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Argos Therapeutics Presents Positive Transplantation And Immunosuppression Data For Soluble CD83 At The American Transplant Congress
Argos Therapeutics announced the presentation of new information on its soluble CD83 (sCD83) protein program in a poster session at the 2009 American Transplant Congress, held May 30-June 3 in Boston. The poster presentation, to be made on June 2 at 5:30pm by Argos" collaborating scientists from the University of Western Ontario, demonstrates that combination therapy with sCD83 can prolong kidney allograft survival in an animal model of transplantation, and that sCD83 attenuates pathological changes in kidney allografts, induces generation of T regulatory cells and inhibits dendritic cell maturation, all of which may contribute to immunosuppression and allograft tolerance.

RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed The Time To Relapse In Patients With Bipolar I Disorder
New data demonstrate that maintenance therapy with RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Treatment (RLAT) significantly delayed the time to relapse compared to placebo in patients with Bipolar I Disorder. Results of the study were presented this week at a major medical meeting.
News of the day
White House Retools Message As GOP Opposition, Public Opinion Push Back
"[T]he White House team is retooling its message and strategy, hoping a more modest approach will reinvigorate Obama"s signature domestic policy initiative and give him a first-year victory for Democrats to carry into the 2010 midterm elections," the Washington Post reports. An early focus on "fast, broad and bipartisan" reforms has given way to realities including a stiff Republican opposition, lack on consensus in his own party, and falling poll numbers. As a result, the administration and Democratic allies have missed a self-imposed August deadline, turned to harsher critiques of industry players and now appear open to both less-ambitious proposals, and procedural measures that could bypass GOP opposition to achieve a partisan reform bill (Connolly, 8/2).
Oncology

AdvanDx Receives FDA 510(k) Clearance For GBS PNA FISH(R) For Rapid Detection Of Group B Strep From Lim Broths

AdvanDx announced it received FDA 510(k) clearance for GBS PNA FISH(R) for detection of Streptococcus agalactiae, aka Group B Strep, from turbid Lim Broths inoculated with vaginal and rectal swabs obtained from pregnant women between 35 and 37 weeks gestation. The 90 minute molecular diagnostic test enables rapid and highly sensitive detection of Group B Strep from Lim Broths to help detect colonization in pregnant women. According to the US Centers for Disease Control and Prevention (CDC), Group B Strep is the most common cause of neonatal morbidity and mortality. Approximately 1 in 4 pregnant women are colonized with Group B Strep and can transmit the bacterium to the newborn during delivery. To prevent the transmission and subsequent infection, women are routinely screened for colonization between 35 and 37 weeks gestation, and if positive, receive antibiotics at the start of labor to eradicate the bacteria. Accurate detection of Group B Strep colonization is therefore crucial to prevent as many infections as possible.(2) During the routine laboratory testing process, vaginal and rectal swabs from pregnant women are inoculated into selective enrichment broth, e.g. Lim Broth, and incubate overnight to stimulate the growth of Group B Strep bacteria. A sample is subsequently taken for further culture workup and identification using conventional, phenotypic methods. This process can take anywhere from 3 to 4 days, and while Lim Broth is highly sensitive and selective for Group B Strep, the subsequent workup and phenotypic identification can be time consuming and may miss some true positive samples.(3) GBS PNA FISH combines the high sensitivity of Lim Broth with the speed, accuracy and ease-of-use of the PNA FISH molecular diagnostic platform to provide accurate Group B Strep detection fit for the routine laboratory workflow. In a recent clinical study, GBS PNA FISH was shown to detect up to 42% more Group B Strep positives than conventional culture methods. The authors of the study also found that the test produced results 2 to 3 days faster and concluded that "use of the PNA FISH assay for the detection of GBS from Lim broth culture showed an increased sensitivity, required decreased specimen handling, and had a shorter turnaround time than culture."(1) "GBS PNA FISH brings another exciting application to the PNA FISH platform and is another critical tool for improving infection prevention and patient management," said Thais T. Johansen, President and CEO of AdvanDx. "The test will enable labs to provide fast and sensitive detection of Group B Strep that in turn may help clinicians provide better preventative care for more pregnant women and their newborns," Johansen added. About PNA FISH(R) PNA FISH is an easy-to-use and highly sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in live bacteria and yeast. The unique properties of the non-charged, peptide backbone of PNA probes enable the use of FISH assays in exceedingly complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of very simple, yet very accurate tests that don"t require the extensive sample preparation necessary for other nucleic acid technologies. PNA FISH tests enable microbiology labs to provide rapid and accurate pathogen identification in hours instead of days. Clinical studies show that the significantly faster results help clinicians provide more appropriate patient therapy that saves lives, reduces unnecessary antibiotic use, reduces patient length of stay and reduces overall hospital costs. About AdvanDx AdvanDx is the world"s leading provider of advanced molecular diagnostic products for the prevention, diagnosis and treatment of life-threatening, bacterial infections. AdvanDx"s easy-to-use products provide fast and accurate results that enable dramatic improvements in patient care and help to save lives and reduce hospital costs. AdvanDx"s products employ standard laboratory techniques and equipment to reduce startup, implementation, technician and maintenance time, while providing fast results without sacrificing accuracy. Major medical centers, reference labs, government institutions and community hospitals throughout the United States, Europe and Asia rely on AdvanDx products as integral parts of their medical care. References: (1) J Clin Microbiol. 2008 Oct;46(10):3470-2. (2) http://www.cdc.gov/groupBstrep (3) Clin Infect Dis. 2004 Oct 15;39(8):1129-35. AdvanDx


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