UCHL1

Abbott said its 15-minute, hand-held blood test could help rule out the need for imaging scans to check for tissue damage in the 24 hours following a possible concussion or traumatic brain injury. Abbott has obtained a new clearance from the FDA for its rapid blood test to check out patients suspected of having a concussion or a mild traumatic brain injury. With a 15-minute result given by a hand-held cartridge reader, the company said its test can be used at an adult’s bedside in an emergency room as well as within urgent care clinics or other healthcare settings to help rule out the need for a CT scan. It is designed to be used within the first 24 hours after a head injury. But you won’t see Abbott’s i-STAT Alinity diagnostic device on the sidelines of sporting events just yet—the FDA’s green light still limits its use to locations with certified laboratory testing privileges. The latest clearance, however, is a step in that direction, as it now allows the hand-held test to use whole, untreated blood samples. Its first FDA nod, from early 2021, had required that blood samples first be spun in a lab centrifuge to separate out the necessary plasma. The test also picked up a separate green light last year for its use on Abbott’s larger Alinity lab hardware. “Clinicians have needed an objective way to assess patients with concussions,” Beth McQuiston, M.D., medical director in Abbott's diagnostics business, said in a statement. The company estimates that nearly 5 million people in the U.S. visit emergency rooms for a TBI each year, while more than half of people who may have a concussion never get checked. “When you look at all the other diseases, or other organs in the body, they all have blood tests to help assess what's happening,” McQuiston said. “Now, we have a whole blood test that can help assess the brain right at the patient's bedside—expanding access to more health providers and therefore patients.” The cartridge-based test searches the blood for two compounds released by the brain following tissue damage, known as ubiquitin C-terminal hydrolase L1 and glial fibrillary acidic protein.  A previous clinical study showed that an early analysis of these biomarkers could also help predict how well a patient will recover from a TBI in the weeks that follow as well as the chances of long-term complications such as comas, disability or death. Abbott said it is currently developing its i-STAT test into one that can be used nearly anywhere as well as with teenagers and children.

The test, run on Abbott's portable i-STAT® Alinity® instrument, uses whole blood to help evaluate patients with a suspected mild traumatic brain injury (mTBI), or concussion The test produces lab-quality results in 15 minutes Clinicians are now able to get a result at the patient's bedside, making the test accessible at urgent care clinics and other healthcare settings outside the hospital emergency room The test can be used to help evaluate patients up to 24 hours after injury ABBOTT PARK, Ill., April 1, 2024 /PRNewswire/ -- Abbott's i-STAT TBI cartridge has received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing. This new clearance will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments including urgent care clinics with a certificate to perform moderate complexity tests. This is an important step toward a future where testing could be done outside traditional healthcare settings, such as on the sidelines of sporting events. The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mild traumatic brain injury or mTBI, commonly known as concussion. Test results can help rule out the need for a CT scan of the head and assist in determining the best next steps for patient care. The ability to perform the test with a whole blood sample means testing can take place at healthcare settings without a lab which helps to accelerate the evaluation of head traumas. With this clearance, the i-STAT TBI test can be used to help evaluate patients up to 24 hours after injury, an important advancement since those injured often wait before seeking care. Nearly 5 million people go to the emergency department for a TBI in the U.S. each year, but more than half of people who suspect they have a concussion never get it checked. For decades, standard TBI assessment has remained the same, with doctors leveraging the Glasgow Coma Scale, a subjective doctor assessment, and CT scans to detect brain tissue damage or lesions. "Emergency departments can be a busy place. It's important to be able to triage patients quickly," said Geoffrey Manley, M.D., PhD, Chief of Neurosurgery at Zuckerberg San Francisco General Hospital, Professor of Neurosurgery at the University of California San Francisco and contact principal investigator for the TRACK-TBI Network. "Historically, that process for suspected concussions was largely subjective. With the help of this whole blood test, we can quickly and objectively determine whether or not a patient needs a CT scan or additional evaluation, right at the point of care. It's an incredibly helpful tool that advances the treatment of traumatic brain injury." How the test works The i-STAT TBI cartridge with the i-STAT Alinity System requires a small venous blood sample, which is applied to the test cartridge. The cartridge is then inserted into the portable i-STAT Alinity instrument. The test measures two biomarkers from the brain that may be released into the bloodstream, indicating a possible brain injury. Testing for these two biomarkers – ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) – in the aftermath of an injury can provide clinicians with essential information about a patient's condition and can help healthcare providers decide an appropriate treatment plan. "Clinicians have needed an objective way to assess patients with concussions," said Beth McQuiston, M.D., medical director in Abbott's diagnostics business. "When you look at all the other diseases, or other organs in the body, they all have blood tests to help assess what's happening. Now, we have a whole blood test that can help assess the brain right at the patient's bedside – expanding access to more health providers and therefore patients." The newly cleared test expands Abbott's TBI test offerings, which includes the i-STAT TBI Plasma test and the ARCHITECT® and Alinity i lab test (serum and plasma), which were all cleared previously. The ability to use whole blood to help assess TBI is an important step in Abbott's vision to make its tests available in all settings where people seek care for head injuries. Abbott is engaged in ongoing research and planning that may, in the future, allow the test to be used in non-healthcare settings and with a broader population including teens and pediatrics. About Abbott: Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at and on LinkedIn, Facebook, Instagram, X and Youtube. The i-STAT TBI blood test was developed in collaboration with the U.S. Department of Defense U.S. Army Medical Research and Development Command's (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA). The USAMRDC has been dedicated to developing a solution for the objective detection and evaluation of TBI for more than two decades and has played a critical role in developing the TBI test on Abbott's i-STAT Alinity platform. The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team was the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care. SOURCE Abbott

▎药明康德内容团队编辑今日，Transposon Therapeutics公布其在研逆转录酶抑制剂TPN-101治疗进行性核上性麻痹（PSP）患者临床2期研究的最终结果。Transposon同时公布TPN-101用于治疗肌萎缩侧索硬化（ALS）和/或额颞叶痴呆（FTD）患者2期试验的中期结果，这些患者的C9orf72基因具有六核苷酸重复扩增（C9orf72相关的ALS/FTD）。分析显示，TPN-101能够稳定PSP患者的临床症状。根据新闻稿，该药物是首个降低关键生物标志物神经丝轻链（NfL）和白细胞介素-6（IL-6）水平的PSP治疗药物。TPN-101亦显示改善ALS患者的肺活量。根据这些积极结果，Transposon计划将TPN-101推进到PSP的3期试验，并将TPN-101的临床开发扩展到阿尔茨海默病。PSP临床2期试验的最终结果该试验的最终48周结果与之前所公布的24周中期结果一致，从第1周到第24周接受安慰剂治疗，然后在第24周改用400 mg TPN-101的受试者，从第24周到第48周，脑脊液（CSF）中的NfL减少，这与从第1周到第24周接受TPN-101治疗受试者所显示的结果相似。而在整个48周治疗期间，全程接受400 mg TPN-101治疗的受试者，其从第1周到第48周的脑脊液NfL水平没有增加。相比之下，PSP自然历史对照患者脑脊液中的NfL水平每年增加9-18%。此外，48周的结果还显示，IL-6细胞因子以及骨桥蛋白（osteopontin）水平进一步降低，并呈现剂量相关性。采用PSP评定量表（PSPRS）进行评估的结果显示，在为期48周的试验中，接受TPN-101治疗的受试者在第24周至第48周期间的临床症状稳定性得到了维持。与此相对，初期使用安慰剂（第1周至第24周）的受试者在第24周至第48周期间PSPRS评分持续下降，说明TPN-101的治疗效果至少延迟了24周，并且落后所见的生物标志物早期效果。C9orf72相关ALS/FTD中期2期试验结果该2期试验的预定中期分析结果显示，从基线到24周，TPN-101治疗影响神经变性、神经炎症和小胶质细胞激活的关键生物标志物，包括NfL、tau、UCHL1、YKL-40、和骨桥蛋白。数据还显示TPN-101可能改善患者的肺活量，肺活量是一种与ALS患者死亡率相关的客观呼吸测量指标。值得注意的是，C9orf72相关的ALS/FTD是一种与中枢神经系统中TDP-43蛋白核移位相关的疾病。TDP-43相关病变也发生在大约50%的阿尔茨海默病患者中。▲Transposon管线图（图片来源：Transposon Therapeutics公司官网） TPN-101（censavudine）是一款潜在“first-in-class”、每日一次的口服LINE-1逆转录酶抑制剂，用于治疗神经退行性疾病和自身免疫性疾病。在一项对220多名艾滋病患者进行的为期48周的研究中，TPN-101显示具有良好的耐受性。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] Transposon Announces Final Results from a Phase 2 Study of its LINE-1 Reverse Transcriptase Inhibitor TPN-101 for the Treatment of Progressive Supranuclear Palsy and Interim Results from a Phase 2 Study of TPN-101 for the Treatment of C9orf72-Related Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia. Retrieved February 13, 2024 from https://www.prnewswire.com/news-releases/transposon-announces-final-results-from-a-phase-2-study-of-its-line-1-reverse-transcriptase-inhibitor-tpn-101-for-the-treatment-of-progressive-supranuclear-palsy-and-interim-results-from-a-phase-2-study-of-tpn-101-for-the-treatmen-302060254.html免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新