风口上总是刀，美女光环加持的Theranos被曝出技术上存在严重的弄虚作假

被“美女和科技”光环加持，估值高达90亿美元的Theranos昨日却遇到了问题，《华尔街日报》曝光其存在弄虚作假，据已经离职的前雇员透漏，通过几点血就能够检测多达240种指标（比如高胆固醇和癌症）的检测设备Edison其实只能检测15种，并且检测结果的可靠性和精确性也存在大大的问题，而更多的指标其实还是通过市场上已经成熟的设备检测获得的。同时，一位跟Theranos有关的律师David Boies表示，Theranos并未将其宣传的所有的血液检测在Edison设备上进行测试，而只是行进在这个目标的路途上。

Theranos创办于2003年，此前相关的报道指出，Theranos之所以能在过去十几年中一直对其技术保密，很大一部分原因是他们处于监管的灰色地带。其他诊断实验室（包括Quest和Laboratory Corporation of America）都利用从制造商处（比如西门子和罗氏诊断）购买的设备完成血液检测。在这些设备进入市场销售之前，制造商必须通过FDA的审批。如此一来，审批流程就使得检测操作技术变得更加透明。但是，Theranos生产自己需要使用的检测设备。只要他们不销售这些设备，也不将其搬离实验室，那么FDA就没必要对其进行审批。

此外，Theranos的豪华董事会也被认为是推动其业务快速扩张的重要推手，董事会成员包括前任参议院共和党多数派领袖比尔·弗里斯特，前任国务卿亨利·基辛格，前任民主党参议院、三军委员会主席山姆·纳姆，前任国防部长威廉·佩里，前任富国银行CEO兼主席理查德·科瓦西维奇等，所有这些人都接受了公司的股票期权和其他形式的酬金。91岁的基辛格曾表示：“Elizabeth Holmes（Theranos的美女CEO）有一种优雅的品质，看起来好像十九岁一般。她好像青春永驻，不会衰老。不过，她的美丽还是比不上智慧。”

针对《华尔街日报》的报道，Theranos专门在其官网发布了官方回应，表示，目前公司业务是得到大量实际客户使用证明的，并曾发表过超过1000页的相关文章证明其业务开展的有效性和可靠性，但不幸的是，《华尔街日报》断章取义，以心怀不满的前员工和行业人员对公司进行了诋毁。

并表示，任何带来变革的新技术，都会引来质疑和原有业务格局的挑战，当然在回应中我们也可以看到Theranos的相关技术和专利并未得到FDA的充分认可，目前FDA其实对其还处于观察阶段。

以下为回应全文：

Statement from Theranos

PALO ALTO, CA (October 15, 2015) – Today’s Wall Street Journal story about Theranos is factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents. Theranos presented the facts to this reporter to prove the accuracy and reliability of its tests and to directly refute these false allegations, including more than 1,000 pages of statements and documents. Disappointingly, the Journal chose to publish this article without even mentioning the facts Theranos shared that disproved the many falsehoods in the article.

Theranos’ products and services have proven accurate and reliable for tens of thousands of satisfied customers through millions of tests and experiences and in ongoing review by our various regulators. Our focus remains on ensuring high quality, real-time, actionable information to improve diagnosis and treatment decisions. When you create innovative technology, scrutiny is to be expected. We have always welcomed that scrutiny – opening up to regulators like no lab before and voluntarily submitting all our tests for FDA review, the gold standard for quality. We received our first FDA clearance this summer based on the very proprietary systems the story is asserting don’t work, and have submitted almost 130 pre-submissions to FDA for tests run on those proprietary systems.

Theranos is working to reinvent the lab experience by providing high quality tests faster, cheaper, and more conveniently, requiring less blood, and causing less patient discomfort than ever before. We lead the industry in transparency and quality, have advocated for FDA regulation of lab tests, for the reduction of Medicare and Medicaid rates, and for transparency in pricing. We’ve partnered with health care leaders, including the Cleveland Clinic, Capital BlueCross and AmeriHealth Caritas. We also have advocated for direct access to lab testing, which will drive price transparency and lower the cost of testing in response to consumer demand; this issue is at the heart of the current movement towards individual engagement and preventive health care.

The sources relied on in the article today were never in a position to understand Theranos’ technology and know nothing about the processes currently employed by the company. We are disappointed that, in an effort to make its story more dramatic, this reporter relied only on the views of four “anonymous” disgruntled former employees, competitors and their allies, instead of reaching out to many of the scientific, health care and business leaders who have actually seen, tested, used and examined our breakthrough technologies. The Journal even declined an opportunity to experience the technology themselves by turning down our offer to send proprietary Theranos devices to their offices so they could have a demonstration of tests conducted themselves, and compare the results to those of other testing providers.

Stories like this come along when you threaten to change things, seeded by entrenched interests that will do anything to prevent change, but in the end nothing will deter us from making our tests the best and of the highest integrity for the people we serve, and continuing to fight for transformative change in health care.

医谷链

《迷人的白富美与神一般的血检颠覆者Theranos》

来源：医谷网