CLSI

The Clinical and Laboratory Standards Institute Announces the Publication of New Antimicrobial Susceptibility Testing Documents CLSI M100-Ed34, M02-Ed14, and M07-Ed12

Retrieved on: 
Tuesday, March 26, 2024
M11, Quality control, Government, Communication, Doctor of Pharmacy, Clinical, Committee, CLSI, Accreditation, Salmonella, Table, Laboratory, M02, M07, Microbiology, Patient safety, Multimedia, Medical device

MALVERN, Pa., March 26, 2024 /PRNewswire/ -- The Clinical and Laboratory Standards Institute (CLSI) has released a new update of CLSI M100—Performance Standards for Antimicrobial Susceptibility Testing, 34th Edition and revised editions of CLSI M02—Performance Standards for Antimicrobial Disk Susceptibility Tests, 14th Edition and CLSI M07—Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, 12th Edition .

Key Points: 
  • MALVERN, Pa., March 26, 2024 /PRNewswire/ -- The Clinical and Laboratory Standards Institute (CLSI) has released a new update of CLSI M100—Performance Standards for Antimicrobial Susceptibility Testing, 34th Edition and revised editions of CLSI M02—Performance Standards for Antimicrobial Disk Susceptibility Tests, 14th Edition and CLSI M07—Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, 12th Edition .
  • The tables presented in CLSI M100 represent the most current information for drug selection, interpretation, and quality control using the procedures defined in CLSI standards CLSI M02 , M07 , and M11 .
  • Users should replace previously published tables with the new edition of CLSI M100 to ensure accurate testing and patient safety.
  • In addition, CLSI will host its annual What's New in the 2024 CLSI Standards for Antimicrobial Susceptibility Testing webinar on 17 April 2024 from 1:00-2:30 PM ET.

GeminiBio Appoints Mike Guerra to its Board of Directors

Retrieved on: 
Tuesday, February 20, 2024
CLS, CLSI, CSBA, Growth, VWR International, Council, Policy, CGMP, Management

FORT LAUDERDALE, Fla. and WEST SACRAMENTO, Calif., Feb. 20, 2024 /PRNewswire/ -- Gemini BioProducts Holding, Inc. ("GeminiBio" or the "Company"), a portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a Florida-based healthcare private equity firm, announced the appointment of Mike Guerra to its Board of Directors.

Key Points: 
  • FORT LAUDERDALE, Fla. and WEST SACRAMENTO, Calif., Feb. 20, 2024 /PRNewswire/ -- Gemini BioProducts Holding, Inc. ("GeminiBio" or the "Company"), a portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a Florida-based healthcare private equity firm, announced the appointment of Mike Guerra to its Board of Directors.
  • Mr. Guerra serves as President and Chief Executive Officer of California Life Sciences (CLS), California's most impactful and influential trade association advocating for California's life sciences industry.
  • In addition, Mr. Guerra currently sits on the Board of Directors for California Life Sciences (CLS), California Life Sciences Institute (CLSI) and serves as Vice Chair of the Council of State Bioscience Associations (CSBA).
  • Mike Guerra added "I am thrilled to join GeminiBio's board of directors and support their continued success and growth in California, and across the US.

ContraFect to Present at the ASM/ESCMID Joint Conference on Drug Development

Retrieved on: 
Tuesday, September 19, 2023
Staphylococcus, MIC, CLSI, Clinical trial, Medical microbiology, Staphylococcus aureus, Patient, Antimicrobial resistance, Clinical and Laboratory Standards Institute, Drug development, Challenge, Campaign, AST, Laboratory, Conference, Clinical, Knee, Peptide, Sosa, Pharmaceutical industry

Dr. Ambler’s presentation will review the current standards for antimicrobial susceptibility testing (AST) for the determination of antibacterial activity of therapeutic agents and the implications for clinical development.

Key Points: 
  • Dr. Ambler’s presentation will review the current standards for antimicrobial susceptibility testing (AST) for the determination of antibacterial activity of therapeutic agents and the implications for clinical development.
  • She will highlight and discuss various antibiotics in current use and several investigational agents that require a modified AST method, such as the Company’s DLAs.
  • Review and approval of new AST methods by standards development organizations, such as the Clinical and Laboratory Standards Institute (CLSI), is essential.
  • The Company will be presenting two posters describing the initial development of the exebacase MIC method for testing Staphylococci other than Staphylococcus aureus (SoSA) and method verification studies performed to evaluate test performance.

Framework Solutions Launches Commercialization Services with Appointment of Key Executive

Retrieved on: 
Thursday, April 27, 2023
Organization, Growth, CLSI, Head, The Journal of Life Sciences, Management, Framework

DANBURY, Conn., April 27, 2023 /PRNewswire/ -- Framework Solutions, LLC ("Frameworks" or the "Company"), a leading provider of end-to-end services to the Life Sciences industry, today announced the appointment of Russ Belden as Head of Commercial Solutions, effective April 26th, 2023.

Key Points: 
  • DANBURY, Conn., April 27, 2023 /PRNewswire/ -- Framework Solutions, LLC ("Frameworks" or the "Company"), a leading provider of end-to-end services to the Life Sciences industry, today announced the appointment of Russ Belden as Head of Commercial Solutions, effective April 26th, 2023.
  • "We are extremely pleased to welcome Russ to the Executive team," said Joe Walsh, CEO of Frameworks.
  • Russ has a results-driven mindset, and his expertise is in all forms of commercialization, commercial and competitive assessments, and gaining alignment of Executive teams & boards on commercialization.
  • "I look forward to adding an array of go-to-market commercial services for emerging biopharma and several unique, highly differentiated services for established mid to large commercial organizations."

DURECT Corporation Announces Appointment of Gail Maderis as Chair of the Board

Retrieved on: 
Tuesday, March 21, 2023
BIO, BS, Chairperson, CLSI, Audit, Compensation, Henri Termeer, MBA, Genzyme, Trustee, Patient, Harvard Business School, HPV, Therapy, Management

CUPERTINO, Calif., March 21, 2023 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today that Gail Maderis has assumed the role of Chair of the Board of DURECT effective March 17, 2023.

Key Points: 
  • CUPERTINO, Calif., March 21, 2023 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today that Gail Maderis has assumed the role of Chair of the Board of DURECT effective March 17, 2023.
  • "We thank Dave for his many years of service on the DURECT Board and wish him well," stated James E. Brown, D.V.M., President and CEO of DURECT.
  • Gail Maderis has been on the DURECT Board since January 2021, serving on the Audit and Compensation committees.
  • Ms. Maderis commented, "I am honored to be elected to serve as Chair of DURECT's Board of Directors.

Rare Event Analysis in Flow Cytometry: Design Control and Validation Aligned with CLSI H62, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, March 15, 2023
CD34, Research, Drug discovery, Drug development, MRD, CLSI, Design controls, Cell, CAR, PNH, Validation, Cytokine, Clinical Laboratory, Clinical trial, Flow cytometry, Doctor of Philosophy, Bone marrow, Bureau of Oceans and International Environmental and Scientific Affairs, Medical device

TORONTO, March 15, 2023 /PRNewswire-PRWeb/ -- Rare event analysis by flow cytometry is relatively common in research settings, in clinical laboratories and during drug discovery and development. For example, in research and drug discovery environments, the measurement of intracellular cytokines and intracellular signaling events (i.e., protein phosphorylation) are some of the more common rare event assays. Whereas in clinical laboratories, assays for rare events often include the measurement of CD34+ hematopoietic stem cells, paroxysmal nocturnal hemoglobinuria (PNH) and minimal residual disease (MRD) of blood cancers. During drug development and clinical trial evaluation of new therapeutic modalities, rare event methods might also include the monitoring of CAR cellular therapies and the efficacy of cell-depleting therapies.

Key Points: 
  • In this free webinar, learn about rare event analysis in flow cytometry using design control and validation approaches aligned with CLSI H62.
  • Attendees will learn how the application of Design Control during assay design and development will lead to successful outcomes.
  • Attendees will learn impact of instrument set-up, panel design and assay optimization on the validation of the assay specificity and sensitivity.
  • Register today and learn about rare event analysis in flow cytometry using design control and validation approaches aligned with CLSI H62.

CAP Marks 10+ Years in Ensuring Quality NGS Testing

Retrieved on: 
Thursday, February 23, 2023
Research, Other Health, General Health, Technology, Infectious Diseases, Continuing, University, Health Technology, Education, Science, Biotechnology, Other Technology, Health, NGS, Clinical, American College, CAP, CDC, Pathology, AMP, Organization, PT, Partnership, American College of Medical Genetics and Genomics, FDA, CLSI, Guideline, Accreditation, Medical genetics, Korea Disease Control and Prevention Agency, ACMG, Exome, Personalized medicine, Food, Food and Drug Administration, Medical device, MD, Genomics

Precision medicine continues to gain momentum from the laboratory benchtop to the patient's bedside, with the CAP leading—as it has for over 10 years—in improving quality of next-generation sequencing (NGS) testing through laboratory accreditation and proficiency testing (PT) programs.

Key Points: 
  • Precision medicine continues to gain momentum from the laboratory benchtop to the patient's bedside, with the CAP leading—as it has for over 10 years—in improving quality of next-generation sequencing (NGS) testing through laboratory accreditation and proficiency testing (PT) programs.
  • “The CAP was the first accrediting organization in the U.S. to publish accreditation requirements specific to NGS to address its emerging use in diagnostic testing,” explained CAP President Emily E. Volk, MD, FCAP, adding that over 10 years ago, the NGS requirements were published in the 2012 Edition of the CAP Molecular Pathology checklist.
  • The CAP is also working with the CDC to develop standards related to NGS testing.
  • CAP launched its first wet specimen NGS germline PT program in 2015; somatic solid tumor and hematologic NGS PT programs were added in 2016.

The National Quality Forum (NQF) Endorses Centers for Disease Control and Prevention's (CDC) New Blood Culture Contamination Quality Measure

Retrieved on: 
Wednesday, February 8, 2023
Consensus, Acute kidney injury, Centers for Medicare & Medicaid Services, Blood culture, Patient safety, Hospital, Blood, Korea Disease Control and Prevention Agency, CSAC, Clinical and Laboratory Standards Institute, Patient, Fungal infection, CLSI, Safety, Magnolia, Sepsis, Medicare, Bloodstream infections, Infection, Risk, CDC, Laboratory, Clinical, Guideline, Invention, CMS, Antimicrobial, Clostridioides difficile infection, NQF, Nursing, Vaccine, Pharmaceutical industry

SEATTLE, Feb. 8, 2023 /PRNewswire/ -- Magnolia Medical Technologies, Inc. ("Magnolia Medical"), inventors of the Steripath® Initial Specimen Diversion Device® (ISDD®) family of products, today commended the NQF Consensus Standards Approval Committee (CSAC) for its formal endorsement of the new CDC Quality Measure 3658, entitled: Adult Blood Culture Contamination Rate; A national measure and standard for clinical laboratories and antibiotic stewardship programs.1

Key Points: 
  • The NQF's recent endorsement of this important new measure reflects the diagnostic significance of blood cultures in the detection of bloodstream infections, including sepsis.
  • The planned use of this measure is to support hospital-specific quality improvement projects, public reporting, and regulatory and accreditation programs associated with the suspected sepsis patient population.
  • Standardizing how blood culture contamination is defined, tracked, monitored, and reported will benefit millions of patients and save our healthcare system billions of dollars under the new standard of care.
  • The CDC Guidelines also provided eight evidence-based practices for reducing blood culture contamination rates, including the use of Initial Specimen Diversion Devices® that divert the initial 1 to 2 mL of potentially contaminated blood prior to blood collection.6,7

FDA Clears 'Selux NGP System' for Rapid Antibiotic Susceptibility Testing

Retrieved on: 
Thursday, January 19, 2023
Biomedical Advanced Research and Development Authority, Infection, NGP, Development, Office of Inspector General, U.S. Department of Health and Human Services, AMR, Administration, CLSI, Regulation of tobacco by the U.S. Food and Drug Administration, Doctor of Pharmacy, FDA, Oregon Health & Science University, Death, BARDA, Food, ASPR, Patient, Oregon Health Plan, Cancer, HHS, Oregon Health and Science University Center for Women's Health, AST, Vaccine, Pharmaceutical industry, FIDSA

The FDA clearance is for Selux Diagnostics' in vitro antimicrobial resistance test, which determines a bacteria's susceptibility to 14 specific antimicrobial agents on the Selux Gram-Positive Panel.

Key Points: 
  • The FDA clearance is for Selux Diagnostics' in vitro antimicrobial resistance test, which determines a bacteria's susceptibility to 14 specific antimicrobial agents on the Selux Gram-Positive Panel.
  • Selux's NGP Gram-Negative panel is currently under review by the FDA.
  • "This clearance represents a significant advance in infectious disease care and the fight to address antibiotic resistance.
  • Our groundbreaking Selux NGP System holds the potential to save lives and decrease overreliance on broad-spectrum antibiotics, a key factor contributing to the rise of superbugs.

BD, Magnolia Medical Technologies Announce Commercial Collaboration to Help Reduce Blood Culture Contamination and Improve Testing Accuracy

Retrieved on: 
Tuesday, October 18, 2022
ZERO, LinkedIn, CDC, Disease, Therapy, Efficiency, BDX, Organization, Laboratory, NYSE, ISDT, Patient, Hospital, Blood culture, Twitter, Collection, Clinical, Centers for Disease Control and Prevention, Solution, Goal, Antimicrobial stewardship, Company, Sepsis, Becton, Dickinson and Company headquarters, Health, Blood, CEO, Awareness, Clinical and Laboratory Standards Institute, Patent, Becton, Safety, Vancomycin, CLSI, Intellectual property, Death, FDA, BD, Pharmaceutical industry, Medical device

FRANKLIN LAKES, N.J., Oct. 18, 2022 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Magnolia Medical Technologies, Inc., today announced a co-exclusive commercial agreement aimed at helping U.S. hospitals reduce blood culture contamination to help improve testing accuracy and ultimately improve clinical outcomes.

Key Points: 
  • FRANKLIN LAKES, N.J., Oct. 18, 2022 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Magnolia Medical Technologies, Inc., today announced a co-exclusive commercial agreement aimed at helping U.S. hospitals reduce blood culture contamination to help improve testing accuracy and ultimately improve clinical outcomes.
  • Reducing blood culture contamination can help improve testing accuracy and ultimately improve clinical outcomes and may lessen the threat of antibiotic resistance by giving health care practitioners more specific, reliable results."
  • Magnolia Medical Technologies develops, manufactures, and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency, and predictability of critical laboratory tests.
  • Magnolia Medical invented and patented the Initial Specimen Diversion Technique (ISDT) and Initial Specimen Diversion Device (ISDD) for blood culture collection and contamination prevention.