miDiagnostics NV, a global technology leader in point-of-care diagnostics, today announced a collaboration agreement with Galapagos to develop a closed-flow, ultra-rapid PCR sterility test for CAR-T batch release in a decentralized manufacturing setting, in compliance with regulatory requirements, including those in the U.S., Europe and Japan.
Under the terms of the agreement, miDiagnostics will develop an ultra-rapid chip-based point-of-care PCR sterility testing method for use with Galapagos’ unique decentralized CAR-T CellPoint manufacturing platform. This will support fully-automated, commercial-scale production of fresh-to-fresh CAR-T therapies at the point-of-care, near the patient.
Financial details are not disclosed.
To date, miDiagnostics offers the fastest and highest performant point-of-care PCR platform on the market. With its extreme miniaturization and silicon technologies at the core of its innovation, miDiagnostics facilitates near-patient testing of high-quality diagnostics. With this collaboration, miDiagnostics will adapt its platform to allow for fully automated sterility testing at the point-of-care.
Galapagos’ decentralized point-of-care CAR-T manufacturing model consists of a proprietary end-to-end xCellit workflow management and monitoring software; a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon Platform); and a proprietary quality control (QC) testing and release strategy. The combination of these three core components allows for the administration of a fresh product, a 7-day vein-to-vein time (i.e. the time between T-cell collection and CAR-T infusion), and providing greater physicians oversight throughout the process.
“We are thrilled about this collaboration to further extend our state-of-the-art, decentralized PCR testing methods into the field of CAR-T cancer therapy,” stated Katleen Verleysen, CEO of miDiagnostics. “We believe that CAR-T treatment, close to the patient, has the potential to truly change the treatment paradigm and significantly improve patient outcomes.”
“We are excited to work with Galapagos and look forward to combining the unique expertise and scientific capabilities of two very innovative companies to create a novel solution for cancer patients,” added Urbain Vandeurzen, Chairman of the Board of Directors of miDiagnostics, and Peter Verhaeghe, Non-Executive Director of the Board of Directors of miDiagnostics. “This is a real demonstration of how Belgian innovation aims transform personalized medicine in a very impactful way.”