nd01.jpg (7718 bytes)NHLBI funds centers for reducing asthma disparities
The National Heart, Lung, and Blood Institute (NHLBI) has created a new program to accelerate research aimed at understanding why certain racial, ethnic, and socioeconomic groups are more severely affected by asthma than other populations and at determining ways to close the gaps in prevalence and treatment of this common chronic disease. The research — and related training activities — will be conducted through five newly established Centers for Reducing Asthma Disparities.

The NHLBI initiative addresses the need to identify the factors that contribute to substantially higher rates of emergency room visits, hospital admissions, and deaths due to asthma among certain populations. African Americans, for example, have a slightly higher asthma prevalence rate than Caucasians (8.5 percent versus 7.1 percent), yet they are three times more likely to be hospitalized or to die from asthma complications, according to the Centers for Disease Control and Prevention. Hispanics and families with low income are also at increased risk.

Scientists at the five new Centers will examine a range of research topics focusing on the differences in asthma prevalence, emergency department use, hospitalizations, and deaths between the ethnic and racial groups, and between low-income populations and their more affluent counterparts. Research projects will evaluate the role of psychosocial factors in disparities in asthma care over time, differences in symptom perception among racial and ethnic groups and how these differences affect patients’ patterns for seeking care, and ways to improve communications between patients and their doctors about asthma treatment. Other studies will focus on the biological and genetic mechanisms involved in asthma disparities, such as ethnic variations in sensitivity to environmental allergens and the interrelationship between genetic susceptibility and stress, smoking, and exposure to diesel exhaust in provoking asthma symptoms.

Further information is available at http://www.nhlbi.nih.gov.

NHLBI launches innovative new proteomics centers
The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, has launched a major initiative to develop innovative proteomic technologies by creating 10 special centers of research, each funded for 7 years. Ultimately, the research is expected to yield new and improved ways to diagnose and treat heart, lung, blood, and sleep disorders.

“These awards take an important step beyond the science of gene research, which has accelerated in recent years and continues to make a huge impact on biomedical research,” said NHLBI Director Dr. Claude Lenfant. “However, research at the level of the gene cannot provide a full picture of what’s going on within a cell. These state-of-the-art centers will help supply that missing information and so advance biomedical research and clinical care.”

“NHLBI also plans to promote proteomic research by making products gained at the centers readily available to other scientists. These products include reagents, techniques, and basic information,” said Dr. Susan Old, NHLBI proteomic program administrator. “This should speed the delivery of potential new clinical applications from research into practice.”

The 10 new NHLBI Proteomics Centers cover topics that include cardiovascular disease, cystic fibrosis, autoimmune disease, asthma and allergies, ischemia and hypoxia.

Further information is available at http://www.nhlbi.nih.gov.

West Nile paralysis is difficult for physicians to diagnose without signs of infection
Paralysis due to West Nile virus is not always accompanied by signs of infection, according to a report presented at the American Neurological Association’s annual meeting, October 13 to 16 in New York City.

Recent reports have described limb paralysis or a “polio-like” condition due to West Nile virus infection in otherwise healthy adults. These patients all had obvious symptoms of infection — such as fevers, headaches, vomiting, or confusion — before limb weakness began to set in. However, researchers in Michigan now report that doctors need to be alert to cases of sudden paralysis that are not preceded by obvious signs of infection.

“I wouldn’t want to alarm the public unnecessarily, particularly since there is little that they can do except avoid mosquito bites. However, I think it is important for people to realize that the infection is not confined to the elderly or immunosuppressed, although it may take a different form in younger people,” said lead author Richard A. Lewis, M.D., a specialist in neuromuscular disorders at Wayne State University in Detroit, Michigan.

The report is intended to make physicians, particularly neurologists, emergency physicians, family physicians and internists, aware of the unusual way these patients may manifest this viral disease, said Lewis.

Officials in Michigan have confirmed more than 400 infections by West Nile virus, and more than 20 deaths. There are probably many more, but the state health department has had difficulty keeping up with the number of samples sent in for study.

Since August, neurologists at Wayne State have encountered patients who eventually tested positive for West Nile virus, but first over a period of hours had become paralyzed in one or two limbs, without pain, fever, or numbness. Some of these patients were not confused and had no signs of a brain infection (encephalitis), although they all had experienced some mild flu-like symptoms a week before their paralysis.

Rapid diagnostic equipment is tested to identify meningitis and whooping cough
Instead of waiting five to seven days to find out if a child brought to the emergency room tests positive for meningitis or whooping cough, new rapid diagnostic testing equipment will provide doctors at UT Southwestern Medical Center at Dallas and Children’s Medical Center of Dallas with an answer in a few hours.

A one-year, $435,000 grant from the Centers for Disease Control and Prevention to Children’s will allow UT Southwestern researchers to develop protocols, procedures and reagents using a thermocycler called GeneXpert. The automated device, which rapidly processes and analyzes DNA samples, is manufactured by Cepheid of Sunnyvale, Calif.

With the new equipment, doctors will be able to quickly diagnose infectious diseases in children brought to the emergency room. Results would be available within hours rather than the five to seven days needed for a culture.

“With the capability of rapid turnaround and ease of DNA testing, the tests could be done seven days a week, 24 hours a day, and even at the patient’s bedside,” said Dr. Beverly Rogers, professor of pathology at UT Southwestern and chief of pathology at Children’s. “This is not possible with current methods.

“This provides high-tech testing capabilities. This instrument allows a health-care worker to take a swab from a patient, dip it in solution, place it in the instrument and walk away. This is bringing molecular diagnoses into the clinical laboratory.”

The new testing methods should allow children to leave the hospital sooner, or even avoid hospitalization altogether, Rogers said.

Research will focus on developing rapid testing for enterovirus and herpes simplex virus, both of which cause meningitis, and Bordetella pertussis, the bacterium that causes whooping cough.

Igen test for blood clots will be tested in multi-center clinical trial in the U.S. and Canada
Igen International of Gaithersburg, Md., has announced that its proprietary test for the diagnosis of venous thromboembolic (VTE) disease will be used in an ongoing multi-center clinical trial sponsored by Canadian Institutes of Health Research (CIHR). The study will test for the presence of urinary fibrinopeptide B (FPB) as a marker for active VTE — which encompasses such conditions as deep vein thrombosis and pulmonary embolism — and can be used to monitor the effectiveness of anti-coagulant therapy. Preliminary studies and data have confirmed that urine FPB levels can be used to screen patients with suspected VTE and to monitor patients following treatment.

Data is available on microinvasive glucose measurement technology
MicroSense International of St. Louis, Mo., presented data on its Pushita glucose measurement technology at the second annual Diabetes Technology meeting held on October 30, 2002 in Atlanta, Ga. MicroSense has recently concluded Phase I clinical trials, and compares performance data for Pushita with existing glucose detection and measurement devices currently on the market.

According to MicroSense, the new technology is both bloodless and painless and does not require the lancing of the finger. By measuring the interstitial fluid at the forefinger, Pushita is intended to address reported glucose measurement deficiencies in currently available glucose meters, which rely on measurements from sites other than the forefinger, commonly called “alternate sites.”

 New 20-minute HIV test nears FDA approval
Amid differences in perspective on whether CLIA “waived” status should be granted (see Editor’s Notebook, page 6), two new rapid HIV tests are nearing FDA approval. The tests that have received notice from the FDA that they are “approvable” are the Oraquick HIV-1 Antibody test from OraSure Technologies of Bethlehem, Pa., and the Reveal HIV test from MedMira Laboratories of Toronto, Ontario, Canada. The rapid tests yield results in only twenty minutes.

Supporters of waived status include President Bush’s Advisory Council on HIV/AIDS (PACHA), The Congressional Black Caucus (CBC), and nearly 100 HIV/AIDS organizations.

“The potential for saving lives by using this technology, we think, is revolutionary,” said Clint Trout, associate director for federal government affairs at AIDS Healthcare Foundation, the nation’s largest AIDS organization. “We think that the rapid test could be for prevention what protease inhibitors have been for treatment,” he added. “The elimination of the week long waiting period (for results) will be the elimination of significant barriers to testing for many high-risk individuals.”

Opponents, including the American Society for Microbiology (ASM) and the American Association for Clinical Chemistry (AACC), claim that the higher level of federal oversight with a “moderately complex” status under CLIA is necessary to ensure the tests are performed accurately, while supporters point out that every state already has testing and counseling networks that are supervised by the states, and argue that only if the tests are widely available to family doctors, emergency rooms, and public health testing and counseling programs can they be of use in curtailing the spread of the epidemic. Currently, it is estimated that nearly 300,000 HIV positive individuals in the United States are unaware of their status.

Known mutations are missing from CF gene in some cases of Cystic Fibrosis
A study presented at the annual meeting of the American Society for Human Genetics by researchers from Johns Hopkins in Baltimore, Md. finds that some patients diagnosed with cystic fibrosis (CF) lack any of the more than 1,000 reported disease-causing mutations in the only known CF gene. The discovery may mean that another gene, as yet unidentified, is to blame for these cases, or perhaps these patients really have another, unknown disease, despite the similarity of symptoms.

Continuous glucose monitoring system is planned for launch overseas in Q3 2003
Roche Diagnostics of Mannheim, Germany, is designing technology to offer people with diabetes a less painful method of monitoring glucose levels from the interstitial fluid of the subcutaneous fatty tissue in the abdomen.

“Each and every person with diabetes has different needs,” said Karsten Jungheim, MD, German Diabetes Institute, Germany. “To identify and meet those needs, I am collaborating with Roche Diagnostics to develop Continuous Glucose Monitoring systems that will allow tighter control of blood glucose levels, improve therapy and outcomes and reduce the potential for complications associated with diabetes.”

“I share Roche’s vision that all people with diabetes on insulin ultimately will be able to benefit from Continuous Glucose Monitoring,” added Tim Heise, MD, Profil, Institute for Metabolic Research, Germany.

Continuous Glucose Monitoring is a step toward the development of an Automated Pancreas, which Roche Diagnostics plans to bring to market. The Automated Pancreas will include a Continuous Glucose Monitor, along with an insulin pump and an algorithm to ensure that the system doses insulin correctly.

Roche Diagnostics’ first-generation Continuous Glucose Monitoring system, the Accu-Chek Monitor, is anticipated for launch in Germany in Q3 2003, followed by other European markets. The Accu-Chek Monitor uses microdialysis to obtain glucose readings from interstitial fluid of the subcutaneous fatty tissue in the abdomen.

The Accu-Chek Monitor provides glucose readings every five minutes for up to four days, which currently is the longest monitoring capability on the market. Readings from this system need to be calibrated to glucose readings from fingertip blood just once every 24 hours and can be read out with a PC during the application as well as at the end. The calibration aligns readings to corresponding blood glucose values and compensates for about 30 minutes physical lag time of the system. The Accu-Chek Monitor can be set to alert users when they move towards becoming hypoglycemic.

The Accu-Chek Monitor will be available through and administered by healthcare professionals only. Because it provides continuous measurements, Roche Diagnostics will make the Accu-Chek Monitor available for research into diabetes.

New coagulation test for use in open-heart surgery pending at FDA
i-STAT Corporation of East Windsor, N.J., has submitted a 510(k) filing for a new cartridge to be used with the i-STAT handheld analyzer for monitoring the coagulation status of blood that is being sent through a heart-lung machine during open-heart surgery. The company anticipates that its kaolin-based activated clotting time (kaolinACT) test will be available in the first quarter of 2003. The company’s celiteACT test, already in commercial distribution, is also used for monitoring coagulation during open-heart surgery.

“The addition of kaolin ACT testing continues to demonstrate our commitment to expanding the range of tests performed on the i-STAT System,” said William P. Moffitt, president and chief executive officer of i-STAT Corporation. “Enabling our customers to consolidate a broad range of point of care tests on our handheld platform provides unique value for them and significant competitive advantage for us.”