Theranos: The Lance Armstrong of blood diagnostics?

​As the opening metaphor suggests, Theranos, once the darling of biotech, has recently come under considerable scrutiny, similar to the prodigal cyclist caught doping to gain an edge. (Credit to Forbes for developing and expanding upon this analogy.)  While it’s not yet absolute that Theranos is guilty of perjuring the methodology and results of their platform to rapidly test a few drops of blood, this $9 Billion valued company is at the least guilty of misleading the public on the maturity of this technology. When this WSJ article surfaced accusations last October, Theranos CEO Elizabeth Holmes went from the cover of Forbes to an exec under fire; holmes' trademark reticence no longer seemed so eccentrically unique. While Holmes' immediately refuted the WSJ claims as false, look what did happen.....the Theranos website  noticeably changed. 

Theranos overstated it's ability to test with it's a "nano" amount of blood.

​The idea supporting the conception of Theranos is noble: blood testing is too expensive, too slow, and too painful, so here’s a technology to rectify all of that. As you can see below, canonical blood testing is fairly cumbersome: use a needle to puncture the arm, take at least a vial of blood, aliquot the samples to individual wells, load the samples to a mass spectrometer, and analyze and report the results. Theranos pioneered a technology called Edison that would perform a slew of diagnostic blood tests with just a finger prick, offering drastically reduced costs and processing times. The key to this platform is microfluidics, the miniaturization and automatization of regular blood testing. 

However, a series of journal articles, failed partnerships, employee testimonials, and even a suicide have cast considerable doubt on the veracity of Theranos’ purported revolutionary testing method.  The most salient arguments cornering Theranos are summarized here:

• the Edison technology is not actually being used to do most blood testing
  • by the end of 2014 less than 10% of tests were using this technology
  • there are claims that tradition Siemens AG machines were used to report results
• Many customers have reported grievously erroneous test results from the Edison testing
  • Potassium levels that would only be possible if “you were dead”
  • Safeway executive received Theranos results that suggested prostate cancer. Retesting by another lab showed normal results to the antigen.
  • One patient, two different results. Theranos results pictured are largely out of normal range. 
• Theranos testing results have not been properly evaluated 
  • Theranos didn't have to prove to the FDA that their tests worked because they don't sell Edison technology to other labs.   
  • There are allegations from former employees that Theranos' president and COO ordered lab personnel to stop using Edison machines for proficiency testing and report only results from  instruments bought from other companies.
  • Theranos' self reported clinical correlations are missing statistics and number of samples, the omission of which is unacceptable in reporting scientific results.
    
• A very small blood sample is problematic for diagnostics
  • Because of the small volume, contamination of the sample occurs much easier
  • Some tests require larger volumes, so the sample would need to be diluted, another step that alters the sample and is likely to introduce error
• Pricking the finger breaks cells
  • Which can introduce fluids from tissues and cells
• The demise of British biochemist, Ian Gibbons, who is the co-inventor of 19 of Theranos patents, suggests trouble at Theranos
  • Dr. Gibbons reportedly told his wife “nothing was working” at the company
  • Dr. Gibbons committed suicide in May 2013
• Dissolved partnerships with Theranos portend more underlying problems
  • Walgreens demands answers to technology questions before it opens up any more clinics
  • $350 million Safeway-Theranos deal fizzled after Theranos missed deadlines for the blood testing roll-out  

While it certainly doesn’t look good for Theranos, there is still a chance that this growing company is simply unequipped to quickly mobilize in response to all of these requests. Is the technology too new? Probably. And as the pedal is pressed in innovation, tech missteps and prematurities will arise.  But what Theranos did do wrong is hide its errors. There is a problem when you can't share your results. Academia could not function without peer-review, accurate reporting, and eventually, collaboration. While I understand the need for tech companies to protect their intelligence, we must not forget to protect the system from corruption. 

That said, I think rapid testing of blood/fluids is a promising horizon.. While my limited research did not uncover widespread commercialization of microfluidic diagnostic technologies, exciting research out of The Methodist Hospital Research Institute, Rutgers University, and Wake Forest Baptist Medical Centre indicate commercialization could be forthcoming. Microfluidics and lab-on-a-chip technology is honestly pretty cool.  Look below to see how this V-chip could provide test results from up to 50 tests using ink and gas (a gross simplification. ) Again, these results came out of a lab, which is really a prototyping environment that does not guaranteed widespread success, but the principles that this V-Chip reside on are worth investing in. 

---

Sources:
1. Forbes: America's Richest Entrepreneur's under 40
2. WSJ: Hot Startup Theranos has Struggled with its Blood-Test Technology
3. Forbes: Is Theranos too Good to be True? 
4. Quantified Health: Theranos Unmasked 
5. WSJ: Safeway, Theranos Split after $350 Million Deal Fizzles
6. WSJ: Walgreens Scrutinizes Theranos Testing
7. Nature Communications: Multiplexed Volumetric Bar-Chart Chip for Point-of-Care Diagnostics. 
​8. Science News: 'Lab-on-a-Chip' technology to cut costs of sophisticated tests for diseases and disorders. 
9. Theranos.com 
10: Tech Insider: Here's what we know about how Theranos' 'revolutionary' technology works