Clinical, Medical & Diagnostic Products
FDA clears new companion diagnostic for KMT2A acute leukaemia
OGT, a global provider of genomic diagnostic and research solutions, has announced that the US Food and Drug Administration (FDA) has granted De Novo authorisation for its CytoCell® KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic (CDx) for Syndax’s Revuforj® (revumenib). Revuforj is approved for the treatment of relapsed or refractory acute leukaemia in patients with KMT2A translocations, including adults and children aged one year and older.
The CytoCell KMT2A Breakapart FISH Probe Kit PDx enables rapid and reliable detection of KMT2A rearrangements (KMT2Ar), helping clinicians identify patients who may benefit from Revuforj therapy. KMT2A translocations are present in over 95% of patients with KMT2Ar acute leukaemia, making timely and accurate testing essential for precision oncology.
By combining OGT’s extensive experience in haematology diagnostics with proven FISH technology, the assay delivers quick turnaround and accessible testing in clinical laboratories. Its use as a CDx supports targeted therapy decisions and provides critical insights for treating a patient group with historically poor outcomes.
“Obtaining FDA authorisation for this companion diagnostic marks an important milestone for our clinical and regulatory teams,” said Dr Leila Luheshi, VP Pharma Partnering at OGT. “The test will help ensure that eligible patients can access Revuforj safely and efficiently.”
The CytoCell KMT2A Breakapart FISH Probe Kit PDx is indicated solely as a companion diagnostic to guide Revuforj treatment. Reporting and interpretation should be performed by qualified pathologists or cytogeneticists.
More information online:
ilmt.co/PL/qBeE 65844pr@reply-direct.com Multilingual diagnostics site supports global partner access
HUMAN Diagnostics has launched a redesigned corporate website, now available in three language versions that went live simultaneously. The new site offers tailored, audience-specific content, features, and services aimed at expanding the company’s global presence and enhancing brand visibility. A newly integrated customer platform serves as the foundation for communication and collaboration with HUMAN’s network of over 240 distribution partners worldwide.
“With the new website, we aim to create a globally consistent brand experience that reflects HUMAN’s value proposition. It is designed to become the central digital medium for interaction and information,” said Thomas König, Associate Director Marketing Communications, about the relaunch.
To support this vision, the design and content of the site have been completely overhauled. “We want to deliver personalised content that our customers expect - on any channel and device. The platform is optimised to improve user experience and facilitate access to our innovative diagnostic solutions. This enables our customers to make informed and confident purchasing decisions,” König added.
For more than 50 years, HUMAN has provided clinical laboratories around the world with a broad product portfolio built on German quality standards. The company supports laboratories in meeting local requirements and everyday challenges through global service and logistics capabilities. Its solutions for point-of-care and mid-throughput testing are designed to empower medical professionals and laboratory staff to make life-saving decisions, promote health equity, and improve patient outcomes.
Built on Pimcore technology, the new platform offers significant benefits to HUMAN’s diverse audiences. For the general public, it features intuitive navigation, comprehensive product information, and multiple interaction options. “Our distribution partners benefit from improved communication and collaboration tools that streamline order processing and inventory management. Pimcore’s robust data management capabilities allow us to centralise and optimise our product information, ensuring that our partners and customers always have access to the most up-to-date data. This results in improved performance and faster response times,” explained Andrii Pushkarov from HUMAN’s Strategic Digital Project Management team.
Explore the new website and discover how HUMAN Diagnostics is committed to advancing healthcare through innovative solutions and exceptional service. More information online:
ilmt.co/PL/nXvN
65474pr@reply-direct.com New automated IHC and ISH solutions for pathology labs
Agilent Technologies has introduced three new models in its Dako Omnis line of staining instruments, designed to support pathology laboratories with varying workloads and diagnostic needs. The expanded portfolio includes the Dako Omnis 110, 165, and 165 Duo, each offering tailored capabilities to help labs optimise throughput, workflow, and precision.
This expansion marks a shift from a single-solution model to a more flexible approach, allowing laboratories to choose the configuration that best aligns with their testing volumes and operational demands. The Dako Omnis 110 is ideal for smaller labs, capable of processing up to 110 immunohistochemistry (IHC) slides per day. The 165 version supports medium-to-high volume environments with capacity for up to 165 IHC slides. Meanwhile, the 165 Duo provides dual capabilities for labs needing to run IHC and in-situ hybridisation (ISH) simultaneously, delivering both speed and flexibility.
All three models retain the core strengths of the original Dako Omnis system, including continuous, case-based slide processing, shared reagent use, and streamlined workflows to reduce turnaround time. A key enhancement across the new instruments is the addition of a direct connection for de-ionised water and non-hazardous waste disposal - features designed to cut down manual handling.
Jessica Barbour, Senior Biomedical Scientist at Aberdeen Royal Infirmary, who participated in instrument testing, highlighted the practical benefits: “Being able to empty waste without interrupting operation is a real advantage. There have been times when full waste containers limited our daily throughput.”
According to Majken Nielsen, Associate Vice President of Marketing and Product Management at Agilent, the new models are a direct response to customer feedback and industry challenges. “Pathology labs are facing higher test volumes, staffing shortages, and increasing diagnostic complexity. Our goal is to provide tools that not only meet these pressures but enhance lab performance overall.”
Availability will initially roll out in the US, Europe, and Australia. More information online:
ilmt.co/PL/pxmj
65484pr@reply-direct.com
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