Theranos's Quick and Easy Genetic Testing Seems Too Good to Be True Because It Probably Is

Wednesday, 18 November 2015 - 6:32PM
Medical Tech
Genetic Engineering
Wednesday, 18 November 2015 - 6:32PM
Theranos's Quick and Easy Genetic Testing Seems Too Good to Be True Because It Probably Is
What is Theranos?

Well, I can tell you what Theranos says they are.

Their website states, "We define Theranos as: Detecting the onset of disease in time for therapy to be effective." They offer cheap blood tests using innovative methods to allow for early diagnosis for potentially fatal diseases. You may be wondering what these innovative methods entail. So am I. So are a lot of people. 

According to CNN, "What we do know about Theranos comes from what the company tells the mass media, from the company website, and through patent applications and highly redacted FDA inspection documents." The company does not talk about how their technology works, they do not publish the work through traditional scientific channels, and as a result, other scientists have not been able to test the processes to see if they actually live up to the company's claims. Theranos says their users are satisfied and that they will publish their data in the future, but are currently protecting their innovative intellectual property. 

Which is where the first issue arises. Dr. John Ioannidis of the Stanford Prevention Research Center is just one expert who does not approve of Theranos's secretive behavior and the questions that arise from this lack of transparency. Though Theranos has gone through the FDA for approval, Ioannidis contends that working in such an isolated environment without input from the broader scientific community is not traditional, scientific, or professional. He questions their results, asking, "Is it reproducible in the scientific community? This is a major deficiency… This is the process we depend on in the scientific community. Let something be tested to see if it is sound." 

Protecting your intellectual property makes sense from a business standpoint, but proper medical procedure calls for reproducible results, and that requires a little more cooperation and sharing, and not just with the FDA. If Theranos's blood tests work, they will create great strides in diagnosis and patient comfort, but at some point they are going to have to stop testing in isolation. 

The biggest difference between Theranos and traditional blood tests is that Theranos uses only a tiny volume of a person's bodily fluids to check for various diseases with quick results, two reasons that make their tests popular with the public. These small samples are made possible through finger-stick technology and Nanotainers, tiny vials used to house the small amount of blood taken for the tests.

Which leads to issue number two. Finger-stick technology has been around for quite some time, and Theranos offers finger-stick tests for more than eighty items on its test menu. However, other companies' finger-stick tests have proven to have limited accuracy and lack a set standardization. Theranos often sites its FDA approval as a sign of their legitimacy, but the FDA has only approved a Theranos finger-stick test for herpes, and the rest of the tests still await approval. Also, after an August inspection, the Nanotainers were declared by the FDA as an "unapproved" medical device, and since then the company has paused its use of the Nanotainer for all but the herpes test. However, a Theranos spokesperson still claims that they offer tests "requiring far less blood" than traditional methods. I can only assume that was the vaguest statement they could conjure. 
 
And their so-called friends are not racing to show their support. Theranos brags about their relationship with Cleveland Clinic, but the hospital is apparently much less vocal. According to CNN, "the hospital system said it won't comment about the product because it has not seen the technology nor worked with it yet." So, if Cleveland Clinic has neither seen nor worked with the technology, it makes you wonder about the nature of their "relationship." 

Theranos might want to make a bit more effort to strengthen the relationship with their formal business ties, because they are having trouble holding on to new ones. 
Safeway is in the process of dissolving an unannounced partnership with Theranos after their finger-prick tests appeared to be less than accurate. A Safeway executive claims that worries arose when they learned that the finger-prick was more a work in a progress, with the prick method often being accompanied by the traditional needle in arm method. They also become concerned when an employee received a test result that suggested they might have prostate cancer, but received normal results when examined by a different lab. A Theranos spokesman states that the Safeway statements "are inaccurate and defamatory."

I have to assume it is hard to defend yourself when you are hiding your information from the scientific community. But when you try so hard to hide your information, you cannot be surprised when people suspect you have something to hide. 
Science
Technology
Medical Tech
Genetic Engineering

Load Comments