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Disruptive Bloodwork Startup May Offer Mostly Vaporware
dmr001 writes: As seen previously, Palo Alto startup Theranos planned to put the power of affordable lab work directly in the hands of patients with tiny fingerprick samples taken at Walgreen's, with four hour turnaround. The company claimed their tests were "made possible by advances in the field of microfluidics." But they were cagey about methodology and didn't use FDA approved analyzers.
Now, the Wall Street Journal reports (paywalled) (among others) that all but one of Theranos' analyzers currently in use is off the shelf, and that their tiny samples may not always have been accurate. Typically cagey founder Elizabeth Holmes vigorously disputes the criticism of her $9 billion startup, but entrenched players like Quest Diagnostics and LabCorp (which do quite well charging orders of magnitude above Theranos' prices) are likely doing a happy dance.
Physicians worrying about patients bringing in their own carcinoembryonic antigen levels and Epstein Barr Virus panels to confirm their Internet diagnoses of cancer and chronic fatigue may also be breathing sighs of relief, albeit with bittersweet regret at the potential loss of the price advantage and milliliter samples.
Now, the Wall Street Journal reports (paywalled) (among others) that all but one of Theranos' analyzers currently in use is off the shelf, and that their tiny samples may not always have been accurate. Typically cagey founder Elizabeth Holmes vigorously disputes the criticism of her $9 billion startup, but entrenched players like Quest Diagnostics and LabCorp (which do quite well charging orders of magnitude above Theranos' prices) are likely doing a happy dance.
Physicians worrying about patients bringing in their own carcinoembryonic antigen levels and Epstein Barr Virus panels to confirm their Internet diagnoses of cancer and chronic fatigue may also be breathing sighs of relief, albeit with bittersweet regret at the potential loss of the price advantage and milliliter samples.
Theranos' "Edison" analyzer is purported to allow accurate, cheap testing with tiny sample sizes. They haven't revealed a lot about how it works. This is in contrast to standard analyzers which cost more (well, they charge more), need your typical 10 ml Vacutainer sample, and have lengthy turnaround times. It turns out Theranos has recently been using standard, commercially-available analyzers for most of its tests, and had to dilute its samples to do so, apparently compromising accuracy.
As the OP, I'm hopeful Theranos now can pull up out of this apparent nosedive, and publish controlled analyses in larger, controlled trials in a peer-reviewed journal. Then the real miracle will be integrating their results with everyone's frickin' EMR.
Even the best testing panels have only found markers for CFS in a statistical manner.
That is - you take a hundred people with CFS, a hundred people without CFS, and you can with certainty tell which group is which.
However, you can't with any useful result test a single individual.
The false positive rate is 45%, and the false negative rate is 45% or so.
CFS is not one disease, it is almost certainly many.
They probably send it to Quest because Quest basically hands out medical record software connections to their order system like candy.
I develop interfaces with labs for an EMR company. Out of all the labs I've dealt with in this country, Quest is the only one where I can go to their website, fill in a form, and have a connection between a doctor and that laboratory done in days-to-weeks. Other labs, even labs I've dealt with for years, connecting a single client with the same software every other client is using takes weeks-to-months. 8 of our clients are based in one hospital (which has been begging everyone to get on board with the 799-pound-EMR-gorilla and won't connect with anything else) and have been waiting over a year (and we only got into the process because one of the doctors is a department head). One of the other major laboratories that we've had connections with for a decade straight up told me that since the doctor had gotten an interface with his old software just last year, they wouldn't do a connection for that doctor again for a while. It would not surprise me at all if the doctor sent the order to Quest because that's the only lab the doctor could send the order to.
They have a product. And from what I've read it can reliably handle something like 18 different tests. What is still questionable is their goal to reach 200+ tests in one go. But they are still working on it. So here we have a hit piece turning the perfect into the enemy of the good.
Also, Quest does not automatically bill the patient first.
Yes, they do. I go to the doctor, they have my insurance information, they send in the bill to the insurance, I get a bill from the provider. The provider sends bloodwork off to a lab of their choosing (despite my objections), the lab has my insurance information, they send me a bill. They don't bill the insurance, I call them, they don't bill the insurance, I call some more, I send letters, they don't bill the insurance. Eventually, they start threatening collections. But how can you collect on an amount when you don't know how much that person owes because you have not yet billed their insurance plan?
Stop blaming your doctor for your own incompetence.
I'm incompetent? I don't work at the doctor's office. How do I control who they send their labwork to. I can and have told them not to send the bloodwork to Quest. They do it anyway. You don't get to decide where it goes, you don't get to just "send" it yourself. The doctor's won't give you your bloodwork even though it came out of your body and they technically should have to get your permission to do anything with it.
I guess you like you getting gang raped by the insurance/doctor/lab companies and that is why you act as an apologist for them.
If you are not allowed to question your government then the government has answered your question.
I don't understand your problem. My doctor just writes me a bloodwork prescription, I walk it over to the local LabCorp, less than a week later the doctor has the results in hand. If you don't like where your doctor is sending your test results to, just ask for a prescription to go and do it yourself. If the doctor refuses, find another doctor.