News Trends Analysis

April 1, 2009

The Observatory

News/ Trends/ Analysis

Two new publications from CAP. The College of American
Pathologists offers two new publications. First, An Algorithmic
Approach to Hemostasis Testing
edited by Kandice Kottke-Marchange,
MD, PhD, FCAP, is a highly illustrated reference book with sections on
hemostasis physiology; basics of lab testing and interpretation; sample
collection and processing; patient history and diagnostic criteria; and
the monitoring of anticoagulant drugs. Case studies and detailed
algorithms related to lab evaluation of bleeding disorders and venous thrombophilic disorders are presented.

Second, to meet the needs of practitioners, a new,
image-intense professional resource called College of American
Pathologists Practical Guide to Gynecologic Cytopathology: Morphology,
Management, and Molecular Methods
is available. Edited by CAP Fellows
David C. Wilbur, MD, and Michael R. Henry, MD, with the extensive input of
the CAP Cytopathology Resource Committee, this book offers comprehensive
coverage of the principles of gynecologic cytopathology and provides
background material relevant to the management of the cytology lab. A review
of CAP gynecologic cytology programs rounds out the guide. For more
information, visit, and click on “Reference Resources and
Publications” or the “Books from CAP Press,” or contact Mary Spila at
800-323-4040, ext. 7841.

Industry watch

Beckman Coulter to acquire diagnostic-systems portion of
Olympus' Life Sciences.
Beckman Coulter Inc.,
developer, manufacturer, and marketer of products that simplify, automate,
and innovate complex biomedical tests, and Olympus Corp.,
Tokyo-headquartered precision technology organization, creating opto-digital
solutions in healthcare, life-science, and consumer-electronics products,
announced recently that they have entered into a definitive agreement.
Beckman Coulter will acquire the diagnostic-systems portion of Olympus' Life
Sciences business for approximately USD $800 million. This acquisition will
broaden Beckman Coulter's chemistry offering. Beckman Coulter's chairman,
president, and CEO said the transaction enhances his organization as a
provider of chemistry products, including its immunoassays, so that
customers, particularly those large hospital and university laboratories
where higher throughput systems are preferred, will benefit from an expanded
range of products. This transaction is expected to close in the third
quarter of 2009.

New tests

New prostate-cancer marker found in urine. Howard Hughes Medical
Institute researchers have identified a new biological marker present in the
urine of patients with prostate cancer that indicates whether the cancer is
progressing and spreading. In experiments reported in the Feb. 12 issue of
the journal Nature, the scientists identified 10 metabolites that
become more abundant in prostate cells as cancer progresses. Their studies
showed that one of these chemicals, sarcosine, helps prostate-cancer cells
invade surrounding tissue. One HHMI investigator and colleagues at the
University of Michigan showed that as prostate cancer develops and
progresses, sarcosine levels increase in both tumor cells and urine samples,
suggesting that measurements of the metabolite could aid in non-invasively
diagnosing the disease. Researchers might also be able to inhibit prostate
cancer's spread by designing drugs that manipulate the sarcosine pathway.

New test helps doctors determine appropriate antibiotic
overuse of antibiotics is widely accepted as the reason that some bacteria
develop resistance. In April 2008, BRAHMS Diagnostica LLC announced that it
received FDA approval for its procalcitonin (PCT) test system: PCT-sensitive
KRYPTOR. The Food and Drug Administration (FDA) approved the PCT system to
help risk stratify patients upon ICU admission for the progression to severe
sepsis or septic shock. The product employs immunofluorescence technology,
requires 50 uL of blood or serum, and has an incubation period of 19
minutes. In October 2007, Baptist Medical Center's laboratory was among the
first in the United States to provide a new test to help physicians rapidly
diagnose sepsis, the severe infection spread through the bloodstream. The
FDA approved the PCT test last year, and an important goal of the test is to
prevent patients from acquiring infections while they are in the hospital.
The PCT is used to help determine which ICU patients might be at risk for
severe sepsis; when a patient's fever is due to a bacterial infection, and
when antibiotic therapy is most appropriate. The director of Clinical
Chemistry at the Baptist's Center says the test is “not a magic bullet but
does provide valuable information in diagnosing and treating sepsis.”

FDA 510(k) clearance of novel molecular assay to diagnose Clostridium
difficile infections.

BD Diagnostics received
clearance from the FDA to market its BD GeneOhm C diff molecular
assay for the rapid detection of the Toxin B gene found in toxigenic C
, the bacterial pathogen responsible for C diff
infection, directly from stool specimens. The molecular assay combines
high sensitivity and specificity, and provides definitive results in
less than two hours, facilitating earlier and more appropriate
antibiotic treatment of patients infected with C diff — and may
lead to earlier implementation of infection-control interventions that
help prevent the transmission of the pathogen to other patients.


May 13.
From 3:00 p.m. to 4:30 p.m. (ET), AACC presents three experts in
endocrinology and rheumatology who will discuss “Emerging Biomarkers of
Bone Turnover: Gaining Ground in Osteoporosis Management.” New
developments and emerging markers can help identify patients at risk of
fractures and also elevate the role biochemical assays (i.e., tests such
as P1NP, CTX, TRAP-5b, and their technical aspects) play in osteoporosis
management. For more information, go to

Recorded program. Washington G-2 Reports
offers an essential update on “CLIA Compliance and Proficiency Testing”
via a recording of the original program with the director of CMS'
Division of Laboratory Services, and the FDA's chief medical officer of
the Office of IVD Device Evaluation and Safety at its Center for Devices
and Radiological Health. Find out about newly proposed changes to the
CLIA cytology proficiency-testing program, what quality-control policy
changes CMS has in store, and what the FDA is planning for lab oversight
this year. To order, call 800-401-5937, ext. 2, and ask for Order Code
9G02R, or e-mail [email protected] .

April 28.
AACC's “Infectious Disease: Is Your Lab Prepared?” is accepting
registrations now for this one-day meeting in Atlanta at
. Learn about dramatic
advances in the field that give the core lab an opportunity to take a
more prominent role in caring for patients with infectious diseases. The
conference is made possible, in part, by a grant from Siemens Healthcare
Diagnostics, with AACC presenting in conjunction with the Association of
Public Health Laboratories and the Centers for Disease Control and

April 28-29.
The 14th annual Executive War College is headed back to the Sheraton New
Orleans! Get the latest and best in lab and pathology management. Go to  to check on updates and registration
information. Sign up, too, for the optional post-event Workshop program
on Thursday, April 30. Concurrent morning Management Master Classes and
afternoon Break-Out Sessions, along with General Sessions during the
day, offer a wide variety of pertinent topics.

May 2-5.
Geraldine Ferraro — first woman VP candidate on a national party ticket
— will be the opening speaker at CLMA's annual ThinkLab Conference
sponsored by Orchard Software in Tampa from May 2-5. More than 50
educational sessions are offered (many new with an interactive focus).
Stay current with trends in the ever-changing lab industry while
obtaining CEUs. ThinkLab's exhibit floor hosts a wide range of industry
vendors swith the latest in lab equipment, products, and services. For
details and to register, go to  or call 610-995-9580.

May 4-6.
The Minnesota ASCLS Clinical Lab Collaborative registration is underway,
with a deadline of April 27. Approximately 550 attendees are expected to
meet with 60 vendors at the Mayo Civic Center in Rochester. Rooms at the
Radisson Plaza Hotel and the Hilton Garden Inn are available. Go to
 for more details and to register.

August 11-12.
“Molecular Diagnostics for Infectious Disease” is an inaugural conference
offered by Cambridge Healthtech Institute at the Ritz-Carlton Hotel in
Washington, DC. Get an insight into how molecular technologies are advancing
the development of clinically useful diagnostic tests for infectious
diseases in humans, animals, and plants, both in developed and developing
worlds. For more information, contact VP-Production Edel O'Regan at
781-972-5423 or e-mail [email protected] .