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Sysmex’s HISCL™ TARC Assay Kit Becomes the First Serum Biomarker for the Diagnosis of Severe Drug Rashes to Receive Insurance Coverage in Japan
Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announced that its HISCL TARC Assay Kit (hereinafter, “the assay kit”), a unique parameter in the field of immunochemistry testing, received insurance coverage in Japan as of December 1, 2024, as an aid in the differential diagnosis of drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DIHS/DRESS1), a type of severe drug rashes. The assay kit is the only serum biomarker in Japan that can be used to diagnose severe drug rashes, for which early diagnosis is crucial. Going forward, patients will be able to utilize this objective and rapid testing method under national insurance coverage.
Severe drug rashes refer to life-threatening conditions that occur after administration of a drug. Representative diseases include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DIHS/DRESS). DIHS/DRESS is a type of drug rashes accompanied by high fever and organ damage, and is a serious disease with a reported mortality rate of 10-20%.2 Early differential diagnosis is crucial because treatment plans vary depending on the type of drug rashes, and the initial response to the onset of the disease determines the subsequent course of the disease condition. However, current diagnosis relies heavily on medical history and clinical findings, emphasizing the need for an objective and rapid diagnostic method.
The assay kit can rapidly measure the serum TARC concentration, which is one of the biomarkers related to inflammatory responses, in 17 minutes, using Sysmex's Automated Immunoassay Systems HISCL-5000/HISCL-800.3 After being launched in April 2014 for the purpose of assisting in determining the severity of atopic dermatitis, the assay kit received additional indications as an aid in determining the exacerbation risks of SARS-CoV-2-positive patients in June 2021 and an aid in the diagnosis of DIHS/DRESS in July 2023. The assay kit is widely used in medical settings across Japan as one of the unique parameters in our immunochemistry testing field.
With the recent insurance coverage for assistance in the differential diagnosis of DIHS/DRESS, objective and rapid testing using serum biomarkers for the diagnosis and treatment of severe drug rashes will be available under insurance coverage for the first time in Japan. By expanding access to this new testing method, we hope to increase the rate of diagnosis of DIHS/DRESS at an early stage and support early and appropriate treatment, thereby contributing to improving patients' quality of life.
Sysmex remains committed to realizing a better healthcare journey4 through the continued expansion of high-value testing parameters that contribute to reducing patient burden, improving the quality of testing, and streamlining medical costs, and will continue to promote business expansion globally.
Product Overview
| Generic name (JMDN) |
Th2 chemokine/TARC kit
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| Product name | HISCL™ TARC Assay Kit |
| In vitro diagnostics approval number in Japan | 225AAAMX00132000 |
| Intended use |
Measuring the amount of human TARC in serum (to assist in determining the severity of atopic dermatitis and assist in the diagnosis of drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DIHS/DRESS); and to aid in determining the exacerbation risks of SARS-CoV-2-positive patients).
|
| Manufacturer and seller | Sysmex Corporation |
Overview of National Health Insurance (NHI) Coverage in Japan
| NHI category |
E2 (existing items, changed)
|
| Item of measurement | D015 Plasma protein immunological testing 18 TARC |
| Measurement method | Chemiluminescence enzyme immunoassay (CLEIA) (quantitative) |
| NHI points |
179
|
| Effective date | December 1, 2024 |
References
April 21, 2014 news release: Sysmex to Launch the HISCL™ TARC Assay Kit for Atopic Dermatitis - Allows for Automated Testing in Only 17 Minutes -
https://www.sysmex.co.jp/en/news/2014/140421.html
June 7, 2021 news release: Th2 Chemokine TARC Kit "HISCL™ TARC Assay Kit" is Approved for an Additional Indication as an Auxiliary for Assessment of COVID-19 Aggravation risk
https://www.sysmex.co.jp/en/news/2021/pdf/210607.pdf
February 26, 2024 news release: Initiated In-house Production of HISCL™ TARC Assay Kit and HISCL™ ANP Assay Kit - Succession of Manufacturing and Marketing Approval from Shionogi to Accelerate Global Expansion and Business Growth in the Immunochemistry Field -
https://www.sysmex.co.jp/en/news/2024/240226.html
https://www.sysmex.co.jp/en/news/2014/140421.html
June 7, 2021 news release: Th2 Chemokine TARC Kit "HISCL™ TARC Assay Kit" is Approved for an Additional Indication as an Auxiliary for Assessment of COVID-19 Aggravation risk
https://www.sysmex.co.jp/en/news/2021/pdf/210607.pdf
February 26, 2024 news release: Initiated In-house Production of HISCL™ TARC Assay Kit and HISCL™ ANP Assay Kit - Succession of Manufacturing and Marketing Approval from Shionogi to Accelerate Global Expansion and Business Growth in the Immunochemistry Field -
https://www.sysmex.co.jp/en/news/2024/240226.html
Terminology
| 1 | Drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DIHS/DRESS): | |||||||
| DIHS/DRESS is a type of severe drug rashes accompanied by high fever and multiple organ damage, and is induced by medications such as anticonvulsants. It is characterized by a delayed onset after drug administration, persisting for more than two weeks after discontinuation of the causative drug, and is accompanied by the reactivation of latent human herpesvirus type 6 (HHV-6) infection in the body. Due to these characteristics, diagnosis is difficult until two to three weeks after the onset of symptoms, and it is said to be difficult to carry out appropriate tests and treatments according to the type of drug rashes in the early stages of onset. | ||||||||
| 2 | Source: Hiroshi Yamamoto et al. “Acute hepatic failure due to drug-induced hypersensitivity syndrome: a case report.” Journal of the Japanese Society of Intensive Care Medicine. 2015;22:127-31. | |||||||
| https://doi.org/10.3918/jsicm.22.127 *Japanese only | ||||||||
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Sysmex promotes the concept of a “healthcare journey.” We view the various healthcare-related events a person experiences throughout their lives (life stages), along with the corresponding processes these involve (such as treatment at healthcare institutions), as a “journey.” Through various collaborations, we aim to offer new value, to make each individual’s healthcare journey better, and to grow as an essential presence in society.
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About Sysmex Corporation
Sysmex Corporation, headquartered in Kobe, Japan, is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey." Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives. For more information about Sysmex, please visit www.sysmex.co.jp/en/.
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- The purpose of this news release is to communicate our business activities to our stakeholders. It may or may not include information about Sysmex's products or their research and development, but this is not intended for promotion, advertising or medical advice. The information contained in this news release is current as of the date of the announcement but may be subject to change without prior notice.