Former Alere and LumiraDx R&D Chief Nigel Lindner Joins CLEU Diagnostics to Launch Revolutionary LabSimple Diagnostic Platform

Associated Press

17-03-2025

CLEU Diagnostics, the company reimagining comprehensive clinical laboratory testing has expanded its team with the addition of Nigel Lindner, PhD as Chief Innovation Officer. Dr. Lindner brings over three decades of experience in advancing innovation in diagnostics, previously as Global Head of R&D at Alere, CEO of Swiss Precision Diagnostics, and CIO at LumiraDx.
'We are incredibly excited about the opportunity to work closely with Dr. Lindner to validate and bring to market this game changing technology,' said Andrew Fleischman, MD, CEO of CLEU Diagnostics.
In joining CLEU Diagnostics, Nigel continues a long career in pursuit of introducing simplicity to lab-quality diagnostic testing. Today, most lab testing is performed by skilled technicians at specialized central laboratories. However, there has been a longstanding vision for comprehensive lab testing to become simple enough to fit into a small portable module that can be used by just about anyone, anywhere. That vision for accessible lab testing will soon become a reality with LabSimple.
'A comprehensive platform that seamlessly integrates a range of diagnostic modalities to bring high-quality core lab testing to the point of need while also being uniquely cost competitive for widespread use has long been a vision for the future of healthcare. The remarkable team at CLEU Diagnostics has solved the key challenges to make this vision a reality. There is going to be a lot of excitement once the magnitude of the achievement of LabSimple becomes better understood by the healthcare industry,' said Dr. Lindner.
The exceptional versatility of LabSimple enables complex analytical techniques, such as chemistry, microscopy, flow cytometry, and single photon counting, to be performed with low cost instruments and disposable test cartridges. Instrument modules, about the size of an iPhone, are stackable to deliver scalable test throughput in any location. Innovation in fabrication of cartridges for complex test panels maximizes manufacturing output to deliver at an ultra-low price point. For the first time, comprehensive point-of-care style testing can be implemented at a cost comparable to a large central laboratory.
'Our platform is not one size fits all. We can engineer low-cost cartridges to meet the unique requirements of each application. The platform has also been designed from the ground up – we created an advanced microfluidic control system, a new technology that facilitates miniaturization of complex analytical systems, such as flow cytometry, that are normally much larger and more expensive,' said Kam Ghofrani, Lead Engineer for CLEU.
LabSimple will launch beginning in late 2026:
Respiratory Viral Panel (Molecular Diagnostics)
Complete Blood Count (Hematology)
Basic Metabolic Panel (Chemistry)
Urinalysis (Chemistry)
The long-term vision for LabSimple is to support all common routine lab tests, and tests that are critical in remote settings with limited access to healthcare.
'The economics and flexibility of LabSimple for the first time enable the business model for a CLIA waived diagnostic platform to become, in many instances, a practical alternative to a central laboratory,' said Scott Kellogg, Chief Business Officer for CLEU. 'Whilst we do not expect to fully replace central lab testing, we do envision a world in which most routine tests are performed on LabSimple, and less common specialty tests are sent to a central lab. This reality may come sooner than people think.'
About LabSimple
LabSimple is a next generation point-of-care style diagnostic platform designed as an all-in-one replacement for the clinical laboratory while being simple enough for anyone to use without training. LabSimple is disruptive because it has the unusual combination of being comprehensive, high performance, simple, and low cost.
LabSimple is a next generation point-of-care style diagnostic platform designed as an all-in-one replacement for the clinical laboratory while being simple enough for anyone to use without training. LabSimple is disruptive because it has the unusual combination of being comprehensive, high performance, simple, and low cost.
Building blocks of the LabSimple Platform
Accurate multi-functional fluidics programmed for each test panel to automate flow control, degassing, reagent handling, and serial dilution
Integration and miniaturization of multiple advanced detection modalities (optical, electrochemical, impedance spectroscopy, microscopy, photometry)
Embedded multi-zone temperature control environment
Uniquely versatile cartridges to meet requirements of any test panel
All with scalable manufacturing at ultra low-cost of goods
These building blocks enable a broad range of advanced assay techniques, including chemistry, immunoassay, molecular diagnostics (isothermal / conventional PCR / digital droplet PCR), microscopic image analysis, flow cytometry, & single molecule counting.
About CLEU Diagnostics
CLEU Diagnostics was founded in 2018 by a group of renowned physicians with the goal of transforming healthcare through innovation. LabSimple is a disruptive, next generation technology that will redefine the $110B US clinical lab testing market.
CLEU Diagnostics was founded in 2018 by a group of renowned physicians with the goal of transforming healthcare through innovation. LabSimple is a disruptive, next generation technology that will redefine the $110B US clinical lab testing market.
SOURCE: CLEU Diagnostics
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PUB: 03/17/2025 07:24 AM/DISC: 03/17/2025 07:25 AM