News Trends Analysis

July 1, 2009

The Observatory

News/ Trends/ Analysis
Infectious diseases

H1N1 flu shots ready by October? Laboratories around the world are racing to produce a strain suitable
for manufacturing vaccine. More than 52,000 people worldwide have been
confirmed as infected with novel influenza A(H1N1) or swine flu at this
writing. U.S. Centers for Disease Control and Prevention (CDC) says a
vaccine for H1N1 could be available as early as October — if vaccine
production and testing run smoothly this summer. The government will
review the safety and effectiveness of what is produced and decide if a
vaccination campaign is warranted. The Secretary of the U.S. Department
of Health and Human Services (HHS) says HHS will take the steps
necessary to prepare for potential commercial-scale production of an
influenza A(H1N1) vaccine. HHS is directing approximately $1 billion to
be used for clinical studies and for commercial-scale production of
vaccine ingredients.


Vaccine shows promise against melanoma. An eight-year, 185-patient clinical trial led by the
Goshen Center for Cancer Care tested the benefit of combining the gp100
vaccine with the high-dose Interleuken-2 (IL-2), a biological therapy
that boosts the immune system. The study investigated whether IL-2 given
with the vaccine would create positive responses for more patients,
making the body's immune response even stronger than with IL-2 alone.
Sponsored by the National Cancer Institute, the study showed a cancer
vaccine doubled the response rate for tumor shrinkage and delayed the
progression of cancer in patients with metastatic melanoma. The vaccine
primes a patient's immune system to locate and attack the cancer by
locating the gp100 protein, a synthetic fragment from a specific protein
found on the surface of melanoma cells.

New technology

Clinicians: sepsis monitor needed. New technologies and/or methods to solve complexities
surrounding the diagnosis and treatment of bacterial sepsis are needed,
according to three surveys of physicians conducted by bioM'erieux. More
than 90% of the doctors surveyed report that they need a tool to help
them monitor the progression of sepsis over a 24-hour period because the
condition can rapidly turn fatal. Frequently, a physician learns
treatment is insufficient only when the patient progresses into full
septic shock. “Due to the lack of advancement in sepsis diagnosis and
because we know the importance of timely treatment of sepsis, physicians
have been forced to continue diagnosing and treating patients with
suspected sepsis based on little more than clinical clues,” says the
medical director of Critical Care Services at Morton Plant Hospital in
Clearwater, FL.

International news

Pathologists fear one in five breast cancer hormone tests
Hundreds of women in Quebec with
breast cancer may have been prescribed the wrong treatment because of
faulty pathology tests, a CBC News investigation has found. In
Newfoundland and Labrador, the issue surfaced recently, as Eastern
Health's pathology lab turned over inaccurate hormone-receptor tests to
almost 400 patients over an eight-year period. More than 100 women died.
Worried that the same problem could occur in Quebec, the province's
pathology association took 15 breast cancer tissue samples, had them
tested by a reliable lab, and then sent the samples to labs across the
province, asking them to re-test for hormone receptors. The results
showed 15% to 20% of the hormone-receptor tests got the wrong result,
and 30% of tests looking for the HER2 protein were wrong.


Blood to diagnose organ rejection. Researchers from the PROOF Centre for Excellence and Vancouver Coastal
Health Research Institute, funded by Genome B.C., have discovered that
blood from heart and kidney transplant patients has genetic biomarkers
that can diagnose and predict acute organ rejection. Biomarkers in
Transplantation, a research initiative that will allow doctors to
identify patients rejecting transplanted organs with a simple blood
test, is making use of advanced genomic, proteomic, and computational
tools to develop the test, which will diagnose rejection before acute
organ rejection occurs, allowing doctors to intervene early and to
personalize a patient's immunosuppressant therapy. After validating the
test in this group of patients in Vancouver, the research team is now
taking the test across Canada in preparation for government approval.


July 18. Reducing Laboratory Quackery and Other Forms of Unnecessary Laboratory Testing” will take place at 5:30 p.m. to 8:00 p.m. at the 14th Annual Management Sciences Division Leadership Seminar at the Hyatt Regency Chicago. $20 fee includes dinner followed by awards presentation and scientific session. Register at .

July 19-23. The AACC/CSCC Annual Meeting and Clinical Lab Expo will take place at Chicago's McCormick Place Convention Center with a variety of professional education sessions and more than 600 companies displaying their products and services. Go to .

August 10-12. “The Next Generation Dx Summit,” at the Ritz-Carlton in Washington, DC, covers enabling point-of-care diagnostics, trends in cancer diagnostics, clinical adoption of next-generation diagnostics, and molecular diagnostics for infectious disease. Go to .

August 17-20. “The Healthcare Colloquium Conference” at Harvard University, Cambridge, MA, is an executive education course on patient safety, healthcare quality enhancement, and medical errors reduction for healthcare executives, clinicians, and patient care staff. Get details at .

August 19-20. The International Swine Flu Summit in Washington, DC, will gather
scientists, public health officials, law enforcers, first responders,
and other experts to discuss pandemic prevention, preparedness,
response, and recovery. Visit .

September 29-30. “Lab Quality Confab” at the Atlanta Hilton features programs on quality
management techniques such as LEAN, Six Sigma, and ISO 15189. Go to

October 1-2. “Molecular Pathology
Essentials: Diagnosis and Targeted Therapy” at the Hotel Scandic
Copenhagen, Denmark, covers molecular diagnostic testing for genetic
disorders, hemoglobinopathies, pharmacogenetics, and more.
Visit .

October 22-23, 2009. “Laboratory Automation: Integrating Quality with Efficiency” at Shangri-La Hotel – Kuala Lumpur, Malaysia, includes industry workshops and presentations that compare and contrast different approaches to automation to show how to select and implement an automation project. Visit events/meetings.

October 24-27. AABB's Annual Meeting and TXPO 2009 for transfusion and cellular-therapy
professionals will take place at the New Orleans Convention Center. The
event will feature 130 educational sessions and nearly 200 exhibitors.
Go to  for more information.

October 29-30. Join top experts at “Lab Automation: Finding the Right Fit for Your Lab”
at the Little America Hotel in Salt Lake City for tips and strategies
for lab automation projects, and tours of the ARUP automated
laboratories. Visit

November 5-6. “Translating Novel Biomarkers to Clinical Practice: Role and Opportunities for the Clinical Laboratory” in Bethesda, MD, will feature discussions of clinical proteomics, biomarker discovery, co-development of therapeutic compounds and proteomic assays, regulation of proteomic technologies, and developments in standardization. Go to .


July 15, 1:00 p.m.-2:00 p.m. CST. “Quality Management Systems in the Laboratory – Creating a Culture of Quality and Sustainability.” Gain a better understanding of critical attributes of a QMS, implementation phases in building a QMS, and key requirements from the ISO 15189 standard. For more information, visit .

September 16, 1:00 p.m.-2:00 p.m. CST. “Panel Discussion: Opportunities and Pitfalls of Implementing a QMS from Early Adopters.” Gain firsthand experience from a panel of CAP 15189 early adopters. For more information, visit .


July 16, 1:00 p.m. EDT. “Lab Managers: How to Become a Better Coach and Create a More Productive Working Environment” features two coaching and staff-development experts who provide strategies for improving productivity and boosting morale in the lab. Call 1-800-560-6363 or register online at .

“How to Achieve Cost Savings for Your Lab by Analyzing Test Utilization Patterns” describes how laboratories can save shave hundreds of thousands of dollars every year by identifying and eliminating expensive tests that are of little to no clinical value. Order the CD at .

Learn how to start up and operate a molecular diagnostics lab with “Molecular 101: Starting Up and Running a Molecular Lab — Workshop DVD.” Go to .


September 17, 1:00 p.m-2:00 p.m. EST. “Real-life Competency Assessment and Training Strategies That Work” teaches how to: measure knowledge and skill; use competency assessments to identify poor performers or manage difficult employees; and focus training efforts on those who need it the most. Visit i.

September 24, 1:00 p.m-2:00 p.m. EST. “Bad Bugs Need Drugs: Challenges of AST for
Staphylococcus (MS05)” is focused on practical laboratory practices and strategies for antimicrobial susceptibility testing of resistant
Staphylococcus infections. Visit .

October 1, 1:00 p.m-2:00 p.m. EST. “Practical Solutions for Laboratory Documents and Records” provides strategies, examples, and practical applications to enhance laboratory documents and records processes, drawn on theory from CLSI guidelines GP26, GP02, and GP21. Visit .