Observatory

News/ Trends/ Analysis

Infectious diseases

CDC watching H1N1 mutation. The Centers for Disease Control and Prevention (CDC) is keeping an eye on a mutation in some strains of the pandemic H1N1 flu that Norwegian researchers isolated from several patients with severe disease, according to the CDC’s National Center for Immunization and Respiratory Diseases, the mutation — seen "sporadically" in the United States — has been associated with mild disease, while the Norwegians isolated it from the first two patients who died of the disease. Norway’s Institute of Public Health reported that the mutation was also found in a patient who had severe disease. In the United States, patients have had severe lower respiratory infections caused by strains without the mutation, as well as mild disease caused by strains with the mutation, according to the CDC. The agency will be watching to see if the mutation spreads and if it is more common in cases of severe disease. Learn more at www.cdc.gov/H1N1FLU .

STD infections rise among young people. Sexually transmitted diseases (STDs) continue to rise, according to the CDC. STDs like chlamydia, gonorrhea, and syphilis were all found to have increased from 2007 to 2008, with reported chlamydia cases setting a record in 2008: 1.2 million cases were reported in 2008, up from 1.1 million in 2007. The CDC’s latest study notes 13,500 syphilis cases were reported in 2008, an almost-18% increase over 2007. Syphilis, nearly eradicated a decade ago, among women rose 36%, but most of the syphilis cases (63%) occurred in men who have sex with men. The CDC estimates that approximately 19 million new STD infections occur each year. Approximately half of them occur in people between 15 to 24 years of age. Many cases of notifiable STDs go undiagnosed. Some common viral infections, such as human papillomavirus and genital herpes, are not reported at all.

Number of new active TB cases rises. The World Health Organization (WHO) released data at the 40th Union World Conference on Lung Health in Cancun, Mexico, that indicates the number of new active tuberculosis (TB) cases worldwide rose from 9.27 million in 2007 to 9.4 million in 2008. TB has been on the rise since the 1980s, with its spread concentrated in Asia and Africa. Experts who were gathered for the conference discussed the possibility of a highly sensitive blood or urine test for TB that could one day replace the current test, which is 100 years old and misses up to 70% of TB cases.

HIV/AIDS

UN says HIV peaked in 1996. The number of people worldwide infected with the virus that causes AIDS has remained virtually unchanged for the last two years, United Nations experts report. Officials say the global epidemic peaked in 1996 and that the disease looks stable in most regions, except for Africa. Last year, HIV infections in sub-Saharan Africa accounted for 72% of the 2.7 million new HIV cases worldwide. In the report by the WHO and UNAIDS, experts estimate there are now about 33.4 million people worldwide with HIV. In 2007, the figure was about 33.2 million.

97 HIV/AIDS drugs and vaccines in development. Chemistry World recently highlighted a new report published by the Pharmaceutical Research and Manufacturers of America that identifies 97 new drugs and vaccines (23 vaccines and 54 antivirals) in development for HIV/AIDS and related conditions. These drugs are either in human clinical trials or awaiting approval by the U.S. Food and Drug Administration (FDA).

Payments offered for HIV testing in China. The New York Times reports that an HIV prevention program in China aimed at promoting blood screening has led more than 110,000 people to be tested so far. The program, which began in 2007, is financed by the Bill and Melinda Gates Foundation, which will spend $50 million over five years in an effort to slow the spread of AIDS in China. Because the testing drive offers financial incentives to blood donors and those drawing blood, the newspaper reports that the initiative has been criticized by some AIDS organizations, while the foundation says the payments are crucial for bringing people face to face with outreach workers.

Worth noting

CAP-accredited labs now display certification mark. The College of American Pathologists (CAP) is providing CAP-accredited laboratories with a certification mark they can display on their materials and in their accredited facilities. This symbol of excellence demonstrates that these laboratories provide quality care under the auspices of the CAP accreditation program requirements. Learn more at www.cap.org .

Abbott retiring some legacy platforms. In an effort to focus on bringing innovative technologies and science to its customers and to ensure all products meet today’s regulatory requirements, Abbott is retiring older, legacy platforms. The IMx, TDx, and TDxFLx platforms, for example, are more than 20 years old, and use equipment and technology that have become difficult to support and service as parts and raw materials are scarce. Retiring older products enables the company to invest in state-of-the art technologies and novel biomarkers in development. Abbott is expected to offer options for those products being retired. A new methotrexate assay to be run on the ARCHITECT is expected to be launched in late 2010 or early 2011 and will be available prior to the retirement of the existing X-Systems assay. With regard to the Fetal Lung Maturity assay, alternatives are still being assessed, including alternative technologies, and no retirement date has been communicated. Abbott plans to give customers at least a 12-month advance notice of assay retirements.

New studies

Homocysteine links to Alzheimer’s disease studied. Middle-aged women with high levels of a specific amino acid in their blood are twice as likely to suffer from Alzheimer’s disease many years later, reveals a thesis from the Sahlgrenska Academy at the University of Gothenburg, Sweden. This discovery could lead to a new and simple way of determining who is at risk long before there are any signs of the illness. The thesis is based on the Prospective Population Study of Women in Gothenburg, which was started at the end of the 1960s when almost 1,500 women between the ages of 38 and 60 were examined, asked questions about their health, and had blood samples taken. Now the samples have been analyzed and compared with information about who later went on to suffer from Alzheimer’s and dementia. Alzheimer’s disease was more than twice as common among the women with the highest levels of homocysteine as among those with the lowest, and the risk for any kind of dementia was 70% higher.

Urine sample may reveal sleep disorder. A urine test could be developed to detect whether a child has obstructive sleep apnea (OSA), which would alleviate the need for costly and inconvenient sleep studies for OSA in children, according to University of Chicago researchers in the Dec. 15 issue of the American Journal of Respiratory and Critical Care Medicine. An estimated 3% of children under the age of 9 have OSA, which can lead to cognitive, behavioral, cardiovascular, and metabolic problems. In a study of 90 children referred to a sleep clinic for evaluation of breathing problems during sleep and 30 children who did not snore, all test subjects underwent standard overnight sleep tests and urine samples were collected the morning after the tests. Researchers found that the expression of a number of the proteins was different in children with OSA than in those with habitual snoring or healthy, non-snoring children.

Blood-lead level linked to depression. Young adults with higher blood-lead levels appear more likely to have major depression and panic disorders, even if they have exposure to lead levels generally considered safe, according to a report in the December issue of Archives of General Psychiatry. Researchers analyzed data from 1,987 adults age 20 to 39 years and found the number of young adults who met diagnostic criteria for major depressive disorder was 134 (6.7%); 44 (2.2%) had panic disorder; and 47 (2.4%) had generalized anxiety disorder. The average blood-lead level was 1.61 mcg/dL. Participants with the highest blood-lead levels (2.11 mcg/dL or more) had 2.3 times the odds of having major depressive disorder and nearly five times the odds of panic disorder as the those with the lowest lead levels (0.7 mcg/dL or less).

Conferences

Feb. 3-5. "Molecular Diagnostics 2010 New Wave of Personalized Medicine" is part of Cambridge Healthtech Institute’s Molecular Medicine Tri-Conference at Moscone North Convention Center, San Francisco. The agenda includes practical challenges in getting diagnostics reimbursed; value-based lab tests; gene patents; and MRSA surveillance programs. Register online at https://chidb.com .

Feb. 25-27."ASCLS Clinical Laboratory Educators’ Conference" at Beau Rivage Hotel, Biloxi, MS, offers educators sessions on the latest areas of science and management, the skills needed by graduates, recruitment strategies, and how to prepare students for clinical practice. Learn more at www.ascls.org/conferences/CLEC2010 .

March 22-25. The Society of Armed Forces Medical Laboratory Scientists Meeting at the Town and Country Resort in San Diego will include breakout sessions, special meetings, workshops, and presentations. Visit www.safmls.org .

March 24-26. The biennial CDC-APHL HIV Diagnostics Conference at the Doubletree Hotel Universal Studios in Orlando will review alternative HIV testing algorithms; new serologic, molecular, and POC HIV testing techniques; and practices for bridging lab and POCT strategies including model QA practices in CLIA-waived testing programs. Learn more at www.hivtestingconference.org .

April 14-16. "Molecular Diagnostics 2010 — Putting MDx to the Test: How Your Lab Can Capitalize on Molecular Diagnostics" at the Hyatt Regency Cambridge (MA) will provide expert insight and advice on how labs can integrate MDx into their business strategies, given the current regulatory and business environment. Learn more at www.g2reports.com .

April 22-23. The 42nd Annual Oak Ridge Conference will be held at The Fairmont in San José, CA, and include four sessions: Diagnostic technologies for resource-limited settings; novel multiplex platforms for diagnostics; emerging detection technologies for diagnostics; and novel separation and sample prep technologies. Learn more at www.aacc.org/events/meetings/Pages/5670.aspx.

April 25-28. The 26th Annual Clinical Virology Symposium and the Annual Meeting of the Pan American Society for Clinical Virology will be held in Daytona Beach, FL, and provide a forum for the meaningful exchange of ideas dealing with viral infections, and the relationship between rapid viral diagnosis, clinical course of viral infections, and preventive and therapeutic modalities for virus infections. Learn more at http://hsc.usf.edu/nocms/medicine/medmicro/virology/index.htm .

April 27-28. The 15th Annual Executive War College at the Sheraton New Orleans is designed to help lab administrators and pathologists learn practical methods for improving the organizational performance and financial success of their labs, including lab-management methods and financial strategies for enhancing profits. Go to www.executivewarcollege.com.

May 4-6. CLMA ThinkLab’10 will take place at the MGM Grand, Las Vegas. ThinkLab ’10 will feature a variety of educational sessions specifically designed for emerging lab leaders as well as seasoned C-Level executives with more than 40 breakout sessions covering a wide range of topics including molecular diagnostics. Learn more at www.clma.org/thinklab.

May 17-19. The Molecular Pathology Essentials Course 2010 at Hyatt Regency Atlanta will focus on the essential knowledge and current practice of clinical molecular pathology, with an emphasis on case-based examples and technologies. Register at http://direct.aacc.org/ProductCatalog/Product.aspx?ID=5744 .

July 25-29. The 2010 AACC Annual Meeting and Clinical Lab Expo at the Anaheim, CA, Anaheim Convention Center will include five plenary sessions, symposia, interactive workshops, short courses, brown bag sessions, meet the experts, chairs invited sessions, posters, and oral abstract presentations. Learn more at http://www.aacc.org/events/2010am/pages/default.aspx .

AUDIOCONFERENCES

 Jan. 20, 2:00 p.m. “Celiac Disease: Advances in Testing and Treatment.” Is your lab up to speed on the most recent advances in celiac disease testing? Learn more about current testing technologies and how physicians use them in diagnosing and managing celiac disease and find out more about genetic tests for celiac disease and when to use them. Register at http://direct.aacc.org/ProductCatalog/Product.aspx?ID=5755.

WEBINARS

Feb. 11, 2:00 p.m. “Cardiac Troponin Sensitivity: Understanding Its Role in Risk Stratification and Early MI Diagnosis” IVD manufacturers have developed new generations of cardiac troponin I assays that have significantly increased low-end analytical sensitivity. Learn more about how to use the newest generation of troponin assays at http://www.aacc.org/events/meetings/Pages/5761.aspx .

March 3, 2:00 p.m. “Customizing Quality Control for Improved Patient Safety” The frequency of running quality control (QC) plays a major role in managing patient risk. This program will provide strategies that will allow you to develop a quality control plan that is specific to your lab’s workflow, minimize patient risk, ensure quality results, and minimize QC run utilization. This program is sponsored by AACC and supported, in part, by Bio-Rad Laboratories and Siemens Healthcare Diagnostics. Register at http://www.aacc.org/events/meetings/Pages/5754.aspx .