Originally Published IVD Technology
April 2004
INDUSTRY NEWS
NotablesThe American Association for Clinical Chemistry (AACC; Washington, DC) Industry Division listserv has been moved to a new provider location. The listserv is a forum for subscribers to discuss and identify common interests and concerns regarding issues pertaining to the relationship between the IVD industry and clinical laboratories.
Members of the IVD industry can subscribe to the listserv and post e-mail messages to the entire list. In addition, the contributions of other subscribers will be distributed to the entire subscriber base via e-mail. As a result, members participate in an IVD-industry-specific newsgroup and forum. Readers can subscribe on-line at https://my.binhost.com/lists/listinfo/aacc-industry-div.
In addition, the annual International Congress of Clinical Chemistry (ICCC) conference organizing committee is soliciting proposals for the ICCC conference to be held in Orlando, FL, on July 24–28, 2005. All proposals must be received by July 1, 2004, and must be submitted electronically using the form on-line at www.aacc.org/2005am/.
From late June until December in 2003, test kits by Chiron Corp. (Emeryville, CA) and Roche (Basel, Switzerland) were used to screen the blood from 6.2 million donations in the United States for West Nile virus (WNV). More than 1000 of these donors tested positive for WNV, establishing the disease as one of the most common illnesses that can be acquired through a blood transfusion, according to a study from the U.S. Centers for Disease Control and Prevention (Atlanta). The manufacturers are now working to improve the ability of the tests to detect low levels of the virus in blood.
Almost two dozen people who received transfusions last summer were known to have contracted WNV and more than 9000 people contracted the disease in 46 states in 2003. The tests are still under consideration for market clearance by FDA. About 75% of U.S. blood-collection centers use Chiron’s Procleix text, developed with Gen-Probe (San Diego); the others use Roche’s TaqScreen test.”
FDA ordered the seizure of neonatal chemistry and isoelectric-focusing diagnostic kits under the Wallac brand name from PerkinElmer Life Sciences (Norton, OH). The IVD kits were considered adulterated under the Federal Food Drug, and Cosmetic Act because they were not manufactured in accordance with FDA’s good manufacturing practice quality system regulation, thereby decreasing the agency’s level of assurance that the devices were safe and effective. The test kits are used to screen for several genetic diseases in newborns and hemoglobin and central nervous system diseases in adults, such as sickle-cell anemia and multiple sclerosis.
A study published in the New England Journal of Medicine suggests that lipoprotein (a) [Lp(a)] may serve as a predictor of risk of stroke in older men. Tests used to measure blood levels of Lp(a) are traditionally used, along with lipid profiles, to screen for risk factors for coronary artery disease and cerebral vascular disease.
In the Cardiovascular Health Study, led by investigators from the Center for Cardiovascular Disease Prevention and Intervention (Dallas) and
Johns Hopkins Hospital (Baltimore), men with the highest levels of Lp(a) had three times the risk of stroke, nearly three times the risk of death from cardiovascular disease, and almost twice the risk of death from all causes when compared with men who had lower baseline Lp(a) levels. No similar findings existed for women. The study followed 5888 men and women aged 65 years and older for seven years.
Roche Diagnostics (Basel, Switzerland) completed its acquisition of Igen International (now
BioVeris; Gaithersburg, MD), providing Roche with broader access to the immunochemistry sector. This acquisition ended a long-standing patent dispute over Igen’s Origen electrochemiluminescent (ECL)-based technology, which was used in several of Roche’s products, including many of its Elecsys instruments and assays. In the last three years Roche has increased sales of its Elecsys immunochemistry product line by over 20% annually.
ECL is a process in which chemiluminescent reactions that lead to the emission of light are initiated electrically, rather than chemically, by applying a voltage to immunological complexes attached to streptavidin-coated microparticles.
Heino von Prondzynski, head of Roche Diagnostics said, “The acquisition of Igen gives Roche nonexclusive rights that permit us to fully exploit the potential of ECL technology in the immunochemistry IVD market to further develop the Elecsys product line. It also allows us to expand our activities in one of the division’s largest and most attractive growth areas—immunochemistry, which accounts for over 25% of the in vitro diagnostics market. We will now continuously extend our menu including a significant number of proteomic markers.”
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