Should have been a lifetime ban.
Should have been a lifetime ban.
Totaly agree with that. Exactly what is this amazing Edison device supposed to diagnose from a microlitre of blood ? According to Wikipedea the FDA provided limited approval for Theranos' Edison device for use in a herpes simplex virus (HSV-1) blood test which tests for disease using a finger-prick's worth of blood,
but did not verify its accuracy.
I'm not a biochemist but I guess you would have to add a reagent to the blood that would then react with the herpes virus and you measure for certain reaction compounds. Obviously it didn't work.
I don't know what the law says but surely this should have been clinically trialled if it's diagnostic equipment.
Elizabeth Holmes is largely a figurehead that had a bad idea that sounded good. The backers and enablers that actually put her on the map are the real villains, and they will suffer nothing other than the loss of other people's money.
Theranos is UBeam is Batteroo is ...
Should have been a lifetime ban.
Totaly agree with that. Exactly what is this amazing Edison device supposed to diagnose from a microlitre of blood ? According to Wikipedea the FDA provided limited approval for Theranos' Edison device for use in a herpes simplex virus (HSV-1) blood test which tests for disease using a finger-prick's worth of blood, but did not verify its accuracy.
I'm not a biochemist but I guess you would have to add a reagent to the blood that would then react with the herpes virus and you measure for certain reaction compounds. Obviously it didn't work.
I don't know what the law says but surely this should have been clinically trialled if it's diagnostic equipment.
Diagnosis of herpes simplex (HSV-1 or HSV-2) in such a test would have to be done using fluorescent antibodies, which has to be added to the blood.
How are existing herpes tests run? Is it only blood, or can they do oral/genital mucosa swabs? I would assume it's blood, since it's a virus, therefor you have antibodies, right?
Fun fact: If you've ever had a cold sore (fever blister), you have herpes! (HSV-1 is more common orally, if I remember right.)
Doubly Fun Fact: 40% of the sexually active population have gentile herpes, though less than 10% will ever have an outbreak. Most who carry it never know, but they can still pass it on (sharing is caring), even without any visible sores! Furthermore, condoms are not always effective protection against herpes; there are a number of factors that can influence the transmission. Normally it's not part of a standard STD panel test and must be specifically requested.
The More You Know! ~~~*
How are existing herpes tests run? Is it only blood, or can they do oral/genital mucosa swabs? I would assume it's blood, since it's a virus, therefor you have antibodies, right?
There is a blood test for HSV IgG - that is antibodies. It will only tell you if you've been exposed. It's possible to have positive HSV IgG and never have an outbreak and not be contagious.
To to a mucosa swab you need to swab fluid from a "deroofed" herpes blister and then do a Tzanck smear or better, a viral PCR test. So you can only do these tests during an outbreak.
A) What a piece of raging shit...
B) Wow! I knew some of the people on this forums were diverse, but holy crap...amazing...
Diagnosis of herpes simplex (HSV-1 or HSV-2) in such a test would have to be done using fluorescent antibodies, which has to be added to the blood.
Fluorescent antibodies, I had a feeling it might be done that way, been there, seen that, excite with a xenon flash lamp and measure the fluorescence using a photo multiplier tube and that was probably 25 years ago, not rocket science and it doesn't need a budget of millions. Use stepper motors to drive a small tray containing maybe 96 small plastic vials takes only a few minutes. Edison device
Should have been a lifetime ban.
Yup, and people get jail time for a
lot less than what she's done.
Theranos is UBeam is Batteroo is ...
Except that Theranos actually used a products to do thousands of medical tests who's results were bogus. People health could be affected. She might be lucky to avoid jail time, we haven't heard the end of this.
B) Wow! I knew some of the people on this forums were diverse, but holy crap...amazing...
mtdoc is our real resident forum medical doctor
It never ceases to amaze me that there will almost always be some expert on the forum in almost any topic that is bought up.
How are existing herpes tests run? Is it only blood, or can they do oral/genital mucosa swabs? I would assume it's blood, since it's a virus, therefor you have antibodies, right?
There is a blood test for HSV IgG - that is antibodies. It will only tell you if you've been exposed. It's possible to have positive HSV IgG and never have an outbreak and not be contagious.
To to a mucosa swab you need to swab fluid from a "deroofed" herpes blister and then do a Tzanck smear or better, a viral PCR test. So you can only do these tests during an outbreak.
Thanks, very interesting. That brings up another question: If there's an outbreak and visible blisters, doesn't that kind of point to herpes in and of itself? So why go through the trouble? (I mean that as a genuine question. I guess maybe there might be other STDs or conditions that present like herpes?)
Also, I'm adding "Deroofed Herpes Blister" to my list of fantastic names for a band!
Except that Theranos actually used a products to do thousands of medical tests who's results were bogus. People health could be affected. She might be lucky to avoid jail time, we haven't heard the end of this.
Weren't all the tests run on standard machines with standard amounts of blood?
Except that Theranos actually used a products to do thousands of medical tests who's results were bogus. People health could be affected. She might be lucky to avoid jail time, we haven't heard the end of this.
Weren't all the tests run on standard machines with standard amounts of blood?
It’s hard to say how Theranos were doing their testing. They have repeatedly obfuscated and misled people about their testing process.
Some (Most? All?) of the blood tests have been done with industry-standard equipment, not their proprietary technology that they always brag about. When government inspectors visited one of their labs, they were shown only standard equipment, not the fancy Edison system. So either Theranos was lying about using their proprietary technology for (at least some of) their testing, or they hid part of their process from the inspectors.
I found this out with a little web research. There’s plenty of information out there, if you don’t stop after the first google result.
Theranos is UBeam is Batteroo is ...
Except that Theranos actually used a products to do thousands of medical tests who's results were bogus. People health could be affected. She might be lucky to avoid jail time, we haven't heard the end of this.
I meant from a investor/funding side. The delivering of invalid results, likely knowingly, is pure evil.
The problem I have with all of this is that the figurehead is the only one being punished.
Thanks, very interesting. That brings up another question: If there's an outbreak and visible blisters, doesn't that kind of point to herpes in and of itself? So why go through the trouble? (I mean that as a genuine question. I guess maybe there might be other STDs or conditions that present like herpes?)
Good question. Yes, Herpes is generally a clinical diagnosis - no lab testing needed: A cluster of small painful blisters in a sensitive area after contact with a new partner = Herpes. I've diagnosed it several times and rarely ordered any lab test.
IIRC Theranos marketed a "home testing kit" which is popular - for obvious reasons...
Using a monoclonal antibody to test is proven technology, just that you need to have a large enough sample so the reaction is visible, or it has to at least contrast to the liquid it is in enough to be readable over the normal non reaction result. Small sample might mean there is only going to be a few hundred reactions, and thus either you need to have an amplification of this result to make it readable, or it has to be a very large contrast result.
Easy to test for hormones in a mostly clear liquid like urine, and as there is a lot of the hormone the test is easy. Not so easy testing for a low concentration of a specific antibody in blood unless you first filter off the red blood cells to get plasma so you can have a clearish liquid. Hard to make a microcentrifuge that is both small, cheap, efficient, disposable, works off a single drop and above all reliable and easy to make in bulk.
From page three of the Flim Flam (Wo)Man's operator's manual: When you can't present a shred of evidence that your technology works as advertised, shovel more bullshit.
http://www.bloomberg.com/news/articles/2016-08-01/theranos-presents-new-product-instead-of-data-backing-old-deviceExpecting Data From Theranos, Lab Experts Get New Product
It was expected to be an academic presentation to show if Theranos Inc.’s controversial blood-testing technology worked, and perhaps explain the science behind the claims that the startup could do lab tests with a fraction of the blood and cost of traditional machines.
Instead, what some of the nation’s top lab-testing scientists and researchers packed into a ballroom at the Pennsylvania Convention Center in Philadelphia got was the introduction of a totally new device.
Founder Elizabeth Holmes, who is facing a two-year ban by U.S. regulators from running a clinical testing company, used the session at the American Association for Clinical Chemistry’s annual scientific meeting to introduce the “miniLab” testing device, a 95-pound diagnostic tool that can fit on a tabletop. The device isn’t yet for sale and hasn’t been approved by regulators, Theranos said in a statement.
Along with the new device came a scaled back vision for the company that not long ago, promised to upend the world of clinical lab testing by running hundreds of tests using a single drop of blood. The miniLab appears to pack a variety of tests that can already be done on a small scale into a single box.
No Game Changer
“They are using the same basic technology that we have been using all along,” said AACC President Patricia Jones, Clinical Director of Chemistry at Children’s Medical Center of Dallas. “But they have miniaturized it, they have put it all in a small platform.”
It’s also not clear how many tests Theranos has validated for use on the machines, or how many finger pricks to collect blood will be needed. “They have a lot of work to do,” Jones said. “There are still so many unanswered questions.”
That assessment was echoed by Stephen Master, a pathologist at Weill Cornell Medicine who helped moderate a question and answer session after Holmes’s presentation.
“It is certainly not yet a game changer,” Master said. While the instruments they presented appeared to have some good engineering behind them, “I certainly didn’t see anything that lives up to the expansive claims they made.”
Cholesterol Test
At the session, Holmes showed several slides comparing test results run on the new machine to existing accuracy standards, including one for a cholesterol panel, that appeared to show the new machine was within guidelines. That wasn’t enough for Master.
“I can buy a point-of-care instrument that does a lipid panel,” he said, referring to existing products already on the market that can run cholesterol tests in a doctor’s office.
The company also said it has developed a test for Zika virus with the miniLab machine that’s been submitted to the U.S. Food and Drug Administration. Angela Stark, an FDA spokeswoman, declined to comment on whether or not the agency had received an application.
Good Comparisons
While the new device may run a smaller number of tests, “the technology appeared to generate results that compared well to existing technologies and that were highly reproducible,” said Eric Schadt, director of the Icahn Institute for Genomics and Multiscale Biology at the Icahn School of Medicine at Mount Sinai.
In introducing the new device, Theranos attempted to hit the reset button. Theranos stopped using an earlier version of its technology, called Edison, after questions arose about their accuracy. The company eventually voided or altered thousands of test results, and some attendees wanted badly to see the company defend or explain its past efforts.
“It is a bait and switch,” said Geoffrey Baird, an associate professor of laboratory medicine at the University of Washington who has been a critic . “We were told we were going to hear about the science of Theranos. This is a new speculative prototype idea that they have,” he said in an interview shortly before the presentation. “It is a completely different instrument” than what Theranos had previously talked about.
The AACC’s Jones introduced Holmes and said that the session wasn’t an endorsement of the company. “This session, as everyone is pretty well aware, has been controversial.”
‘Highly Skeptical’
“We want to see how this works, and that it works,” Jones said in an interview before the meeting. Among her colleagues, almost “everybody is pretty highly skeptical.”
Announcing Holmes’ intent to appear at the meeting in April, the AACC said that its members -- who represent clinical lab testing professionals, researchers and doctors -- would see the company “clarify the science, accuracy, and reliability of Theranos’ technologies, as well as its impact on patient care and safety.”
Once lauded as a potentially revolutionary company in the lab industry, Theranos has fallen far. U.S. inspectors said they found failures so severe as to jeopardize patients’ health at Theranos’s lab in Newark, California, leading to proposed sanctions this year that would ban Holmes from running a laboratory company for two years, along with monetary penalties and cancellation of payments from federal health insurance programs.
“We take full responsibility for our lab operations and are working diligently to rectify all outstanding issues,” Holmes said during her presentation Monday.
The company also has also come under scrutiny by House Democrats, the U.S. Securities and Exchange Commission and the U.S. Attorney’s Office for the Northern District of California. Researchers have called on the startup to publish data supporting its technology in a peer-reviewed scientific journal, where independent scientists could evaluate the data, which it has yet to do.
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Just saw her being ripped apart by Sanjay Ghupta on CNN's Anderson Cooper 360.
It's dead, stick a fork in it. Everything they are doing now is just theater for plausible deniability in case management and board get sued for gross negligence and thus become personally liable.
