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."
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Economic Times
an hour ago
- Economic Times
He is biologically 24 years old at the age of 41, and his longevity secret involves 3 key supplements
Dr. Mohammed Enayat, a 41-year-old longevity expert from London, claims his biological age is just 24. By tracking his health with wearables and diagnostics, he tailors his lifestyle and relies on three daily supplements—B complex with folate, magnesium, and omega-3s. (Screenshot: Instagram/bydr.e) At 41, most people brace for midlife fatigue. But Dr. Mohammed Enayat, a primary care physician and founder of HUM2N longevity clinic in London, is defying that narrative. With cutting-edge diagnostics and a personalized wellness regime, Enayat claims his biological age is just 24—a full 17 years younger than what his passport states. What's behind this age-defying transformation? According to a report from Business Insider , it's not a magic elixir or an exotic detox. It's a meticulous science-backed regimen driven by relentless self-monitoring, strategic lifestyle choices, and three humble yet powerful supplements. For the past seven years, Dr. Enayat has treated his body like a data lab. He wears devices like the Oura Ring and the Whoop strap to monitor his sleep, recovery, and activity. On top of that, he undergoes frequent blood, urine, and microbiome testing. These insights help him fine-tune everything from nutrition to training—and yes, his supplement stack. While the definition of 'biological age' is still a topic of debate, Enayat uses metrics from GlycanAge and TruAge PACE, which assess inflammation and epigenetic changes. His most recent results—taken 18 months ago—indicated a biological age of 24. But Enayat is the first to admit: supplements are just a part of the bigger puzzle. 'While I believe these supplements have supported my biological age reversal, I credit them as one component in a much broader framework,' he told Business Insider . View this post on Instagram A post shared by HUM2N (@hum2n) Though his supplement intake evolves with his body's changing needs, three remain constant in his rotation—B complex with folate, magnesium, and omega-3 fatty acids. These are what he calls his 'core' supplements. One reason Dr. Enayat includes this duo daily is a personal one. 'I have a methylation gene defect,' he said, referring to a condition that leads to elevated homocysteine levels—a marker that increases inflammation and risk for cardiovascular disease. To combat this, he relies on a methylated B complex with folate to normalize his levels. Even without this genetic predisposition, Enayat recommends B vitamins during periods of stress or sleep deprivation, when the body's demand for them increases. The benefits? Improved mood, better brain health, and potential dementia prevention. Despite magnesium being plentiful in foods like dark leafy greens and legumes, Enayat says his levels are consistently low. He turns to magnesium bisglycinate, a highly absorbable form, to fill the gap. 'When I take magnesium, my muscles ache less and I fall asleep more easily,' he noted. While only 2% of Americans are thought to be deficient in magnesium, it remains essential for over 300 enzymatic reactions in the body. Known for their heart-healthy reputation, omega-3 fatty acids also make Enayat's daily lineup. Found naturally in fish, walnuts, and chia seeds, omega-3s reduce inflammation and lower blood pressure. For those who don't get enough through diet—like Enayat—a supplement can help close the gap. A recent Nature Aging study added further intrigue, showing that older adults who consumed a gram of omega-3 daily had younger biological ages than those who didn't. Dr. Enayat is the face of a growing movement where medicine, technology, and personal agency intersect. While he doesn't present his regimen as a universal blueprint, his case offers an exciting glimpse into what's possible when modern science meets old-school discipline. So, can you turn back your biological clock? Maybe not overnight—but for Enayat, it starts with knowing your numbers, trusting the data, and supporting your body from the inside out. Supplements might not be the secret to immortality, but in the right hands, they just might be a step toward living younger, longer.
Time of India
2 hours ago
- Time of India
3 overlooked symptoms in 40s that may lead to Alzheimer's later
According to the World Health Organisation, over 57 million people worldwide were living with dementia as of 2021. While Alzheimer's typically shows up much later in life, what often slips through the cracks are the subtle changes that begin to appear years—sometimes decades—before a formal diagnosis. There's a tendency to brush off certain symptoms in the 40s as stress, aging, or simply being too busy. But what if some of these signs are the brain's early warning system? What if they are telling a story that the body hasn't fully caught up with yet? Experts like Tyler Bradley, a brain and body coach, suggest that early brain inflammation, metabolic stress, and sleep dysregulation may quietly lay the foundation for neurodegenerative issues. Here are 3 symptoms that don't raise red flags—but maybe should. Brain fog that feels too persistent to ignore Everyone forgets things once in a while—keys, names, what someone just said. It's normal, right? Consistent brain fog—difficulty focusing, losing the thread mid-conversation, or constantly searching for words—can signal early neurological inflammation. It's not just about being tired or stressed. Recent neuroscience points to poor glucose regulation in the brain as one of the causes of this foggy state. The brain, being an energy-intensive organ, suffers deeply when insulin resistance or metabolic syndrome sneaks in during midlife. It doesn't scream—it whispers, in the form of forgetfulness that feels just a little too frequent. Alzheimer's disease is a brain disorder that slowly destroys a person's memory and thinking skills. It is a progressive neurological disorder that causes the brain to shrink (atrophy) and brain cells to die. This disease leads to a loss of cognitive functioning, such as thinking, remembering, and reasoning, along with behavioural abilities, to the point where it disrupts a person's daily life and routines. Emotional reactivity that's new and unexplained Life gets more stressful in the 40s. Kids, jobs, aging parents—it's natural to feel on edge. A brain that's overwhelmed metabolically becomes more reactive emotionally. When tiny stressors begin triggering big emotional waves—irritation, anxiety, even sadness—it's worth pausing. This change isn't always external. The nervous system may become more sensitive because of inflammation in the microglial cells—the brain's immune defense team. This means the emotional thermostat is broken, and the brain is operating in survival mode far more often than it should. Everyday drinks can feel harmless, comforting, even. A chilled diet soda after a long day, a sugar-loaded coffee to push through work, or a glass of skim milk at bedtime. These seem like small indulgences. But when science speaks, it's worth listening—especially when it's about the brain Restless sleep that feels more like survival than rest Everyone wakes up at 2 am sometimes. Maybe it's just hormones, or drinking water too late. The brain uses deep sleep to clean itself through a system called the glymphatic system. When that gets disrupted, toxins build up—especially amyloid plaques, which are strongly associated with Alzheimer's. Waking up in the middle of the night feeling wired, or sleeping 8 hours and still waking up tired, could mean the brain is missing the deep restorative states it needs. This isn't always insomnia—it's often neurochemical imbalance from a system that's struggling to regulate itself. One step to a healthier you—join Times Health+ Yoga and feel the change
Hindustan Times
3 hours ago
- Hindustan Times
Engineering humanity & where to draw a line
The future of human reproduction and genetic design is accelerating faster than most people understand, driven not by national debates or international accords, but by software startups, biotech investors, and quiet breakthroughs in fertility clinics. Nucleus Genomics recently unveiled Nucleus Embryo, a genetic screening platform that allows prospective parents to assess up to 20 embryos for more than 900 conditions and traits. These include not only polygenic risk scores for diseases such as cancer and Alzheimer's but also traits such as intelligence, height, and anxiety. In short, it offers a pathway to genetic optimisation — allowing parents to select not only healthier babies but the human features they want. Orchid, another US startup, pioneered full-genome sequencing of IVF embryos for disease screening. Once exclusive to the ultra-wealthy, Orchid's services are rapidly becoming more affordable, pointing to a future where embryo selection could become a standard step in family planning for both the middle and upper class. Meanwhile, Coinbase CEO Brian Armstrong, known for backing radical biotech ventures, has announced plans to launch a US company that would go beyond selection into embryo editing. Thanks to recent advances in base editing, it is now possible to alter individual DNA letters with high precision rewriting, rather than merely reading the code of life. The commercial race toward Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) babies has begun — and this is something I have long been both excited and terrified about. In a 2017 Washington Post article, I asked: 'Human editing has just become possible. Are we ready for the consequences?' I warned that CRISPR had made embryo editing technically feasible, but that society wasn't prepared for the moral fallout. I feared we would drift from preventing disease to designing our children. We have crossed this Rubicon. While the global community debates ethics and oversight, China is racing ahead with few restraints. Chinese scientists are editing the genes of animals — and even human embryos — not only to treat disease but to enhance traits such as intelligence and strength. Their goal appears to be the creation of so-called superhumans. Without international standards and ethical guardrails, unchecked ambition in any one country can pose risks for all of humanity. India must pay close attention. It has already misused reproductive technology: Ultrasound machines meant for foetal health monitoring were widely repurposed for sex selection. In Haryana, the sex ratio at birth has declined to 910 girls for every 1,000 boys. In a society shaped by caste, colourism, and academic pressure, gene editing could easily be co-opted to entrench inequality under the banner of 'better futures'. But more than vigilance, India must lead. With a deep-rooted traditions of spiritualism, karma and ethics, and respect for human dignity, it is uniquely positioned to offer the moral leadership this moment demands. Its scientific community is world-class, and its track record — from generic medicine to vaccine equity — shows it can pair innovation with compassion. The concerns extend far beyond reproduction. Gene-edited crops could marginalise small farmers if patented seeds are controlled by large corporations. CRISPR-based therapies, already costing more than $500,000 in the West, could deepen biological inequality. Even gene drives, designed to eliminate diseases such as malaria, could threaten delicate ecosystems like the Sundarbans if not deployed with care. To lead responsibly, India must act on four fronts. First, accelerate research. Universities and public institutions should partner with socially responsible entrepreneurs to build local expertise in gene editing, synthetic biology, and bioethics. This collaboration can ensure innovation is aligned with the public interest and rooted in Indian values rather than imported priorities. Second, access must be equitable. India has done this before with lifesaving generic drugs and can do this again. Public funding and subsidies must ensure CRISPR therapies reach rural and tribal populations suffering from genetic disorders like thalassemia. Third, the entire regulatory framework needs to be updated because existing biotech laws predate CRISPR. A new structure, co-created with scientists, ethicists, civil society, and patients, must define what is allowed, what is off-limits, and how oversight will function. Real engagement with the public, not just top-down mandates, will be essential. Fourth, India must lead globally. As it did in championing affordable vaccines, it can help shape international norms for genetic science, banning non-medical trait selection, regulating gene drives, and insisting on transparency and accountability. India can set the ethical benchmark, not merely follow it. We now have a rare opportunity to prove that scientific progress and moral clarity can coexist, but the window is narrow. We cannot rely on Silicon Valley, where profit is the only true metric of success, nor on China, where State control and repression define scientific ambition. Both paths risk taking humanity into dangerous territory. The world needs a third way, rooted in spiritual values, ethical reasoning, and the belief that technology must serve the many, not just the powerful, and this is the role India must play. Vivek Wadhwa is CEO, Vionix Biosciences. The views expressed are personal.
