What happens when Silicon Valley meets Washington

New Yorker ran a story back in December 2014 about how Theranos, a Silicon Valley darling valued at $9 billion (the same as Sikorsky; Sheryl Sandberg and the New York Times would want us to remember that, had the company been founded by a man instead of a woman, it would be valued much more highly and therefore Elizabeth Holmes would be worth a lot more than $4.5 billion).

The killjoys at the Wall Street Journal today, however, report that getting regulatory approval for the new machine is proving challenging. Even worse, the true enemy might be Biology, that great humbler of scientists and engineers:

In 2005, Ms. Holmes hired Ian Gibbons, a British biochemist who had researched systems to handle and process tiny quantities of fluids. His collaboration with other Theranos scientists produced 23 patents, according to records filed with the U.S. Patent and Trademark Office. Ms. Holmes is listed as a co-inventor on 19 of the patents.

The patents show how Ms. Holmes’s original idea morphed into the company’s business model. But progress was slow. Dr. Gibbons “told me nothing was working,” says his widow, Rochelle.

In May 2013, Dr. Gibbons committed suicide. Theranos’s Ms. King says the scientist “was frequently absent from work in the last years of his life, due to health and other problems.” Theranos disputes the claim that its technology was failing.

The Journal made a disturbing chart showing the results of six tests by Theranos compared to results from traditional hospital tests. For those six tests (out of an unstated larger number), Theranos found that the patient was outside the normal range while the hospital tests were normal.

Perhaps this will end up as a good reminder to investors that when the FDA and Biology are involved, not every company can be a Tesla…

Some interesting reader comments from the Journal:

A woman with zero medical and engineering training claim invented a earth-shattering testing machine that beats all existing technologies and equipment that human race have accumulated so far. So she was born with all knowledge far surpassing human being has possessed. A very good theme for a sci-fi fiction.

Is she married? I’d be willing to take care of mansion and other domestic duties (hire her a fashion consultant, cook dinner, coordinate social calendar, etc.). Prenuptial agreement not required.

All, including the author, are focusing on the wrong issue. The fact is ALL of them: labcorp, quest and theranos are weak on accuracy. Results routinely come back with a HUGE range on the “answer”. The solution is implementing mass spectrometry to whatever test possible This is where diagnostics is moving. And one company, applied isotope tech, possesses the method which makes mass spectrometers more accurate (now testing human blood for metals). They are more accurate by far then all of them, including the reference labs theranos aspires to!

I had a very well respected and well published doctor tell me recently that he and his research team sent 3 tubes of the SAME PATIENT SAMPLE to three different labs, and got back wildly different results on a mass-spectrometry assay (which is supposed to be the gold standard for this particular test, and more accurate than the radioassay). One result varied by 100% another by close to 50%. One reason results have to be always interpreted within the lab provided reference ranges, but even that, do not assume the result you receive is pinpoint accurate. It may not be. Blood tests are good at detecting things wildly out of whack, and within closer thresholds to normal ranges treat cautiously and retest at an interval.

Interesting article, of course what’s driving this want to be IPO is the opportunity to exploit the already ridiculously expensive Lab Corp / Qwest-for higher prices, market. Recent lab script from my doctor produced a quoted 1200 dollar lab corp “cash” price while internet company, Private MD, (using Lab corp drawing center) was 330, herein lies the problem, somebody’s making money at 1200 bucks for, in this case, Male Hormone panel tests. Where is the economy of scale ? It seems the more consolidated these companies become the ore expensive their product becomes, go figure. Anyway, we should all hope the Theranos’s of the world succeed, we need the competition.

I did a medical residence in clinical pathology (lab medicine). I worked in a major hospital lab for 2 years. I practiced medicine for more than 30 years. I have reviewed test results for thousands of blood samples. It is difficult to make generalizations from one test result, but here are ideas for future review. In general, blood test results for calcium are accurate and rarely outside the “normal = reference” ranges. This is because the body carefully regulates calcium in blood. A high calcium far outside normal range is unlikely. It is rarely affected so much by fasting or diet or medications. All results are consistently elevated (WSJ graph). Usually means sample became concentrated during extraction, storage, etc. I agree that now labs draw too much blood. Personally, I require lab drawing on pediatric tubes, and only as much as needed x tests (which I know). However, tiny draws may alter blood chemistry.

[Update, 10/16: “Hot Startup Theranos Dials Back Lab Tests at FDA’s Behest” is a WSJ follow-up story subtitled “Firm has stopped collecting tiny vials of blood drawn from finger pricks for all but one of its tests.”]

4 thoughts on “What happens when Silicon Valley meets Washington

  1. Theranos is nothing but smoke and mirrors. Anybody with molecular biology and biochemistry and biomedical engineering experience would tell you that 205 tests from a few droplets of blood is an exaggeration. Yes we have microfluidics, but small amounts like that would only work well with dna/rna that can be amplified with PCR. What about hormones? peptides? enzymes? ions? antibodies? are you really telling me it can all be done? Why hasn’t Siemens/Roche/Genentech/etc been working on a device that can do at least 50 tests in one machine? How could it be that a person who started as a 19-year-old without any biomedical or engineering training cover so much scientific terrain? If George Church were leading it, I might believe, but c’mon! This is not coding up an OS or app.. Biology will humble even the best of scientists.

  2. I am unclear on the value proposition of this company. If someone has to draw blood, does it really matter if they take 5 ml or 50 ml? Won’t they use a needle, either way. I must be missing something here.

  3. Theranos has always looked like a scam to me. One there is the issue Germant turns up that there is only so much you can do with a droplet of blood that has been in contact with your skin. No way you are going to get anything quantitative out of that.

    Maybe I am unusual, but I like the phlebotomy clinic I go to. The waiting room is pleasant, you don’t wait long there, the people are nice, then they send you on your day. I just don’t see that blood tests are a rate liming step for the healthcare system.

    And so far as politics goes, note that the Noam Chomsky/South End Press sort of people point out that Theranos has connections to the people who financed Bush II.

  4. “Biology will humble even the best of scientists” classic and so true!!m, I am a MD working in transplantation and biology had slapped me so many times and indeed humble me

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