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圣迭戈Genalyte公司成功研发十分钟埃博拉病毒测试仪
圣迭戈Genalyte公司成功研发十分钟埃博拉病毒测试仪
2014/10/25 9:22:39 | 浏览:3969 | 评论:0

圣迭戈Genalyte公司成功研发十分钟埃博拉病毒测试仪


Local research:Ebola test results in 10 minutes

SAN DIEGO(CBS 8)- San Diego researchers are on the forefront in fighting the Ebola crisis. Carlsbad researchers created the serum, ZMAPP, an experimental drug to treat two U.S. doctors who contracted the Ebola virus and survived. 

Now, a San Diego company is working to create an Ebola test that can show results in 10 minutes.

San Diego's
Genalyte works with several of the world's top pharmaceutical companies and they are now working with the Federal Drug Administration and the Center for Disease Control and Prevention on a low-maintenance and operational instrument to test for Ebola with a finger prick of blood.

"There is no combination of rapid and sensitive tests and we fill that gap," said Genalyte CEO Cary Gunn, Ph.D.

Gunn says the rapid test shows Ebola and other infection results in 10 minutes, other instruments can take 15 minutes, but those companies also need FDA approval.

"An installation of our instruments can do 100 samples per hour," said Gunn.

Currently, the FDA has only approved a polymerase chain reaction test(PCR) that can take two hours for results.

Gunn says with the National Institute of Health, National Cancer Institute and private funding it has helped create the instrument that can cost more than a $100,000 but each chip is $10 to test. Gunn says he's been working on the technology for seven years.

"This is Silicon Valley technology applied to diagnostics," said Gunn.

The silicon chip measures proteins as blood flows over it test for Ebola.

Liberian Thomas Eric Duncan had to wait days before being diagnosed with Ebola and later died, already spreading it two nurses in Dallas.

"The story around quarantining people and having to take their temperature and wait for them to become symptomatic before they report themselves, obviously there is a problem with that," said Gunn.

Now the CEO of the San Diego company is asking for the FDA to fast-track the instrument for approval.

"The fact that there is an opportunity to make a difference and to deploy the technology of a rapid result from a finger prick is very important to the way this entire epidemic unfolds," said Gunn.

He says next week Genalyte's Ebola test will be evaluated in government labs.

The FDA sent CBS News 8 this statement, "Federal law and FDA regulations prohibit the agency from sharing information about products that are in development or may be under review. FDA understands the importance of quickly diagnosing Ebola cases in the U.S. and abroad. We are committed to working with companies in the most expedited manner to increase the availability of authorized diagnostic tests for Ebola for emergency use during this epidemic."

In other local Ebola research, San Diego's Scripps Research Institute Erica Ollmann-Saphire, Ph.D. who helped create ZMapp is using
crowdfunding to raise money to cure Ebola.

圣迭戈科研人员当前都在争取奋斗在埃博拉危机最前沿。自ZMAPP公司的实验性血清药物救活了两位感染了埃博拉病毒的美国医护人员后,另一个圣迭戈高科技公司聚集之地的卡洛斯巴德(Carlsbad),一家叫Genalyte公司的研究人员目前研发成功一种埃博拉病毒测试仪,可以在十分钟内显示病毒结果。

圣迭戈Genalyte正与多家世界顶尖制药公司正与美国联邦药物管理局(FDA)和疾病预防控制中心(CDCP)一起研发一种低维护成本的测试仪,取得针尖手指的血液样本获得及时检测。

目前美国只有FDA批准使用的聚合酶链反应试验(PCR)的技术,其测试结果需等两个小时之久。而“结合快速、灵敏的病毒检测仪,我们公司填补了这一空白。”  Genalyte首席执行官Cary Gunn博士向媒体表示。Cary Gunn博士同时表示,他们公司的十分钟测试仪和另外一家公司研发的十五分钟测试仪日前已呈送FDA评估审核,可望下星期得到结果。

Cary Gunn博士透露这个测试的实际成本约10美元,相比之下美国国立卫生研究院,美国国家癌症研究所和私人资金帮助创建的仪器每台超过10万美元。他说他有七年时间在研究这种“硅谷芯片技术”的应用 – 用蛋白质血液流动数据测试埃博拉以及其它病毒,同时测试时间可大大缩短。

Genalyte公司研发团队至少有两名华裔科研人员。


另外,曾经帮助ZMapp研发的圣迭戈斯克里普斯研究所Erica Ollmann-Saphire博士团队目前正加强药物研发使命克敌埃博拉。

(圣迭戈华文网海黛报道 SanDiegoChinesePress.com)

 

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