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Indica Labs Broadens HALO Digital Pathology Solutions Availability in Asia Pacific, Featuring CE-IVDR Marked HALO AP® Platform

NextEdge Admin

03 Jul 2024

3 min 0 sec

Indica Labs has expanded its presence in the Asia Pacific (APAC) region through new distributorship agreements with MRL Cybertec Corporation, Pathology Ware International, Minh Khang Technical Service & Trading Co. Ltd., and Histocenter. These partnerships cover distribution in the Philippines, Thailand, Vietnam, and Malaysia respectively, bolstering Indica Labs' reach beyond its established markets in China and Japan.

Steven Hashagen, CEO of Indica Labs, expressed enthusiasm about the expanded network, highlighting the extensive digital pathology experience and established customer bases of the new resellers. This strategic move aims to accelerate the adoption of Indica Labs' products in APAC, facilitated by the distributors' track record in selling digital pathology instrumentation and software.

Eric Runde, COO at Indica Labs, emphasized their pursuit of IVD registrations in APAC following regulatory clearances in Europe and the USA, anticipating significant market uptake. The agreements enable APAC distributors to offer HALO AP®, a CE-IVDR marked digital pathology platform, alongside HALO Clinical AI Solutions such as HALO Prostate AI, Lung PD-L1 AI, Breast IHC AI, and SlideQC BF.

Maristel Abigail R. Lim from MRL Cybertec Corp highlighted their excitement at partnering with Indica Labs to enhance histopathology workflows in the Philippines, leveraging Indica's AI technology and their own expertise in diagnostics distribution.

HALO AP® is currently CE-IVDR marked for diagnostic use in Europe, the UK, and Switzerland, with additional regulatory compliance built-in for FDA 21 CFR Part 11, HIPAA, and GDPR. However, products like HALO AI Prostate, Lung PD-L1 AI, Breast IHC AI, and SlideQC BF are labeled for research use only in the US and other countries not explicitly covered by CE-IVDR regulations.

Indica Labs' expansion into APAC represents a strategic alignment with regional market dynamics and regulatory frameworks, positioning them to strengthen their clinical footprint and enhance support for digital pathology solutions across diverse healthcare landscapes.