photoBoston Biomedica unit launches C6 Lyme peptide ELISA
BBI Clinical Laboratories of New Britain, Conn., a subsidiary of Boston Biomedica of West Bridgewater, Mass., has launched a new antibody test for Lyme disease — the C6 Lyme Peptide ELISA (VlsE).

The test for antibodies to a surface lipoprotein found in all strains of Borrelia burgdorferi was first reported late last year by Dr. S. J. Norris and coworkers at the University of Texas, and by Dr. Mario Philipp and his group at Tulane University. The newly discovered protein, VlsE, has the ability to change its structure, thus avoiding the patient’s immune response. VlsE consists of both variable and invariable parts. One of the invariable parts, C6, produces a strong antibody response in patients with Lyme disease and is able to distinguish between patients with Lyme disease and those who have been vaccinated to help prevent the disease.

Many of the tests currently in use have a positive reaction as a result of the recently approved Lyme disease vaccine, which has been administered to thousands of people during the past year. The C6 Lyme Peptide ELISA (C6 LPE) has several features that contribute to its accuracy and reproducibility in a range of patients. Those include: the ability to detect antibodies to U.S. and European strains of B. Burgdorferi; high specificity for Lyme disease (patients with autoimmune disease, non-Lyme arthritis, syphilis, IM, and lupus erythematosis will not test positive with this C6 LPE); and improved sensitivity in all stages of Lyme disease including those patients with late stage disease.

In addition to the new VlsE, BBI Clinical Laboratories offers a validated tests for tickborne pathogens, including confirmatory tests for Lyme disease, and tests for human ehrlichiosis and another tickborne pathogen, Babesia microti.

photoMedical Analysis Systems appoints new president, cuts work force and receives Dept. of Defense quality award
Medical Analysis Systems, Inc. of Camarillo, Calif., has appointed Marty Solberg as its new president. Solberg, who will report to CEO and former MAS president, Ivan Modrovich, will head up daily operations for the company’s worldwide clinical diagnostics business.

MAS, which provides in vitro diagnostic quality assurance reagents, software and services, also announced that it will cut nearly 28 percent of its work force to stimulate growth and reduce costs.

In late August, MAS was awarded a 2000 U.S. Army SBIR (Small Business Innovation Research) Phase II Quality Award for developing VecTest, a rapid assay for detecting malaria parasites in infected mosquitoes. The project was one of four selected among 23 nominations submitted by the Army Laboratories and Centers that participate in the SBIR program.

VecTest was developed at MAS subsidiary Navix, Inc., with funding from the Walter Reed Army Institute of Research through SBIR.

photoNew test detects and monitors peptic ulcer and gastric cancer
An aid to detect and monitor the presence of peptic stomach ulcers and gastric carcinoma, or stomach cancer has been introduced by Biomerica, Inc., Newport Beach, Calif. The Pepgen test determines the quantity of Pepsinogen-1 present in human serum and can be used to measure the efficacy of treatment.

Peptic ulcers are developed by excessive secretion of pepsin/pepsinogen, which can be caused by bacterial infection, anxiety, stress, alcohol, and using anti-inflammatory drugs. According to Biomerica, roughly 10 percent of the U.S. population develops peptic ulcers. The company also said close to 60 percent of the U.S. population over age 60 develop peptic and duodenal ulcers, and they are twice as likely to occur in men than women.

Levels of Pepsinogen-1 circulating in the blood vary depending on the disease type. In patients with peptic ulcers, serum Pepsinogen-1 levels are noticeably elevated, thus the level of Pepsinogen-1 can be an important marker to detect the presence of peptic ulcer, and judge the effectiveness of treatment. In cases of gastric cancer, serum Pepsinogen-1 levels are consistently depressed, meaning the test can be used to distinguish between two different diseases. The Pepgen test can be used in a small lab with minimal equipment, or it can be automated for an ELISA instrument in a larger lab without changes to the product performance or efficacy.

Market review tracks changes in U.S. clinical lab market
The total U.S. market for diagnostic equipment for clinical laboratories was valued at $6.1 billion in 1999, according to RDCL-00 U.S. Clinical Laboratory Diagnostics Market Review, a publication of Business Communications Co. of Norwalk, Conn.

Over the next five years, the U.S. in vitro diagnostics industry, including laboratory equipment and point-of-care products, is expected to grow at an annual rate of 2 percent. However, sales growth in the clinical lab market is expected to remain stagnant due to industry consolidation and cost containment needs. The study estimates an average annual growth rate of 0.3 percent from 1999 to 2004.

Within this market, the review shows that the clinical chemistry and immunochemistry fields are expected to see a decline within the coming forecast period. The $440 million hematology sector will grow at an average rate of 2.2 percent to reach $490 million by 2004.

The top 10 diagnostics manufacturers, dominated by pharmaceutical companies, represent some 80 percent of industry sales, according to Business Communications. Roche Diagnostics and Abbott Laboratories, the leading diagnostics manufacturers, together have more than 35 percent of the IVD market. Major competitors include Bayer Diagnostics, Beckman Coulter, bioMerieux, Bio-Rad, Dade Behring, Instrumentation Laboratories, Diasorin, Olympus America, International Remote Imaging Systems, Ortho Clinical Diagnostics, Sigma Diagnostics and Sysmex Diagnostics.

On the demand side, private labs, including hospital, reference, other independent labs and single-analysis services such as doctor’s offices, constitute 99 percent of all the labs, with the remaining 1 percent being government funded. Hospital labs and reference labs account for 9 percent of the total, but represent more than 90 percent of clinical lab revenue.

Diagnostic Deals
photoSwiss lab automation systems developer Tecan has acquired Gamera Bioscience Corp., a Boston-based, high-tech company that specializes in the development of miniaturized lab-on-a-chip, high-throughput assays. This $10 million acquisition gives Tecan access to Gamera’s micro-fluidics technology, LabCD, a consumable compact disc with micro-scale fluid paths, reaction chambers and valves.

Quest Diagnostics Inc. of Teterboro, N.J., has selected the Roche Diagnostics’ Hemoglobin A1c (HbA1c) assay to monitor diabetic patients. The assay, which runs on the Cobas Integra analyzer, is one of only a few automated assays that meet the certification requirements of the National Glycohemoglobin Standardization Program.

LabCorp of Burlington, N.C., signed a multiyear national contract with Nashville-based GPO HealthTrust Purchasing Group, L.P. The agreement renews LabCorp’s existing reference lab relationship with HCA and its recent spin-offs Triad Hospitals and LifePoint Hospitals. It also extends LabCorp’s total service offerings to all HPG members which include hospitals, surgery centers, clinics, physicians, integrated delivery networks and affiliate members.

Digene Corp. of Gaithersburg, Md., announced that LabCorp is extending its present HPV DNA testing service to reflex testing on specimens with ASCUS liquid cytology results. Since January, LabCorp has been offering HPV HC2 DNA testing for U.S. physicians and patients. During that time, LabCorp has offered HPV testing on samples collected in liquid-based cytology preservative, but not in a reflex format. Digene and LabCorp have been educating physicians on the published data supporting the clinical use of the HC2 test, which detects both the specific types of human papillomavirus that indicate a high risk of developing cervical cancer and the low risk benign types usually associated with genital warts. There are more than 70 types of HPV, 23 of which can affect the genital tract. Only 13 types cause cervical cancer. These high risk types have been detected in 99.7 percent of cervical cancer cases.

Beckman Coulter of Fullerton, Calif., has received FDA clearance for its reticOne System, used to measure reticulocytes. The measurement of reticulocytes can help assess erythropoietic activity and diagnosis anemias, internal hemorrhaging, hemoglobinopathies and certain nutritional or vitamin deficiencies. Their measurement also is useful as an indicator of recovery following bone marrow transplantation.

Ohio and Massachusetts became the 15th and 16th states respectively to pass safety needle legislation. Signed by Gov. Bob Taft, the Ohio law requires healthcare facilities to provide their employees with safety needles to protect themselves from accidental needlesticks. In Massachusetts, Gov. Paul A. Cellucci signed House Bill 5394 “An Act Relative to Needlestick Injury Prevention” into law. Karen Daley, president of the Massachusetts Nurses Association and a proponent of the bill, said the signing represents a major victory, and that the next step must guarantee protection against accidental needlesticks for workers in doctor’s offices, nursing homes and home healthcare.

Atlanta-based Serologicals Corp. has doubled the capacity at its Serologicals Ltd. manufacturing facilities in Livingston, Scotland, the site of the company’s diagnostic products unit.

American Medical Laboratories & Associated Pathologists Laboratories, (AML/PML) of Chantilly, Va., and Las Vegas, a national clinical reference lab created by a 1999 merger has become one of the first to offer Roche Diagnostics’, Indianapolis, Cobas Amplicor CT/NG Test. The automated dual test for C. trachomatis and N. gonorrhoeae, run on the Cobas Amplicor system, a single tabletop workstation, uses Roche’s patented PCR technology. The test enables these STDs to be detected with greater sensitivity than culture or direct DNA probe.

photoStudy shows SpectRx’s bilirubin analyzer eliminates painful test for infant jaundice
A study involving 490 newborn babies confirmed that its SpectRx’s BiliChek Non-invasive Bilirubin Analyzer is capable of using light to painlessly measure bilirubin, the cause of infant jaundice. The study, done by the Georgia-based point-of-care technology company SpectRx, Inc., also showed that the BiliChek biophotonic device accurately measures jaundice in babies of a variety of races and can be used as a replacement for the often-painful heel stick blood test.
Using SpectRx’s proprietary biophotonic technology, the handheld device shines light onto an infant’s forehead, analyzes the reflected light and displays results in the same measurement units as the blood test, but without the pain and risk of infection associated with blood tests.

The study was conducted at Pennsylvania Hospital in Philadelphia,and Northside Hospital in Atlanta. According to the results, which were published in the medical journal Pediatrics (Vol. 106, Issue 2), BiliChek measurements showed strong correlation with blood samples tested by the high-performance laboratory analyzer at the University of Wisconsin.

The overall correlation of the BiliChek device to the blood tests was 0.91 when comparing 1,788 measurements in a mixed race population. The study also showed that the device was capable of identifying infants at high risk for developing jaundice after being released from the hospital.

SpectRx’s BiliChek is indicated for use as a monitoring and screening device before, during, and after phototherapy treatment in more than 50 countries. In the United States, the BiliChek is cleared for use before phototherapy.

Three new Premier executives hail from diagnostics industry
Two former executives from Becton Dickinson of Franklin Lakes, N.J., and one from Abbott Laboratories have been chosen to take over important leadership roles at Premier, the nationwide strategic healthcare alliance headquartered in San Diego.

Steven R. LaNeve, former worldwide vice president and general manager of Becton Dickenson’s global Injection Systems business, takes over the reins as executive vice president for relationship management involving the alliances 1,900-member organizations. He will also play a key role in the executive team, guiding Premier’s business strategies.

La Neve will have chief responsibility for the field organization and systems through which Premier integrates and customizes its services for member healthcare facilities.

Howard E. Sanders, former president of Becton Dickinson Healthcare Systems, U.S. Region, has been named chief operating officer of Premier’s Purchasing Partners, L.P., the alliance’s group purchasing and supply chain services arm, which is based in Chicago.

James G. Wetrich, former divisional vice president for group accounts at Abbott Laboratories in Chicago, is Premier’s new vice president for business partner relationship management. He also is working out of the Chicago office.

Amelung acquired by St. Louis-based Sigma-Aldrich
St. Louis-based Sigma-Aldrich Corp. has acquired Amelung GmbH of Lemgo of Germany for $28 million. Founded in the 1950s, Amelung develops and manufactures coagulation instruments, reagents and controls.

Sigma-Aldrich’s Diagnostics Division, which has been the exclusive worldwide distributor of Amelung instruments since 1996, plans R & D investments to enhance the performance of existing analyzers and add a new mid-range analyzer, new reagents and tests to offer a comprehensive, competitive line.

Sigma-Aldrich’s plans to step up sales and marketing of integrated systems is expected to result in a minor reduction (roughly $.01 per share) in projected income over the next 12 months. Later results are expected to benefit overall earnings. A special charge for purchased in-process research and development, expected to be in the range of $.02-$.05 per share will reduce projected income for 2000, Sigma-Aldrich said, and details regarding this charge will be reported in the third quarter.

photoCalypte’s HIV-1 antibody urine test gains access to more than 40 Sub-Saharan African countries
Calypte Biomedical Corp. of Alameda, Calif., has expanded its mobile HIV-1 antibody urine testing program from South Africa to 41 countries in sub-Saharan Africa. The expansion is in response to the strong support of medical professionals, AIDS activists and government officials at July’s 13th International AIDS Conference, where the mobile testing program was unveiled.

Calypte and its distribution partners, American Edge Medical Co., and African Medical Solutions, plan to duplicate the distribution approach already implemented in South Africa, to extend HIV testing and education to many more countries in sub-Saharan Africa. American Edge in partnership with South African-based AMS, which was formed specifically to market Calypte’s products in Africa, will expand its exclusive rights as distributor of Calypte’s urine HIV-1 antibody products from South Africa to the other African countries.

AMS uses shipping containers, the large metal boxes commonly used to transport goods on ships and trains, and has them custom engineered into clinics. These clinics are then transported by train or truck to outlying townships and remote areas in South Africa to administer Calypte’s HIV urine test and provide people with education about the disease. AMS also is using motor vehicles that have been modified into state-of-the-art mobile clinics to access some areas. AMS expects to deploy the first container clinic to South Africa before year-end and expand throughout the region in 2001.

Unlike blood samples, non-medical professionals can obtain urine samples with Calypte’s urine HIV-1 antibody tests. The tests have a longer shelf life, are not considered hazardous, and do not require refrigeration. According to the National Institutes of Health Fact Sheet on HIV Infection and AIDS, there is no evidence that HIV is spread through urine.