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NEWS


Nucleix partners with Menarini for Bladder EpiCheck


A. Menarini Diagnostics and Nucleix have announced a long-term commercial agreement for the exclusive distribution of the Bladder EpiCheck test in Europe. Under the new agreement, Menarini will assume exclusive marketing of the non- invasive Bladder EpiCheck test in Europe in the months ahead, aiming to accelerate its adoption.


This non-invasive CE-marked test detects primary or recurrent bladder cancer and upper tract urinary cancer. Bladder EpiCheck is included in the European Association of Urology (EAU) Clinical Guidelines as


a urine test that might be used in the initial diagnostic workup of bladder cancer to avoid / implement cystoscopy and in follow-up to monitor for non- muscle invasive bladder cancer (NMIBC) tumour recurrence to replace or postpone cystoscopy. The test is also included in the EAU Clinical Guidelines as an ancillary tool in the diagnosis and monitoring of upper tract urothelial carcinoma (UTUC). Surveillance is of paramount importance for NMIBC patients due to the high rates of recurrence and risk of progression to life-threatening disease. For high-risk NMIBC patients, follow up can be as frequent as every three months and requires invasive cystoscopies. By providing a non-invasive monitoring test, Bladder EpiCheck could detect high- grade disease early and potentially reduce the frequency of cystoscopies, which may, in turn, decrease the burden of bladder cancer surveillance for patients and health systems alike while improving patient outcome by identifying the patients who will benefit most from intervention. “I am pleased to be working with A. Menarini Diagnostics to further build the Bladder EpiCheck market in Europe,” commented Chris Hibberd, Executive Chairman & CEO of Nucleix. “Given the broad presence of Menarini, we believe it is the right partner to expand the market footprint for our liquid biopsy test that we believe will transform bladder cancer care by supporting doctors in optimising decision-making for the benefit of patients.”


12


Digital bone marrow imaging added to partnership


Beckman Coulter and Scopio Labs, a medtech company that develops digital cell morphology workflow solutions, have announced expansion of their long-term partnership to include a global distribution agreement for Scopio’s Full- Field Bone Marrow Aspirate (FF-BMA) application. Bone marrow aspirate analysis is a vital procedure providing essential information for the assessment of various haematologic diseases. By aspirating a small sample of the liquid portion of bone marrow, clinicians can examine the cellular composition, as well as the morphology and maturity of the blood cells. However, traditional BMA analysis uses manual, labour-intensive, time-consuming methods that are heavily reliant on highly skilled haematopathologists to ensure accuracy. Scopio’s FF-BMA Application transforms BMA analysis by combining high-resolution full-field imaging with a robust AI-powered decision support system into a fully digital workflow seamlessly integrated with Scopio’s X100 and X100HT scanners. It also enables haematopathologists to review bone marrow smears remotely (via a secure hospital network), potentially reducing turnaround time, fostering collaboration, facilitating


second opinions, and bolstering diagnostic confidence. Scopio’s X100 / X100HT with FF-BMA application is CE-marked. “In today’s laboratory , there is limited technology available to assist in the analysis of bone marrow aspirate,” said Chris Hagen, Senior Vice President and General Manager, Core Lab Specialty Products for Beckman Coulter Diagnostics. “We are thrilled to expand our partnership with Scopio and continue to bring full-field, AI-powered, digital-imaging innovations to clinical laboratories worldwide.” Since 2022, Beckman Coulter and Scopio have been working together to accelerate adoption of the next generation of digital cell morphology. Scopio’s X100 and X100HT digital cell morphology platforms employ full-field imaging and AI decision support eliminating the need for manual microscopy.


StatLab Medical to acquire Diapath


StatLab Medical Products has announced that it has reached an agreement to acquire Diapath, an Italian manufacturer of histology and cytology products and equipment.


The integration of Diapath, with its highly innovative equipment offerings, manufacturing capabilities, and established customer base across Europe, Asia-Pacific, Middle East and Africa, and Latin America, positions StatLab to expand its market access, unlocking significant potential for growth and enhancing its global leadership.


The transaction is expected to close during the third quarter of 2024, subject to regulatory approvals. Upon closing, Diapath founder Vladimiro Bergamini will transition to a senior advisor role at StatLab, and Chief Operating Officer


Alberto Battistel will join StatLab’s executive leadership team and help steer the Diapath business unit as its Managing Director.


“This combination is a pivotal milestone in our strategy to manufacture the full array of products supporting the entire anatomic pathology workflow,” said Sung-Dae Hong, CEO of StatLab. “Our partnership with Diapath will provide an opportunity to expand its equipment brand throughout global markets, including the US.” Headquartered in Martinengo, near


Bergamo, Italy, Diapath was founded in 1997 by Vladimiro Bergamini. Over the past 27 years, focused investments have enabled the business to expand beyond consumables manufacturing and into the design, development, and production of a variety of core histology instruments.


OCTOBER 2024 WWW.PATHOLOGYINPRACTICE.COM


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