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
Rapid triple-detection test speeds fl u and COVID-19 diagnosis
QuidelOrtho Corporation is broadening its point-of-care diagnostic offerings with the launch of the QUICKVUE Influenza + SARS Test, a CLIA-waived, 510(k)-cleared rapid immunoassay designed for use in physician office laboratories, urgent care centres, emergency departments, pharmacies, and decentralised hospital labs.
The new test provides simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2 antigens from a single patient sample, delivering results in as fast as 10–15 minutes. By helping clinicians quickly distinguish between flu and COVID-19 - two respiratory illnesses with overlapping symptoms - the test supports faster treatment decisions, improved patient outcomes, and reduced community spread.
Designed for professional use, the QUICKVUE Influenza + SARS Test combines an easy-to-collect nasal swab with a streamlined processing workflow and a clear visual readout. Its rapid turnaround and cost-effective design make it an accessible tool for a variety of healthcare settings, without the need for instrument-based testing.
The launch complements QuidelOrtho’s existing SOFIA™ 2 Flu + SARS Antigen FIA platform, offering a visually read option alongside instrument-based testing and reinforcing the company’s leadership in point-of-care respiratory diagnostics. The QUICKVUE Influenza + SARS Test is available across the United States through QuidelOrtho’s established distribution channels.
More information online:
ilmt.co/PL/6D4Y 66040pr@reply-direct.com
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