Technology Holds Promise for Early Detection of Breast Cancer
Power3 Medical and the University of Texas MD Anderson Cancer Center were recently granted exclusive rights to the patents and technologies of their NAF test for early detection of breast cancer.

 The technology developed by the two organizations provides detection, diagnosis, and monitoring of breast cancer through proteomic analysis of nipple aspirate fluids. The fluid, obtained through a noninvasive procedure utilizing a modified breast pump, is collected from the breast duct region where most breast cancers originate. When analyzed by Power3 Medical’s methodology and technology, the proteins in the fluid reveal specific disease protein footprints.

 “We have identified 130 protein biomarkers that we believe not only provide for the early detection of breast cancer, but reveal the blueprint for how cancer develops,” says Ira Goldknopf, PhD, chief scientific officer of Power3 Medical. “This technology holds great promise for commercialization in large markets with the potential to achieve an earlier and more accurate diagnosis of breast cancer and ultimately identify specific drug targets for earlier treatment.”

Contact: Power3 Medical Products Inc (212) 752-9445;

People’s Republic of China Signs Pact to Help Control Spread of HIV/AIDS
In an important step to help combat the spread of HIV/AIDS in China, the People’s Republic of China’s Ministry of Health has signed an agreement with the Safe Blood International Foundation™. The organization provides safe blood to developing countries to help stop the spread of HIV/AIDS and other blood-borne diseases.

nd03.jpg (5207 bytes)Under the terms of the pact, the Ministry of Health of the People’s Republic of China and Safe Blood International Foundation will establish the Safe Blood for China Foundation. Under the guidance of the Ministry of Health, the partnership’s goals include reducing the spread of HIV/AIDS through blood transfusions by changing how blood is donated. The foundation also will revamp blood-bank and hospital transfusion software and increase the supply of safe blood throughout China by eliminating contaminated blood through improved testing and quality control.

“We are pleased to partner with Safe Blood International Foundation in order to further advance our national program to fight the spread of AIDS throughout the People’s Republic of China,” says Wenhan Bi, MD, a representative of the Ministry of Health of China. “We have chosen Safe Blood International Foundation because of its proven safe blood strategies throughout the world and its understanding of our culture and our people.”

The Safe Blood for China Foundation will manage safe blood development projects, implement proposals for blood-bank renovation and staff training, and coordinate other programs, including relevant information technology for the People’s Republic of China.

“Safe Blood International Foundation is ready to implement its safe blood program throughout China,” says Jeffrey Busch, chairman and founder of Safe Blood International Foundation. “Professional staff will be recruited from within China and around the world to provide human resources and high-quality blood safeguard programs to help fight the spread of HIV/AIDS and other blood-borne diseases through blood donation and blood transfusion.”

nd04.jpg (10250 bytes)The Safe Blood for China Foundation will be headquartered in Beijing, with offices in Washington, DC. The Washington office will be responsible for fund-raising, accounting, and meeting reporting requirements of various funding agencies and foundations. The Beijing office will provide management of the safe blood development projects, prepare proposals for blood bank renovation, train staff, and coordinate the implementation of the safe blood program.

Contact: Safe Blood International Foundation (202) 204-2570;

Clinical Trial Begins for West Nile Virus Blood-Screening Assay
Since the start of this year’s mosquito season, ongoing screening of the US blood supply using the West Nile virus blood-screening assay, Procleix®, has detected 20 infected donations. The assay, labeled specifically for investigational use only has prevented the transfusion of virally contaminated blood to as many as 60 blood recipients. Based on these proven benefits, Gen-Probe and Chiron, the two companies responsible for the development of the assay, have officially begun the clinical trial of Procleix.

nd05.jpg (18667 bytes)“West Nile virus continues to increase as a health concern as the virus spreads across the United States,” says Andrew Heaton, MD, vice president and chief medical officer, Chiron Blood Testing. “Chiron is committed to increasing the safety of the blood supply, and we are hopeful that the Procleix assay will be an important advance in addressing this new health threat.”

Both Gen-Probe and Chiron are confident about the successful outcome of the clinical trials. The pivotal clinical trial, which is being conducted at five US blood centers, will evaluate the Procleix assay’s sensitivity, specificity, and reproducibility on the semiautomated instrumentation platform called eSAS. Blood will be tested in pools of 16 and individually in the trial, which is expected to last approximately 4 months.

Gen-Probe and Chiron began the IND testing of the Procleix assay in August on the fully automated, high-throughput TIGRIS® amplified nucleic acid testing (NAT) instrument. The TIGRIS system is expected to increase the efficiency of testing individual blood donations. Testing individual donations enables more sensitive detection of West Nile virus, which is often present only in small numbers in blood.

“Beginning the trial on schedule and in time for the peak mosquito season is another important milestone in what has been a remarkably rapid development program to address an emergent health care concern,” says Jim Godsey, PhD, Gen-Probe’s executive vice president of development. “We remain on track with plans to file a biologics license application, or BLA, to commercialize the West Nile virus assay in the first quarter of 2005.”

Contact: Gen-Probe (800) 523-5001;

nd06.jpg (11672 bytes)Millipore Water-Purification Systems Receives UL Marking for Safety
Millipore’s Synergy® and Synergy 185 water-purification systems are now listed by Underwriters Laboratories Inc (UL) for meeting UL and c-UL (Canadian) mechanical and electrical safety criteria. UL is an independent, not-for-profit product testing and certification organization that provides facilities, such as medical, academia, and government laboratories, with information on UL and c-UL listings for product safety.

According to UL, Millipore’s Synergy water-purification systems meet the specific requirement of the Laboratory Electrical Instruments category (UL61010-1). To ensure compliance with all UL and c-UL rules, UL audits are conducted regularly. A wide range of Millipore’s water-purification systems have already received the UL and c-UL registration mark, including the Milli-Q®, Direct-Q®, Elix®, RiOs™ and Simplicity units.

Millipore provides European Conformity, UL, and c-UL marked water-purification systems with the scientific and engineering expertise and professional support for installation, validation, and maintenance of water purification systems.

Contact: Millipore Tech Service (978) 715-4321;

ChildLab Reference Laboratory Selects Atlas LabWorks

Atlas Medical Software recently announced that ChildLab®, a pediatric and specialty reference laboratory for children, has selected the Atlas LabWorks™ outreach product for use in the ChildLab facility.

Located in Columbus, Ohio, the specialty outreach lab offers more than 1,000 different clinical lab and surgical pathology pediatric tests in Ohio and surrounding states. ChildLab’s tests and processes are designed for the special needs of children, including the use of capillary punctures instead of venipunctures and the importance of reporting results with age-adjusted references for appropriate interpretation.

“We’d been looking for an outreach system for about a year and a half,” says Cheryl Hamon, reference laboratory manager at ChildLab. “We serve a wide outreach area and we needed a system that could provide connectivity to our doctors and hospitals in this large region. LabWorks has been able to provide this connectivity for us.”

According to Renee Cuevas, reference laboratory coordinator at ChildLab, the lab also needed a flexible system that could be modified for its pediatric patients. “Some modifications were significant, such as changing the date of birth to days instead of years and reference ranges in days instead of months,” says Cuevas. “Others, including adjusting the size of specimen labels to fit the smaller containers needed for a child’s test volume, were small, but important. Another important factor in our selection process was that LabWorks integrated with our Web site extremely well.”

Atlas LabWorks is a lab order entry and result reporting solution for outreach laboratories. The system is part of Atlas’ Total Outreach Management solution, which is designed to enhance service requests to physician clients.

Contact: Atlas Medical Software
(818) 224-6238;

Southwestern Medical Solutions to Incorporate Non-Invasive AD Test
According to Southwestern Medical Solutions, some 4 million Americans suffer from Alzheimer’s disease (AD), an incurable and fatal neurological disease common among the elderly. The current diagnosis procedures are invasive, painful, and expensive—causing additional stress to family members of diagnosed patients.

nd07.jpg (8887 bytes)Southwestern Medical Solutions has recently added the urine test for early, noninvasive detection of AD to its Labguard Accucheck™ technology. Labguard Accucheck is an on-site collection and diagnostic testing technology that addresses inefficiencies and unwarranted risks associated with procedures and devices now in use.

Until the development of the urine test, detection and diagnosis of probable AD involved a spinal tap to collect cerebrospinal fluid for analysis of beta amyloid precursor and tau proteins (Tau/AB42 test).

The urine test analyzes a first-morning urine sample for levels of a brain protein called neural thread protein. By helping to identify AD early, Southwest Medical Solutions predicts that the test will allow patients to receive available therapies when they can be most effective—before irreversible damage occurs. The company’s Alzheimer’s test will be most useful as a confirmatory test, used in conjunction with other relevant medical data and physicians’ clinical assessment of patients’ symptoms. Researchers also predict that using a simple urine test will help to identify those who are at increased risk for AD.

Contact: Southwest Medical
Solutions Inc (877) 576-0936;

Ventana and Quantum Dot Announce Agreement
Ventana Medical Systems Inc and Quantum Dot Corp have announced a comprehensive licensing and supply agreement relating to QDC’s Qdot® nanocrystal technology for in vitro diagnostic applications in anatomic pathology and cytology. Ventana also will incorporate QDC technology in its research and pharmaceutical discovery platforms.

nd08.jpg (5385 bytes)Under the terms of the agreement, QDC will supply Qdot nanocrystals for Ventana’s incorporation into next-generation rapid, quantitative, and multiplexed assays for cancer diagnosis and disease management.

“The choice of our Qdot nanocrystals for Ventana’s expansion into fluorescent in vitro diagnostics continues to validate the value of our technology,” says George Dunbar, chief executive officer of QDC. “Leveraging Ventana’s development expertise and worldwide sales and distribution capabilities is an effective way to provide Qdot nanocrystal products to anatomic pathology customers. This is a good model for future field-defined partnerships for our company.”

Contact: Ventana Medical Systems Inc (800) 277-2155;

ECRI Annual Conference to Examine Overweight and Obesity Treatments
In 2003, the Centers for Disease Control and Prevention declared obesity the most important public health issue in the United States. According to the organization, the condition is linked to an increased risk of death from cardiovascular disease, diabetes, and a variety of cancers. Two thirds of Americans are overweight, and half of those categorized as overweight are obese.
ECRI’s 12th Annual Conference on research evidence, health policy, law, and regulation is scheduled for October 27–28 in Plymouth, Pa. It will explore what is and is not known about the effectiveness of a broad range of prevention and treatment strategies and technologies for overweight and obesity.

The conference theme, “Preventing and Treating Overweight and Obesity: How Effective are the Interventions?” will broaden understanding of the available clinical evidence on the effectiveness of prevention and treatment strategies, and help professionals make better decisions for care.

“There is so much information about overweight and obesity, but not much guidance on what to do about it,” says Jeffrey Lerner, PhD, president and CEO of ECRI. “This conference addresses critical issues, and will focus on finding out which programs and strategies work to prevent overweight, and how the clinical community can effectively treat obesity and morbid obesity to reduce the known risk it brings for serious disease.”

ECRI’s 2004 conference will consist of three main sessions. The first session, “Primary Prevention and Population-based Treatment Strategies,” will examine the available clinical evidence on interventions to prevent and treat overweight and obesity in people without a diagnosis of any chronic disease.

“Testing Obesity and Morbid Obesity,” the second session, will focus on the relative effectiveness of behavioral, pharmaceutical, and surgical treatment programs currently reimbursed by public and private payors. Speakers will discuss key operational consideration and patient-safety issues regarding the delivery of bariatric services.

The third session, “Using the Policy Tools of Laws and Regulation,” will look at the leading state initiatives being developed through Medicaid programs and health departments. The session also addresses the regulation of claims made by manufacturers of prescription drugs, dietary supplements, and medical devices.

Contact: ECRI;

Collaboration Provides On-Site Blood Coagulation Monitoring
HemoSense has entered into a 3-year agreement with Genesis HealthCare Corp to use HemoSense’s INRatio® Prothrombin Time (PT) Monitoring System in Genesis HealthCare’s nursing centers. The portable INRatio will be used to monitor PT for appropriate anticoagulation therapy patients who are taking the blood-thinning drug Coumadin®.

The INRatio System, representing the latest in patented clot detection technologies, is the most recent entry in the handheld PT monitoring device market. Genesis selected INRatio for its ease of use, laboratory-like accuracy, and innovative onboard quality controls, which ensure the reliability of every test in real time. In the home care market, anticoagulation patients typically have venous blood drawn and sent to a lab for analysis, but this can take days, complicating the management of Coumadin patients. The INRatio system provides PT results in less than 2 minutes using one drop of fresh whole blood from a finger stick. The test method will allow caregivers to make immediate medication dosage changes—an important component of effective anticoagulation therapy.

Contact: HemoSense (877) 436-6444;

Global Med Technologies Training Classes Now PACE Approved
Wyndgate Technologies‚ a division of Global Med Technologies Inc, will offer professional acknowledgment for continuing education (PACE) credits during its training classes for both SafeTrace‚ and SafeTrace Tx®. PACE is offered by the American Society for Clinical Laboratory Science (ASCLS), a preeminent organization for clinical laboratory science practitioners. PACE continuing education contact hours satisfy continuing education requirements for federal, state licensure, local (employer), and regulatory agency recertification.

Wyndgate received approval to offer PACE credits for all of its training classes for the SafeTrace donor management system and the SafeTrace Tx advanced transfusion management system. Additionally, Wyndgate has received approval to offer PACE credits for its customized report writing class and its program on validation of blood bank systems. These classes also have been approved for both California and Florida laboratory scientists and personnel through the PACE program at no additional charge.

“We’re excited about our ability to offer PACE credits during our SafeTrace and SafeTrace Tx system training classes,” says Tom Marcinek, president and COO of Global Med Technologies. He adds that customers will have the added benefit of receiving continuing education credits for attending these sessions, and the company will continue to add to its list of PACE-approved classes as it develops new programs to meet customer needs

Contact: Global Med Technologies (303) 238-2000;

Stand Up For Patient Safety Campaign Welcomes Newest Member
The National Patient Safety Foundation (NPSF) recently announced that Miami Valley Hospital has joined its efforts to improve patient safety.

The Stand Up for Patient Safety campaign, sponsored by the NPSF, brings together leading hospitals and health systems committed to developing a hospital-driven, patient-focused safety agenda.

When the NPSF launched the campaign in 2002, it had 17 founding members to offer hospitals and health systems a meaningful way to participate in the national patient safety movement. Today, the campaign includes more than 168 hospitals and health systems.

“The campaign is driven by its members whose needs define the program offerings,” says Diane Pinakiewicz, interim executive director of the NPSF. “Supported by the resources and expertise of the NPSF, the program provides educational tools and programs, conferences on safety topics, forums for sharing best practices, and materials for internal and external communication.”

The decision to include Miami Valley Hospital in the campaign’s efforts was an easy one. According to the NPSF, Miami Valley has a proactive approach to patient safety that not only encompasses internal hospital committees, but includes enthusiastic participation in an international patient safety collaborative sponsored by the Institute for Healthcare Improvement in Boston.

“Facilities such as Miami Valley benefit Stand Up because of their leadership on patient safety and leadership in the community,” adds Pinakiewicz. “Stand Up has grown from a campaign to a national program, which includes many educational initiatives, provides tools to keep issues front and center, and increases the emphasis on patient safety in hospitals and health systems because of the participation from members such as Miami Valley Hospital. We are very excited to have them join in on our efforts.”

Contact: National Patient Safety Foundation (703) 506-3280;

Cedars-Sinai Installs Equipment to Improve Safety of Blood Products
Isensix Inc recently announced the expansion of its Advanced Remote Monitoring System™ (ARMS) at Cedars-Sinai Medical Center’s Department of Pathology. The system is being utilized in the facility’s medical center in the microbiology laboratory, the core laboratory, the special testing laboratory, and in laboratory support services.

According to Isensix, the ARMS system is designed to improve the safety of stored blood products, reagents, and clinical samples, and to simplify compliance by making record keeping and documentation of corrective actions easier. The system continuously monitors key environmental parameters such as temperature, humidity, and CO2, along with door alarms and thermocycler applications.

ARMS supports visual and audible alarms with notifications by email, pager, and mobile text. Alarm escalation features are built in to the system so that management is informed if problems persist. ARMS is scalable, enabling one system to monitor hundreds of sensors at multiple geographic locations.

“We are proud to have a prestigious healthcare provider such as Cedars-Sinai Medical Center confirm the value of the ARMS™ system,” says William Son, president of Isensix. “We value our partnership and look forward to working with them on future safety and quality enhancements.”

The ARMS system has also been installed in several other facilities, including Children’s Hospital San Diego, the National Genetics Institute in Los Angeles, and UCLA Medical Center.

Contact: Isensix Inc (866) 634-2767;

GE Healthcare Speeds Assay Development
GE Healthcare, a combination of the former Amersham and GE Medical Systems, will address bottlenecks in the drug discovery process with the introduction of a range of pre-developed protocols for G-protein-coupled receptors (GPCR) membranes.

According to sources with GE, assays for GPCRs are extremely important in the drug discovery process because they are involved in receptor activation. GPCRs account for approximately 30% of all targets studied in high throughput screening. The latest estimates suggest that the 80 launched drugs that target GPCRs generate $60 billion in annual sales. GPCRs are involved in screening for such factors as allergy, cardiovascular, depression, obesity, cancer, and pain.

The pre-validated protocols offered by GE Healthcare provide substantial time-savings of as many as 15 days during the GPCR assay development stage. The new scintillation proximity assay (SPA) GPCR assays offer researchers working in high throughput screening environments pre-developed assay conditions for GPCR receptor-ligand binding studies.

“GE Healthcare is continually working to help cut development time throughout the drug discovery process,” says John Sutton, vice president product management, cell analysis and screening at GE Healthcare. “This is the first time that SPA GPCR protocols have been available in this way. By providing ready-made optimum assay conditions for GPCR ligand binding studies, GE Healthcare is reducing assay development process time for researchers, therefore enabling them to focus on screening potential drug candidates.”

Contact: GE Healthcare (732) 457-8000;

E-Learning Creates Better Lab Partners
Knowledge Anywhere has developed a technology-based learning system to help improve sales productivity among companies in the field of clinical diagnostics. The company’s e-learning is an emerging training tool designed to improve sales productivity, cut company training expenses, and fit efficiently into the modus operandi of most salespeople.

The e-learning program familiarizes new hires and updates existing sales forces using Web-based learning programs. The company’s courseware provides sales teams with the tools to better understand the lab environment and its inner workings. It is designed to help alleviate the potential pitfalls of asking naïve (and potentially deal-breaking) questions, and to reduce misunderstandings about a lab’s needs, and attempts to sell through a product that isn’t relevant.

The uniquely designed courses provide a more in-depth look at each department within a lab, an overview of the roles and responsibilities of functional areas of the lab, and an explanation of the focus, volume of work, and key drivers for the lab’s smooth operation. Additionally, the online programs, which can be self-paced or executed Web conference-style for immediate needs, reinforce the need for taking the course and becoming grounded in the dynamics and inner-workings of specific laboratory departments, to significantly increase sales productivity.

Contact: Knowledge Anywhere (800) 850-2025;