News/ Trends/ Analysis

May 1, 2010

Judge rules against gene patents. On March 29,
a U.S. District Court judge invalidated seven patents covering the BRCA1 and
BRCA2 genes, which are linked to an increased risk of breast and ovarian
cancer. The judge ruled that the patents were “improperly granted” because
they involved a “law of nature.” The patents over the BCRA1 and BCRA2 genes
allowed Myriad Genetics, the company that holds the patents with the
University of Utah Research Foundation, to charge $3,000 for a screening
exam to detect cancerous mutations to the genes, and prevented other
organizations from developing alternative tests, which prevented women from
getting a confirmatory test from another laboratory. Researchers interested
in any type of research on the BCRA1 and BCRA2 genes have had to obtain (and
often pay for) the company's permission to perform their research. Myriad
Genetics is expected to appeal the decision.

Patients at Wisconsin hospital contract
Legionnaires' disease. 
Eight people who have been to Aurora
St. Luke's South Shore in Cudahy, WI, between Feb. 24 and March 10 have
been diagnosed with Legionnaires' disease, according to state health
officials. Officials have not yet pinpointed the source of the outbreak.
Legionnaires' disease is caused by the inhalation of aerosolized water
contaminated with
Legionella bacteria, which can be spread through ventilation
systems, plumbing systems, medical devices that create aerosols, and
decorative fountains. According to the Centers for Disease Control and
Prevention (CDC), each year an estimated 8,000 to 18,000 people are
hospitalized with Legionnaires' disease in the U.S. with fatality rates
between 5% and 40%.

Illinois sandwich shop source of Shigella
A Subway restaurant in Lombard, IL, has been identified as
the source of a
Shigella outbreak which has afflicted at least 116 people; 13
were hospitalized. The restaurant has been closed pending an
investigation, according to health officials. The bacterium Shigella
is transmitted primarily by fecal-oral, person-to-person means. It can
also occur through contaminated food or water. Every year, about 14,000
cases of shigellosis are reported in the United States. Because many
milder cases are not diagnosed or reported, the actual number of
infections may be 20 times greater, according to the CDC.

C diff surpasses MRSA in hospitals.
New data shows infections from Clostridium difficile (C
are surpassing methicillin-resistant
Staphylococcus aureus (MRSA) infections in community hospitals.
This is according to research presented by the Duke Infection Control
Outreach Network. The Duke team looked at data from 28 hospitals in
Georgia, North Carolina, South Carolina, and Virginia. During a two-year
period, the number of
C diff infections in the hospitals was 25% higher than the rate
of MRSA infections. The researchers say MRSA infections have declined
steadily since 2005, but
C diff infections have increased since 2007.


Plasma from female donors may not be as risky
as once thought.
Three years after the U.S. blood-banking industry
issued recommendations that discourage transfusing plasma from female
donors because of a potential antibody reaction, Duke University Medical
Center researchers discovered that female plasma may have some
advantages. A team of Duke scientists conducted a retrospective study of
Red Cross donor and hospital data from a period when female plasma was
not restricted. After examining heart-surgery outcomes for lung
problems, prolonged length of hospital stay, or death, researchers found
patients receiving female-donor plasma did better than similar patients
receiving male-donor plasma. The recommendations to restrict plasma
transfusions were based on evidence tying female-donor plasma to
transfusion-related acute lung injury (TRALI). Evidence reveals that
TRALI is more likely to occur after using female plasma, because women
are more likely to have antileukocyte antibodies, which are produced
during pregnancy.

Senators ask FDA to lift ban on gay men
donating blood.
A group of U.S. senators is calling for the
Food and Drug Administration (FDA) to lift the ban on gay men donating
blood. Sen. John Kerry (D-MA) was one of 18 senators — 17 Democrats and
one independent — who sent a letter on March 4 to the FDA commissioner,
urging the agency to lift the lifetime ban on men who have engaged in
homosexual relationships since 1977. The lifetime ban on blood donation
by gay men was put in place in 1983 — at the height of uncertainty
regarding the AIDS epidemic. The senators urged the commissioner to
focus on unprotected sex as a determination for prospective blood
donors. Kerry says donated blood is thoroughly tested for HIV and other
diseases, limiting the risk of tainted blood entering the blood supply
to nearly zero.

Infectious diseases

MDR-TB on the rise in some parts of the
About 4% of tuberculosis (TB) cases worldwide are
thought to be unresponsive to the usual TB drugs. In a report released
on March 18 on the global status of drug-resistant TB (based on data
from 2008), the World Health Organization (WHO) says nearly half of
people with the disease are in China and India, but some of the hardest
hit regions include nations of the former Soviet Union. In the Russian
city of Murmansk, 28% of new TB cases in 2008 were multidrug-resistant
(MDR) — the highest level ever reported to WHO. Previously, the highest
recorded level was 22% in Baku City, Azerbaijan, in 2007, according to
the report. In Kazakhstan and Tajikistan, the rates of MDR-TB were 25%
and 17%, respectively. In Moldova and Belarus, the rates were 25% and
17%. In Estonia and Latvia, the rates were 15% and 12%. The United
States reported only 11,540 new cases of TB in 2008, with less than 1%
(108 cases) reported as drug resistant.

Industry watch

Change makes 3.0 the new 4.0 for PSA
A change in laboratory standards has artificially
lowered prostate specific antigen (PSA) levels reported to physicians,
confusing thresholds for biopsy and potentially leading to missed
cancers, MedPage Today reports. Assays calibrated to WHO
standards gradually adopted since 2000 yield PSA levels 22% to 25% lower
than those under the old standards, warned a research team from
Memorial-Sloan Kettering Cancer Center in New York City. When
researchers analyzed nationally-representative data, they found that
close to 34% of cancers would be missed if the traditional PSA cutoff of
4.0 ng/mL — determined under the old standards — continued to be used
with assay values determined under the new standards. Learn more at

New studies

Heel-stick test not effective screening tool
for CMV.
New research shows that testing DNA in blood samples
collected from newborns is not an effective way to detect cytomegalovirus
(CMV), an infection that is a major cause of hearing loss in children,
HealthDay News
reports. Dried blood spots (DBS) are collected from all
infants born in the United States to conduct metabolic screening. Since
these blood samples are readily available, there is great interest in using
polymerase chain reaction (PCR) to test for CMV. In this study, published in
the April 14 issue of the Journal of the American Medical Association,
researchers from the University of Alabama-Birmingham compared CMV detection
using DBS real-time PCR testing and saliva rapid-culture testing, which can
be used for identifying CMV but is not suitable for mass screening. Compared
with saliva rapid-culture testing, DBS real-time PCR had low sensitivity and
did not identify approximately two-thirds of the CMV infections. Learn more


July 25-29. The 2010 AACC Annual Meeting
and Clinical Lab Expo at the Anaheim, CA, Convention Center will include
plenary sessions, symposia, interactive workshops, short courses, brown
bag sessions, posters, oral presentations, and more, as well as more
than 650 exhibitors. Learn more at

Sept. 23-24. The 6th International
Symposium on the Clinical Applications of Serum Free Light Chain
analysis and Hevylite will be held in Bath, U.K. Sessions will include
measurements in monoclonal gammopathies, myeloma kidney, and
inflammatory diseases; presentations on intact immunoglobulin
kappa/lambda ratios in a variety of clinical situations; and results
from recent studies. Visit


May 25, 1:00 p.m. ET. “Protecting Yourself
from Phlebotomy-Related Lawsuits” identifies common errors in the
performance of venipunctures that cause injuries to patients and can
bring legal action against phlebotomists, labs, and hospitals. The
program will outline policies, procedures, and practices that can
minimize the risk of litigation. For more information, go to

May 26, 11:00 a.m. ET.  “Whole Blood
Bilirubin Screening at the POC Improves Neonatal Outcomes and Workflow
Efficiency” covers guidelines on neonatal jaundice and
hyperbilirubinemia; the challenges with existing testing methodologies;
and whole-blood point-of-care total bilirubin testing. Register at

Published: May, 2010