【国际】Exosome Diagnostics研发新进展

Johnny

Exosome Diagnostics在非小细胞肺癌病人样本的exosome中检测到EML4-ALK融合转录本。

血浆心芯片检测EML4-ALK突变可更精确地帮助病人找到治疗靶点。公司计划下半年启动EML4-ALK体液活检测试

马萨诸塞州剑桥市，2015年4月20日——美国一家革命性基于体液的分子诊断开发者，外泌体诊断公司今天发表声明，研发数据显示在非小细胞肺癌病人血浆样本的exosome中检测EML4-ALK突变和特异的融合转录本。该数据昨天在美国癌症研究协会（American Association for Cancer Research, AACR）的年会上海报展示，标题为“基于血浆的诊断检测非小细胞肺癌病人的EML4-ALK融合转录本”。

公司的EML4-ALK体液活检测试正处于临床验证阶段。该检测方法是通过分离分析血液中外泌体RNA来检测EML4-ALK融合转录本，可为非小细胞肺癌病人的个体化治疗提供依据。

原文：

Exosome Diagnostics Presents Data Demonstrating Ability to Detect EML4-ALK Fusion Transcripts on Exosomal RNA in Patients with Non-Small Cell LungCancer

Plasma-based assay detects EML4-ALK mutation, specific associated fusionvariants; Holdspotential to help more precisely match patients with targeted therapies

Company plans to launch EML4-ALK liquid biopsy testin second half of 2015

CAMBRIDGE, Mass., April 20, 2015 – Exosome Diagnostics, Inc., adeveloper of revolutionary, biofluidbased molecular diagnostics, todayannounced data demonstrating the ability to detect the EML4-ALK mutation andspecific associated RNA fusion transcripts in blood plasma of patients withnon-small cell lung cancer (NSCLC). The data were presented at a poster session yesterday, Sunday, April 19,2015, titled, “Plasma-based diagnostics for detection of EML4-ALK fusiontranscripts in NSCLC patients,” at the American Association for Cancer Research(AACR) Annual Meeting in Philadelphia, Pa.

Currently undergoing clinicalvalidation, the company’s novel EML4-ALK liquid biopsy test is designed to isolateand analyze exosomal RNA (exoRNA) from a blood sample to detect EML4-ALK fusiontranscripts, with the goal of informing more individualized treatment decisionsfor patients.

“We’re very encouraged bythese data and believe our EML4-ALK liquid biopsy test, with its unique abilityto analyze RNA from plasma, can address the significant need for moresensitive, accurate EML4-ALK detection,” said Vince O’Neill, M.D., ChiefMedical Officer atExosome Diagnostics. “There are many known fusions of the ALK gene; we believeour assay’s demonstrated ability to differentiate which fusion is present willhelp guide more precise, personalized treatment selection for patients.”

In the study, the ExosomeDiagnostics EML4-ALK assay detected all EML4-ALK fusion transcripts based onthe presence of the ALK kinase domain; importantly for therapy selection, theassay was able to differentiate between the three major known fusion transcriptvariants, which represent the vast majority of all EML4-ALK-positive cases. Theassay displayed high selectivity over wild type background, and data showedcorrelation with tissue-based analysis (FISH). Additionally, unlike usingcirculating tumor cells (CTCs) for liquid biopsy, this test can be performed oneither fresh or frozen plasma, and does not require special shipping or storageprovisions.

Patients with NSCLC in whomthe EML4-ALK mutation is accurately detected can be matched to treatment withapproved ALK kinase inhibitors. In addition, there are several other therapiesin clinical development currently being evaluated to target this mutation.Exosome Diagnostics’ EML4-ALK liquid biopsy test is designed to be a complementto tissue biopsy or an alternative when proceeding with a tissue biopsy is notdesirable or possible. Requiring only a blood draw, the test helps overcomecertain challenges associated with tissue biopsies and fine-needle aspirates,including potential surgical complications, availability of tissue, and tissuesample heterogeneity, which can lead to mutations going undetected. Uponcompletion of further validation studies, Exosome Diagnostics plans to beginmaking the EML4-ALK liquid biopsy test available to physicians in the secondhalf of 2015.

Exosome Diagnostics’ Chief Scientific Officer,Johan Skog, Ph.D., willgive a separate oral presentation tomorrow, Tuesday, April 21, 2015, at theAACR Meeting titled, “Exosomes: Next-generation diagnostics,” as part of the Major Symposium: LiquidBiopsy Approaches for Detecting, Monitoring, and Characterizing Human Cancer. This symposium will be heldfrom 1:00 – 3:00 p.m. ET in the Terrace Ballroom II-III (400 Level) at thePennsylvania Convention Center.

Aboutthe Technology
ExosomeDiagnostics’ EML4-ALK liquid biopsy test utilizes the company’s proprietary, patented exosome-basedtechnology todetect the presence of the mutation and specific associated fusions. Exosomesare messengers released by all living cells into biofluids, such asplasma/serum, urine, cerebrospinal fluid and saliva. Exosomes contain RNA, DNAand proteins from their cell of origin. Exosome Diagnostics’ technologyplatform can achieve real-time access to comprehensive molecular informationabout cells in the body without direct access to the actual cells. Thecompany’s platform is uniquely versatile, enabling the development of teststhat can analyze either exosomal RNA (exoRNA) alone or, when appropriate,simultaneously isolate and analyze exoRNA and cell-free DNA (cfDNA).

In addition to the EML4-ALKliquid biopsy test, Exosome Diagnostics also plans to launch liquid biopsy testsfor the T790M resistance mutation in lung cancer, as well as for prostatecancer and other solid tumor cancers in the second half of 2015.

AboutExosome Diagnostics
ExosomeDiagnostics is a privately held company focused on developing andcommercializing revolutionary biofluid-based diagnostics to deliver personalized precisionhealthcare that improves lives. The company’s novel exosome-based technologyplatform can yield comprehensive and dynamic molecular insights to transformhow cancer and other serious diseases are detected, diagnosed, treated andmonitored.

宝莲

顶一个，感谢。。

hereissyk

https://www.clinicaltrials.gov/c ... e&Search=Search  查了一下好像没有这家公司啊。