ISO 15189

Quanterix Expands Laboratory Developed Test Menu with Launch of Neurofilament Light Chain Test

Retrieved on: 
Monday, January 9, 2023

NfL is a well-studied biomarker for neuro-axonal injury with wide applicability to different neurological disorders.

Key Points: 
  • NfL is a well-studied biomarker for neuro-axonal injury with wide applicability to different neurological disorders.
  • Any disorder or injuring force resulting in neuronal damage can lead to the release of NfL into the interstitial fluid and cerebrospinal fluid (CSF).
  • A fraction of these proteins diffuses into the blood, where concentrations are typically 50- to 100-fold lower than in CSF and difficult to measure with conventional immunoassay technologies.
  • “Assessment and monitoring of brain health is incredibly difficult and typically performed in limited fashion by surgery or imaging.

Quanterix Launches First pTau-181 Plasma Laboratory Developed Test for Clinical Diagnostic and Research Applications in the U.S.

Retrieved on: 
Wednesday, July 27, 2022

Quanterix LDT the first pTau-181 plasma test released for clinical use in the U.S. is a quantitative immunoassay intended for the measurement of pTau-181 concentration in human plasma.

Key Points: 
  • Quanterix LDT the first pTau-181 plasma test released for clinical use in the U.S. is a quantitative immunoassay intended for the measurement of pTau-181 concentration in human plasma.
  • Today is a big, new translational step on our mission as our pTau-181 plasma test will aid in the diagnostic evaluation of patients suspected of having Alzheimers disease.
  • Alongside our pTau-181 clinical test, we also continue to innovate by making markers like NfL available to advance neurodegenerative disease research and therapeutic clinical trials.
  • The pTau-181 LDT will be offered through Quanterix Accelerator Laboratory , a CLIA-licensed and ISO 15189 accredited laboratory fully equipped to support both clinical diagnostic testing and translational research.

BioAgilytix Closes Acquisition of Australia-based 360biolabs®

Retrieved on: 
Thursday, October 14, 2021

DURHAM, N.C., Oct. 14, 2021 /PRNewswire/ -- BioAgilytix Labs, LLC (BioAgilytix), a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development, announced today that, following Australian Foreign Investment Review Board ("FIRB") approval, it officially closed the purchase of 360biolabs®. The acquisition of the company, now known as 360biolabs, a BioAgilytix company, expands BioAgilytix's capabilities into first-in-human trials (FIH), early-phase clinical trials and adds additional capacity by joining 360biolabs' internationally recognized quality systems in Melbourne and Brisbane with its existing laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California and Hamburg, Germany.

Key Points: 
  • "We are delighted to announce the final close of the 360biolabs acquisition, as it's such positive and exciting news for our global team and customers.
  • Our expanded capacity, expertise and agility to now serve clients across all geographies is unprecedented," said Jim Datin, President and CEO of BioAgilytix.
  • BioAgilytix selected White & Case as legal counsel to oversee the closing of the acquisition, with Lazards Australia and Allens representing 360biolabs.
  • 360biolabs, a BioAgilytix company, is the leading and most comprehensive specialty laboratory in the Australia and New Zealand region.

BioAgilytix Closes Acquisition of Australia-based 360biolabs®

Retrieved on: 
Thursday, October 14, 2021

DURHAM, N.C., Oct. 14, 2021 /PRNewswire/ -- BioAgilytix Labs, LLC (BioAgilytix), a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development, announced today that, following Australian Foreign Investment Review Board ("FIRB") approval, it officially closed the purchase of 360biolabs®. The acquisition of the company, now known as 360biolabs, a BioAgilytix company, expands BioAgilytix's capabilities into first-in-human trials (FIH), early-phase clinical trials and adds additional capacity by joining 360biolabs' internationally recognized quality systems in Melbourne and Brisbane with its existing laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California and Hamburg, Germany.

Key Points: 
  • "We are delighted to announce the final close of the 360biolabs acquisition, as it's such positive and exciting news for our global team and customers.
  • Our expanded capacity, expertise and agility to now serve clients across all geographies is unprecedented," said Jim Datin, President and CEO of BioAgilytix.
  • BioAgilytix selected White & Case as legal counsel to oversee the closing of the acquisition, with Lazards Australia and Allens representing 360biolabs.
  • About 360biolabs, a BioAgilytix company360biolabs, a BioAgilytix company, is the leading and most comprehensive specialty laboratory in the Australia and New Zealand region.

University of Utah, ARUP, and Techcyte Develop NanoSpot.AI, a New Ultra-Fast Test for COVID-19 Antibodies

Retrieved on: 
Thursday, April 29, 2021

View the full release here: https://www.businesswire.com/news/home/20210429005795/en/\nAfter a NanoSpot.A1 rapid COVID-19 antibody test has been completed, the person administering the test takes a picture of the test card using a mobile phone.

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20210429005795/en/\nAfter a NanoSpot.A1 rapid COVID-19 antibody test has been completed, the person administering the test takes a picture of the test card using a mobile phone.
  • The image is transmitted to Techcyte Inc. for analysis using Techcyte\xe2\x80\x99s artificial intelligence-based image analysis tool.
  • One of the spots displays the test result while the other two confirm the test was properly run.
  • ARUP is ISO 15189 CAP accredited.\nHeadquartered in Orem, Utah, Techcyte Inc. is the world leader in AI-based digital diagnostics for liquids and cells.

ARUP Announces Retirement of CEO Sherrie L. Perkins, Appointment of President Andy Theurer to Replace Her as CEO

Retrieved on: 
Tuesday, April 13, 2021

b'SALT LAKE CITY, April 13, 2021 /PRNewswire/ --ARUP Laboratories today announced the retirement of CEO Sherrie L. Perkins, MD, PhD, effective June 30, 2021.

Key Points: 
  • b'SALT LAKE CITY, April 13, 2021 /PRNewswire/ --ARUP Laboratories today announced the retirement of CEO Sherrie L. Perkins, MD, PhD, effective June 30, 2021.
  • In the role, Perkins led ARUP through a time of enormous growth and change, and recently, through a global pandemic.
  • Before becoming president in 2017, when Perkins became CEO, he had been senior vice president and chief financial officer for 17 years.
  • ARUP is ISO 15189 CAP accredited.\nPhotos of all of the ARUP executives are available upon request.\nView original content to download multimedia: http://www.prnewswire.com/news-releases/arup-announces-retirement-of-ceo...\n'

Agiomix Receives the First ISO 15189 Accreditation for Next Generation Sequencing in the Region

Retrieved on: 
Sunday, March 14, 2021

DUBAI, UAE, March 14, 2021 /PRNewswire/ -- Agiomix has received the ISO 15189:2012 Accreditation from the Emirates International Accreditation Centre for Next Generation Sequencing clinical assays.

Key Points: 
  • DUBAI, UAE, March 14, 2021 /PRNewswire/ -- Agiomix has received the ISO 15189:2012 Accreditation from the Emirates International Accreditation Centre for Next Generation Sequencing clinical assays.
  • This makes Agiomix the first and only clinical laboratory in the region to have both the CAP and ISO 15189 accreditation for its Next Generation Sequencing (NGS) clinical genetic testing.
  • Dr. Walaa Allam, Associate Director of Business development at Agiomix commented, "With this additional reputable international accreditation, Agiomix now has the unique capacity to offer its healthcare partners and patients, unparalleled clinical diagnostics services in the area of genetics, we are very pleased and honored by this accreditation and we look forward to more international recognition as our services and family grow."
  • Agiomix is a leading Clinical Genetics and Specialty Diagnostics Laboratory, serving patients, healthcare providers and partner laboratories across the globe, with focus on the Middle East, Africa and Asia markets, Agiomix is both CAP and ISO 15189 accredited.

Agiomix Receives the First ISO 15189 Accreditation for Next Generation Sequencing in the Region

Retrieved on: 
Sunday, March 14, 2021

DUBAI, UAE, March 14, 2021 /PRNewswire/ -- Agiomix has received the ISO 15189:2012 Accreditation from the Emirates International Accreditation Centre for Next Generation Sequencing clinical assays.

Key Points: 
  • DUBAI, UAE, March 14, 2021 /PRNewswire/ -- Agiomix has received the ISO 15189:2012 Accreditation from the Emirates International Accreditation Centre for Next Generation Sequencing clinical assays.
  • This makes Agiomix the first and only clinical laboratory in the region to have both the CAP and ISO 15189 accreditation for its Next Generation Sequencing (NGS) clinical genetic testing.
  • Dr. Walaa Allam, Associate Director of Business development at Agiomix commented, "With this additional reputable international accreditation, Agiomix now has the unique capacity to offer its healthcare partners and patients, unparalleled clinical diagnostics services in the area of genetics, we are very pleased and honored by this accreditation and we look forward to more international recognition as our services and family grow."
  • Agiomix is a leading Clinical Genetics and Specialty Diagnostics Laboratory, serving patients, healthcare providers and partner laboratories across the globe, with focus on the Middle East, Africa and Asia markets, Agiomix is both CAP and ISO 15189 accredited.

British High Commissioner Dr. Christian Turner Inaugurates Robot-Operated Covid-19 Testing Lab in Islamabad

Retrieved on: 
Sunday, November 15, 2020

Built in the United Kingdom by Opencell UK, the laboratory is a Biosafety Level 2 plus (BSL-2+) facility built to ISO 15189 standards.

Key Points: 
  • Built in the United Kingdom by Opencell UK, the laboratory is a Biosafety Level 2 plus (BSL-2+) facility built to ISO 15189 standards.
  • The state-of-art lab is specified to meet the requirements for high throughput Covid-19 RT-qPCR testing.
  • Due to the use of 5 liquid handling robots, this lab requires as little as 6 staff members to operate all the shifts.
  • While speaking at the event, High Commissioner Dr. Christian Turner thanked Ambassador Ali Jehangir Siddiqui for "making him excited about the project.

Smith Earns ISO/IEC 17025 Accreditation at Its European Distribution Center

Retrieved on: 
Monday, August 19, 2019

ISO/IEC 17025 accreditation establishes technical competence for the defined procedures and operation of a laboratory's quality management system.

Key Points: 
  • ISO/IEC 17025 accreditation establishes technical competence for the defined procedures and operation of a laboratory's quality management system.
  • Smith's global headquarters in Houston and Asian headquarters in Hong Kong received ISO/IEC 17025 accreditation in 2012 and 2013, respectively.
  • The ISO/IEC 17025 standard outlines both the specific mechanical testing requirements for electronic components and calibration services for equipment in the lab.
  • "Earning ISO/IEC 17025 accreditation in Amsterdam further showcases Smith's commitment to providing the highest-quality electronic components to customers worldwide," continued Wehby.