott Laboratories’ Diagnostics Division. SpectRx, in collaboration with Abbott and its MediSense Products unit, is developing a continuous glucose monitor for diabetics.
     Monahan joined Abbott’s Diagnostics Division in 1992 as vice president and general manager of hematology, following the company’s acquisition of Unilever’s hematology business.
     Monahan had previously served as president of Unilever’s Unipath Division and as president and CEO of Sequoia Turner Corp., prior to its acquisition by Unilever. He has also had top-level management positions with Coherent Inc., Baxter Travanol Laboratories, Inc. and Warner Lambert Co. Most recently he served as acting CEO for Informed Diagnostics, Inc., and consults for medical companies.