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Affymax Announces Data Monitoring Committee Review Of Phase 3 Hematide Program
Affymax, Inc. (Nasdaq:AFFY) announced that the independent Data Monitoring Committee (DMC), which provides oversight for the Phase 3 program for Hematide™, has completed another review and has informed the company that the cumulative safety data generated thus far from the EMERALD and PEARL Phase 3 trials support continuation of the studies. In the Phase 3 program, Hematide is being evaluated to treat anemia in chronic renal failure patients on dialysis and not on dialysis.

Number Of Abortion Procedures Continues To Decline In Minnesota And Wisconsin
The following summarizes news coverage of state abortion statistics in Minnesota and Wisconsin.~ Minnesota: The number of abortions performed in Minnesota decreased for the second consecutive year in 2008, according to an annual report from the state Department of Health, the Minneapolis Star Tribune reports. Except for a one-time increase in 2006, the number of abortions in Minnesota has trended downward since a peak in 1980, when 19,028 procedures were performed. The new report found that 12,948 abortions were performed in the state in 2008, a decrease of 895 from 2007. Women ages 20 to 24 accounted for about one-third of the procedures, the most among any age group. The number of procedures among teenagers continued a decline that began in the 1990s but had leveled off slightly earlier this decade, the report found. The report also found that less than one-third of women reported using contraception and about one in seven was married at the time of conception (Von Sternberg, Minneapolis Star Tribune, 7/1).~ Wisconsin: Wisconsin abortion providers performed 8,229 procedures in 2008, the lowest number since the state began collecting statistics in 1974, according to an annual report by the state Department of Health Services, the AP/Milwaukee Journal-Sentinel reports. The number of abortions has declined annually since 2003, when 10,557 procedures were performed. State law requires abortion providers to provide DHS with the data. According to the report, slightly more than half of abortions took place in the first eight weeks of pregnancy. Women who had never been married accounted for about three-fourths of all procedures. The report found that 12% of abortions occurred among women ages 35 and older; 34% were among women ages 20 to 24; 11% were among women ages 18 and 19; and 6% were among girls ages 15 to 17. The number of abortions among minors decreased from 551 in 2007 to 500 in 2008, with parents providing consent in 452 of those cases (Richmond, AP/Milwaukee Journal-Sentinel, 6/30).
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Medical Devices

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® 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 exiting 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® 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. References 1. Montague NS, Cleary TJ, Martinez OV, Procop GW. Detection of group B streptococci in Lim broth by use of group B streptococcus peptide nucleic acid fluorescent in situ hybridization and selective and nonselective agars. J Clin Microbiol. 2008 Oct;46(10):3470-2. 2. US Centers for Disease Control and Prevention. Preventing Group B Strep. http://www.cdc.gov/groupBstrep/ 3. Davies HD, Miller MA, Faro S, Gregson D, Kehl SC, Jordan JA. Multicenter study of a rapid molecular-based assay for the diagnosis of group B Streptococcus colonization in pregnant women. Clin Infect Dis. 2004 Oct 15;39(8):1129-35. AdvanDx


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