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The following is a review of diagnostics related medical research worldwide

The information is updated the first week of every month - so ... make this a regular stop in your information gathering activities.

The following information has been compiled from publicly available sources, StratCom does not assume any responsibility for the accuracy or the authenticity of the information and StratCom cannot be held liable for errors.

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Research News for October 1996

Research presented in Stroke 1996;27:1719-1733 performed by Dr. Mathieu Zuber of the Hopital Sainte-Anne in Paris has shown that resistance to activated protein C due to a mutation in coagulation factor V, known as factor V Leiden mutation, is an important risk factor for venous thrombosis. A case-control study of 19 patients with cerebral venous thrombosis and 57 healthy control subjects showed the mutation was found in a heterozygous form in 4 of the 19 patients with [cerebral venous thrombosis] (21%) and in only 1 of the 57 control subjects (2%)...In 3 of the 4 patients positive for the mutation, [cerebral venous thrombosis] developed in the presence of an acquired prothrombotic state, including oral contraceptive use in 2 patients and puerperium in the third. The research concluded Factor V Leiden mutation is a risk factor for cerebral venous thrombosis and may be the most common inherited coagulation defect associated with this condition.

According to Dr. Jonathan Braun of UCLA, data obtained from the Multicenter AIDS Cohort Study, has shown that individuals with high levels of the preimmune anti-gp 120 IgG antibody appear to be more resistant to sexually transmitted HIV infection than individuals with low levels of this antibody. HIV-1 gp 120 is an immunoglobulin superantigen that binds to preimmune serum immunoglobulin. Individuals with high levels of preimmune anti-gp 120 IgG were more resistant to HIV infection compared with those with low levels of this antibody. A fivefold difference in HIV susceptibility based on levels of preimmune anti-gp 120 IgG.

Findings, published in the New England Journal of Medicine, Oct 16, indicated the same process of cell suicide that builds and remodels tissues in the womb may be slowly destroying heart muscle in people with some types of heart disease and might eventually lead to ways for doctors to counteract the deterioration of heart failure.

A report in Diabetes 1996;45:1193-1196 demonstrated, the presence of autoantibodies against the newly characterized GM2-1 pancreatic islet ganglioside identifies patients with markedly increased diabetes risk. In a prospective study, the researchers compared 24 newly diagnosed type I diabetic subjects, 20 islet-cell autoantibody-negative first-degree relatives of type I diabetics and 25 age-matched healthy controls. In addition, they followed 31 islet-cell autoantibody-positive first-degree relatives of type I diabetic subjects, 14 of whom developed diabetes themselves over 10 years. Anti-GM2-1 autoantibodies were expressed in a high percentage of newly-diagnosed type I diabetic subjects (71%), while no significant difference was found in the expression of antibodies directed against other pancreatic gangliosides (GM3, GD3, GD1a) among the different groups studied. Anti-GM2-1 autoantibodies were also present in [islet-cell autoantibody-positive] relatives (64%) even before the onset of symptoms and was strongly correlated with progression to disease. In fact, autoimmunity to GM2-1 was documented in all such subjects within five years before developing diabetes. Hence, this the GM2-1 autoantibody may identify a cohort of islet-cell autoantibody-positive individuals who are at high risk for diabetes.

The use of filtered blood, according to a study in the September 28 issue of The Lancet, significantly reduces post-transfusion infections in colorectal surgical patients. The study recommends routine use of filtration for leukocyte reduction of blood for all colorectal surgical patients. Other clinical studies suggest leukocyte reduction may also benefit all of the surgical patients. The presence of contaminating donor white cells in transfused blood have been linked to post-surgical infections.

A promising new type of artificial hemoglobin has been developed by scientists from the University of Tokyo, working under the PRESTO 21 research program of the Japan Science and Technology Corporation. The new artificial hemoglobin is made by placing porphyrin at the center of a dendritic polymer, or "dendrimer." A dendrimer is formed when a number of polymer chains grow off from a core molecule and branch so many times that the resulting compound is a tight ball, with numerous chain ends. When this dendrimer-porphyrin compound is put in an organic solvent and oxygen is bubbled through the solution, the compound acts like hemoglobin, grabbing oxygen when it is present in high concentrations and releasing it when the concentration is low. Porphyrin alone does not work well in the body because it tends to bind together or react with water, losing its activity. And past efforts to develop artificial hemoglobin by wrapping porphyrin in a surfactant have failed because the complex tends to break down in the body. In contrast, the dendrimer-porphyrin compound is very stable, as the porphyrin forms atomic-level bonds with the dendrimer, the group explained.

A study published in the American Journal of Respiratory Critical Care Medicine 1996 and performed by Dr. Marin H. Kollef, Washington University School of Medicine, has shown that the measurement of endotoxin levels in bronchoalveolar lavage (BAL) fluid may be a better diagnostic test than Gram stain examination for the diagnosis of gram-negative pneumonia. Measurement of endotoxin levels allows for a more rapid diagnosis of gram-negative pneumonia compared with standard culture techniques. Since early detection could allow for earlier administration of antimicrobial treatment they investigated the sensitivity and specificity of endotoxin levels in the detection of the responsible pathogens. A cutoff value of greater than 5 endotoxin units/ml for the concentration of endotoxin in BAL fluid yielded a diagnostic sensitivity of 100%, whereas Gram staining diagnosed only 63.2% of gram-negative pneumonia cases. Dr. Kollef proposes that the use of endotoxin concentrations in BAL fluid in the diagnosis of gram-negative pneumonia could reduce both disease-related mortality and the generation of multiresistant organisms.

Medical Device Technologies Inc.'s study, San Diego, confirms passage of bacteria and viruses through surgical latex gloves. The company's studies, conducted at an independent testing laboratory as well as at a major university, show that latex gloves exposed to fluid and mechanical stress similar to conditions encountered in surgery allowed the passage of viruses and bacteria in 10-30 percent of the latex gloves tested within a one-hour testing period. Gloves that are permeable to microorganisms expose patients and health-care professionals to potential infectious diseases, including HIV and Hepatitis B and C. The report concludes, with the adoption of a continuous latex glove monitoring system, used in conjunction with a glove-changing protocol, latex gloves can be made a more effective infection barrier.

The American Society of Clinical Oncology (ASCO) has developed clinical practice guidelines for the use of tumor marker tests in the prevention, screening, treatment, and surveillance of breast and colorectal cancers. The Society notes, in a special article in the October, Journal of Clinical Oncology, that the guidelines are intended for use in caring for patients not enrolled in a clinical trial. For colorectal cancer, ASCO recommends carcinogenic embryonic antigen (CEA) levels be measured preoperatively only if it would change surgical management. They also suggest monitoring CEA levels every 2-3 months for 2 years or more. ASCO says existing data are insufficient to recommend the "...routine use of lipid-associated sialic acid (LASA), CA 19-9, DNA index, DNA flow cytometric proliferation analysis, p53 tumor suppressor gene, and ras oncogene.

For breast cancer, ASCO recommends measuring estrogen receptors and progesterone receptors on every primary specimen, but on subsequent specimens only if it would lead to a change in management. Data are insufficient to recommend the routine use of DNA index [and] DNA flow cytometric proliferation analysis, as well as CA 15-3, CEA, c-erbB-2, p53 or cathepsin-D. 15-3 and CEA levels can be used to document treatment failure.

According to an article in the September 1 Family Practice News, Dr. Weisiger, University of California, San Francisco, School of Medicine, reported that hepatitis C is found in approximately 1% of volunteer blood donors, and hepatitis G is slightly more prevalent, being detected in 1.5% to 1.7% of donors. Hepatitis G virus infection is usually clinically silent and nearly always chronic. Progression to cirrhosis with chronic hepatitis G infection is probably very low, but Dr. Weisiger cautioned that nonhepatic manifestations of this virus may well exist, and we just don't now about them. Currently, the only specific test for hepatitis G is by polymerase chain reaction assay.

Israeli researchers have found a high prevalence of anticardiolipin antibodies in young patients with acute myocardial infarction. They believe that the presence of these antibodies is a marker for increased risk of reinfarction and thromboembolic events. Their report in the October issue of the American Journal of Medicine, communicated the results of a study involving 124 survivors of acute myocardial infarction, aged 65 or less. Fourteen percent of the 124 patients were anticardiolipin-antibody positive (either IgM or IgG) upon admission, compared with three percent of matched controls. During the follow-up period, the rate of thromboembolic events and myocardial reinfarction was significantly higher in the anticardiolipin-antibody positive patients as compared with the negative group.

Researchers at City of Hope National Medical Center, Duarte, CA, have found that the presence of human papilloma virus type 18 (HPV18) is an independent prognostic factor of a higher risk of disease recurrence in women with early stage cervical cancer. The study, published in the October issue of the Journal of the National Cancer Institute, found HPV DNA was detected in 85% of the 291 tumors tested -- HPV16 was detected in 52%, HPV18 in 20% and other types of HPV in 13%. Eighty-eight percent of the squamous tumors contained HPV DNA, compared with 79% of adenocarcinomas, in which the predominant type was HPV18. Women aged 45 years and younger with a history of smoking were more likely to have HPV DNA in their tumors, but the HPV type was not associated with established prognostic factors. DNA was extracted from fresh cervical tumor samples obtained between 1983 and 1993 from 291 women receiving primary treatment for all stages of cervical carcinoma. Polymerase chain reaction was used to detect and type HPV DNA in the tumor samples.

Researchers at the Scripps Research Institute, La Jolla, found new evidence for the role of autoimmune factors in chronic fatigue syndrome. A report in the October issue of the Journal of Clinical Investigation, indicated approximately 52% of chronic fatigue syndrome patients develop autoantibodies to components of the nuclear envelope. More than half of the 60 serum samples collected reacted with the nuclear antigens. The nuclear envelope-specific autoantibodies reacted predominantly with the nuclear envelope protein lamin B1. The autoantibodies were of the IgG isotype. This, conclude the researchers, provides new laboratory evidence for an autoimmune component in chronic fatigue syndrome."

UCLA researchers report, in the October issue of The Journal of Urology that polymerase chain reaction assays of prostate specific antigen offer no immediate benefit for preoperative cancer testing because of a high false-positive rate. They were studying the effectiveness of an assay they had developed. The PCR test is sensitive and specific enough to detect the presence of one prostate cancer cell in 10 cc of whole blood. But after they analyzed prostate specimens from 121 patients, they determined that circulating prostate specific membrane antigen PCR signals were identified mostly in patients with advanced prostate cancer and were not of value for preoperative staging. Further study will determine whether the UCLA assay will be useful in the prediction of patient prognosis or survival.

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* Research News - September 1996
* Research News - August 1996
* Research News - July 1996
* Research News - June 1996

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