Proterixbio

2023年2月10日

分享这篇文章提供的新闻分享本文BILLERICA,质量。,2023年2月10日/ ProterixBio,公司今天宣布的提供预示®ST2试验作为一种通过ProterixBio高复杂性的CLIA实验室测试服务。这个试验被FDA允许使用与临床评估作为一个援助在评估患者的预后诊断出患有慢性心脏衰竭。心力衰竭是一种慢性,渐进条件的心无法提供所需的血容量来支持身体功能至关重要。心失败,泵体积减少导致器官损伤和肺积液和四肢。心力衰竭患者需要广泛的医疗管理和他们提前与疾病有很高的医疗负担,全球住院和死亡。改善预后和个别心脏衰竭患者的危险分层可能会促进提高这些患者的临床管理。蛋白质ST2(抑制致瘤性2)interleukin-1受体家族的成员。ST2表示为两个亚型替代促进剂所产生的拼接和3 '处理。一个同种型膜结合版本(ST2L)函数作为IL-33受体,而其他同种型是一种可溶性(sST2)绑定IL-33作为诱饵受体的功能和防止ST2L信号。 Both ST2 and IL-33 function as "alarmins" that alert the immune system to cellular damage. Cardiac stress has been shown to result in an upregulation and release of ST2 and IL-33 1,2. IL-33 signaling has been shown to be cardioprotective, whereas sST2 blocks IL-33 signaling thereby reducing the cardioprotective function of IL-33. Elevated levels of sST2 are thought to block the cardioprotective signal of IL-33 and lead to increased stress on the heart, resulting in tissue fibrosis and disease progression 3. Thereby, sST2 levels can provide a measure that aids in the prognosis of patients diagnosed with heart failure, as evidenced in the Presage® ST2 assay findings in the HF-ACTION cohort 4,5. The Presage® ST2 assay provided by ProterixBio is a 510(k) cleared device 5 providing a quantitative measure of soluble ST2 in serum or plasma (K3EDTA and Heparin). The assay cutoff of 35ng/mL was established between the 90th and 95th percentile of a reference cohort self-declared as healthy with no history of heart disease. sST2 levels greater than 35ng/mL are demonstrated to be predictive of increased risk for Cardiovascular Disease hospitalization and mortality and all cause hospitalization and mortality within the referenced study period (4 years). sST2 levels have demonstrated value, in conjunction with clinical evaluation, as an aid in the prognosis of patients diagnosed with chronic heart failure. And, more recently, sST2 levels have demonstrated independent prognostic value in a large prospective clinical trial aimed at treatment, ARNI compared to ACEI, with improved outcomes in patients with heart failure with reduced ejection fraction, the PARADIGM-HF Trial 6. The Presage® ST2 Assay is intended to be used only in patients with chronic heart failure and should not be used for diagnosis of heart failure. "I am excited about the opportunity to have a rapidly available complementary biomarker that will better guide intensive heart failure management. We utilize sST2 as a complement to proBNP — Soluble ST2 provides appreciation of the chronicity of the underlying disease state. When we observe improvements in both we recognize our heart failure management is positively impacting patient care." said Christopher Bell, Acute Care Nurse Practitioner at Cardiology Associates of North Mississippi. References: 1 Weinberg EO, Lee RT, et al. Expression and Regulation of ST2, an Interleukin-1 Receptor Family Member, in Cardiomyocytes and Myocardial Infarction. Circulation. 2002 December 3; 106(23): 2961–2966. 2 Sonada S, Lee RT, et al. IL-33 and ST2 comprise a critical biomechanically induced and cardioprotective signaling system. J Clin Invest 2007;117:6:1538-1549. 3 Pascual-Figal DA, Januzzi JL. The biology of ST2: the International ST2 Consensus Panel. Am J Cardiol. 2015;115(suppl 7):3B–7B. 4 Ahmad T, Fiuzat M, Neely B. et al. Biomarkers of Myocardial Stress and Fibrosis as Predictors of Mode of Death in Patients with Chronic Heart Failure. JACC Heart Fail. 2014 June ; 2(3): 260–268. 5 sST2 Presage Assay Kit 510k - https://www.accessdata.fda.gov/cdrh_docs/reviews/K111452.pdf 6 O'Meara E, Prescott MF, et al. Independent Prognostic Value of Serum Soluble ST2 Measurements in Patients With Heart Failure and a Reduced Ejection Fraction in the PARADIGM-HF Trial (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure). Circ Heart Fail. 2018;11:e004446. SOURCE ProterixBio, Inc