Blood-Test Startups Try to Crawl Out From the Shadow of Elizabeth Holmes
The ghost of Theranos looms over the biotech industry, but entrepreneurs are working to bring less-audacious versions of Holmes’s vision to life
As Daniel Levner tells it, the “Theranos effect” came in three distinct waves. First, he says, when the company was at its peak, many investors wouldn’t bother funding other blood-testing startups, because how could anyone compete with the youngest, female, self-made billionaire? Then, as news broke that the technology might not work as advertised, investors began to wince at any sight of blood businesses. Finally, when a seminal book on the company’s spiral to dissolution hit stores last year, it became clear that the problems were unique to Theranos, says Levner, who co-founded a blood-test startup. The account described Elizabeth Holmes as a zealot chasing a dream without the science or ethics to carry her there.
Now, even as court proceedings, a popular podcast series, a much-anticipated movie starring Jennifer Lawrence in development and this week’s release of an HBO documentary keep interest in the story alive, the blood business is flowing again. Investors are buying in, and several venture-backed companies say they’re making real, provable progress toward more efficient or affordable blood tests.
Although some entrepreneurs would prefer to never utter the name Theranos, they tend to accentuate ways their businesses are different. No one says they’re building an all-in-one machine that can fit on a desk and do hundreds of tests on a few drops of blood. Most say they’re working carefully to perfect a few tests to start, in cooperation with respected authorities.
“It would be an audacious statement to say every test would work with a finger prick,” says Levner, co-founder of Sight Diagnostics Ltd. “Right now, we can do one test really well.” That was enough to secure $28 million in funding last month for a system that Levner says can recreate a blood sample as a digital file for a computer to analyze. A form of artificial intelligence then looks at a blood cell’s shape, size and other characteristics and delivers a result in a few minutes, compared with the hours or even days it takes for traditional tests, he says.
Sight Diagnostics Ltd.的联合创始人Levner说：“如果一滴血就可以满足所有的测试，这个吹的有点大”。“但现在，我们可以把一个测试做的非常好了。可以让投在血液样本数字文件重建、辅以计算机分析这个项目的2800万美元不至于打水漂。这是一种形式的人工智能，可以观察血细胞的形状，大小和其他特征，并在几分钟内得出结果，区别于传统测试所需的几个小时甚至几天。
Another company, Karius Inc., aims to accurately identify more than a thousand pathogens in order to rapidly diagnose diseases, but it requires a full, intravenous blood draw. Orphidia Inc. says it needs only drips of blood from a finger prick for its portable device to complete lab tests in as few as 20 minutes, but it supports just seven tests right now. Even Tyler Shultz, a former Theranos engineer who helped bring the company down by whistleblowing to Wall Street Journal reporter and Bad Blood author John Carreyrou, is back. He runs a company, Flux Biosciences, that plans to use blood, urine and saliva to measure biological markers to test fertility and dietary issues, among other things, according to its website.
另一家公司Karius Inc.旨在准确识别超过一千种病原体，以便快速诊断疾病，但它需要完整的静脉血液抽取；Orphidia Inc.表示，只需20分钟便可完成实验室测试，只需一次刺破手指用几滴血，即可完成实验室测试，但目前仅支持七项测试；甚至Tyler Shultz，就是这位前Theranos工程师，通过向华尔街日报记者和Bad Blood的作者John Carreyrou举报加速了公司的倒闭，现在又回来了。他经营着一家名为Flux Biosciences的公司，该公司计划使用血液，尿液和唾液来测量生物指标，以测试生育能力和饮食问题等。
Theranos hasn’t deterred Silicon Valley from its growing obsession with health care. Google, Intel Corp. and other industry giants, along with startups staffed by clusters of Ph.D.s, have fixed their gaze on the heavily regulated industry. But computer code hasn’t yet been able to solve the challenge of keeping human beings healthy. Biology just isn’t as hackable as a machine.
The “massive fraud” perpetuated by Holmes, as the U.S. securities regulator described it, left some patients with faulty diagnoses and potential health consequences. (Holmes settled with the Securities and Exchange Commission without admitting wrongdoing.) The good news is the Theranos bust should scare away future peddlers of snake oil, says Dylan Morris, a partner at Charles River Ventures. “Any time there’s a scam that gets uncovered, that’s bad for all the other people trying to run the same scam,” says Morris, who had his own blood-testing startup that shuttered after failing to find a viable business model. “The nuances of how hard it is to actually make and sell a medical device have been brought to the forefront, and I think that’s a good thing.”
正如美国证券监管机构所描述的那样，伊丽莎白·霍姆斯长期存在的“大规模欺诈”给一些患者带来了错误的诊断和潜在的健康风险。 （霍姆斯在没有承认不法行为的情况下，与美国证券交易委员会达成和解。）好消息是，Theranos半身像应该吓跑未来的蛇油小贩，Charles River Ventures的合伙人Dylan Morris说。Morris说：“任何时候都会发现一个被揭露的骗局，这对所有其他试图运行相同骗局的人来说都是不利的。”他自己的血液测试初创公司在未能找到可行的商业模式后关闭了。 “真正得去制造和销售医疗设备的难度已经被提升到了最前沿，我认为这是一件好事。”
Sight Diagnostics makes a machine about the size of a toaster that works with finger-prick samples. But its aim is modest. The startup offers two tests: malaria, which was its first offering, and a complete blood count, a frequently ordered test. The company stresses it’s doing things by the book. It says the technology was approved by regulators for sale throughout Europe and recently concluded clinical trials in the U.S. at Boston Children’s Hospital and Columbia University Irving Medical Center in New York, as it works toward Food and Drug Administration approval.
The OLO blood diagnostic machine from Sight Diagnostics. Photo: Sight Diagnostics
Karius, meanwhile, says advances in computing and genomics make a new kind of disease-detection system possible. The company says it can identify pathogens found in traces of genetic material in blood and return results overnight. At $2,000, Karius is more expensive than some traditional tests that require pathogens to be cultured in a Petri dish, but founder Mickey Kertesz says it can save money and lives by drastically reducing the time patients must stay under hospital care as they wait for a diagnosis. Last month, the prestigious journal Nature Microbiology published a peer-reviewed validation study of Karius technology, a fact the company heralds with a banner at the top of its website.
When problems at Theranos first emerged, Nature published an editorial that was widely discussed in the medical community. It argued that health care can be disrupted but that companies must test their inventions thoroughly and publish proof of their claims. The sentiment left an impact on the biotech business. “Theranos was just claiming to do everything at once. We have a long-term vision, but we’re going step by step,” says Aron Rachamim, CEO of Orphidia. “We need to teach ourselves to walk before we can run.”
当Theranos的问题首次出现时，Nature发表了一篇在医学界广泛讨论的社论。认为医疗保健可能会因此事件受到干扰，但公司必须彻底检验他们的发明，并公布产品证明文件。业界的这种情绪对生物技术业务产生了影响。 “Theranos声称要一次性做完所有的事情。我们有一个长远的愿景，但我们会一步一步走，“Orphidia首席执行官Aron Rachamim说。 “在我们能跑之前，我们会先学怎么走。“
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