BD Diagnostics and the College of American Pathologists (CAP) have announced the launch of a new strategic alliance that will provide solutions to advance laboratory quality for improved patient outcomes in China and India. BD and CAP announced the collaboration during the American Association for Clinical Chemistry (AACC) Annual Meeting in Houston, Texas.

Laboratories play a critical role in the diagnosis and treatment of disease for the more than 2.5 billion people who live in China and India. The BD/CAP Strategic Alliance will improve access to external quality assurance/proficiency testing (PT) that can have a direct and positive impact on laboratory quality, and therefore, patient outcomes. Together BD and CAP will provide education to improve awareness of global practice standards and training that will help laboratories achieve their quality improvement goals. Additionally, BD will manage PT distribution, including sales, shipping, and first-line client service.

“The clinical laboratory and pathology contribute more than 70 percent of the information used to determine diagnoses and drive treatment decisions,” said CAP President Stanley J. Robboy, MD, FCAP. “CAP has all of the tools necessary to help laboratories improve and monitor efforts that drive quality performance. This strategic alliance with BD will increase access to these essential resources, helping laboratories accelerate their quality improvement journey so that they can contribute to better quality care, differentiate themselves and their institutions, and be recognized globally among the best providers of laboratory and pathology services.”

CAP’s Laboratory Accreditation, Surveys, PT programmes, and other quality management resources combined with BD’s in-depth clinical knowledge of preanalytical systems provide a comprehensive, expert-based toolkit to help laboratories in China and India continuously improve the quality of the testing services they provide to patients. Through participation in CAP accreditation, laboratories in China and India can demonstrate their compliance to the most robust and comprehensive clinical laboratory testing standards in the world.
Having operated in China since 1994 and in India since 1996 supporting public and private sector partners in enhancing laboratory standards, BD has extensive experience in deploying clinical expertise and educational resources in these regions, as well as a deep understanding of the unique needs of laboratories throughout these countries. Today in China, there are 18 CAP-accredited laboratories and nearly 100 laboratories participating in PT. In India, of the 71 laboratories participating in CAP PT, 42 have achieved CAP accreditation. BD’s access and logistics experience will support CAP PT importation and ensure more timely delivery and quality, reduce participants’ administrative work, and allow billing in local currency. Market launch of this initiative will begin in China and India in August 2013 with PT distribution initiated in January 2014.

www.bd.com     www.cap.org

Researchers at Case Western Reserve University have found that a single gene poses a double threat to disease: Not only does it inhibit the growth and spread of breast tumours, but it also makes hearts healthier.

In 2012, medical school researchers discovered the suppressive effects of the gene HEXIM1 on breast cancer in mouse models. Now they have demonstrated that it also enhances the number and density of blood vessels in the heart – a sure sign of cardiac fitness.

Scientists re-expressed the HEXIM1 gene in the adult mouse heart and found that the hearts grew heavier and larger without exercise. In addition, the animals’ resting heart rates decreased. The lowered heart rate indicates improved efficiency, and is supported by their finding that transgenic hearts are pumping more blood per beat. The team also discovered that untrained transgenic mice ran twice as long as those without any genetic modification.

‘Our promising discovery reveals the potential for HEXIM1 to kill two birds with one stone – potentially circumventing heart disease as well as cancer, the country’s leading causes of death,’ said Monica Montano, PhD, associate professor of pharmacology, member of the Case Comprehensive Cancer Center, who created the mice for the heart and breast cancer research and one of the lead researchers.

Hypertension and subsequent heart failure are characterised by a mismatch between the heart muscles’ need for oxygen and nutrients and blood vessels’ inability to deliver either at the rate required. This deficit leads to an enlarged heart that, in turn, often ultimately weakens and stops. The researchers showed that increasing blood vessel growth through the artificial enhancement of HEXIM1 levels improved overall function – HEXIM1 may be a possible therapeutic target for heart disease.

The study is the sixth from the team of Dr. Montano and Michiko Watanabe, PhD, professor of paediatrics, genetics, and anatomy at Case Western Reserve School of Medicine and director of Pediatric Cardiology Fellowship Research at Rainbow Babies and Children’s Hospital.
‘Our Cleveland-based collaborative research teams revealed that increasing HEXIM1 levels brought normal functioning hearts up to an athletic level, which could perhaps stand up to the physical insults of various cardiovascular diseases,’ Watanabe said.

The results build on the team’s findings last year that showed increased levels of HEXIM1 suppressed the growth of breast cancer tumours. Using a well-known mouse model of breast cancer metastasis, researchers induced the gene’s expression by locally delivering a drug, hexamethylene-bisacetamide using an FDA-approved polymer. The strategy increased local HEXIM1 levels and inhibited the spread of breast cancer. The team is currently making a more potent version of the drug and intends to move to clinical trials within a few years. Case Western Reserve University School of Medicine

A new technology is showing promise as the basis for a much-needed home test to diagnose influenza quickly, before the window for taking antiviral drugs slams shut and sick people spread the virus to others, scientists reported here today. In a presentation at the 246th National Meeting & Exposition of the American Chemical Society (ACS), they described how it also could determine the specific strain of flu virus and help select the most effective drug for treatment.
Suri Iyer, Ph.D., explained that such a fast, inexpensive diagnostic test — similar to the quick throat swabs for strep throat and to home pregnancy tests — is especially important for flu, which causes widespread illness and an average of 36,000 deaths annually in the United States alone.

‘Just going to the doctor’s office or hospital for diagnosis can be counterproductive during a major flu outbreak,’ Iyer explained. ‘It carries the risk of spreading the disease. During the last swine flu outbreak, hospitals in some areas went on TV to tell people not come to the ER. Not only could they spread the virus, but ERs did not have the facilities to test hundreds of worried people.’

Such a test also is important because antiviral drugs can ease symptoms of the disease and enable people to recover sooner and return to school, work and other activities, Iyer added. But to be most effective, the medications must be taken within two days after symptoms first appear.

Iyer, of Georgia State University in Atlanta, and University of Cincinnati colleague Allison Weiss, Ph.D., launched research on a fundamentally new approach for diagnosing flu and other viral disease because of drawbacks with existing tests. Those tests can produce results in about 15 minutes. However, they are expensive and sometimes come up negative when the patient actually does have the flu. As a result of that uncertainty, the U.S. Centers for Disease Control and Prevention encourages doctors to confirm test results with viral culture, which takes 3 to 10 days. But waiting this long for confirmation shuts the window on antiviral treatment.

Existing flu tests use antibodies that recognise flu virus antigens, proteins on the flu virus’ surface. Iyer and Weiss took a different approach, which involves using carbohydrates to detect the antigens, and has advantages over antibody-based approaches. Flu viruses have two major antigens, haemagglutinin and neuraminidase, which determine the specific strain of flu virus. Changes in haemagglutinin and/or new combinations of haemagglutinin and neuraminidase signal the emergence of a new strain of virus. That happened in the spring of 2009, when the new ‘swine flu’ ignited concerns about a worldwide epidemic.

In the ACS presentation, Iyer explained how the new test technology uses various forms of carbohydrates that can capture the haemagglutinin and neuraminidase, and via a colour change or other signal, indicate both infection and the specific type or strain of flu virus. Information on the strain would be important, enabling doctors to pick the most effective antiviral drug. The new approach has other potential advantages, including quicker results, lower cost and greater reliability, he said.

So far, the approach is living up to expectations, with laboratory experiments verifying that it can detect flu viruses. Iyer and Weiss plan to move ahead in the autumn with tests on samples taken from human volunteers. Their vision is for a package similar to a strep throat or pregnancy test that gives an easy-to-read colour change. American Chemical Society

In a study of the co-occurrence of attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) in early school-age children (four to eight years old), researchers at the Kennedy Krieger Institute found that nearly one-third of children with ASD also have clinically significant ADHD symptoms. The study also found that children with both ASD and ADHD are significantly more impaired on measures of cognitive, social and adaptive functioning compared to children with ASD only.

Distinct from existing research, the current study offers novel insights because most of the children entered the study as infants or toddlers, well before ADHD is typically diagnosed. Previous studies on the co-occurrence of ASD and ADHD are based on patients seeking care from clinics, making them biased towards having more multi-faceted or severe impairments. By recruiting patients as infants or toddlers, the likelihood of bias in the current study is significantly reduced.

‘We are increasingly seeing that these two disorders co-occur and a greater understanding of how they relate to each other could ultimately improve outcomes and quality of life for this subset of children,’ says Dr. Rebecca Landa, senior study author and director of the Center for Autism and Related Disorders at Kennedy Krieger. ‘The recent change to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) to remove the prohibition of a dual diagnosis of autism and ADHD is an important step forward.’

Participants in this prospective, longitudinal child development study included 162 children. Researchers divided the children into ASD and Non-ASD groups. The groups were further categorized by ADHD classification according to parent-reported symptoms of ADHD on the Hyperactivity and Attention Problems subscales of the Behavioral Assessment System for Children-Second Edition, a standard assessment specifically designed to identify the core symptoms of ADHD.

Results revealed that, out of 63 children with ASD in the study, 18 (29%) were rated by their parents as having clinically significant symptoms of ADHD. Importantly, the age range for children in the study (four to eight) represented a younger and narrower sample than has been previously reported in published literature. ‘We focused on young school-aged children because the earlier we can identify this subset of children, the earlier we can design specialized interventions,’ says Dr. Landa. ‘Tailored interventions may improve their outcomes, which tend to be significantly worse than those of peers with autism only.’

Researchers also found that early school-age children with co-occurrence of ASD and ADHD were significantly more impaired than children with only ASD on measures of cognitive and social functioning, as well as in the ability to function in everyday situations. They were also more likely to have significant cognitive delays (61 versus 25 percent) and display more severe autism mannerisms, like stereotypic and repetitive behaviours. The study findings suggest that children with the combined presence of ADHD and ASD may need different treatment methods or intensities than those with ASD only in order to achieve better outcomes.

Dr. Landa and her team recognise that this research supports the need for future prospective, longitudinal studies of attention, social, communication and cognitive functioning from the time that the first red flags of ASD are identified. Such research will lead to important insights about the relative timing of onset and stability of disruption to attention mechanisms and barriers to successful functioning in children with co-occurring ASD and ADHD. Kennedy Krieger Institute

Reversing inflammation in the fluid surrounding the brain’s cortex may provide a solution to the complex riddle of Parkinson’s, according to researchers who have found a link between pro-inflammatory biomarkers and the severity of symptoms such as fatigue, depression and anxiety in patients with the chronic disease.

Lena Brundin of Michigan State University’s College of Human Medicine was part of a research team that measured inflammatory markers found in cerebrospinal fluid samples of Parkinson’s patients and members of a control group.

‘The degree of neuroinflammation was significantly associated with more severe depression, fatigue, and cognitive impairment even after controlling for factors such as age, gender and disease duration,’ said Brundin, an associate professor in the college and a researcher with the Van Andel Institute.

‘By investigating associations between inflammatory markers and non-motor symptoms we hope to gain further insight into this area, which in turn could lead to new treatment options.’
Inflammation in the brain long has been suspected to be involved in the development of Parkinson’s disease, specifically in non-motor symptoms such as depression, fatigue and cognitive impairment. Recent research suggests inflammation could drive cell death and that developing new drugs that target this inflammation might slow disease progression.

Parkinson´s disease is the second most common degenerative disorder of the central nervous system; the causes of the disease and its development are not yet fully understood.

‘The few previous studies investigating inflammatory markers in the cerebrospinal fluid of Parkinson’s patients have been conducted on comparatively small numbers of subjects, and often without a healthy control group for comparison,’ Brundin said.

In the study, 87 Parkinson’s patients were enrolled between 2008 and 2012. For the control group, 37 individuals were recruited. Participants underwent a general physical exam and routine blood screening. Researchers looked at the following markers: C-reactive protein, interleukin-6, tumor necrosis factor-alpha, eotaxin, interferon gamma-induced protein-10, monocyte chemotactic protein-1 and macrophage inflammatory protein 1-β.

The study was carried out in collaboration with researchers from Lund University in Sweden, Skåne University Hospital in Sweden and the Mayo Clinic College of Medicine in Florida. Michigan State University