CLIA

Devyser and Thermo Fisher Scientific collaborate to promote laboratory services to advance pharmaceutical research

Retrieved on: 
Wednesday, September 13, 2023
Certification, Medicare, Centers for Medicare & Medicaid Services, CMS, CLIA, Thermo Fisher Scientific, Pharmaceutical industry

STOCKHOLM, Sept. 13, 2023 /PRNewswire/ -- Devyser and Thermo Fisher Scientific have entered into a collaboration agreement to promote laboratory services.

Key Points: 
  • STOCKHOLM, Sept. 13, 2023 /PRNewswire/ -- Devyser and Thermo Fisher Scientific have entered into a collaboration agreement to promote laboratory services.
  • The goal is to partner with pharmaceutical companies to support their development projects utilising Devyser's unique assays in its CLIA-certified laboratory.
  • The companies will work together to promote the Devyser laboratory services to support and advance research and development for pharmaceutical companies.
  • Being able to support pharmaceutical companies' development projects to enable new and improved therapies is a part of our vision for Devyser.

Psomagen Puts Spatial Biology and Multiomics in Focus, first CRO to launch 10X Genomics Xenium™ in situ Analyzer services in North America

Retrieved on: 
Tuesday, September 12, 2023
Tissue, DNA, Genomics, CAP, Gene expression, RNA, Proteomics, Science, Multiomics, CLIA, Protein, Contract research organization, Developmental biology, Gene, Neurology, Microscope, Fine chemical, Rosenbergia xenium

ROCKVILLE, Md., Sept. 12, 2023 /PRNewswire/ -- Multiomics CRO Psomagen is thrilled to announce the launch of Spatial Biology services for 10X Genomics Xenium™.

Key Points: 
  • ROCKVILLE, Md., Sept. 12, 2023 /PRNewswire/ -- Multiomics CRO Psomagen is thrilled to announce the launch of Spatial Biology services for 10X Genomics Xenium™.
  • According to Psomagen CEO Dr. Su Hong , "Psomagen's omics expertise makes us the perfect partner for North American customers."
  • Psomagen is a trusted Contract Research Organization (CRO) with nearly 20 years of genomics experience.
  • "Introducing spatial biology marks a pivotal moment in the evolution of Psomagen as a multiomics provider," stated Dr. Su Hong.

Jason Park Appointed to Newly Created Position of Managing Director for CLIA in North America and Senior Vice President of Global Government Affairs

Retrieved on: 
Tuesday, September 12, 2023
Park, Yale University, Travel, Senior, Head, Policy, Expedia Group, Human, Negotiation, Government, Akin Gump Strauss Hauer & Feld, CLIA, Columbia University School of Social Work, United States Senate Committee on Finance, Strategic Homeport, Cruise Lines International Association, Columbia Law School, Cruise line, Political science

WASHINGTON, Sept. 12, 2023 /PRNewswire/ -- Cruise Lines International Association (CLIA), the leading voice for the global cruise industry, welcomes Jason Park to the new role of Managing Director for CLIA in North America, and Senior Vice President for Global Government Affairs.

Key Points: 
  • WASHINGTON, Sept. 12, 2023 /PRNewswire/ -- Cruise Lines International Association (CLIA), the leading voice for the global cruise industry, welcomes Jason Park to the new role of Managing Director for CLIA in North America, and Senior Vice President for Global Government Affairs.
  • In this position, Park will oversee government relations, public affairs, policy development, membership and commercial efforts in the United States and Canada, reflecting similar CLIA structures in Europe, Australasia, and South America.
  • "North America is the largest passenger source market for cruising and encompasses the homeports for many of cruising's most popular itineraries.
  • I look forward to making an impact in furthering the common interests of CLIA members in North America and in collaboration with CLIA's global team."

Acutis Biosciences' CSO Dr. Abdel Halim Co-Authors a Precision Medicine Study in NEJM

Retrieved on: 
Thursday, September 7, 2023
Tissue, DNA, The New England Journal of Medicine, LDT, Qualitative research, Circulating tumor DNA, Therapy, NGS, 2005 in television, Liquid biopsy, CTA, Toxicology, Taiho Pharmaceutical, Biomarker, IHC, NEJM, CLIA, Patient, Medicine, Neoplasm, CDX, FDA, FGFR2, PCR, Cholangiocarcinoma, Medical imaging, Pharmaceutical industry, Medical device, Molecular diagnostics

Study demonstrates the clinical value of circulating tumor DNA (ctDNA) in molecular profiling.

Key Points: 
  • Study demonstrates the clinical value of circulating tumor DNA (ctDNA) in molecular profiling.
  • The study demonstrated the clinical value of circulating tumor DNA (ctDNA) in molecular profiling to assess patient's eligibility for targeted therapeutics.
  • With ctDNA blood samples you are guaranteed as low as 1% failure rate compared to tumor tissues" said Dr. Halim.
  • Acutis CEO Jibreel Sarij added, "Dr. Halim and his team are making significant impact to bring forward clinical research testing and genomic profiling to enable biopharma with deeper insights and transform precision medicine".

New environmental data report confirms step change in cruise industry uptake of new environmental technologies

Retrieved on: 
Wednesday, September 6, 2023
Sustainability, Table, Cruise line, NOx, Investment, Atmosphere, International Association, Research, Baltic Sea, SSE, CLIA, Biofuel, Private sector, Methanol, Carbon, Ship, Running, Liquefied natural gas, Wind, Sulfur, Science and technology in Asia, Ontario Basic Income Pilot Project, Cruise Lines International Association, Natural gas, Fuel oil, Renewable energy, Jet fuel, Tourism, Sewage treatment, EU, LNG

WASHINGTON, Sept. 5, 2023 /PRNewswire/ -- Cruise Lines International Association (CLIA), the leading voice of the global cruise industry, today released its 2023 Global Cruise Industry Environmental Technologies and Practices Report, showing concrete progress by the sector in advancing its environmental and sustainability agenda.

Key Points: 
  • WASHINGTON, Sept. 5, 2023 /PRNewswire/ -- Cruise Lines International Association (CLIA), the leading voice of the global cruise industry, today released its 2023 Global Cruise Industry Environmental Technologies and Practices Report, showing concrete progress by the sector in advancing its environmental and sustainability agenda.
  • Examples of progress cited include the number of alternative fuels pilot programs and trials currently in place with cruise ships.
  • Our data shows a step change in the uptake of new environmental technologies by our cruise line members.
  • Already today cruise lines are building the ships of the future which will run on new, more sustainable engine technologies.

EQS-News: Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division

Retrieved on: 
Tuesday, September 5, 2023
West Pharmaceutical Services, GMP, GLP, Laboratory, Drug development, Investigational New Drug, Clinical Laboratory, History, JMI, TIC, Chemistry, San Francisco Bay Area, CLIA, CDMO, Head, Contract research organization, Inspection, Knowledge, Testing, inspection and certification, FDA, IND, Medical writing, Fine chemical, Element, Certification

Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division

Key Points: 
  • Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division
    The issuer is solely responsible for the content of this announcement.
  • Element unveils fully integrated pharma services platform, strengthening its expanding Life Sciences Division
    05 September 2023 – Element Materials Technology (Element), a leading global Testing, Inspection and Certification (TIC) company, has launched an integrated offering for its pharmaceutical services.
  • With the unveiling of our integrated pharmaceutical services platform, Element Life Sciences now stands ready to address these challenges head-on.
  • Element Life Sciences stands as a steadfast partner, empowering pharmaceutical companies to overcome obstacles and advance their groundbreaking innovations in the dynamic and ever-evolving landscape of the life sciences industry.

LivaNova Unveils Essenz In-Line Blood Monitor with U.S. FDA 510(k) Clearance and CE Mark

Retrieved on: 
Wednesday, August 30, 2023
Cardiology, Software, Health, FDA, Medical Devices, Health Technology, Technology, Other Health, Partnership, PLC, ILBM, LIVN, Perfusion, Hematocrit, Oxygen, CE marking, Food and Drug Administration, LivaNova, CPB, Multimedia, Temperature, Cardiopulmonary bypass, Sale, United Arab Emirates, CLIA, Journal, Acute kidney injury, GDP, Patient, Risk, Stazione Sperimentale per le Industrie delle Essenze e dei Derivati dagli Agrumi, Clinical Laboratory Improvement Amendments, Perfusionist, HLM, Partial pressure, Food, Monitoring (medicine), Medical device, Medical imaging

LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark for its Essenz™ In-Line Blood Monitor (ILBM), which provides accurate and continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures.

Key Points: 
  • LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark for its Essenz™ In-Line Blood Monitor (ILBM), which provides accurate and continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures.
  • “Dynamic conditions can rapidly change a patient’s blood parameters during a cardiopulmonary bypass procedure,” said Marco Dolci, LivaNova President, Cardiopulmonary.
  • “The Essenz In-Line Blood Monitor provides continuous monitoring throughout a patient’s procedure.
  • It consists of a next-generation heart-lung machine (HLM), a patient monitor and accurate sensing technology that now includes the ILBM.

TwinStrand Biosciences Announces Executive Leadership Changes to Accelerate Adoption of Duplex Sequencing for Minimal Residual Disease (MRD) Testing for Hematological Malignancies and Cell Therapy Monitoring

Retrieved on: 
Tuesday, August 29, 2023
Duplex sequencing, Toxicity, DNA, NGS, Research, Independent director, Doctor of Philosophy, AML, CLIA, RUO, Patient, Cell, Growth, Management, Pharmaceutical industry, EU

TwinStrand® is also pleased to announce that David Canner, Partner at Soleus Capital, and Jason Myers, Independent Director, will join the TwinStrand Board of Directors.

Key Points: 
  • TwinStrand® is also pleased to announce that David Canner, Partner at Soleus Capital, and Jason Myers, Independent Director, will join the TwinStrand Board of Directors.
  • TwinStrand currently provides Duplex Sequencing assays for research use for minimal residual disease detection and genomic safety via the company's off-the-shelf kit solutions utilized on installed NGS platforms.
  • "Specifically, in markets like Acute Meyloid Leukemia and Cell Therapy Monitoring, exquisite sensitivity for detecting patient mutations promises dramatic improvement in managing the patient's treatment course.
  • We plan to establish our patented sequencing technology as the "one-stop" technology solution for all error-corrected sequencing (ecNGS) markets, from CLIA LDT to IVD-R kits in Europe.

Biomerica Reports Fiscal 2023 Year End Results

Retrieved on: 
Friday, August 25, 2023
SAB, Migraine, Osteoarthritis, Helicobacter pylori, LDT, Mayo Clinic, CRC, Hereditary diffuse gastric cancer, The American Journal of Gastroenterology, Intellectual property, EZ, Clinical and Translational Gastroenterology, COVID-19, CVS, Coronavirus Scientific Advisory Board, Completeness, Large intestine, Ulcerative colitis, Gastroesophageal reflux disease, Colorectal cancer, CLIA, American Journal, Phlebotomy, Patient, Physician, IBS, National accounts, Rome, FDA, Stomach, Pharmaceutical industry, Walmart, Gastroenterology

Net sales for the fiscal year ended May 31, 2023 were $5.3 million as compared to net sales of $18.9 million in fiscal 2022.

Key Points: 
  • Net sales for the fiscal year ended May 31, 2023 were $5.3 million as compared to net sales of $18.9 million in fiscal 2022.
  • Net loss was $7.1 million for fiscal 2023 compared to a net loss of $4.6 million for fiscal 2022.
  • The decrease in sales for fiscal 2023 was related to the Company’s decrease in sales of COVID-19 antigen tests in fiscal 2023 compared to the prior fiscal year.
  • Sales revenues excluding Covid test sales increased by 15% for fiscal 2023 compared to fiscal 2022.

Swift Sensors Launches Enhanced Regulatory Reporting for Refrigeration Monitoring Across Industries

Retrieved on: 
Friday, August 25, 2023
Vaccine, Temperature, Food, Internet of things, Refrigeration, Food quality, Sensor, Foodservice, Government, Science, Internet, School, Food storage, CLIA, Restaurant, White House Executive Chef, Buffer, Safety, Software, Instrumentation, Medical device, Warehouse, Swift

AUSTIN, Texas, Aug. 24, 2023 /PRNewswire-PRWeb/ -- Swift Sensors, a leading provider of wireless sensor technology, launched an enhanced set of reports for creating temperature logs that meet regulatory requirements for restaurants, schools, and medical labs. As part of the Swift Sensors remote monitoring and alert system, enhanced reports automate the process of creating temperature logs for various regulatory and government requirements, including health inspections for restaurants and food service establishments, school lunch programs, and CLIA-certified medical labs. For complete information, please see the Swift Sensors Refrigeration Monitoring page.

Key Points: 
  • Swift Sensors, a leading provider of wireless sensor technology, launched an enhanced set of reports for refrigeration monitoring including temperature logs that meet regulatory requirements for restaurants, schools, and medical labs.
  • For complete information, please see the Swift Sensors Refrigeration Monitoring page.
  • The core value of Swift Sensors' refrigeration monitoring system lies in its real-time alert system.
  • The Refrigeration Monitoring System is available for purchase directly through Swift Sensors and authorized distributors.