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Everyone seems to criticize Theranos but I'm 99% sure other labs have similar variances in results without a WSJ story. The FDA should investigate Quest and the

Everyone seems to criticize Theranos but I'm 99% sure other labs have similar variances in results without a WSJ story. The FDA should investigate Quest and the other labs. With the Electronic Health Records, relying on a single lab result could be problematic.

semi-extrinsic 11y ago
It appears that most tests done by Theranos are using the same techniques as any other lab, so naturally the variances would be similar. The only test their Edison machine is FDA approved for is herpes simplex. They have caught some flak, however, for allegedly diluting blood samples before standard analysis.
- djhn 11y ago
  What ends would diluting it achieve?
  - jkimmel 11y ago
    They take smaller blood draws from finger tip pricks that aren't large enough in volume to run on a standard machine from Siemens et al. To get around this, they supposedly dilute the samples to a point where the concentrations of analytes are well below the machines minimum operating specifications.
    - dekhn 11y ago
      Theranos responded that they use the exact manufacturer dilution protocol on their volumes. I don't know of any fact-based article saying they were operating the machines below their minimum specs.
    - daughart 11y ago
      My understanding is that only the Edison machine uses finger prick amounts. However, it sounds like since these machines don't work they are using standard instruments. For these they take venous blood draws, just using a child-sized vacuum tube instead of an adult-sized vacuum tube. She talked about using the child-sized vacuum tubes in an interview. Not really a big differentiator in my opinion.
  - dekhn 11y ago
    Basically, the story is this: 1) The founder of Theranos is afraid of blood 2) Theranos invents a new low volume blood draw technology and test mechanism (which contains many subtests) 3) The test they use to augment their limited test is a commercial product that works on larger volumes of blood 4) because their test doesn't actually work all that well (I actually don't know enough about this part, as their work is mostly secret) they have to pivot a bunch of of their tests to using a different company's test machine 5) Those other commercial products actually do work with smaller volumes of blood, diluted to larger volumes, in case you can't get a large volume from a patient There isn't anything wrong with Theranos diluting blood to make their tests work with another commercial product (this is a legitimate use). However, it does seem to suggest that the technology that hyped Theranos up to a multibillion value isn't as good as was claimed; instead, Theranos is mostly just another conventional provider of diagnostic tests. If they're just another conventional provider, it sort of kills the whole startup story and investment, because why would you invest in a disruptor if you can make money from the establishment? That said, it's common to see startups start with a really ambitious goal, fail, then pivot to become more conventional companies with decent but not spectacular revenue streams.
    - kzhahou 11y ago
      > because their test doesn't actually work all that well (I actually don't know enough about this part, as their work is mostly secret) they have to pivot a bunch of of their tests to using a different company's test machine This is like if every time you fetched an Uber, a yellow cab showed up! Except for one market out of 200, where they run five black cars, in a small SF neighborhood.
      - dekhn 11y ago
        yes, that is how 95% of startups that don't go out of business end up. also, the yellow cab has a little black hoodie that makes it look like a limo.
danso 11y ago
One of the complaints against Theranos is that they've published very little peer-review research about their results, nevermind their methodology and technology. [1] [2] Since you 99% sure that other labs have problems, are you suggesting that all the other labs rely on technology that also have a dearth of peer-review published results? [1] http://jama.jamanetwork.com/article.aspx?articleid=2110977 http://jama.jamanetwork.com/article.aspx?articleid=2110977 > As of January 5, 2015, a search in PubMed using Theranos as a search term identified affiliations for only 2 unrelated articles coauthored by Theranos Inc employees, although these 2 reports do not offer insights about their company. [2] http://www.newyorker.com/magazine/2014/12/15/blood-simpler http://www.newyorker.com/magazine/2014/12/15/blood-simpler > Clarke argues that finger-stick blood tests aren’t reliable for clinical diagnostic tests; because the blood isn’t drawn from a vein, the sample can be contaminated by lanced capillaries or damaged tissue. Holmes strongly disagrees: “We have data that show you can get a perfect correlation between a finger stick and a venipuncture for every test that we run.” When I asked for evidence, I was sent a document by Daniel P. Edlin, Theranos’s senior product manager, titled “Select Data.” It purported to show favorable results from numerous comparison tests. I asked Edlin if the tests had been conducted by an independent third party. He replied by e-mail: “The clinical tests were conducted by a combination of Theranos and external labs,” but he wouldn’t say which ones. > When I asked Holmes for evidence that her tests were independently audited, she said that there have been “tens” of audits and “external third-party comparisons” of Theranos’s tests, including those done by the hospital groups that are adopting its finger-prick tests and the pharmaceutical companies that have contracted with Theranos for testing their products. Holmes says that Theranos is certified in forty-eight states, with two more applications pending, under the federal Clinical Laboratory Improvement Amendments of 1988. Under the amendments, laboratories like hers must be certified before they can perform tests for the general public, and their performance is evaluated three times a year by the College of American Pathologists. Holmes also pointed me to a pilot study published by Hematology Reports, an online-only peer-reviewed journal; she is listed as a co-author. The report, released in April, concluded that Theranos tests “correlated highly with values obtained” from standard lab tests.
- neurotech1 11y ago
  The lack of peer-reviewed research for Theranos is a valid criticism. The method and technology used in other labs likely is peer-reviewed at some level, so not disagreeing on that point. What I am suggesting is that other labs do have variances in results, on certain lab tests. The OP did say that there was a 7% variation in Platelet results in successive days, using the Stanford lab. Quest Diagnostics have had previous settlements with DoJ for "inaccurate and unreliable" lab test kits. [0] [0] http://www.justice.gov/opa/pr/quest-diagnostics-pay-us-302-million-resolve-allegations-subsidiary-sold-misbranded-test-kits http://www.justice.gov/opa/pr/quest-diagnostics-pay-us-302-m...

semi-extrinsic 11y ago

It appears that most tests done by Theranos are using the same techniques as any other lab, so naturally the variances would be similar. The only test their Edison machine is FDA approved for is herpes simplex. They have caught some flak, however, for allegedly diluting blood samples before standard analysis.

djhn 11y ago
What ends would diluting it achieve?
- jkimmel 11y ago
  They take smaller blood draws from finger tip pricks that aren't large enough in volume to run on a standard machine from Siemens et al. To get around this, they supposedly dilute the samples to a point where the concentrations of analytes are well below the machines minimum operating specifications.
  - dekhn 11y ago
    Theranos responded that they use the exact manufacturer dilution protocol on their volumes. I don't know of any fact-based article saying they were operating the machines below their minimum specs.
  - daughart 11y ago
    My understanding is that only the Edison machine uses finger prick amounts. However, it sounds like since these machines don't work they are using standard instruments. For these they take venous blood draws, just using a child-sized vacuum tube instead of an adult-sized vacuum tube. She talked about using the child-sized vacuum tubes in an interview. Not really a big differentiator in my opinion.
- dekhn 11y ago
  Basically, the story is this: 1) The founder of Theranos is afraid of blood 2) Theranos invents a new low volume blood draw technology and test mechanism (which contains many subtests) 3) The test they use to augment their limited test is a commercial product that works on larger volumes of blood 4) because their test doesn't actually work all that well (I actually don't know enough about this part, as their work is mostly secret) they have to pivot a bunch of of their tests to using a different company's test machine 5) Those other commercial products actually do work with smaller volumes of blood, diluted to larger volumes, in case you can't get a large volume from a patient There isn't anything wrong with Theranos diluting blood to make their tests work with another commercial product (this is a legitimate use). However, it does seem to suggest that the technology that hyped Theranos up to a multibillion value isn't as good as was claimed; instead, Theranos is mostly just another conventional provider of diagnostic tests. If they're just another conventional provider, it sort of kills the whole startup story and investment, because why would you invest in a disruptor if you can make money from the establishment? That said, it's common to see startups start with a really ambitious goal, fail, then pivot to become more conventional companies with decent but not spectacular revenue streams.
  - kzhahou 11y ago
    > because their test doesn't actually work all that well (I actually don't know enough about this part, as their work is mostly secret) they have to pivot a bunch of of their tests to using a different company's test machine This is like if every time you fetched an Uber, a yellow cab showed up! Except for one market out of 200, where they run five black cars, in a small SF neighborhood.
    - dekhn 11y ago
      yes, that is how 95% of startups that don't go out of business end up. also, the yellow cab has a little black hoodie that makes it look like a limo.

danso 11y ago

One of the complaints against Theranos is that they've published very little peer-review research about their results, nevermind their methodology and technology. [1] [2] Since you 99% sure that other labs have problems, are you suggesting that all the other labs rely on technology that also have a dearth of peer-review published results? [1] http://jama.jamanetwork.com/article.aspx?articleid=2110977 http://jama.jamanetwork.com/article.aspx?articleid=2110977 > As of January 5, 2015, a search in PubMed using Theranos as a search term identified affiliations for only 2 unrelated articles coauthored by Theranos Inc employees, although these 2 reports do not offer insights about their company. [2] http://www.newyorker.com/magazine/2014/12/15/blood-simpler http://www.newyorker.com/magazine/2014/12/15/blood-simpler > Clarke argues that finger-stick blood tests aren’t reliable for clinical diagnostic tests; because the blood isn’t drawn from a vein, the sample can be contaminated by lanced capillaries or damaged tissue. Holmes strongly disagrees: “We have data that show you can get a perfect correlation between a finger stick and a venipuncture for every test that we run.” When I asked for evidence, I was sent a document by Daniel P. Edlin, Theranos’s senior product manager, titled “Select Data.” It purported to show favorable results from numerous comparison tests. I asked Edlin if the tests had been conducted by an independent third party. He replied by e-mail: “The clinical tests were conducted by a combination of Theranos and external labs,” but he wouldn’t say which ones. > When I asked Holmes for evidence that her tests were independently audited, she said that there have been “tens” of audits and “external third-party comparisons” of Theranos’s tests, including those done by the hospital groups that are adopting its finger-prick tests and the pharmaceutical companies that have contracted with Theranos for testing their products. Holmes says that Theranos is certified in forty-eight states, with two more applications pending, under the federal Clinical Laboratory Improvement Amendments of 1988. Under the amendments, laboratories like hers must be certified before they can perform tests for the general public, and their performance is evaluated three times a year by the College of American Pathologists. Holmes also pointed me to a pilot study published by Hematology Reports, an online-only peer-reviewed journal; she is listed as a co-author. The report, released in April, concluded that Theranos tests “correlated highly with values obtained” from standard lab tests.

neurotech1 11y ago
The lack of peer-reviewed research for Theranos is a valid criticism. The method and technology used in other labs likely is peer-reviewed at some level, so not disagreeing on that point. What I am suggesting is that other labs do have variances in results, on certain lab tests. The OP did say that there was a 7% variation in Platelet results in successive days, using the Stanford lab. Quest Diagnostics have had previous settlements with DoJ for "inaccurate and unreliable" lab test kits. [0] [0] http://www.justice.gov/opa/pr/quest-diagnostics-pay-us-302-million-resolve-allegations-subsidiary-sold-misbranded-test-kits http://www.justice.gov/opa/pr/quest-diagnostics-pay-us-302-m...