SPECT Found Useful in Identifying Alzheimer’s Disease
It’s been nearly a century since Alzheimer’s disease (AD) was first identified. Today, according to the Alzheimer’s Disease Education and Referral Center, 4 million Americans suffer from AD. About 3% of men and women ages 65 to 74 have AD, and nearly half of those age 85 and older may have the disease.

 In the time since the disease was first identified there has been no foolproof way to diagnose the illness in a living patient. But a new method used by doctors at University of Texas Southwestern Medical Center at Dallas is almost 100% accurate when combined with clinical assessment. According to Frederick Bonte, MD, director of the Nuclear Medicine Center at UT Southwestern, testing blood flow in a specific region of the brain may boost the degree of diagnostic certainty in difficult cases from 90% to almost 100%.

A study being done at the center points to single-photon emission computed tomography (SPECT) and its ability to be used to identify a characteristic sign of Alzheimer’s disease and distinguish it from a group of illnesses known as frontotemporal diseases, which comprise the second-leading cause of dementia in the elderly.

SPECT is a radioisotope test that produces a 3-D picture of the amount of blood flowing in certain regions of the brain. People with Alzheimer’s have reduced blood flow in some areas of the brain, one of which is called the posterior cingulate cortex. This region helps process information from the parietal cortex and the hippocampus. This area of the brain is responsible for storing vocabulary words and geographical information.

“The dementing diseases are becoming a very important socio-economic problem, in addition to being a group of scientific problems of incredible difficulty,” says Bonte. “The prospects are quite hopeful now that effective treatments for Alzheimer’s disease—and possibly a cure—will emerge in the not-too-distant future. This makes it even more important to find out who really has Alzheimer’s disease and is, therefore, eligible for treatment and who has one of the other dementing diseases, for whom these new treatments would be ineffective.”

In the study, SPECT was used to measure brain blood flow in the posterior cingulate cortex of 60 people, ages 54 to 92. Twenty of the patients were suspected of having Alzheimer’s disease, 20 were believed to have frontotemporal disease, and the remaining 20 volunteers had no evidence of dementia. Of those suspected of having Alzheimer’s, 16 exhibited significant blood-flow reductions in the posterior cingulate cortex. Of the 20 patients suspected of having frontotemporal disease, only one showed signs of reduced blood flow in the region. That patient was later reevaluated and diagnosed with Alzheimer’s disease.

Evidence of shrinkage in brain structures, such as the hippocampus and parietal cortex, is also central to diagnosing Alzheimer’s. This shrinkage, or atrophy, can be seen on a standard MRI. Still, autopsy remains the definitive diagnostic tool for Alzheimer’s disease.

Contact: University of Texas Southwestern Medical Center (214) 648-2509; www.utsouthwestern.edu

Inaugural ALA LabFusion 2004 Deemed a Success
The first ALA LabFusion exhibition, presented by the Association for Laboratory Automation, reported great success after the June 2004 event in Boston.

ALA LabFusion 2004 focused on biopharmaceutical development and applications, as well as practical implementations, including technology acquisitions, pharmaceutical technologies, process chemistry, and system validation and qualification. There were more than 160 researchers from universities nationwide, and podium presentations from industry leaders. ALA LabFusion 2004 also boasted 100 exhibitors showcasing current products and services in laboratory automation. More than 1,371 laboratory professionals participated in the inaugural event, including 859 attendees.

The Association for Laboratory Automation is a global, nonprofit organization committed to fueling innovation in the field of laboratory technologies.

“With ALA LabFusion 2004, we have planted a seed that is already propagating. Our fellow researchers and exhibitors recognize a positive momentum here. We are already focused on the curriculum for ALA LabFusion 2005,” says ALA President Peter Grandsard.

The LabFusion 2005 conference and exhibition on emerging laboratory technologies and tools is scheduled for January 30–February 3 at the San Jose McEnery Convention Center in San Jose, Calif. The 2005 event will provide attendees with information on laboratory technologies across diverse industries, including biotechnology, pharmaceuticals, clinical, and the environment.

Contact: Association for Laboratory Automation (866) 263-4928; www.labautomation.org

Abbott Brings the Show to You
Packed snugly in a bright orange semitrailer, Abbott’s new ARCHITECT® ci8200 immunochemistry system has been traveling the country since April in an effort to educate clinicians about its benefits and advancements in diagnostics.

 The ci8200 provides immunochemistry integration by combining benefits of clinical chemistry and immunoassay testing on one platform. From carryover reduction to clot detection, the user-friendly system has been designed to enhance lab workflow productivity. For example, it allows the user to load 93 different assays at one time and to monitor where the sample is at any time during the testing cycle. Additionally, the system can run as many as 200 immunoassay tests and as many as 1,200 clinical chemistry tests an hour.

Initially, the Architour™ was scheduled to stop in more than 105 cities nationwide to allow laboratory professionals to see the ci8200 system. However, due to the response to the tour, the company has employed a second truck to revisit cities, as well as to stop at other requested areas on its way to the Western half of the country. With the more than 200 stops scheduled for the second truck, Abbott expects to reach more than 7,000 viewers nationwide before the truck pulls into the garage this winter.

 With three tours a day, and 20 guests per tour, the Architour gives Abbott a chance to showcase its latest in lab automation and to provide a tailored overview for each facility visited.

“We’re trying to make it as convenient as possible, and it appears to be working,” says Amy Woodworth, public affairs manager for Abbott. “We’ve even had several instances in which hospital administrators show up to take the tour. These are people who do not necessarily use the equipment, yet they are responsible for the purchasing decisions within their facilities. The Architour provides them, as well as those who will be using the equipment directly, with a hands-on opportunity to see how it works—to kick the tires, so to speak.”

Abbott plans to continue the mobilization of its two ci8200 immunochemistry systems throughout the United States until the end of 2004. In the future, the company plans to keep a truck located on each side of the Mississippi for use in upcoming diagnostic laboratory visits.

Contact: Abbott Laboratories (800) 323-9100; www.abbott.com

Phase I Trial for Thrombin Inhibitor ARC183 Begins
Archemix Corp and Nuvelo Inc have officially begun the dosing in a Phase I clinical trial of ARC183, an antithrombin aptamer that is being developed as an anticoagulant/antithrombotic for potential use in coronary artery bypass graft (CABG) surgery. The open-label dose escalation study will evaluate the safety, tolerability, anticoagulation activity, and titratability of ARC183. The initial portion of the Phase I program will be conducted in 16 normal volunteers; then the program will evaluate ARC183 in patients with coronary artery disease.

“The data we plan to generate from this trial will educate us on the safety and tolerability of ARC183,” says Claude Benedict, MD, head of development at Archemix. “The study also will validate the anticoagulant activity of this novel compound.”

“Advancing ARC183 into clinical trials represents a significant achievement both in our collaboration with Archemix and in the expansion of Nuvelo’s clinical pipeline,” says Steven Deitcher, MD, vice president of medical affairs for Nuvelo. “We look forward to rapidly generating the clinical data necessary for the continued development of ARC183 as a potential replacement for heparin-protamine in CABG surgery.”

According to the American Heart Association, more than 500,000 CABG procedures are performed annually in the United States, and more than 700,000 are performed worldwide. Heparin is the anticoagulant currently used in the majority of CABG surgeries; however, it has significant limitations, such as bleeding and heparin-induced thrombocytopenia (HIT). It is also difficult to dose accurately and requires dose monitoring. In addition, heparin requires protamine to reverse its anticoagulant effects.

Experiments in animal models suggest that the potent ARC183 has many desirable properties for CABG surgeries, including rapid onset and predictable anticoagulant effects, reduced bleeding complications, no risk of HIT, and a short half-life, negating the need for an antidote. In addition, as an aptamer, ARC183 has all the advantages normally attributed to aptamers, such as high specificity and affinity for its targets as well as chemical synthesis allowing for scalable production and stable shelf life.

ARC183 is the first product candidate in Archemix’s aptamer portfolio. In January 2004, a worldwide collaboration agreement was formed with Nuvelo for the development and commercialization of ARC183. Under the terms of the agreement, Archemix will initially lead development and be responsible for all clinical development activities. Nuvelo will have the option to lead commercialization efforts in which both companies may participate. As part of the transaction, Archemix and Nuvelo will equally share all costs associated with the development and marketing of ARC183 and will have 50/50 ownership of the compound.

Contact: Archemix Corp (212) 588-8788; www.archemix.com; or Nuvelo Inc (408) 215-4000; www.nuvelo.com

Collaboration Supports Molecular and Genomic Diagnostics
Health Line Clinical Laboratories has signed a 5-year strategic alliance agreement with Roche Diagnostics to establish itself as a molecular center to perform routine molecular diagnostic testing, esoteric genomic testing, and other related diagnostic services using Roche’s Polymerase Chain Reaction (PCR) and other genomic technologies.

 Throughout the course of the agreement, Health Line will continue to leverage its strengths in the reference laboratory market and combine them with Roche’s expertise and support in molecular and genomic diagnostics.

Contact: Roche Diagnostics (317) 521-2000; www.roche.com

GenoMed Tests First Line of Defense Against Viral Bioterrorism
With increased awareness of possible terrorist attacks, GenoMed has begun to test a possible antidote against viruses often mentioned as weapons of bioterrorism, particularly West Nile virus.

GenoMed’s patent-pending approach, which uses a class of blood pressure pills to gently reduce excessive inflammation by a patient’s own immune system, has achieved a 100% response rate so far among 12 patients with an intact immune system who came down with West Nile virus encephalitis.

The treatment being developed by GenoMed will be effective on such viruses as SARS, bird flu, hantavirus, respiratory syncytial virus (RSV), monkeypox, ebola virus, West Nile virus, St Louis encephalitis, Eastern Equine encephalitis, smallpox, dengue, Crimean-Congo hemorrhagic fever, and polio. The company also is pursuing a possible approach against all lethal viruses, including HIV.

Contact: GenoMed (314) 983-9938; www.genomedics.com

Beckman Coulter Supports Health Care Network
Beckman Coulter has signed a $25 million, 5-year agreement with St Joseph Health System to provide its integrated health care delivery network with a wide range of diagnostic laboratory instrument systems, software, and test kits.

According to the agreement, Beckman Coulter will be the sole-source provider of automation, immunoassay, data management, and general chemistry products for the purchasing organization and supply-chain management company. The agreement also covers Beckman Coulter’s full range of automation equipment, including the Power Processor sample-processing system and related automation modules and connections.

“This contract will enable our integrated delivery network to standardize on Beckman Coulter instrument systems and tests for improved patient care and cost savings,” says Jim McManus, vice president of finance for St Joseph Health System.

Additionally, Beckman Coulter will offer its Access® 2 immunoassay system, UniCel® DxI 800 Access immunoassay system, DL 2000 data manager, SYNCHRON LX®20 PRO clinical system, and the SYNCHRON LX®i 725 clinical system, which performs more than 140 chemistry and immunoassay tests.

“Our newest agreement with St Joseph Health System enables us to provide members of the health network with 100% of their routine laboratory testing requirements,” says Robert Kleinert, vice president of the Americas, clinical diagnostics division of Beckman Coulter.

Contact: Beckman Coulter (800) 877-6242; www.beckmancoulter.com

Cell Culture Provider Poised for Growth
Diagnostic Hybrids Inc (DHI) has received a $10 million minority investment led by Summit Partners that will enable DHI to fund new research and development initiatives, expand its facilities, and pursue technology and company acquisitions.

Founded in 1983, DHI develops and manufactures genetically engineered tissue cell cultures, monoclonal antibody kits, and biological reagents for hospital and commercial medical laboratories. More than 700 laboratories across North America and Europe use DHI products and reagents to diagnose viral diseases and identify the presence of auto-antibodies in serum.

“Our partnership with Summit Partners will enable us to take advantage of the exciting opportunities before us, to accelerate these advances to our customers, and continue to develop and grow as an organization in southeast Ohio,” says David Scholl, PhD, president and CEO of DHI.

Contact: Diagnostic Hybrids Inc (800) 344-5847; www.dhiusa.com

LifePoint Signs Agreement
LifePoint Inc announced that the Hendricks County Circuit Court in Danville, Ind, has signed a 3-year agreement for use of the IMPACT® test system. The system will enable probation officers to test juveniles and other individuals under the supervision of the County Probation Department.

“The IMPACT test system is being introduced into both our preliminary and continuing drug test programs,” says Stephen Schmalz, director of Hendricks County Circuit Court Probation Department. “Besides the obvious advantage of being able to test almost anywhere without the need for a bathroom or an observed urine sample (major benefits when testing juveniles), the IMPACT Test System helps make concealing illegal drug use a lot harder to do. It has proven to be a great tool that we expect to improve our ability to detect illicit drug use and it may prove to be an additional deterrent.

“Urine tests are difficult to administer, require gender-specific collections, and are subject to substitution and adulteration of the sample by the donor. Testing saliva using the Impact system removes these administrative hurdles from day-to-day testing regimens and enables law enforcement officers to more efficiently manage their time and resources,” says Schmalz.

Contact: LifePoint Inc (909) 418-3003; www.lifepointinc.com

Ortho-Clinical Diagnostics to Introduce its VITROS 350 Chemistry System

Ortho-Clinical Diagnostics will launch its VITROS® 350 chemistry system to enhance laboratory productivity while reducing labor requirements. The system features a new flat-panel, touch-sensitive monitor with adjustable positions for increased operator ergonomics and ease of use. Additional software updates are expected to provide improved throughput and greater levels of productivity. The VITROS 350 System software will support the VITROS Chemistry Products dHDL Slides. This no-pretreatment, direct HDL method is currently under development.

Although the system is still in development, the VITROS 350 will continue to provide the same benefits as the VITROS system, which includes lower hands-on labor costs while improving efficiency.

Contact: Ortho-Clinical Diagnostics; www.orthoclinical.com