News/ Trends/ Analysis

Jan. 1, 2010
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 .

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.


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 .

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
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

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).

In memoriam

Joan Hughes Logue, 73, Clinical Laboratory
Management Association (CLMA) founder and nationally recognized
consultant in laboratory management, regulations, and Medicare
reimbursement, died of lung cancer Nov. 20, 2009, at her home in
Longwood, FL. Logue, who was principal of Health Systems Concepts and
Health Software Consultants in Longwood, founded CLMA in 1976. In May
2009, she led a two-hour session on medical-coding regulations at CLMA's
ThinkLab in Tampa. In 2005, she received the Public Service National
Leader Award for Lifetime Achievement presented by Washington G-2
Reports. A native of Michigan, Logue earned a bachelor's degree in
medical technology from the University of Texas. She was a recognized
expert on Medicare laboratory billing and reimbursement issues. Her
consulting expertise brought about the development of automated
compliance systems, such as the MediBill Analyst.


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

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

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

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

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 .

April 22-23. The 42nd Annual Oak
Ridge Conference will be held at The Fairmont in San Jos'e, 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

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

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

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

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

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


 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


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

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