CLIA

Keystone Lab Announces Addition of Tianeptine to Testing Menu

Retrieved on: 
Tuesday, February 13, 2024
Clozapine, Anxiety, Opioid use disorder, Modafinil, Diphenhydramine, FDA, Pain, MC5, Aripiprazole, Food and Drug Administration, Forensic toxicology, Loperamide, Death, Keystone, Neptune, Abdominal pain, Patient, CLIA, Urine, Tianeptine, Depression

ASHEVILLE, N.C., Feb. 13, 2024 /PRNewswire/ -- Keystone Lab , a dual-CAP accredited and CLIA certified lab based in Asheville, NC, has officially added tianeptine to its in-house urine clinical toxicology menu.

Key Points: 
  • ASHEVILLE, N.C., Feb. 13, 2024 /PRNewswire/ -- Keystone Lab , a dual-CAP accredited and CLIA certified lab based in Asheville, NC, has officially added tianeptine to its in-house urine clinical toxicology menu.
  • Keystone provides clinical and forensic toxicology testing services throughout the southeastern U.S. and is one of few labs in the southeast to offer testing for tianeptine.
  • In addition to tianeptine and its metabolite, tianeptine metabolite MC5, Keystone has also added clozapine, N-desmethylclozapine, aripiprazole, aripiprazole metabolite OPC-3373, modafinil, diphenhydramine, loperamide, and 7OH-mitragynine to its in-house menu.
  • "By adding tianeptine testing in-house, Keystone is able to listen to its clients and provide the best service possible to their patients."

Enable Biosciences Publishes Study Revealing ADAP Technology's Improved Accuracy in T1D Risk Prediction

Retrieved on: 
Tuesday, February 13, 2024
ADAP, SAN, Real-time, Doctor of Philosophy, NPV, PPV, Laboratory developed test, Risk, Autoantibody, Carolyn Bertozzi, Risk assessment, CLIA, RBA, T1D, CAP, NIDDK, Public, Pharmaceutical industry

Detailed findings are presented in the article "Advances in risk predictive performance of pre-symptomatic type 1 diabetes via the multiplex Antibody-Detection-by-Agglutination-PCR (ADAP) assay," published in Frontiers of Endocrinology.

Key Points: 
  • Detailed findings are presented in the article "Advances in risk predictive performance of pre-symptomatic type 1 diabetes via the multiplex Antibody-Detection-by-Agglutination-PCR (ADAP) assay," published in Frontiers of Endocrinology.
  • This pivotal study underscores the ADAP assay's ability to detect islet autoantibodies, which are indicative of a high risk of progression to clinical T1D.
  • Dr. Jason Tsai, PhD, CTO of Enable Biosciences, elaborates on the significance of the findings: "These study results reinforce the strength of our ADAP technology in early T1D detection.
  • For more insights into Enable Biosciences and the impact of their ADAP technology, please visit www.enablebiosciences.com .

binx health Enters into National Distribution Agreement with Cardinal Health to Increase Access to the CLIA-waived, FDA-cleared binx io

Retrieved on: 
Monday, February 12, 2024
Cardinal, Hospital, POC, FDA, Infection, Female, Pharmacy, Cardinal Health, Emergency, World Congress, Patient, CLIA, Diagnosis, Male, Gonorrhea, Chlamydia, STI, Medical imaging

Collaborating with Cardinal Health provides binx health with additional access to the acute clinical care settings via its vast sales network in the market.

Key Points: 
  • Collaborating with Cardinal Health provides binx health with additional access to the acute clinical care settings via its vast sales network in the market.
  • We are proud that we have earned their trust in binx and the binx io," said Jeffrey Luber, binx health’s Chief Executive Officer.
  • With this distribution collaboration, together binx health and Cardinal Health teams will help improve access to the treatment of CT/NG.
  • For more information about the binx io, visit mybinxhealth.com/binx-io or contact your Cardinal Health representative.

Previse Unveils New Headquarters and State-of-the Art Lab to Meet Growing Demand for Esopredict Test

Retrieved on: 
Thursday, February 8, 2024
DNA methylation, Growth, Heart, Health, Physician, GI, DNA, Risk, Patient, Research, CLIA

BALTIMORE, Feb. 8, 2024 /PRNewswire/ -- Previse, a company focused on improving health for patients with gastrointestinal diseases, today announced that it has relocated its headquarters and opened a new state-of-the-art CLIA high complexity laboratory in Baltimore, MD to meet demands for the company's first clinically available test, Esopredict.

Key Points: 
  • Esopredict, the first and only commercially available test that assesses DNA methylation levels to risk stratify patients with esophageal pre-cancer, analyzes epigenetic biomarkers to provide GI physicians and their patients personalized predictive data to guide patient treatments and endoscopic surveillance.
  • The expansion of Previse's CLIA lab increases its testing capacity to serve an additional 10,000 patients annually, which is a significant stride towards improving access to precise and expeditious diagnostic services.
  • Daniel Lunz, Co-founder and CEO, commented on the growth, "Our new headquarters and the expanded lab reflect our unwavering commitment to enhancing the value provided to physicians and patients, which is at the heart of our innovation-driven ethos."
  • The move will also expand the research capabilities of Previse, as the company develops additional innovative technologies including minimally invasive tests for upper GI disease detection and monitoring and to further service ongoing research partnerships.

Fapon at Medlab Middle East 2024: Advancing Local Healthcare through IVD Technologies

Retrieved on: 
Wednesday, February 7, 2024
Partnership, Growth, HCV, Therapy, HIV, Exhibition, HBV, CLIA, IVD, NGS, PCR, Medical device

Dedicated to leveraging its cutting-edge technologies and vast industry experience, Fapon aims to support the growth of the local IVD industry, enhancing local healthcare services while strengthening its global diagnostics ecosystem.

Key Points: 
  • Dedicated to leveraging its cutting-edge technologies and vast industry experience, Fapon aims to support the growth of the local IVD industry, enhancing local healthcare services while strengthening its global diagnostics ecosystem.
  • Committed to empowering local IVD companies and boosting the development of the local healthcare industry in the Middle East, Fapon has established a strategic partnership with the China Innovation Center (C.I.C.)
  • This collaboration aims to introduce Fapon's innovative technologies, products, and services in diagnostics and therapeutics for the medical advancement of the local healthcare industry.
  • Looking ahead, Fapon will remain rooted in the local market in the Middle East, strengthening collaborations with local partners and enhancing healthcare services for the local region.

Celerion Achieves Milestone With CLIA Certification for Its Bioanalytical Laboratory, Expanding Capabilities in Clinical Trials and Diagnostic Testing

Retrieved on: 
Tuesday, February 6, 2024
Health, Clinical Trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, CMS, Accreditation, Clinical trial, Certification, Clinical Laboratory, Neutralizing antibody, Diagnosis, CLIA, Pharmaceutical industry

Celerion , a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) certification for its state-of-the-art bioanalytical laboratory located in Lincoln, Nebraska.

Key Points: 
  • Celerion , a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) certification for its state-of-the-art bioanalytical laboratory located in Lincoln, Nebraska.
  • Celerion’s clinical laboratories, including their Lincoln site, have been CLIA-certified and CAP-accredited for over 25 years, which helped facilitate the CLIA certification of the laboratory.
  • The CLIA certification is a testament to Celerion’s adherence to the highest standards of laboratory quality and competence.
  • With this certification, Celerion’s bioanalytical laboratory is now able to conduct lab-developed tests in specialized areas such as diagnostic immunology.

Ultima Genomics Announces End of Early Access and Upcoming Launch of UG 100™

Retrieved on: 
Tuesday, January 30, 2024
Biotechnology, Pharmaceutical, Medical Supplies, Oncology, Health, Medical Devices, Health Technology, Genetics, Partnership, Whole genome sequencing, Genomics, Liquid biopsy, Workflow, Gold, Research, DNA, Access, Science, Environment, Patient, Exact sciences, Diagnosis, CLIA, Broad Institute, Laboratory, Chemistry, Harvard University, Drug discovery, Automation, Weill Cornell Medicine, Disease, Biophysics, Silicon, Biology, MIT, Physiology, Doctor of Philosophy, Medicine, Cancer, Genome, Early access, SNV

The UG 100™ is an ultra-high throughput system purposefully built for high-volume applications.

Key Points: 
  • The UG 100™ is an ultra-high throughput system purposefully built for high-volume applications.
  • “After much anticipation, we are excited to publicly announce the full commercial availability of the $100 genome at the upcoming AGBT conference in February,” said Gilad Almogy, Founder and CEO of Ultima.
  • We are excited to be an early adopter of Ultima’s technology and the first to have the instrument installed in the Asia-Pacific region.
  • Ultima will be introducing the UG 100™ and will be providing additional information about its ppmSeq™ technology on February 6th at the AGBT conference as part of its Gold Sponsorship plenary presentation.

bioAffinity Technologies In The News

Retrieved on: 
Tuesday, January 30, 2024
Technology, Surgery, Medical Devices, General Health, Science, Genetics, Clinical Trials, FDA, Biotechnology, Health, Health Technology, Research, Software, Other Health, Radiology, Pharmaceutical, Oncology, Intelligence, Lung cancer, College, Therapy, Clinical Laboratory, Sputum, CLIA, BIAF, Laboratory, Artificial intelligence, TCPP, Patent, Lung, Accreditation, CAP, Porphyrin, Cancer, Malignancy, Medical imaging

bioAffinity Technologies , Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer and lung disease, provides a summary of recent Company news.

Key Points: 
  • bioAffinity Technologies , Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer and lung disease, provides a summary of recent Company news.
  • Precision Pathology Laboratory Services (PPLS), a bioAffinity Technologies company, successfully passed the rigorous biannual inspection required for College of American Pathologists (CAP) accreditation.
  • ScienceSoft , which provides IT consulting and software development services to more than 1,200 clients around the globe, recently published a case study of its work with bioAffinity Technologies.
  • More than 1,000 people registered for Webull Corporate Connect’s recent investment webinar that featured bioAffinity Technologies ’ President and CEO Maria Zannes and two other healthcare executives.

Beckman Coulter Unveils DxC 500 AU Chemistry Analyzer, Expanding Portfolio with Proven Six Sigma Performance

Retrieved on: 
Tuesday, January 30, 2024
Senior, Sigma, CLIA, QC, Beckman Coulter, Chemistry, Small Business Saturday, DXC, Medical device

DUBAI, UAE, Jan. 29, 2024 /PRNewswire/ -- Beckman Coulter Diagnostics, a clinical diagnostics leader, will unveil its new DxC 500 AU Chemistry Analyzer, an automated clinical chemistry analyzer, at Medlab Middle East in Dubai, taking place February 5-8, 2024. The DxC 500 AU Chemistry Analyzer is one of several recent Beckman Coulter solutions designed to address the complete needs of healthcare systems that are looking to complement central hub laboratories by advancing the technology and capabilities of satellite and independent hospital laboratories.

Key Points: 
  • DUBAI, UAE, Jan. 29, 2024 /PRNewswire/ -- Beckman Coulter Diagnostics, a clinical diagnostics leader, will unveil its new DxC 500 AU Chemistry Analyzer, an automated clinical chemistry analyzer, at Medlab Middle East in Dubai, taking place February 5-8, 2024.
  • The new DxC 500 AU Chemistry Analyzer advances capabilities of spoked labs with a broad menu of high-quality assays that deliver consistent, commutable results across Beckman Coulter's AU clinical chemistry systems, positively impacting clinical decision-making and patient outcomes."
  • The DxC 500 AU Chemistry Analyzer features advanced automation technology, onboard guided workflows, and standardized reagents for use across healthcare networks.
  • The DxC 500 AU Chemistry Analyzer is for in vitro diagnostic use only.

World Market for Laboratory Information Systems (LIS): Software, Hardware, and Implementation for Clinical Labs, 2022-2027 - ResearchAndMarkets.com

Retrieved on: 
Monday, January 22, 2024
Health, Pharmaceutical, Technology, Clinical Trials, Software, Growth, LIMS, CLIA, Implementation, Hardware, Laboratory, Nature, Research, ROW, United, LIS, Medical device

The "World Market for Laboratory Information Systems (LIS): Software, Hardware, and Implementation for Clinical Labs, 2022-2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "World Market for Laboratory Information Systems (LIS): Software, Hardware, and Implementation for Clinical Labs, 2022-2027" report has been added to ResearchAndMarkets.com's offering.
  • This new report examines the current and potential world opportunity for healthcare laboratory information system (LIS) software, hardware, and implementation.
  • The report also reviews the nature and direction of trends and research, and gives insight into some issues facing the industry.
  • Further, large manufacturers that have made names for themselves in the field, as well as smaller firms with market niches are highlighted.