Leica Giải Phẫu Bệnh, Hóa Mô Miễn Dịch IHC ISH & Digital Pathology

04/12/2025

Very good news for our Pathologist community!!!
Thank you for your attention to this matter!
NEWS ALERT: Indica Labs Receives FDA Clearance for Enterprise Digital Pathology Platform with Industry-Leading DICOM-Compatible Aperio Scanner from Leica Biosystems

NEWS ALERT: Indica Labs Receives FDA Clearance for Enterprise Digital Pathology Platform with Industry-Leading DICOM-Compatible Aperio Scanner from Leica Biosystems

We are excited to share that The Food and Drug Administration (FDA) has issued a 510(k) clearance for the enterprise digital pathology platform HALO AP Dx in conjunction with Leica Biosystems Aperio GT 450 DX Scanner for in-vitro diagnostic use. Naveen Chandra, Vice President and General Manager of Digital Pathology at Leica Biosystems, shared:

"Since announcing the strategic agreement between Leica Biosystems and Indica Labs earlier this year, we have delivered new cutting-edge solutions such as Aperio HALO AP and the Aperio AI store. This latest FDA clearance is testament to our shared rapid pace of innovation, which will continue in 2026 and beyond."

The clearance comes at a vital time, as pathology faces growing volumes and complexity in addition to clinical workforce shortages. Digital pathology platforms like HALO AP Dx help laboratories address these challenges by streamlining diagnostic workflows and creating new opportunities for remote collaboration, innovation, and scalability.

This milestone reflects what’s possible when industry leaders work to accelerate innovation in digital pathology. Read the full announcement here: https://ow.ly/o7ws50XBiEF



For In Vitro Diagnostic Use.

HALO AP Dx (K252762) is FDA-cleared for primary diagnostic use with the Leica Biosystems’ Aperio GT 450 DX Scanner and Hamamatsu NanoZoomer® S360MD Slide scanner in the USA. In addition, HALO AP Dx provides built-in compliance with FDA 21 CFR Part 11 and HIPAA. PRR-MAR-000003v1

Aperio HALO AP is CE marked under IVDR for in-vitro diagnostic use. Algorithms available from the Aperio AI Store, exclusive to Aperio HALO AP, may have different regulatory classifications. Not all products are available in all regions

13/10/2025

Hẹn gặp Quý Thầy Cô, Pathologist và ACE mình trong lĩnh vực Giải Phẩu Bệnh cuối tuần này tại Hanoi nhé🫶🫶🫶

🌟 Hội nghị Khoa học Giải phẫu bệnh ASEAN lần thứ 2 & Hội thảo Giải phẫu bệnh - Tế bào bệnh học Việt Nam lần thứ 12 🌟

Công ty Minh Khang hân hạnh đồng hành cùng Leica Biosystems tham gia Hội nghị Khoa học Giải phẫu bệnh ASEAN lần thứ 2, kết hợp với Hội thảo Khoa học Giải phẫu bệnh - Tế bào bệnh học Việt Nam lần thứ 12.

📅 Thời gian: Ngày 18-19/10/2025
📍 Địa điểm: Khách sạn Quân đội, số 1A Nguyễn Tri Phương, Ba Đình, thành phố Hà Nội.

Đây là sự kiện khoa học quan trọng quy tụ các chuyên gia, bác sĩ, và nhà nghiên cứu hàng đầu trong khu vực ASEAN, cùng chia sẻ những thành tựu, xu hướng và thách thức mới trong lĩnh vực Giải phẫu bệnh.

👉Chúng tôi rất mong được đón tiếp Quý khách tại sự kiện để trải nghiệm thiết bị tiên tiến, chia sẻ tri thức và kiến tạo giá trị bền vững cho cộng đồng y khoa.
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31/05/2025

ASCO25: AstraZeneca, MindPeak study finds AI refines HER2 classification
https://firstwordhealthtech.com/story/5965547
Using AI assistance during HER2 screening can significantly improve the identification of HER2-low and HER2-ultralow breast cancers, according to an abstract released ahead of the American Society of Clinical Oncology (ASCO) meeting.

At present, immunohistochemistry (IHC) testing and in situ hybridisation (ISH) are the standard tests to detect HER2 protein expression on breast cancer tumours. These screening methods can be difficult and time-intensive. Moreover, both rely on the human eye for spotting abnormalities, which can be unreliable. According to the researchers, about a third of HER2-ultralow breast cancers may be incorrectly classified as HER2-null using current methods, making patients ineligible for HER2-targeted therapy.

To improve HER2 evaluation, an AI-supported assessment tool was developed for pathologists by researchers at Mindpeak, a digital pathology firm based in Germany.

For the study, 105 pathologists from 10 countries conducted HER2 scoring on 20 digital breast cancer cases with and without assistance from Mindpeak's AI tool. The study was funded by AstraZeneca, which markets HER2-directed antibody-drug conjugate (ADC) Enhertu (fam-trastuzumab deruxtecan-nxki). Mindpeak and AstraZeneca announced a research partnership in March to assess the potential of Mindpeak's Breast H&E solution.

In five sessions spanning three exams, pathologists completed 1,940 readings; the first two tests were conducted manually, while AI was used in the third. Their readings were compared with IHC scores determined by an independent panel of expert pathologists for reference.

Using AI assistance during HER2 screening can significantly improve the identification of HER2-low and HER2-ultralow breast cancers, according to an abstract released ahead of the American Society ...

30/05/2025

Danaher and Leica Biosystems Announce Diagnostic Development and Commercialization Partnership to Scale Precision Medicine -https://www.leicabiosystems.com/news/astrazeneca-precision-medicine-partnership/

09/12/2024

Cuối tuần này, mời Quý ACE mình trong lĩnh vực Giải Phẫu Bệnh đến với Hội Thảo Giải Phẫu Bệnh Các Tĩnh Phía Nam Lần Thứ 14 | Dec 14 -15 tại TPHCM nè hen.
https://www.leicabiosystems.com/en-sg/digital-pathology/
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