Antibiotic prophylaxis

Cepheid Receives FDA Clearance for Xpert® Xpress GBS

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Lundi, mars 11, 2024
PCR, Obstetrics, Streptococcus, Rheumatic fever, EVP, INT, Risk, Cepheid variable, Antibiotic prophylaxis, Antimicrobial stewardship, Fungal infection, Genome, Woman, American College, GBS, Negative, ACOG, Infant, Food, Sintering

SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS). This next-generation test incorporates new dual targets in highly-conserved regions of the GBS genome to improve sensitivity and bacterial strain coverage. The test is designed for use on Cepheid's GeneXpert® systems.

Key Points: 
  • SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS).
  • Xpert Xpress GBS allows for the use of intrapartum direct PCR testing for women with unknown or unavailable antepartum GBS status.
  • With the capability of returning positive results as early as 30 minutes,2 Xpert Xpress GBS can provide real-time GBS status and inform decisions about empiric antibiotic prophylaxis if appropriate, to prevent GBS transmission during birth.
  • With Xpert Xpress GBS, Cepheid continues to provide fast, accurate, and reliable PCR solutions to facilitate evidence-based treatment and improved clinical care.

2023 Kappa Delta Ann Doner Vaughn Award Presented to Michelle Ghert, MD, FRCSC, and the PARITY Investigators for First-Ever International Multi-Center Randomized Controlled Trial in Orthopaedic Oncology

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Vendredi, février 10, 2023
Cefuroxime, Clostridioides, Caregiver, Christianity in Singapore, McMaster University, Journal, Infection, Bone, Pelvic floor dysfunction, American Medical Association, Korea Disease Control and Prevention Agency, The Journal of Bone and Joint Surgery, Antibiotic prophylaxis, Antibiotic-associated diarrhea, Clostridioides difficile, Medicine, Patient, Cancer, Cefazolin, Megacolon, Staphylococcus, Oncology, Kappa Delta, Biostatistics, Incidence, Database, Bone sarcoma, Research, RCT, Soft-tissue sarcoma, Tibia, Mortality, Amputation, Risk, FRCSC, CDC, Optimism, Staphylococcus aureus, Immune system, Femur, Survival, MD, SSI, Quality of life, Surgeon, Bone disease, Doctor of Philosophy, JAMA Oncology, Dentistry, Pharmaceutical industry

Their work resulted in the first-ever international, multi-center randomized controlled trial (RCT) in orthopaedic oncology as well as the largest collaborative effort in orthopaedic surgery with regards to the number of countries collaborating.

Key Points: 
  • Their work resulted in the first-ever international, multi-center randomized controlled trial (RCT) in orthopaedic oncology as well as the largest collaborative effort in orthopaedic surgery with regards to the number of countries collaborating.
  • "However, in orthopaedic oncology, where we treat rare diseases, it was a shift in our research paradigm.
  • I give a lot of credit to the first few clinical sites that joined the study as they took a leap of faith."
  • The PARITY investigators work resulted in 13 manuscripts published in peer-reviewed journals, including The Journal of the American Medical Association (Oncology).

Cepheid Receives CE Mark for Xpert® Xpress GBS

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Lundi, novembre 7, 2022
PCR, Pregnancy, Antibiotic prophylaxis, Culture, EVP, IVD, Antimicrobial stewardship, Cepheid (company), Marketing, INT, GBS, Molecular biology, Risk, Genome, Infection, Cepheid variable, Infant, Cancer, Solution, Sintering, Vaccine

SUNNYVALE, Calif., Nov. 7, 2022 /PRNewswire/ -- Cepheid announced today that it has received the CE mark for Xpert®Xpress GBS, a molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS). Xpert Xpress GBS test is expected to begin shipping to European customers this month.

Key Points: 
  • This next-generation test improves the current IVD test, Xpert GBS, by enhancing gene coverage and incorporating new dual targets in highly-conserved regions of the GBS genome.
  • With positive results as early as 30 minutes,1 Xpert Xpress GBS enables testing at the time of delivery, which provides real-time GBS status as compared to antepartum culture results earlier in pregnancy.
  • With Xpert Xpress GBS, Cepheid continues to provide fast, accurate, and reliable PCR solutions to facilitate evidence-based treatment and improved clinical care.
  • Xpert Xpress GBS is clearedto be used for screening of pregnant females, in line with the European consensus for intrapartum GBS testing.2The test is designed for use onCepheid'sGeneXpertsystems throughout Europe.

Palette Life Sciences Celebrates Twenty Years of Deflux Treatment for Vesicoureteral Reflux (VUR) in the United States

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Mardi, novembre 9, 2021
Urine, Antibiotic prophylaxis, Kidney, Pediatric urology, Urology, Caregiver, Education, VUR, Recurrence, CEO, Disease, Hyaluronic acid, Professor, FAAP, Sugar, UTI, Emory University School of Medicine, Goal, Urinary tract infection, Research, PMID, Radiation, FDA, Board, Incidence, AAP, GLOBE, Polysaccharide, Reflux nephropathy, Physician, Globe, Antibiotic, Palette, Patient, Pharmaceutical industry, Wine, Animal, Medicine

SANTA BARBARA, Calif. and STOCKHOLM, Sweden, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Palette Life Sciences, Inc., a fully integrated life sciences company dedicated to improving patient outcomes, today announced the 20th anniversary of Deflux in the United States, the only FDA-approved minimally invasive, highly effective treatment for vesicoureteral reflux (VUR).

Key Points: 
  • SANTA BARBARA, Calif. and STOCKHOLM, Sweden, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Palette Life Sciences, Inc. , a fully integrated life sciences company dedicated to improving patient outcomes, today announced the 20th anniversary of Deflux in the United States , the only FDA-approved minimally invasive, highly effective treatment for vesicoureteral reflux (VUR).
  • Deflux has been widely used as a minimally invasive treatment for VUR ever since, providing a highly effective, non-surgical treatment alternative to long-term antibiotics.
  • Deflux was available through Nestl Skin Health until 2018, when Palette Life Sciences entered into an agreement with Nestl Skin Health to license worldwide commercialization and development rights for Deflux.
  • Intermediate to long-term follow-up indicates low risk of recurrence after double hit endoscopic treatment for primary vesicoureteral reflux.