Press Releases
Indica Labs Expands Availability of HALO Digital Pathology Solutions in Asia Pacific Region Including CE-IVDR Marked HALO AP® Platform
Albuquerque, NM, 2 July, 2024 – Life Science Newswire – Indica Labs today announces the expansion of their reseller network in the Asia Pacific (APAC) region. New distributorship agreements have been inked with MRL Cybertec Corporation, Pathology Ware International, Minh Khang Technical Service & Trading Co. Ltd., and Histocenter, for distribution in the Philippines, Thailand, Vietnam, and Malaysia, respectively. The new partnerships build upon Indica’s previous commercial success in China and Japan where sales have grown substantially in recent years.
Steven Hashagen, CEO of Indica Labs, said “We are delighted to expand our reach in the APAC region by onboarding resellers whose extensive digital pathology experience and existing customer base will facilitate immediate results and high-quality support of our products in the region.”
The carefully selected resellers have a successful track record of selling digital pathology instrumentation and software in the APAC region, allowing Indica Labs to rapidly grow its clinical presence and customer base.
“With regulatory clearances secured in Europe and the USA, we’re now actively pursuing multiple IVD registrations in the APAC region, which we anticipate will drive adoption,” said Eric Runde, COO at Indica Labs.
Under the new agreements, APAC distributors can now offer HALO AP®, a CE-IVDR marked enterprise digital pathology platform, and HALO Clinical AI Solutions that seamlessly integrate into HALO AP® as RUO products. HALO Clinical AI Solutions include HALO Prostate AI, Lung PD-L1 AI, Breast IHC AI, and SlideQC BF. In addition, the newly onboarded APAC resellers will offer HALO®, HALO AI, and HALO Link solutions for AI-based quantitative image analysis and image management for applications in the life sciences.
“For 28 years, MRL Cybertec Corp has proudly served the Philippines as an importer, distributor, and support service provider of in vitro diagnostics products, with a special focus on histopathology laboratories,” said Maristel Abigail R. Lim of MRL Cybertec Corp. “As a trusted name in the distribution of histopathology solutions, we are excited to announce our partnership with Indica Labs. This collaboration will bring their innovative AI technology to our product offerings, aiming to boost efficiency and optimize workflows in histopathology labs throughout the country.”
HALO AP® is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AP® is For Research Use Only in the US and is not FDA cleared for clinical diagnostic use. In addition, HALO AP® provides built-in compliance with FDA 21 CFR Part 11, HIPAA, and GDPR.
HALO AI Prostate is CE-marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AI Prostate is For Research Use Only in the US and is not FDA cleared for clinical diagnostic use. HALO AI Prostate is accessed via the HALO AP® enterprise digital pathology platform.
Lung PD-L1 AI is For Research Use Only and not intended for clinical diagnostic use. Lung PD-L1 AI is accessed via the HALO AP® enterprise digital pathology platform.
Breast IHC AI is For Research Use Only and not intended for clinical diagnostic use. Breast IHC AI is accessed via the HALO AP® enterprise digital pathology platform.
SlideQC BF is a quality control tool for whole slide images and is not regulated as a medical device under Regulation EU 2017/746 (IVDR) or MDR 2002 (UK).
In all other countries, HALO AP, HALO Prostate AI, Lung PD-L1 AI, Breast IHC AI, and SlideQC BF are for research use only and not for clinical diagnostic purposes.
About Indica Labs: Indica Labs is the global leader in AI-powered digital pathology software and services. Our flagship HALO® and HALO AI platform revolutionizes quantitative evaluation of whole slide images. HALO Link provides collaborative image management while HALO AP® and HALO AP Dx deliver enterprise digital pathology for primary diagnosis with regulatory clearances in multiple markets. Through a commitment to open pathology, performance, scalability, and ease-of-use, we help pharma companies, diagnostic labs, hospitals, research organizations, and Indica’s own Cloud and Pharma Services make discoveries and diagnoses that transform patient care and scientific discovery.
