In a groundbreaking collaboration, Visiopharm and the UK National External Quality Assessment Scheme for Immunocytochemistry and In-Situ Hybridisation (UK NEQAS ICC & ISH) are setting new standards in the quality control of IHC testing, harnessing cutting-edge AI technology alongside rigorous external quality assessment.

The need for this initiative is clearly demonstrated in the highly concerning data that reveal 25-30% of laboratories repeatedly fail to meet minimum proficiency standards when testing for critical predictive biomarkers, most often due to false negative results. Given that these tests significantly influence patient treatment decisions, the implications of such inaccuracies are profound.

The alliance introduces a comprehensive toolkit for pathology laboratories, designed to maintain staining quality and align with the latest clinical and regulatory requirements. Visiopharm’s innovative Qualitopix solution enables daily and continuous measuring, monitoring, and documentation of staining consistency/quality, promptly identifying and addressing any deviations. When coupled with UK NEQAS ICC & ISH’s rigorous four-monthly assessments, the laboratory is assured of end-to-end quality assurance monitoring.

Mr. Andy Dodson, Director of UK NEQAS ICC & ISH, highlighted the gravity of the current situation: “The present figures concerning IHC testing accuracy are worrying. The direct link between test precision and patient outcomes cannot be overstated. This joint initiative, combining Visiopharm’s AI-driven internal quality control with our external quality assessment, aims to significantly enhance testing quality, a critical factor in delivering optimal patient care.”

This initiative is poised to redefine industry benchmarks, facilitating laboratories’ adherence to the stringent requirements of the recently revised ISO15189:2022 standard and other regulatory mandates, thereby ensuring superior patient care.

Dr. Michael Grunkin, CEO of Visiopharm, stressed the initiative’s ultimate goal: “At the heart of our mission is patient care. Through this collaboration, we are committed to providing laboratories with the advanced tools necessary for enhancing diagnostic precision. Our joint efforts are expected to play a pivotal role in ensuring patients receive the most effective treatments available.“

About Visiopharm

Visiopharm is a leading provider of AI-driven precision pathology software for research and diagnostics. In research, it is a technology leader providing tools that help scientists, pathologists, and image analysis experts produce accurate data for all types of tissue-based research. In diagnostics, it is a leader within clinical applications, with no less than nine diagnostic algorithms cleared under IVDR for EU and UK customers. These applications provide diagnostic decision support and can be easily activated and integrated into existing lab workflows. Founded in 2002, Visiopharm is privately owned and operates internationally with over 750 customer accounts in more than 40 countries. The company’s headquarters are located in Denmark’s Medicon Valley, with legal entities in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China.

For more information visit visiopharm.com.

About UK NEQAS ICC & ISH

UK NEQAS ICC & ISH is at the forefront of external quality assessment for advanced diagnostic testing in cellular pathology, committed to elevating the standards of IHC and ISH biomarker testing and ensuring adherence to the highest quality and regulatory standards. Founded in 1986, it was one of the first to introduce external quality assessment into clinical cellular pathology. The Scheme is fully accredited to ISO/IEC standards both in the UK and internationally. It operates worldwide, providing a fully comprehensive EQA service to clinical laboratories in more than 50 countries.

For more information visit ukneqasiccish.org.

CND’s Biomarker Testing Services Utilizing Groundbreaking NerValence™ System Unveiled at the AD/PD™ 2024 Parkinson’s and Alzheimer’s Disease Conference

Scottsdale, Ariz – CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today will unveil its NerValence pathology detection system at the AD/PD 2024 conference in Lisbon, Portugal. NerValence, developed through a strategic collaboration with precision pathology company Visiopharm, significantly enhances CND’s biomarker testing services for clinical trials targeting the alpha-synuclein protein in patients with suspected Parkinson’s disease, dementia with Lewy bodies, and related disorders.

“As an expansion of CND’s cutaneous testing services, NerValence is poised to transform the way we identify, quantify, and monitor the misfolded, pathological form of the alpha-synuclein protein in patients,” said Todd Levine, MD, CND’s Chief Medical Officer. “Our work with Visiopharm has demonstrated how innovative digital technology can enhance the detection and measurement of this key biomarker to optimize drug development for Parkinson’s disease and other synuclein-based disorders.”

NerValence features machine learning algorithms that recognize and differentiate microscopic structures, nerves, and important disease markers that can be found in cutaneous tissue. The system was designed and developed by CND in partnership with Visiopharm as a pathology assistance tool for CND’s Syn-One Test^® and is used exclusively by CND pathologists and researchers at the company’s CLIA-certified laboratories in Scottsdale. Syn-One relies on the analysis of skin biopsy samples collected from patients who have signs and symptoms of Parkinson’s disease and related disorders known as synucleinopathies and has demonstrated greater than 95% sensitivity and specificity in detecting phosphorylated alpha-synuclein. Syn-One, as supported by NerValence, is a laboratory developed test (LDT) ordered by neurologists and other clinicians across the US to aid the diagnosis of thousands of patients. NerValence’s unique ability to enhance the identification, tracking, and measuring the volume of alpha-synuclein in cutaneous nerves offers significant benefit in targeting clinical trial patients for the development of disease-modifying therapies.

“Utilizing our novel deep learning technology to power this crucial advancement in neurodegenerative diseases represents a significant leap forward in analyzing peripheral nerves,” said Michael Grunkin, Visiopharm Chief Executive Officer. “Collaborating with CND Life Sciences on its deployment of NerValence will continue to be a major priority as we advance AI-driven precision pathology to enhance biopharmaceutical drug development.”

Stop by our Exhibit Booth #66 at the AD/PD 2024 conference to get a first-hand look at the NerValence system. Also be sure to check out our posters titled “The Synuclein-One Study: Cutaneous Alpha-Synuclein Deposition in Parkinson’s Disease,” Poster Board #0544 and “The Synuclein-One Study: Cutaneous Alpha-Synuclein Deposition in Dementia with Lewy Bodies and Mild Cognitive Impairment,” Poster Board #0561. Both posters will be available for viewing from March 6-7 during designated poster hours.

About CND Life Sciences

CND Life Sciences is dedicated to supporting the care of patients facing the potential diagnosis of a neurodegenerative disease and other neurological conditions. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND launched the Syn-One Test^® in 2019 as the world’s first commercially available test to detect, visualize, and quantify phosphorylated alpha-synuclein located in cutaneous nerves. This laboratory developed test analyzes three small skin biopsies collected from the patient in a physician’s office through a 15-minute minimally invasive procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic evaluations in the skin. The Syn-One Test is supported by technology licensed from Beth Israel Deaconess Medical Center in Boston and leverages a decade of published science from leading academic institutions in multiple countries. The Company has research collaborations with multiple biopharmaceutical companies and has been awarded three prestigious NIH SBIR grants to advance the validation and clinical utility of its Syn-One Test.  For more information visit cndlifesciences.com or connect with us on LinkedIn.

Disclosure: Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke and the National Institute on Aging (NIA) of the National Institutes of Health under Award Numbers R44NS117214, R44AG076072, and R44NS127696. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Visiopharm

Visiopharm is a leading provider of AI-driven precision pathology software for research and diagnostics. In research, it is a technology leader providing tools that help scientists, pathologists, and image analysis experts produce accurate data for all types of tissue-based research. In diagnostics, it is a leader within clinical applications, with no less than nine diagnostic algorithms cleared under IVDR for EU and UK customers. These applications provide diagnostic decision support and can be easily activated and integrated into existing lab workflows. Founded in 2002, Visiopharm is privately owned and operates internationally with over 750 customer accounts in more than 40 countries. The Company’s headquarters are located in Denmark’s Medicon Valley, with legal entities in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China. For more information visit visiopharm.com.

Contact: 

Lisa DeScenza
LaVoieHealthScience
(978) 395-5970
ldescenza@lavoiehealthsceince.com

SOURCE: CND Life Sciences