PoCGS® and BiTTE® Validated Through Medical Field Trials in Vietnam and Indonesia

—Conducted under METI/MEJ FY2024 International Deployment Program for Healthcare Industries —

CarbGeM Inc. (Headquarters: Shibuya-ku, Tokyo; CEO: Masakazu Nakajima), a pioneer in advancing real-world adoption of image-based AI technologies in life sciences, has successfully conducted medical field trials in Vietnam and Indonesia. These trials validated the utility of its proprietary solutions: the PoCGS® automated Gram stainerand the BiTTE® AI-based microbial classification support software.
The demonstration was carried out under the FY2024 International Deployment Program for Healthcare Industriespromoted by the Ministry of Economy, Trade and Industry (METI) and Medical Excellence JAPAN (MEJ).

About the Products Used in the Field Trials

CarbGeM delivers products and services that drive improvements in diagnostics, research efficiency, and quality control through automation and standardization in the life science sector. By addressing challenges such as skilled labor personnel and regional disparities, the company enables medical and industrial fields to achieve faster and more accurate results.

PoCGS®-iE Research Use Only Automated Gram Stainer

Project Objectives

  1. Challenges to Address
  • Evaluate the practical applicability of PoCGS® and BiTTE® in clinical settings in Vietnam and Indonesia
  • Develop localized sales strategies and establish distribution networks tailored to each country
  1. Goals to Achieve
  • Verify that PoCGS® and BiTTE® deliver functionality and accuracy comparable to results validated in Japan
  • Identify target customer segments, pricing structure, and appropriate value propositions to build effective go-to-market strategies

Implementation Details and Evaluation Methods

  1. Field Trials in Clinical Settings
    Field trials were conducted using blood culture-positive patient samples provided by local medical institutions in Vietnam and Indonesia. The PoCGS® system was used for Gram staining, and BiTTE® was applied to estimate the bacterial species. These tests aimed to verify the practical effectiveness of both solutions under local conditions.
  2. Evaluation Criteria
  • PoCGS®: Performance was evaluated based on stain quality, uniformity, and reproducibility in comparison to conventional local methods.
  • BiTTE®: Effectiveness was measured by comparing the AI-based microbial classification results against assessments made by trained local lab technicians.
  1. Market Research and Pre-Marketing
    Preliminary marketing efforts were conducted to identify local medical needs, workflows, and target demographics. Insights gathered were used to adapt sales strategies and establish groundwork for market entry in both countries.

Participating Countries and Institutions

  • Vietnam: Bach Mai Hospital (One of the three largest hospitals in Vietnam)
  • Indonesia: Department of Microbiology, Faculty of Medicine, Universitas Indonesia
    (Affiliated with the country’s largest university hospital, Dr. Cipto Mangunkusumo Hospital)

Summary of Evaluation Results

  • PoCGS® (Automated Gram Stainer)
    The device achieved high-quality and highly uniform staining results.
    • High quality: Stains clearly distinguished between Gram-positive and Gram-negative bacteria, as well as non-bacterial elements
    • Consistency: Consistently produced high-level staining across all samples with excellent reproducibility
    • Local feedback: Technicians from participating institutions commented that the quality exceeded that of manual staining methods used at their facilities
  • BiTTE® (AI-based Microbial Classification)
    AI-driven microbial estimation demonstrated accuracy equal to or greater than that of skilled local technicians in both countries, validating the non-inferiority of the AI model in real-world conditions.

Future Outlook

CarbGeM will continue its field evaluations of PoCGS® and BiTTE® in Vietnam and Indonesia. CarbGeM is committed to expanding its evidence base for these solutions and promoting their adoption as AI-assisted diagnostic tools in emerging healthcare markets.

About CarbGeM Inc.

CarbGeM applies its proprietary AI image analysis technology to the field of infectious disease diagnostics through the convergence of biology, digital engineering, and integrated software-hardware design. CarbGeM pursues open innovation with leading institutions both in Japan and abroad, contributing to the global effort to combat antimicrobial resistance (AMR).

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