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Business Wire
7 days ago
- Business
- Business Wire
Fujirebio Expands Its Neuro Testing Portfolio With the Launch of the Fully Automated Lumipulse® G sTREM2 Assay for Research Use Only
GENT, Belgium & MALVERN, Pa. & TOKYO--(BUSINESS WIRE)--H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G sTREM2 assay for the fully automated LUMIPULSE® G immunoassay analyzers. This CLEIA (chemiluminescent enzyme immunoassay) assay is available for Research Use Only (RUO) and allows for the quantitative measurement of soluble Triggering Receptor Expressed on Myeloid Cells 2 (sTREM2) in human cerebrospinal fluid (CSF) and blood within just 35 minutes. sTREM2 complements established biomarkers like GFAP, NfL, and pTau by adding essential insight into neuroinflammation - offering a more complete picture of the disease on a single platform. Share sTREM2 is a promising biomarker of microglial activation, offering researchers insights into neuroinflammation linked to Alzheimer's and other neurodegenerative diseases. sTREM2 can be valuable for capturing the dynamics of inflammatory responses or for monitoring inflammatory modulators. This test complements Fujirebio's growing portfolio of neuro biomarkers, including GFAP, NfL, and pTau, and reinforces the company's leading position in advancing neuro biomarker research tools and diagnostics. 'By adding sTREM2 to our neuro portfolio, we're enabling a more comprehensive view of neurological disease mechanisms,' said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc. 'sTREM2 complements established biomarkers like GFAP, NfL, and pTau by adding essential insight into neuroinflammation - offering a more complete picture of the disease on a single platform.' The new test allows researchers and clinical research professionals to further study and understand the potential clinical utility of this promising microglial biomarker. The availability of the assay on the fully automated random access LUMIPULSE G analyzers gives researchers access to convenient, accurate, and robust measurement of sTREM2. Already widely available for routine use in neurological disease testing worldwide, these analyzers meet all necessary quality, throughput, and regulatory requirements. About Fujirebio Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality RUO and in vitro diagnostics (IVD) testing. It has more than 50 years' accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products. Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio offers a comprehensive line-up of manual and fully automated assays for neurological diseases and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information can be found at
NDTV
21-05-2025
- Health
- NDTV
In A First, Alzheimer's Blood Test Available in US From June
The first blood test to help diagnose Alzheimer's disease will be available from late June in the US following regulatory clearance for its use last week, according to the Japanese company behind the innovation. The test will initially be available at about 50 American research institutes and hospitals that specialise in Alzheimer's disease, Goki Ishikawa, head of Fujirebio Holdings Inc., a unit of Japan's H.U. Group Holdings Inc., said in an interview Tuesday. It's partnering with bigger rivals like Beckman Coulter Inc. to help develop and manufacture their products, he said. The Food and Drug Administration cleared the blood test to help diagnose Alzheimer's disease last week, potentially making it easier to find and treat patients with the memory-robbing disease that affects nearly 7 million Americans. The test was cleared for use in people at least 55 years old and who exhibit signs of the disease. It is designed to detect amyloid, a protein that can build up in the brain and is a hallmark of Alzheimer's, the most common form of dementia in the elderly. The process, which takes roughly 30 minutes from drawing the blood to diagnosis, will be available to patients at a fraction of the cost of a PET scan. The method is viewed as a critical step in making new types of Alzheimer's treatments widely accessible. Until now, patients typically have to get a specialised PET scan to detect amyloid in their brains or undergo cerebrospinal fluid tests, both of which are more expensive and invasive. The lack of quick and easy tests has until now slowed the rollout of new Alzheimer's drugs like Eisai Co. and Biogen Inc.'s Leqembi and Eli Lilly & Co.'s Kisunla. The company plans to file data to seek approvals in Japan as early as August and Europe within this year, Ishikawa said. In China, Fujirebio's undisclosed partner will probably submit data to regulators next year, he added. The company's partner in India, Agappe Diagnostics Ltd., has already filed data to seek clearance in the country, according to Ishikawa. "We have a presence in Japan but that's not necessarily the case in markets overseas," said Ishikawa. "We can't get the market shares by ourselves, but if we supply the raw materials to partners, we can benefit through them."
Straits Times
21-05-2025
- Health
- Straits Times
First Alzheimer's blood test available in US in June
The first blood test to help diagnose Alzheimer's disease will be available from late June in the US. PHOTO: ISTOCKPHOTO WASHINGTON – The first blood test to help diagnose Alzheimer's disease will be available from late June in the US following regulatory clearance for its use last week, according to the Japanese company behind the innovation. The test will initially be available at about 50 American research institutes and hospitals that specialise in Alzheimer's disease, Mr Goki Ishikawa, head of Fujirebio Holdings Inc., a unit of Japan's H.U. Group Holdings Inc., said in an interview on May 20. It's partnering with bigger rivals like Beckman Coulter Inc. to help develop and manufacture their products, he said. The Food and Drug Administration cleared the blood test to help diagnose Alzheimer's disease last week, potentially making it easier to find and treat patients with the memory-robbing disease that affects nearly seven million Americans. The test was cleared for use in people at least 55 years old and who exhibit signs of the disease. It is designed to detect amyloid, a protein that can build up in the brain and is a hallmark of Alzheimer's, the most common form of dementia in the elderly. The process, which takes roughly 30 minutes from drawing the blood to diagnosis, will be available to patients at a fraction of the cost of a PET scan. The method is viewed as a critical step in making new types of Alzheimer's treatments widely accessible. Until now, patients typically have to get a specialised PET scan to detect amyloid in their brains or undergo cerebrospinal fluid tests, both of which are more expensive and invasive. The lack of quick and easy tests has until now slowed the rollout of new Alzheimer's drugs like Eisai Co. and Biogen Inc.'s Leqembi and Eli Lilly & Co.'s Kisunla. The company plans to file data to seek approvals in Japan as early as August and Europe within this year, Mr Ishikawa said. In China, Fujirebio's undisclosed partner will probably submit data to regulators next year, he added. In India, it partners with Agappe Diagnostics Ltd. 'We have a presence in Japan but that's not necessarily the case in markets overseas,' said Mr Ishikawa. 'We can't get the market shares by ourselves, but if we supply the raw materials to partners, we can benefit through them.' BLOOMBERG Join ST's Telegram channel and get the latest breaking news delivered to you.
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Business Standard
20-05-2025
- Health
- Business Standard
First blood test for Alzheimer's in US from June, starting at 50 hospitals
The first blood test to help diagnose Alzheimer's disease will be available from late June in the US following regulatory clearance for its use last week, according to the Japanese company behind the innovation. The test will initially be available at about 50 American research institutes and hospitals that specialize in Alzheimer's disease, Goki Ishikawa, head of Fujirebio Diagnostics Inc. that developed the test, said in an interview Tuesday. The company, a unit of Japan's H.U. Group Holdings Inc., is also partnering with bigger rivals like Beckman Coulter Inc. to help develop and manufacture their products, he said. The Food and Drug Administration cleared the blood test to help diagnose Alzheimer's disease last week, potentially making it easier to find and treat patients with the memory-robbing disease that affects nearly 7 million Americans. The test was cleared for use in people at least 55 years old and who exhibit signs of the disease. It is designed to detect amyloid, a protein that can build up in the brain and is a hallmark of Alzheimer's, the most common form of dementia in the elderly. The process, which takes roughly 30 minutes from drawing the blood to diagnosis, will be available to patients at a fraction of the cost of a PET scan. The method is viewed as a critical step in making new types of Alzheimer's treatments widely accessible. Until now, patients typically have to get a specialized PET scan to detect amyloid in their brains or undergo cerebrospinal fluid tests, both of which are more expensive and invasive. The lack of quick and easy tests has until now slowed the rollout of new Alzheimer's drugs like Eisai Co. and Biogen Inc.'s Leqembi and Eli Lilly & Co.'s Kisunla. The company plans to file data to seek approvals in Japan as early as August and Europe within this year, Ishikawa said. In China, Fujirebio's undisclosed partner will probably submit data to regulators next year, he added. In India, it partners with Agappe Diagnostics Ltd. 'We have a presence in Japan but that's not necessarily the case in markets overseas,' said Ishikawa. 'We can't get the market shares by ourselves, but if we supply the raw materials to partners, we can benefit through them.'
Mint
16-05-2025
- Health
- Mint
FDA Approves First Blood Test to Diagnose Alzheimer's Disease
(Bloomberg) -- US regulators have approved the first blood test to help diagnose Alzheimer's disease, potentially making it easier to find and treat patients with the mind-robbing disease that affects nearly 7 million Americans. The test made by Fujirebio Diagnostics Inc., a unit of Japan's H.U. Group Holdings Inc., was cleared for people 55 years and older who exhibit signs and symptoms of the disease, the US Food and Drug Administration said in a statement. It is designed for the early detection of amyloid, a protein that can build up in the brain and is a hallmark of Alzheimer's, the most common form of dementia in the elderly. The development and approval of blood tests that can spot which patients are likely to have toxic amyloid in their brains has been viewed as a critical step toward making drugs to treat the condition more widely accessible. While the test is approved for people who are already exhibiting signs of cognitive impairment, studies show amyloid begins accumulating in the brains of some patients years before symptoms begin. To qualify for drug treatment, patients now generally get a specialized PET scan to detect amyloid in their brains or undergo a cerebrospinal fluid test. The PET scans are expensive and require specialized equipment, while the spinal fluid tests involve an invasive procedure. The need for these tests has slowed the rollout of new Alzheimer's drugs like Leqembi from Eisai Co. and Biogen Inc., and Eli Lilly & Co.'s Kisunla. Fujirebio's newly approved test, called Lumipulse, only requires a blood draw, making it less invasive and potentially easier for patients to access. It's unclear how much it will cost or when it will be available. It's intended for patients at a specialized care setting who are experiencing cognitive decline, according to the FDA. The blood test shouldn't be used alone to diagnose the disease, in part because of the risk of false positive or negative results, the agency said. Other clinical evaluations and additional tests should be used to determine treatment options, it said. More stories like this are available on
