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HEALTH TIPS WEEKLY - Thursday, July 19, 2007
"News That Keeps You Healthy"
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FDA approves new breast cancer lab test
WASHINGTON,-- The U.S. Food and Drug Administration has app-
roved the first molecular-based laboratory test for detect-
ing whether breast cancer has metastasized. The GeneSearch
BLN Assay test approved Monday detects molecules that are
abundant in breast tissue but are scarce in a normal lymph
node.The FDA said the presence or absence of breast cancer
cells in underarm lymph nodes is a strong predictor of whe-
ther the cancer has spread and is used to help decide appro-
priate therapy for women with metastatic breast cancer. "The
GeneSearch BLN Assay offers a new approach to sentinel node
testing," said Dr. Daniel Schultz, director of the FDA's
Center for Devices and Radiological Health. "Results of this
rapid test are available while patients are on the operating
table, providing a way for some women to avoid a second
operation." The GeneSearch BLN Assay is manufactured by Ver-
idex, a Johnson & Johnson subsidiary located in Warren, N.J.
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New therapy for H. pylori infection found
DAVIS, Calif., -- U.S. scientists have developed immunizat-
ion methods that can offer long-term protection against Hel-
icobacter pylori infections. University of California-Davis
researchers said the new methods might also contribute to a
possible ulcer vaccine. H. pylori is a bacterium colonizing
the digestive tract of 50 percent of the world's population.
Infection can lead to chronic gastritis, peptic ulcer dis-
ease and gastric cancer. But expensive antibiotics currently
used against H. pylori are encountering increasing resist-
ance. In the University of California-Davis study, mice
were immunized in four groups: orally alone, intramuscularly
alone, orally followed by intramuscularly, and intramuscul-
arly followed by orally and then challenged orally with H.
pylori after three months. The researchers found mice rec-
eiving intramuscular immunization alone or a combination of
oral and intramuscular vaccinations had significantly red-
uced bacterial loads and no detectible H. pylori in their
intestinal tract. Mice immunized just orally or intramuscu-
larly followed by orally weren't protected and had decreased
antibody responses. "This study demonstrates the ability to
induce long-term immunity against H. pylori, provides corr-
elates of protection, and illustrates the crucial role of
the immunization route(s)," said the researchers. The res-
earch appears in the July issue of the journal Infection and
Immunity.
Combination cancer therapy is developed
PHILADELPHIA,-- U.S. medical researchers have identified a
combination therapy as a way to sensitize treatment resist-
ant human cancer cells. The University of Pennsylvania Sch-
ool of Medicine researchers suggest the therapy might help
to selectively eliminate cancer cells, while leaving healthy
cells intact, thereby providing a cancer treatment with few-
er side effects. To test the ability of the combined therapy
in treating cancerous tumors, Dr. Wafik El-Deiry and coll-
eagues administered TRAIL, a tumor necrosis factor-related
molecule naturally produced by the body's immune system that
promotes cell death, and sorafenib, an inhibitor currently
used to treat renal cancer, to mice with colon carcinomas.
The researchers found the combined sorafenib and TRAIL ther-
apy reduced the size of tumors in mice with few side eff-
ects, demonstrating the potential effectiveness of the comb-
ined treatment on human colon cancers. "Our findings are
exciting because TRAIL in combination with sorafenib appears
to be much less toxic than current chemotherapy drugs," said
El-Deiry. "Plus, sorafenib is already available in a pill
form."¨ The study is reported in the July issue of the jour-
nal Cancer Cell.
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New early disease diagnosis method created
WEST LAFAYETTE, Ind.,-- U.S. scientists have developed a
technique that provides a new way of detecting genetic dis-
orders found in infants and young children. Researchers from
Purdue and Indiana universities used a simple chemical reac-
tion to improve the ability to detect important molecules in
complex fluids such as blood and urine. Purdue Professor
Daniel Raftery said the technique makes the markers for some
genetically caused metabolic disorders up to 100 times more
visible. "This technique allows us to profile a class of
biomarkers ... that would otherwise be very difficult to
detect," he said. "The increased sensitivity could allow
doctors to diagnose a range of diseases at very early sta-
ges." He said the technique also could catch borderline
cases that might have otherwise gone undiagnosed until ser-
ious symptoms arose. Indiana University Associate Professor
Bryan Hainline said the combination of Purdue's research
strength in chemistry and the Indiana University School of
Medicine team's knowledge of pediatric metabolic disorders
allowed researchers to quickly advance the technology. Raft-
ery, Hainline, Narasimhamurthy Shanaiah, M. Aruni Desilva,
G.A. Nagana Gowda and Michael Raftery present the study in
the July 10 issue of the Proceedings of the National Acad-
emy of Sciences.
FDA approves cervical disk device
WASHINGTON, -- The U.S. Food and Drug Administration Tuesday
announced approval of the first device designed to treat
cervical degenerative disc disease. The Prestige Cervical
Disc, manufactured by Medtronic Sofamor Danek of Memphis,
is used to treat one of the most common causes of neck and
arm pain. "The approval of this artificial disc means that
people with cervical degenerative disc disease now will have
another surgical option for treating this condition," said
Dr. Daniel Schultz, director of the FDA's Center for Devices
and Radiological Health. "This device will help relieve pain
and restore function." The FDA said current surgical treat-
ments involve removing a diseased or bulging disc in a pat-
ient's neck and fusing two or more bony vertebrae. The Pres-
tige Cervical Disc allows the option of replacing the impai-
red natural disc. The FDA said it based its approval on the
company's laboratory and animal testing, and on its clinical
study of 541 patients. As a condition of approval, the comp-
any will conduct a post-approval study during the next seven
years to evaluate the longer term safety and effectiveness
of the device. The Prestige Cervical Disc was approved as
a class III, or high-risk, device.
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Study explains cancer vaccines might fail
BALTIMORE,-- U.S. scientists have identified an "escape
route" that cancers use to evade the body's immune system,
allowing the cancer to spread. Researchers, including Johns
Hopkins University scientists, said such escape hatches exp-
lain why anticancer vaccines mostly fail. In the latest res-
earch, investigators describe how myeloid-derived suppressor
cells, which normally keep the immune system in check and
prevent it from attacking otherwise healthy tissue, can sup-
press the anti-tumor response to cancer. The suppressor
cells block other immune system cells, CD8 "killer" T cells,
from binding with proteins that identify the foreign anti-
gens on the surface of unhealthy cancer cells, marking them
for destruction, the team reported. The researchers said
their experiments also suggest the chain reactions in T-cell
tolerance are reversible, raising the possibility of vaccine
and drug therapies that break through the blocked immune
system. The study -- conducted at Johns Hopkins, the Univ-
ersity of South Florida, and the University of Nebraska --
was reported in the July 1 issue of the journal Nature
Medicine.
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