Review

. 2023 Feb;58(2):79-97.

doi: 10.1007/s00535-022-01932-1. Epub 2022 Dec 5.

SWOT analysis of noninvasive tests for diagnosing NAFLD with severe fibrosis: an expert review by the JANIT Forum

Yoshihiro Kamada¹, Takahiro Nakamura², Satoko Isobe³, Kumiko Hosono⁴, Yukiko Suama⁵, Yukie Ohtakaki⁶, Arihito Nauchi⁷, Naoto Yasuda⁸, Soh Mitsuta³, Kouichi Miura⁹, Takuma Yamamoto¹⁰, Tatsunori Hosono¹¹, Akihiro Yoshida¹², Ippei Kawanishi¹³, Hideaki Fukushima¹⁴, Masao Kinoshita¹⁵, Atsushi Umeda¹⁶, Yuichi Kinoshita¹⁷, Kana Fukami¹⁸, Toshio Miyawaki⁵, Hideki Fujii¹⁹, Yuichi Yoshida²⁰, Miwa Kawanaka²¹, Hideyuki Hyogo^{22

23}, Asahiro Morishita²⁴, Hideki Hayashi²⁵, Hiroshi Tobita²⁶, Kengo Tomita²⁷, Tadashi Ikegami²⁸, Hirokazu Takahashi²⁹, Masato Yoneda³⁰, Dae Won Jun³¹, Yoshio Sumida³², Takeshi Okanoue³³, Atsushi Nakajima³⁰; JANIT Forum

Affiliations

¹ Department of Advanced Metabolic Hepatology, Osaka University Graduate School of Medicine, 1-7, Yamadaoka, Suita, Osaka, 565-0871, Japan.
² Medicine Division, Nippon Boehringer Ingelheim Co., Ltd., 2-1-1, Osaki, Shinagawa-Ku, Tokyo, 141-6017, Japan.
³ FibroScan Division, Integral Corporation, 2-25-2, Kamiosaki, Shinagawa-Ku, Tokyo, 141-0021, Japan.
⁴ Immunology, Hepatology & Dermatology Medical Franchise Dept., Medical Division, Novartis Pharma K.K., 1-23-1, Toranomon, Minato-Ku, Tokyo, 105-6333, Japan.
⁵ Medical Information Services, Institute of Immunology Co., Ltd., 1-1-10, Koraku, Bunkyo-Ku, Tokyo, 112-0004, Japan.
⁶ Product Development 1St Group, Product Development Dept., Fujirebio Inc., 2-1-1, Nishishinjuku, Shinjuku-Ku, Tokyo, 163-0410, Japan.
⁷ Academic Department, GE Healthcare Japan, 4-7-127, Asahigaoka, Hino, Tokyo, 191-8503, Japan.
⁸ Ultrasound Business Area, Siemens Healthcare KK, 1-11-1, Osaki, Shinagawa-Ku, Tokyo, 141-8644, Japan.
⁹ Department of Medicine, Division of Gastroenterology, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
¹⁰ Cardiovascular and Diabetes, Product Marketing Department, Kowa Company, Ltd., 3-4-10, Nihonbashi Honcho, Chuo-Ku, Tokyo, 103-0023, Japan.
¹¹ Clinical Development & Operations Japan, Nippon Boehringer Ingelheim Co., Ltd., 2-1-1, Osaki, Shinagawa-Ku, Tokyo, 141-6017, Japan.
¹² Medical Affairs Department, Kowa Company, Ltd., 3-4-14, Nihonbashi Honcho, Chuo-Ku, Tokyo, 103-8433, Japan.
¹³ R&D Planning Department, EA Pharma Co., Ltd., 2-1-1, Irifune, Chuo-Ku, Tokyo, 104-0042, Japan.
¹⁴ Diagnostics Business Area, Siemens Healthcare Diagnostics KK, 1-11-1, Osaki, Shinagawa-Ku, Tokyo, 141-8673, Japan.
¹⁵ Marketing Dep. H.U. Frontier, Inc., Shinjuku Mitsui Building, 2-1-1, Nishishinjuku, Shinjuku-Ku, Tokyo, 163-0408, Japan.
¹⁶ Clinical Development Dept, EA Pharma Co., Ltd., 2-1-1, Irifune, Chuo-Ku, Tokyo, 104-0042, Japan.
¹⁷ Global Drug Development Division, Novartis Pharma KK, 1-23-1, Toranomon, Minato-Ku, Tokyo, 105-6333, Japan.
¹⁸ 2Nd Product Planning Dept, 2Nd Product Planning Division, Fujirebio Inc, 2-1-1, Nishishinjuku, Shinjuku-Ku, Tokyo, 163-0410, Japan.
¹⁹ Departments of Hepatology, Graduate School of Medicine, Osaka Metropolitan University, 1-4-3, Asahi-Machi, Abeno-Ku, Osaka, Osaka, 545-8585, Japan.
²⁰ Department of Gastroenterology and Hepatology, Suita Municipal Hospital, 5-7, Kishibe Shinmachi, Suita, Osaka, 564-8567, Japan.
²¹ Department of General Internal Medicine2, Kawasaki Medical School, Kawasaki Medical Center, 2-6-1, Nakasange, Kita-Ku, Okayama, Okayama, 700-8505, Japan.
²² Department of Gastroenterology, JA Hiroshima Kouseiren General Hospital, 1-3-3, Jigozen, Hatsukaichi, Hiroshima, 738-8503, Japan.
²³ Hyogo Life Care Clinic Hiroshima, 6-34-1, Enkobashi-Cho, Minami-Ku, Hiroshima, Hiroshima, 732-0823, Japan.
²⁴ Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, 1750-1, Oaza Ikenobe, Miki-Cho, Kita-Gun, Kagawa, 761-0793, Japan.
²⁵ Department of Gastroenterology and Hepatology, Gifu Municipal Hospital, 7-1, Kashima-Cho, Gifu, Gifu, 500-8513, Japan.
²⁶ Division of Hepatology, Shimane University Hospital, 89-1, Enya-Cho, Izumo, Shimane, 693-8501, Japan.
²⁷ Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Defense Medical College, 3-2, Namiki, Tokorozawa, Saitama, 359-8513, Japan.
²⁸ Division of Gastroenterology and Hepatology, Tokyo Medical University Ibaraki Medical Center, 3-20-1, Chuo, Ami-Machi, Inashiki-Gun, Ibaraki, 300-0395, Japan.
²⁹ Liver Center, Faculty of Medicine, Saga University Hospital, Saga University, 5-1-1, Nabeshima, Saga, Saga, 849-8501, Japan.
³⁰ Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, 3-9, Fukuura, Kanazawa-Ku, Yokohama, Kanagawa, 236-0004, Japan.
³¹ Department of Internal Medicine, Hanyang University College of Medicine, Seoul, 04763, Korea.
³² Division of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University, 21 Yazako Karimata, Nagakute, Aichi, 480-1195, Japan. sumida19701106@yahoo.co.jp.
³³ Department of Gastroenterology & Hepatology, Saiseikai Suita Hospital, Osaka, 1-2, Kawazono-Cho, Suita, Osaka, 564-0013, Japan.

PMID: 36469127
PMCID: PMC9735102
DOI: 10.1007/s00535-022-01932-1

Review

SWOT analysis of noninvasive tests for diagnosing NAFLD with severe fibrosis: an expert review by the JANIT Forum

Yoshihiro Kamada et al. J Gastroenterol. 2023 Feb.

. 2023 Feb;58(2):79-97.

doi: 10.1007/s00535-022-01932-1. Epub 2022 Dec 5.

Authors

Affiliations

¹ Department of Advanced Metabolic Hepatology, Osaka University Graduate School of Medicine, 1-7, Yamadaoka, Suita, Osaka, 565-0871, Japan.
² Medicine Division, Nippon Boehringer Ingelheim Co., Ltd., 2-1-1, Osaki, Shinagawa-Ku, Tokyo, 141-6017, Japan.
³ FibroScan Division, Integral Corporation, 2-25-2, Kamiosaki, Shinagawa-Ku, Tokyo, 141-0021, Japan.
⁴ Immunology, Hepatology & Dermatology Medical Franchise Dept., Medical Division, Novartis Pharma K.K., 1-23-1, Toranomon, Minato-Ku, Tokyo, 105-6333, Japan.
⁵ Medical Information Services, Institute of Immunology Co., Ltd., 1-1-10, Koraku, Bunkyo-Ku, Tokyo, 112-0004, Japan.
⁶ Product Development 1St Group, Product Development Dept., Fujirebio Inc., 2-1-1, Nishishinjuku, Shinjuku-Ku, Tokyo, 163-0410, Japan.
⁷ Academic Department, GE Healthcare Japan, 4-7-127, Asahigaoka, Hino, Tokyo, 191-8503, Japan.
⁸ Ultrasound Business Area, Siemens Healthcare KK, 1-11-1, Osaki, Shinagawa-Ku, Tokyo, 141-8644, Japan.
⁹ Department of Medicine, Division of Gastroenterology, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
¹⁰ Cardiovascular and Diabetes, Product Marketing Department, Kowa Company, Ltd., 3-4-10, Nihonbashi Honcho, Chuo-Ku, Tokyo, 103-0023, Japan.
¹¹ Clinical Development & Operations Japan, Nippon Boehringer Ingelheim Co., Ltd., 2-1-1, Osaki, Shinagawa-Ku, Tokyo, 141-6017, Japan.
¹² Medical Affairs Department, Kowa Company, Ltd., 3-4-14, Nihonbashi Honcho, Chuo-Ku, Tokyo, 103-8433, Japan.
¹³ R&D Planning Department, EA Pharma Co., Ltd., 2-1-1, Irifune, Chuo-Ku, Tokyo, 104-0042, Japan.
¹⁴ Diagnostics Business Area, Siemens Healthcare Diagnostics KK, 1-11-1, Osaki, Shinagawa-Ku, Tokyo, 141-8673, Japan.
¹⁵ Marketing Dep. H.U. Frontier, Inc., Shinjuku Mitsui Building, 2-1-1, Nishishinjuku, Shinjuku-Ku, Tokyo, 163-0408, Japan.
¹⁶ Clinical Development Dept, EA Pharma Co., Ltd., 2-1-1, Irifune, Chuo-Ku, Tokyo, 104-0042, Japan.
¹⁷ Global Drug Development Division, Novartis Pharma KK, 1-23-1, Toranomon, Minato-Ku, Tokyo, 105-6333, Japan.
¹⁸ 2Nd Product Planning Dept, 2Nd Product Planning Division, Fujirebio Inc, 2-1-1, Nishishinjuku, Shinjuku-Ku, Tokyo, 163-0410, Japan.
¹⁹ Departments of Hepatology, Graduate School of Medicine, Osaka Metropolitan University, 1-4-3, Asahi-Machi, Abeno-Ku, Osaka, Osaka, 545-8585, Japan.
²⁰ Department of Gastroenterology and Hepatology, Suita Municipal Hospital, 5-7, Kishibe Shinmachi, Suita, Osaka, 564-8567, Japan.
²¹ Department of General Internal Medicine2, Kawasaki Medical School, Kawasaki Medical Center, 2-6-1, Nakasange, Kita-Ku, Okayama, Okayama, 700-8505, Japan.
²² Department of Gastroenterology, JA Hiroshima Kouseiren General Hospital, 1-3-3, Jigozen, Hatsukaichi, Hiroshima, 738-8503, Japan.
²³ Hyogo Life Care Clinic Hiroshima, 6-34-1, Enkobashi-Cho, Minami-Ku, Hiroshima, Hiroshima, 732-0823, Japan.
²⁴ Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, 1750-1, Oaza Ikenobe, Miki-Cho, Kita-Gun, Kagawa, 761-0793, Japan.
²⁵ Department of Gastroenterology and Hepatology, Gifu Municipal Hospital, 7-1, Kashima-Cho, Gifu, Gifu, 500-8513, Japan.
²⁶ Division of Hepatology, Shimane University Hospital, 89-1, Enya-Cho, Izumo, Shimane, 693-8501, Japan.
²⁷ Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Defense Medical College, 3-2, Namiki, Tokorozawa, Saitama, 359-8513, Japan.
²⁸ Division of Gastroenterology and Hepatology, Tokyo Medical University Ibaraki Medical Center, 3-20-1, Chuo, Ami-Machi, Inashiki-Gun, Ibaraki, 300-0395, Japan.
²⁹ Liver Center, Faculty of Medicine, Saga University Hospital, Saga University, 5-1-1, Nabeshima, Saga, Saga, 849-8501, Japan.
³⁰ Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, 3-9, Fukuura, Kanazawa-Ku, Yokohama, Kanagawa, 236-0004, Japan.
³¹ Department of Internal Medicine, Hanyang University College of Medicine, Seoul, 04763, Korea.
³² Division of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University, 21 Yazako Karimata, Nagakute, Aichi, 480-1195, Japan. sumida19701106@yahoo.co.jp.
³³ Department of Gastroenterology & Hepatology, Saiseikai Suita Hospital, Osaka, 1-2, Kawazono-Cho, Suita, Osaka, 564-0013, Japan.

PMID: 36469127
PMCID: PMC9735102
DOI: 10.1007/s00535-022-01932-1

Abstract

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease. Nonalcoholic steatohepatitis (NASH) is an advanced form of NAFLD can progress to liver cirrhosis and hepatocellular carcinoma (HCC). Recently, the prognosis of NAFLD/NASH has been reported to be dependent on liver fibrosis degree. Liver biopsy remains the gold standard, but it has several issues that must be addressed, including its invasiveness, cost, and inter-observer diagnosis variability. To solve these issues, a variety of noninvasive tests (NITs) have been in development for the assessment of NAFLD progression, including blood biomarkers and imaging methods, although the use of NITs varies around the world. The aim of the Japan NASH NIT (JANIT) Forum organized in 2020 is to advance the development of various NITs to assess disease severity and/or response to treatment in NAFLD patients from a scientific perspective through multi-stakeholder dialogue with open innovation, including clinicians with expertise in NAFLD/NASH, companies that develop medical devices and biomarkers, and professionals in the pharmaceutical industry. In addition to conventional NITs, artificial intelligence will soon be deployed in many areas of the NAFLD landscape. To discuss the characteristics of each NIT, we conducted a SWOT (strengths, weaknesses, opportunities, and threats) analysis in this study with the 36 JANIT Forum members (16 physicians and 20 company representatives). Based on this SWOT analysis, the JANIT Forum identified currently available NITs able to accurately select NAFLD patients at high risk of NASH for HCC surveillance/therapeutic intervention and evaluate the effectiveness of therapeutic interventions.

Keywords: Artificial intelligence; Biomarker; Elastography; NAFLD/NASH; Scoring system.

PubMed Disclaimer

Conflict of interest statement

TN and TH are employees of Nippon Boehringer Ingelheim Co., Ltd. SI and SM are employees of Integral Corporation. YK and KH are employees of Novartis Pharma KK. YS and TM are employees of the Institute of Immunology Co., Ltd. YO and KF are employees of Fujirebio Inc. AN is an employee of GE Healthcare Japan. NY is an employee of Siemens Healthcare KK. TY and AY are employees of Kowa Company, Ltd. IK and AU are employees of EA Pharma Co., Ltd. HF is an employee of Siemens Healthcare Diagnostics KK. MK is an employee of H.U. Frontier, Inc.

Figures

**Fig. 1**
The JANIT Forum project plan Based on this SWOT analysis of NITs, a sub-analysis of the CLIONE study (cross-sectional trial in Japan) is underway. The next step of the JANIT Forum is the prospective CLIONE 2.0 study (longitudinal and intervention trial). Our goal is to establish standardized NITs for the assessment of NAFLD, which will enable us to diagnose disease severity and assess treatment response in NAFLD patients

See this image and copyright information in PMC

References

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SWOT analysis of noninvasive tests for diagnosing NAFLD with severe fibrosis: an expert review by the JANIT Forum

Affiliations

SWOT analysis of noninvasive tests for diagnosing NAFLD with severe fibrosis: an expert review by the JANIT Forum

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

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Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical