So what is the backlash really about? Industry naysayers are undoubtedly upset that the public will be able to access these tests for less than the cost of a cheap meal. Boo hoo.
Laboratory Equipment
07/08/2015
Michelle Taylor, Editor-in-Chief
Elizabeth Holmes and her company Theranos are having a great week. First, the FDA cleared the company’s finger stick technology. And just a few days later, the state of Arizona passed a law that will usher in a new generation of preventative health care, and open an even wider door for Theranos' blood tests.
Holmes, a Stanford University dropout, founded Theranos in 2003. The consumer health company’s goal is to facilitate health information to consumers easily, inexpensively and at the time it matters most. To make this possible, Theranos developed painless finger-prick blood tests. With just a few drops of blood, these lab tests can scan for disease and conditions almost instantaneously.
Holmes upended the blood-testing industry when she debuted her tests to the public in 2013. What’s even better is how inexpensive the tests are—153 tests Theranos provides cost under $10, including one for herpes.
On July 5, Arizona passed a law—with bipartisan support—that allows residents to access and pay for any lab test themselves, without being required to first get a doctor’s note in response to a health issue or dependent on insurance eligibility.
“Today, lab tests are often only reimbursed when the need for those tests are justified by symptoms of illness, which means many tests are ordered only when people are already sick. Even then, the majority of lab test orders don't get filled because services are costly and inaccessible,” Holmes wrote in an op-ed published in AZ Central the day the law was passed.
Detecting disease early
Holmes’ company is built on the premise that detection of disease after symptoms start is too late.
“By the time there are already symptoms, it can often be too late to fundamentally do something about it. We define Theranos as: Detecting the onset of disease in time for therapy to be effective. So we can begin to build a world where no one finds out too late that something is wrong. And no one has to say goodbye too soon,” reads the company’s website.
The new Arizona law that allows Theranos’ test to be even more accessible is definitely a step in the right direction. As is the FDA’s approval of the company’s finger-prick blood test for herpes on July 2.
The FDA approved the entire Theranos system, including Theranos’ test device, analytical software and proprietary Nanotainer Tubes. The device is a highly automated platform designed to reduce common human errors associated with the manual processing of samples, and the tubes allow samples of just a few drops of blood.
What’s unusual about this FDA approval is it was voluntary—Theranos did not need to seek approval.
The FDA does not currently require Laboratory Developed Tests (LDTs) to be submitted for review in order to be sold to the public. However, according to its press release, “Theranos believes that the rigor of FDA review helps to ensure that tests are properly designed and interpreted, consistently manufactured, and of the highest quality.”
Earlier this year, Theranos publically expressed its support of the FDA’s proposal to strengthen the regulation and oversight of LDTs. In fact, Theranos is the first lab to voluntarily commit to submitting all its LDTs to the FDA for review.
Backlash
Despite seeking FDA approval, some in the industry still do not approve of Theranos. According to the Washington Post, competitors and others in the medical community have criticized the company for its lack of transparency. Apparently, some believe Theranos should release information on exactly how the technology works, including raw data and protocols.
Professor John Ioannidis, an influential biomedical researcher, wrote in the Journal of the American Medical Association: “Theranos is just one example among many for which major efforts and major claims about biomedical progress seem to be happening outside the peer-reviewed scientific literature. The main motive appears to be to develop products and services, rather than report new discoveries as research scholarship. Products, services, and profit appear to be more important than scientific publications.”
Maybe it’s just me, but I don’t see the problem in what Ioannidis describes. Millions of companies are out for a profit, but that doesn’t mean their science is any less innovative or life-changing.
Theranos offers the herpes test for $9.07 compared with the average of about $200. That doesn’t seem like a product or service just out for a profit to me.
I understand that Ioannidis wants Theranos to release its information, but why should it? Big pharmaceutical companies don’t release information about their drugs. Heck, those companies are doing everything they can to hold onto their drug patents for just a little bit longer.
New drugs from pharma are released to the public after extensive trials and subsequent federal approval—which is similar to Theranos’ process for approval.
For the herpes test review, Theranos provided study data to the FDA from 818 subjects of varying age and ethnicity, demonstrating that its system could be run accurately using a finger stick compared with commercially available tests that use blood drawn from a vein. Theranos devices and tests were all compared against an FDA-cleared, commercially available reference method. Holmes said that data will become public this week.
Even after all of this, Ioannidis told the Post it is still not enough. It may not be enough for Ioannidis, but I’m willing to give a company dedicated to saving lives a little wiggle room.
Laboratory Equipment
07/08/2015
Michelle Taylor, Editor-in-Chief
Elizabeth Holmes and her company Theranos are having a great week. First, the FDA cleared the company’s finger stick technology. And just a few days later, the state of Arizona passed a law that will usher in a new generation of preventative health care, and open an even wider door for Theranos' blood tests.
Holmes, a Stanford University dropout, founded Theranos in 2003. The consumer health company’s goal is to facilitate health information to consumers easily, inexpensively and at the time it matters most. To make this possible, Theranos developed painless finger-prick blood tests. With just a few drops of blood, these lab tests can scan for disease and conditions almost instantaneously.
Holmes upended the blood-testing industry when she debuted her tests to the public in 2013. What’s even better is how inexpensive the tests are—153 tests Theranos provides cost under $10, including one for herpes.
On July 5, Arizona passed a law—with bipartisan support—that allows residents to access and pay for any lab test themselves, without being required to first get a doctor’s note in response to a health issue or dependent on insurance eligibility.
“Today, lab tests are often only reimbursed when the need for those tests are justified by symptoms of illness, which means many tests are ordered only when people are already sick. Even then, the majority of lab test orders don't get filled because services are costly and inaccessible,” Holmes wrote in an op-ed published in AZ Central the day the law was passed.
Detecting disease early
Holmes’ company is built on the premise that detection of disease after symptoms start is too late.
“By the time there are already symptoms, it can often be too late to fundamentally do something about it. We define Theranos as: Detecting the onset of disease in time for therapy to be effective. So we can begin to build a world where no one finds out too late that something is wrong. And no one has to say goodbye too soon,” reads the company’s website.
The new Arizona law that allows Theranos’ test to be even more accessible is definitely a step in the right direction. As is the FDA’s approval of the company’s finger-prick blood test for herpes on July 2.
The FDA approved the entire Theranos system, including Theranos’ test device, analytical software and proprietary Nanotainer Tubes. The device is a highly automated platform designed to reduce common human errors associated with the manual processing of samples, and the tubes allow samples of just a few drops of blood.
What’s unusual about this FDA approval is it was voluntary—Theranos did not need to seek approval.
The FDA does not currently require Laboratory Developed Tests (LDTs) to be submitted for review in order to be sold to the public. However, according to its press release, “Theranos believes that the rigor of FDA review helps to ensure that tests are properly designed and interpreted, consistently manufactured, and of the highest quality.”
Earlier this year, Theranos publically expressed its support of the FDA’s proposal to strengthen the regulation and oversight of LDTs. In fact, Theranos is the first lab to voluntarily commit to submitting all its LDTs to the FDA for review.
Backlash
Despite seeking FDA approval, some in the industry still do not approve of Theranos. According to the Washington Post, competitors and others in the medical community have criticized the company for its lack of transparency. Apparently, some believe Theranos should release information on exactly how the technology works, including raw data and protocols.
Professor John Ioannidis, an influential biomedical researcher, wrote in the Journal of the American Medical Association: “Theranos is just one example among many for which major efforts and major claims about biomedical progress seem to be happening outside the peer-reviewed scientific literature. The main motive appears to be to develop products and services, rather than report new discoveries as research scholarship. Products, services, and profit appear to be more important than scientific publications.”
Maybe it’s just me, but I don’t see the problem in what Ioannidis describes. Millions of companies are out for a profit, but that doesn’t mean their science is any less innovative or life-changing.
Theranos offers the herpes test for $9.07 compared with the average of about $200. That doesn’t seem like a product or service just out for a profit to me.
I understand that Ioannidis wants Theranos to release its information, but why should it? Big pharmaceutical companies don’t release information about their drugs. Heck, those companies are doing everything they can to hold onto their drug patents for just a little bit longer.
New drugs from pharma are released to the public after extensive trials and subsequent federal approval—which is similar to Theranos’ process for approval.
For the herpes test review, Theranos provided study data to the FDA from 818 subjects of varying age and ethnicity, demonstrating that its system could be run accurately using a finger stick compared with commercially available tests that use blood drawn from a vein. Theranos devices and tests were all compared against an FDA-cleared, commercially available reference method. Holmes said that data will become public this week.
Even after all of this, Ioannidis told the Post it is still not enough. It may not be enough for Ioannidis, but I’m willing to give a company dedicated to saving lives a little wiggle room.