News Release

June 27, 2024

FUJIFILM Wako Pure Chemicals Launches New Pyrogen and Endotoxin Tests

Alternatives to Traditional Pyrogen and Endotoxin Testing,
LumiMAT™ Pyrogen Detection Kit and PYROSTAR™ Neo+ will be available in July 2024

OSAKA, Japan, June 27th, 2024 - FUJIFILM Wako Pure Chemicals Corporation announces the launch of two new tests: LumiMAT™ Pyrogen Detection Kit (LumiMAT), a next-generation monocyte activation test (MAT)1 for in vitro2 pyrogen testing, and PYROSTAR™ Neo+, a recombinant protein reagent for the detection of bacterial endotoxins. Alternatives to traditional pyrogen and endotoxin tests, the new LumiMAT and PYROSTAR™ Neo+ testing kits will be available worldwide in July 2024.

Pyrogens, including gram-negative bacterial endotoxins, are substances which produce fever, inflammatory reactions, and, in extreme cases, death,3 when introduced into the bloodstream. Guidelines require that parenteral biological products, drugs, and medical devices that come in contact with the blood stream are tested for pyrogens.

Developed as an alternative to the rabbit pyrogen test, LumiMAT screens several cell lines4 and is a rapid, robust, and highly sensitive assay for the detection of pyrogens, offering several advantages over traditional MAT assays currently available on the market. Most commercially available MAT assays utilize peripheral blood mononuclear cells (PBMCs)5 to measure cytokines released by monocytic cells upon exposure to pyrogens via ELISA,6 and can result in lot-to-lot variation and long testing times (up to 1.5 days). In contrast, LumiMAT uses human NOMO-1 cells7selected in a screen based on their high sensitivity to lipopolysaccharide (LPS) and a wide range of non-endotoxin pyrogens, as well as their reproducibility and stability. In addition, LumiMAT utilizes a luciferase reporter assay8 to detect activation of the transcription factor NF-κB,9 producing results in approximately 5 hours. The European Pharmacopoeia recently announced plans to replace the rabbit pyrogen test by 2026, with a clear preference for the MAT.

PYROSTAR Neo+, a recombinant protein-reagent for the detection of gram-negative bacterial endotoxin utilizes the Kinetic Chromogenic Assay (KCA)10 to measure endotoxin content. The reagent is composed of recombinant Factor C, Factor B, and a proclotting enzyme, allowing for endotoxin detection that offers the same sensitivity as the traditional LAL11 reagent. In addition, PYROSTAR Neo+ shows reduced interference with some drugs and improved reactivity to naturally occurring endotoxins, enabling use in a wider range of samples and applications, including product safety assessment and testing of pharmaceutical materials and water used for their manufacture.

“With a longstanding history contributing to public health and patient safety through quality control testing solutions for pharmaceuticals, we are proud to introduce two new testing kits for pyrogens and endotoxins to lead the industry forward,” said Koichi Yoshida, president of FUJIFILM Wako Pure Chemicals Corporation. “Our robust lineup of testing kits provides options for the pharmaceutical and medical device industries to choose the appropriate kit for their application. We will continue to help ensure the safety of healthcare products for patients around the world.”


Product Image

「LumiMAT™ Pyrogen Detection Kit- Cells」

「LumiMAT™ Pyrogen Detection Kit- Reagent Set」


  1. LumiMAT™ uses NanoLuc® technology; NanoLuc® technology is licensed from Promega Corporation. Licensed Patents: U.S. Pat No. 8557970 and U.S. Pat. No. 8669103, and all patents and patents pending which claim priority to the same priority application(s) as U.S. Pat. No. 8557970 and U.S. Pat. No.8669103. NanoLuc® is a registered trademark of Promega Corporation.
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