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Fujifilm applies for manufacturing and marketing approval for a SARS-CoV-2antigen test kit using silver amplification immunochromatography method*
Capital investment for Vietnam production site decided, to provide a stable global supply

TOKYO, December 17, 2020 — FUJIFILM Corporation (President: Kenji Sukeno) is pleased to announce that it has filed an application with the Pharmaceuticals and Medical Devices Agency to obtain manufacturing and marketing approval for a rapid and simple antigen test kit for detecting SARS-CoV-2, using silver amplification immunochromatography method*, as in-vitro diagnostic medical device. This kit has been developed with the use of highly-sensitive detection technology based on silver halide amplification response used in the photo-developing process.

In a bid to establish a production structure for this test kit, Fujifilm is making a capital investment in FUJIFILM YUWA MEDICAL PRODUCTS VIETNAM COMPANY LIMITED (Head office in Bình Dương, Vietnam), which manufactures Fujifilm's diagnostics medical products. The investment has been chosen for the third round of a business support program by the Japan External Trade Organization (JETRO) for diversifying overseas supply chains.

Antigen tests can be carried out quickly and produce results on the spot. Despite these advantages, antigen tests have lower sensitivity than PCR tests and there are growing needs for the improvement of their sensitivity. From their advantages, antigen tests are now being considered globally for use not only at hospitals but also at airports, event venues and other premises as economic activities begin to resume. This has created the need for ensuring stable supply of antigen test kits.

From October this year, Fujifilm and the Public University Corporation Yokohama City University (Kanagawa, Japan) jointly develop the rapid and simple antigen test kit for SARS-CoV-2 using silver amplification immunochromatography method, which is Fujifilm's proprietary highly-sensitive detection technology. The test kit is due to be produced at Fujifilm's Ashigara Site in the Kanagawa Factory. However, in anticipation for the product's global deployment in the future, FUJIFILM YUWA in Vietnam will start gradually reinforcing its production facilities next year to ensure supply stability for the test kit.

<About FUJIFILM YUWA>
FUJIFILM YUWA is a joint venture of Fujifilm and Yuwa Corporation (Head office in Nagano, Japan), established in May this year in the complex of Yuwa's Vietnamese subsidiary, YUWA VIETNAM Co., Ltd., for the manufacturing of Fujifilm's diagnostic medical products. The venture went into full operation in November this year, producing reagents for Fujifilm's clinical chemistry analyzer “Fuji Dri-Chem” for the European and North American markets**. Fujifilm has decided to make a capital investment in the venture to add capacity for producing antigen test kit for SARS-CoV-2.

[Image]About FUJIFILM YUWA
Company name FUJIFILM YUWA MEDICAL PRODUCTS VIETNAM COMPANY LIMITED
Location Thu Dau Mot City, Binh Duong, Vietnam
Establishment May 2020 (operation commenced in November 2020)
Capital participation ratio Fujifilm 51%, Yuwa 49%

The Fujifilm Group has contributed to making SARS-CoV-2 testing faster by supplying PCR test reagents and the reagents for use with the fully-automated immunoassay system “μTASWako g1,”*** capable of performing simple and rapid PCR testing in full automation. (These SARS-CoV-2 reagents are currently available in Japan only.) By providing a wide range of products and services that meet the needs of medical frontline, the Fujifilm Group will continue to help improve the efficiency of SARS-CoV-2 testing while contributing to the improvement of the quality of life and medical care.

  • * Immunochromatography is a testing method in which a specimen (e.g. nasopharyngeal swab) is processed in a reagent. If the specimen contains a test substance (e.g. virus), it binds with a labeled antibody in the reagent to generate an immune complex. When the complex is captured by an antibody which is coated beforehand along a detection line, the line manifests color, indicating a positive result (containing antigens). The method produces results easily and rapidly, and is therefore used frequently for detecting an infectious disease that requires quick treatment.
  • ** Only reagents for veterinary use are produced for the North American market.
  • *** Medical device notification number 27B3X00024000016, manufactured and marketed by FUJIFILM Wako Pure Chemical Corporation

[Silver amplification technology for use in the antigen test kit to be developed]

[Silver amplification technology for use in the antigen test kit to be developed]

For inquiries on information in this media release, contact:

Media Contact:
FUJIFILM Holdings Corporation
Corporate Communications Division
Pulic Relations Group
TEL: +81-3-6271-2000
Customer Contact:
FUJIFILM Corporation
Medical Systems Business Division
TEL: +81-3-6271-1375

Note:

  • * This news release is issued by FUJIFILM Corporation in Japan.
  • * Fujifilm makes no representation that products on this news release are commercially available in all countries and regions(including US and EU). Approved uses of healthcare products vary by country and region.
  • * Specifications and appearance of products are subject to change without notice.