Breakthrough Of Instant Diagnosis

[Forrest]

Re: Breakthrough Of Instant Diagnosis

Like a gun, hammer or any tool, this new blood testing technology can be used for good or ill. The privacy concerns are real. But speaking as someone who needs frequent blood tests but who has such crappy veins that blood tests are all but impossible, this new technology is a godsend. I'm not willing to live my entire life in miserable health or die from a treatable disease because I'm afraid of NSA-type spying on my blood. The ways the information could be used against me are a problem, but only if I'm alive. Without blood monitoring I might not be alive at all. This technology is coming in the nick of time for me, because nearly all my attempts to get "routine" bloodwork are ending in failure.

Shiny...I am not against anything that can be used for good, particularly in health matters. I have to get tested quarterly myself, and resent having to have them. Being diabetic, I test up to four times a day, and even the tiniest drop is painful since it is on a fingertip.

I was merely replying to the thought that a product derived in secrecy, and maintained in secrecy, might not be the best way to improve things. On the other hand, if I were worried about info leaking out as I finalize each patented process, I might be just as concerned about info leaking out.

I am sure that blood testing can be done from micro samples, since it is already available for test for one particulate level, and hope the brilliant young inventor is the new Steve Jobs for medical devices.

I would like it even better if they could invent the Star Trek medical scanner...it doesn't even need to touch you!

[shiny!]

Re: Breakthrough Of Instant Diagnosis

Shiny...I am not against anything that can be used for good, particularly in health matters. I have to get tested quarterly myself, and resent having to have them. Being diabetic, I test up to four times a day, and even the tiniest drop is painful since it is on a fingertip.

I was merely replying to the thought that a product derived in secrecy, and maintained in secrecy, might not be the best way to improve things. On the other hand, if I were worried about info leaking out as I finalize each patented process, I might be just as concerned about info leaking out.

I am sure that blood testing can be done from micro samples, since it is already available for test for one particulate level, and hope the brilliant young inventor is the new Steve Jobs for medical devices.

I would like it even better if they could invent the Star Trek medical scanner...it doesn't even need to touch you!

I wasn't arguing with you, only pointing out that I don't want to see fear over possible misuse of information keep potentially useful technologies from taking off.

As long as TPTB can collect data on us through phones, street cameras, the internet, credit cards, etc, I think the misuse of blood test information is sort of a moot point.

Edit: a Star Trek scanner in every home would be cool!

[lakedaemonian]

Re: Breakthrough Of Instant Diagnosis

I wasn't arguing with you, only pointing out that I don't want to see fear over possible misuse of information keep potentially useful technologies from taking off.

As long as TPTB can collect data on us through phones, street cameras, the internet, credit cards, etc, I think the misuse of blood test information is sort of a moot point.

Edit: a Star Trek scanner in every home would be cool!

I've posted before about mid level health care providers combined with new technology such as:

http://www.qualcommtricorderxprize.org/

http://www.startrek.com/article/10-m...tion-an-update

http://en.wikipedia.org/wiki/Tricorder_X_PRIZE

Not the "end all be all" but simply huge potential for either reducing or controlling medical costs as well as improving diagnosis/outcome.

[Bundi]

Re: Breakthrough Of Instant Diagnosis

Thanks for the nice note.

But in reply to your points, I'm sure you understand that data collection thru diagnostic monitoring leads to and enables control systems.... and the better the sensory systems the increased fidelity of the control systems. So, while you assume that this control will be employed to "improve" public health, it is my contention that it will be used to CONTROL public health. My evidence for this is to look at how the food industry employs science to design food systems that attack human health, while the pharmaceutical and medical industries create "solutions", that target the symptoms caused by these core conditions, which create new conditions while leaving the core condition untreated.

Hi Reggie,

I’m glad you are contributing your perspectives. The future seems fraught with risks around privacy and information power and it would be naïve to think that for-profit enterprises will think of individual privacy first, economics second. That said, I am learning that it is very difficult to exist (specifically, feed the family) with an off the grid ideology. I would love to think that all of the uses of one’s individual data will be governed by that individual's knowing consent or denial of consent. Perhaps there will be a technology driven shift toward consumer/individual control as some technologists proclaim. I kind of doubt it but at the end of the day each of us has to contend with the issue and some will smarten up and attempt to gain personal control, others will go with the flow, and still others will enjoy the luxury of a “cash only” existence and limited data footprint but this last scenario is encumbered by real practical limitations for most of us.

As an example of the ongoing aggregation of medical records by for profit companies.

Practice Fusion (private) http://practicefusion.com/

Claims to have aggregated 75 million patient records in its electronic platform service made available to medical practices in the U.S.

Shockingly, investors seem to see a lot of value in this platform with this article suggesting a $700 million valuation and venture funding flowing into the company in every higher amounts.

http://venturebeat.com/2013/09/24/pr...-series-d-ipo/


Here is another data healthcare play rolling up patient data.

Explorys https://www.explorys.com/about-us (spun out of the Cleveland clinic in 2009)

From company website…

Since its founding, Explorys has developed the world’s most scalable platform for Enterprise Performance Management (EPM) and one of the largest healthcare databases in the world derived from numerous and diverse financial, operational, and medical record source systems.

Explorys’ healthcare customers include some of the most prominent healthcare systems in the United States, together accounting for over $45 billion in care. With over 100 billion clinical, financial, and operational data elements, spanning 40 million patients, 200 hospitals, and over 100,000 providers, Explorys’ secure cloud-computing platform is being used by 14 major integrated healthcare systems to identify patterns in diseases, treatments, and outcomes. Our network includes Cleveland Clinic, Trinity Health, St. Joseph Health System, Catholic Health Partners, and many others with patients in all 50 state.

There is a lot of healthcare data aggregation taking place these days.

As an aside from the big data aspect of this “personalized medicine” push, below is a link to FDA policy guidance (issued just last month, October 2013) on an assortment of structural, scientific, and regulatory evolutions at the FDA since 2000 or so. This is an interesting document as it touches on several trends discussed in this thread and provides a sense for the timing that has been at work as these trends unfold. The last handful of pages may be most interesting to readers but taking a moment to look through the entire document provides a bigger picture feel for these trends.


http://www.fda.gov/downloads/Science.../UCM372421.pdf

[Bundi]

Re: Breakthrough Of Instant Diagnosis

Interesting discussion from a general context perspective even if the views are all from industry leadership. I found it helpful.

http://www.youtube.com/watch?v=8gMp0YC0_kM

Google Tech Talk
October 22, 2012

ABSTRACT

Discussing the evolution, current opportunities and future trends in big data
Presented by Google and the Fung Institute at UC Berkeley

SPEAKERS:

Moderator: Hal Varian, an economist specializing in microeconomics and information economics. He is the Chief Economist at Google and he holds the title of emeritus professor at the University of California, Berkeley where he was founding dean of the School of Information.

Panelists:
Theo Vassilakis, Principal Engineer/Engineering Director at Google
Gustav Horn, Senior Global Consulting Engineer, Hadoop at NetApp
Charles Fan, Senior Vice President at VMware in strategic R&D

[vt]

Re: Breakthrough Of Instant Diagnosis

Star Trek Tricorder Device

http://www.dailymail.co.uk/sciencete...s-disease.html

[Bundi]

Re: Breakthrough Of Instant Diagnosis

Yet despite its big names, revolutionary goals, groundbreaking technology and apparent ramp-up, Theranos continues to move stealthily. Requests to speak with Holmes or other executives, board members and the company’s financiers were consistently rebuffed, and the company declined to provide any answers to written questions.
“We are not granting interviews at this time or providing information past what is currently available on our website,” a company spokeswoman said in an Aug. 15 email message. “As we have additional news to share, we will be sure to follow up with you directly.”

Looks like we will find out if it is hype or reality or something in between. Capital Blue Cross is a relatively small insurer at ~$3B per year so it isn't like Aetna signed them to a national deal but still worth keeping an eye on it.

"Executives at Capital Blue Cross Pennsylvania, a health insurer that partnered with Theranos on July 8, seemed to have done the most thorough job vetting the Theranos technology among those I spoke to yesterday.

Chief Executive Gary D. St. Hilaire said that he and his team had been watching Theranos closely for four years, since a venture capital fund they participate in with other Blue Cross/Blue Shield insurers invested in the company.

“Our folks have spent quite a bit of time out at their company headquarters,” St. Hilaire says. “We have tremendous confidence in the team and certainly have had that technology demonstrated to us in more than one or two ways.” He adds that his confidence in Theranos was built long before FDA approval.

Aji Abraham, a senior vice president at Capital, says that he went so far as to get tested using Theranos himself and compare the results to a recent blood test. Neither he nor his doctor noticed any significant differences. Abraham says he can’t detail what formal tests he put Theranos through because of patient privacy law.

Right now, Capital Blue Cross is using Theranos in addition to other testing providers, not instead of them. But Hilaire still says he expects the deal to save money, both because the tests will be cheaper and because more patients will get them. Something like half of blood tests that doctors prescribe never happen, which can make patients less healthy and more expensive in the long run.

http://www.forbes.com/sites/matthewh...s-a-few-tests/

Running A Few Tests On Theranos: Can Elizabeth Holmes Revolutionize Diagnostics?

Elizabeth Holmes, the world’s youngest female billionaire, and her company, Palo Alto-based Theranos, have seized the public imagination with a vision of replacing traditional blood tests with a cheaper, faster, and less painful alternative. But Theranos’ technology remains shrouded in mystery, even controversy, as the company that aims to replace traditional blood tests with mere finger pricks begins to slowly expand from its initial footholds in California and Arizona.

Theranos is offering tests for less money, and at a faster turnaround time, than giants like Laboratory Corp. of America or Quest Diagnostics. It says that it can analyze blood tests that used to require using a needle and syringe to draw a vial of blood with just a drop taken from a pricked finger. The tests will be available in drug stores – there is already a partnership with Walgreens — and will be analyzed at nearby laboratory facilities that use proprietary technology. More groups have signed on, including, this morning, an insurer focused on the Medicaid market called AmeriHealth Caritas.

How much is real and how much is hype? I’m not going to provide a final answer here. I still have no idea how Theranos’ technology works. But I’m more confident than I was before after spending a day talking to the company’s partners.

Here are a few reasons for that confidence: The Food and Drug Administration has just posted a detailed explanation of its decision to clear Theranos’ one approved test, and, to my eyes, it does give some validation of their technology. Yesterday, I spent 50 minutes on the phone with Holmes herself and another hour talking to three of her partners: Capital Blue Cross Pennsylvania, a large insurance plan there; the Carlos Slim Foundation, which is working with Theranos in Mexico; and AmeriHealth Caritas, the insurer focused on Medicaid plans that is pairing up with Theranos today. They were thoughtful about what they were buying and its potential to change the way they did things.

I want it to all be true, because Holmes’ moral challenges to the way health care works now are so obvious and compelling. Take this, her stance on lab industry pricing practices:

“Someone in need comes to you and, because they don’t have the right kind of insurance that can allow the price of these lab tests to be low, you charge them thousands of dollars for a lab test? There’s something wrong with that. We believe very strongly that these tests need to be affordable, and they need to be operator consistent, with transparent prices, and that needs to happen in a way that an average person can afford them.”

Everybody who’s ever gotten a blood test probably agrees with that. Here is what I learned yesterday.

FDA approval

There’s a lot of skepticism about Theranos. Michael Cherny, an analyst at ISI Evercore, an investment bank, wrote in a recent note to investors:


“What we consistently hear about Theranos from people in the field (people with many more degrees than I have) is that the reason for the secrecy is that there is nothing THAT proprietary about the technology (their words, not ours). In a session at the May Executive War College conference, one clinician noted that the “only thing Theranos has revolutionized is pricing transparency and a great PR campaign.”

A recent opinion piece in Clinical Chemistry and Laboratory Medicine, a scientific journal, asserted that “most of the company’s claims are exaggerated.” The author, Eleftherios P. Diamandis of Mount Sinai Hospital in Toronto, argued that Theranos likely has few cost or speed advantages over current technologies and that, without more robust testing, “Theranos technology’s quality and robustness will remain in question.”

When critics say that Theranos should publish more data, Holmes responds that she is doing something better: getting approval from the Food and Drug Administration for 120 different Theranos tests. This is not standard practice in the industry.

Many blood tests are actually not FDA approved, because tests that are developed by the lab that uses them have been exempt from many regulations. Holmes argues that FDA approval is a much higher hurdle than simply publishing in a medical journal. It’s great that Theranos is doing this.

That said, Theranos has a tendency to overstate what we can know from its single FDA approval, granted earlier this month. The approval is for a single test – for herpes simplex 1, which causes cold sores and, less often, genital sores. Theranos tends to present it as a validation for its technology – one press release says simply that the company “received clearance of its lab technology from the FDA” – instead of emphasizing that this is an approval for using that technology for detecting herpes virus. That’s an important distinction: every test will require its own approval.

But the FDA has just made public its decision letter to Theranos and a far more detailed memo around the agency’s thinking. The 29-page memo doesn’t explain how the Theranos system works, but does compare samples on the existing technology and using Theranos’ new technology. Not only are the test results substantially the same, but Theranos’ device is able to replace a blood draw with just a drop of blood, as advertised.

Holmes agrees that her company’s speed and cost is based on logistics as well as technology. Theranos has started offering tests that it can’t yet integrate into its systems, using full blood draws. It still charges at most 50% of what Medicare allows, sometimes losing money on the tests. If big laboratory companies really have equally low chemical costs, why are their tests so expensive?

“Nobody else seems to be interested in offering lab tests for less than Medicare’s reimbursement rate!” says Holmes.

Testing the blood test

Executives at Capital Blue Cross Pennsylvania, a health insurer that partnered with Theranos on July 8, seemed to have done the most thorough job vetting the Theranos technology among those I spoke to yesterday.

Chief Executive Gary D. St. Hilaire said that he and his team had been watching Theranos closely for four years, since a venture capital fund they participate in with other Blue Cross/Blue Shield insurers invested in the company.

“Our folks have spent quite a bit of time out at their company headquarters,” St. Hilaire says. “We have tremendous confidence in the team and certainly have had that technology demonstrated to us in more than one or two ways.” He adds that his confidence in Theranos was built long before FDA approval.

Aji Abraham, a senior vice president at Capital, says that he went so far as to get tested using Theranos himself and compare the results to a recent blood test. Neither he nor his doctor noticed any significant differences. Abraham says he can’t detail what formal tests he put Theranos through because of patient privacy law.

Right now, Capital Blue Cross is using Theranos in addition to other testing providers, not instead of them. But Hilaire still says he expects the deal to save money, both because the tests will be cheaper and because more patients will get them. Something like half of blood tests that doctors prescribe never happen, which can make patients less healthy and more expensive in the long run.

Theranos has promised to build one of its labs near Capital Blue Cross’s new drug store, where a Theranos testing center is currently up and running. Until then, samples are being flown across the country to California for testing. Hilaire says that results are still coming back in 24 to 48 hours – faster than he might expect for nearby laboratories Capital Blue Cross uses.

Mexican effort

Ricardo Mujica Rosales, the executive director of the Carlos Slim Foundation, was also drawn by the promise of lower costs. The Slim Foundation is working with front-line clinics across Mexico to try to provide blood tests for cholesterol, kidney proteins, and other lab results to 1 million people as part of an effort to battle health problems caused by obesity. Some of those tests will now happen on Theranos equipment.

“We’ll be able to do this in a much more efficient way,” Rosales says. “It’s easier to do, we do it at a lower cost, and we give the results in a faster way than we’re currently doing.” However, the Slim Foundation hasn’t done much to put Theranos’ technology through its paces. “We trust what they’re doing,” Rosales says.

Building lots of Theranos testing centers in Mexico would seem a huge effort for a company that is trying to gain footholds in several U.S. states. But Holmes says that the project will require a far more limited array of tests for these patients, and will therefore be cheaper and easier to manage.

Medicaid patients

Usually, patients using Medicaid, the U.S. government’s system for getting health insurance to the poor, are the last ones to get a new technology. Not so with Theranos: the company is announcing this morning a partnership with AmeriHealth Caritas, a for-profit company that administers Medicaid health plans. AmeriHealth is owned by two non-profit Blue Cross/Blue Shield Plans and covers some 7 million people.

Paul Tufano, AmeriHealth’s CEO, says he reached out to Holmes after reading about her in the press. He saw not so much an opportunity to cut laboratory costs as a way to involve Medicaid patients, who he says often come into the healthcare system only through the emergency room, with a new, and unthreatening, way to get their laboratory results.

“It’s the prick of a needle instead of a full blood draw,” says Tufano. “It’s also walking into a retail establishment they may already be used to. It’s a simple way to change the whole way the Medicaid population relates to the healthcare system.”

He also says that he’s confident that all the noise about Theranos tests is just that – that the tests are quite accurate.

“Our folks have had a significant amount of interaction with Theranos,” Tufano says, “and we wouldn’t make something available for our members if we didn’t feel comfortable in the technology underlying it.”

There’s not yet a timeline for the AmeriHealth rollout.

Does any of this mean for sure that Theranos is going to revolutionize the way we get blood tests? No. Revolutions are hard. And it would be nice to have more information on what is going on inside Theranos’ black box. But what we can see is promising. And how many other hot startups are actually promising to cut healthcare costs? I want to know more, but what I heard yesterday made me more confident that Holmes is running a real company that we all need to continue to watch.

[Bundi]

Re: Breakthrough Of Instant Diagnosis

A bit more on the regulatory front...

Theranos Receives CLIA Waiver, Paving the Way for GreaterAccessibility of Health Information at the Time and Place it Matters
First-Ever CLIA-Waived HSV Test and Test System

PALO ALTO, CA (July 16, 2015) – Theranos, Inc. todayannounced that its test and Theranos test system for the herpes simplex 1 virusIgG (HSV-1), which was cleared by the U.S. Food and Drug Administration (FDA)on July 2, 2015, has now received a Clinical Laboratory Improvement Amendments(CLIA) Waiver from FDA, permitting its use in locations outside of traditionalclinical laboratories. This decision is a significant step forward in furtherdecentralizing Theranos’ lab testing services and allowing them to be providedat the time and places it matters most. The CLIA Waiver is also one more stepin Theranos’ commitment to reinvent laboratory services for individuals andtheir physicians.

FDA has concluded that the Theranos test and technology iseligible for waiver under CLIA. The waiver means FDA determined the Theranostest and technology is reliable and accurate and can be used in a broader setof locations outside of a traditional CLIA certified laboratory, includingTheranos Wellness Centers. This is the first HSV test and test system toreceive a CLIA waiver.

FDA’s determination came after review, by multiple FDAdivisions, of extensive data demonstrating that the test and underlyingTheranos System perform at least as well in the field with non-laboratorypersonnel as by trained operators in a traditional laboratory setting.Specifically, the Theranos System has built in fault-tolerance to deal withconditions that otherwise would impact results and performance and mitigateerrors associated with otherwise unpredictable environments. Theranos provideddata demonstrating that certain conditions would not affect the integrity ofresults reported for its HSV-1 test, including temperature fluctuations, humidity,tilting, power fluctuations, contamination, and storage and shippingconditions, among other variables in samples and conditions.

The waiver categorization therefore allows Theranos tooperate its technology both within its CLIA certified laboratories and alsowithin locations outside of its certified laboratories, including TheranosWellness Centers, currently located in 42 locations in Arizona, one in PaloAlto, California and one in Harrisburg, Pennsylvania. “Receiving this CLIAWaiver is an important milestone in fulfilling Theranos’ mission to provideactionable information at the time it matters,” said Elizabeth Holmes, founderand CEO of Theranos. “Having the ability to make our test and system morebroadly available in a variety of settings is critical to our aspirations tocontribute to public health, as we continually innovate to provide the bestlaboratory testing services in the world. The ability for individuals and theirhealth care providers to receive test results in near real-time will play apivotal role in bettering diagnostic and treatment decisions.”

The FDA announcement regarding Theranos’ CLIA Waiver comesshortly after the agency announced its first review and clearance of Theranos’test and test system for the herpes simplex 1 virus IgG (HSV-1). Theranosprovided comprehensive data to the Agency on its test systems and methods, itschemistry, its hardware, and its software in the company’s foundational systemand LDT application. Specifically, Theranos provided study data from 818subjects of varying age and ethnicity, demonstrating that its system could berun accurately using only a finger stick as well as a traditional venous drawacross large numbers of Theranos devices, all compared against an FDA cleared,commercially available reference method.

Theranos’ HSV-1 studies included matrix comparison studiesacross 69 Theranos devices. Use of such a large number of devices in thestudies is unusual, as such studies are often run on a single or small numberof devices. The larger number of devices allows for comprehensivecharacterization of variation across devices, which can be a source of variancein data across laboratories. Theranos’ HSV-1 clinical studies also includedsensitivity and specificity studies with hundreds of human samples – bothcapillary and venous, CDC panel testing – which demonstrated 100% agreementwith the results provided by CDC, low-prevalence population tests, and otherstudies.

Theranos also completed full submissions for its HSV-1 IgGtest on venous serum, venous plasma, capillary plasma and capillary wholeblood, to demonstrate equivalence on its system across the different sampletypes, in contrast to conventional tests which have only been cleared forvenous samples.

Additionally, Theranos demonstrated performance of its testacross multiple finger sticks (9) collected from each subject, validating notonly the robustness of the assay but also the reproducibility of its fingerstick blood collection method and Theranos Nanotainer Tubes for this method.

The FDA’s review process for 510(k) notifications is widelyrecognized as one of the most rigorous regulatory hurdles in the world forevaluation of the performance, accuracy, and intended use of diagnostic tests.Theranos believes that the rigor of the FDA’s clearance and waiver processeshelps to ensure that tests are properly designed and interpreted, consistentlymanufactured, and of the highest quality. For that reason, Theranos has beenworking with FDA over an extended period of time to develop a transparent modelfor FDA review of laboratory developed tests (LDTs), has led the industry bycommitting to submitting all of its tests for FDA review even though they arenot required to do so, and has expressed its public support for FDA’s proposalto strengthen the regulation and oversight of LDTs.

Theranos is leading transparency in lab testing, includingcommitting to FDA review of all of its LDTs and publishing its prices, labproficiency testing scores, customer satisfaction scores, guest visit times,and more, to realize a system in which individuals become more engaged andearly detection and prevention of disease become realities.

[shiny!]

Re: Breakthrough Of Instant Diagnosis

This is a dream come true! My veins are so terrible, "routine" blood tests have always been an agony for me. Plus, now I can frequently monitor some things that tend to fluctuate a lot. I'm no longer dependent on seeing a doctor to beg them for another test, then wait for my next visit to get the results.

Jul 3, 2015

Theranos Recognizes Milestone in New Era of Preventive Health

PHOENIX, AZ. (July 3, 2015) – Theranos, Inc. (Theranos) today applauded Arizona’s groundbreaking new Direct Access law, an important step toward a new era of preventive health care in our country.

Starting today, Arizonans are able to obtain and directly pay for any laboratory test from a participating licensed lab without first being required to obtain a health care provider’s order or work through insurance eligibility. Physicians are protected from liability associated with individually directed testing, better enabling them to work with their patients on preventive testing and care. Insurance providers and payers assume no additional costs as tests are all paid for out of pocket.

Theranos believes this law could serve as a model for our nation, and that expanded testing options will allow more people to take charge of their health — to work with their physicians preventively before chronic disease starts – not after – moving away from treating illness only after it has taken hold.

Theranos’ revolutionary lab services make tests more efficient, convenient, and affordable than ever before. Theranos lab tests are available in forty-two Theranos Wellness Centers in the Phoenix area, and Theranos is now expanding throughout the state. Anyone can walk into these Wellness Centers at convenient hours and get accurate, rapid lab testing with transparent prices that are always at least 50-80% below Medicare reimbursement rates.

“This law is an important milestone in building a health care system that empowers people to take control of their own health and work with their physicians to prevent disease and detect it early, when there is still time to change outcomes,” said Elizabeth Holmes, founder and CEO of Theranos.

The legislation that enabled this change makes Arizona the first state to institute this comprehensive framework for laboratory testing, expressly recognizing individual’s rights to their own health information. Theranos worked closely with leaders in Arizona to pass this completely bipartisan legislation. “My administration is focused on making Arizona the easiest and most attractive place in the nation for 21st-century companies like Theranos to operate and grow,” said Governor Doug Ducey. “By reducing burdensome regulations and red tape, this law not only shows innovative companies we’re open and ready for business, it also gives Arizonans access to more efficient, cost-effective services while promoting preventive health care and price transparency. That’s good for business, good for patients and providers, and good for taxpayers – an all-around win for Arizona.” Theranos also worked with Representative Heather Carter, Senator Nancy Barto, and many leaders in the physician community.

Elizabeth Holmes added: “Our mission at Theranos is focused on changing the health care paradigm to one in which early detection and prevention become reality. To do this, we must empower individuals to own their health, including increasing their access to important health information, establishing price transparency, and raising standards.” Theranos believes this law will drive price transparency and lower cost testing in response to consumer demand, and that this is the bedrock of a movement toward individual engagement and preventive health care. Individual engagement will drive prices down, and lower cost testing will remove a critical impediment in effective care today which is that many can’t afford the tests physicians order and are not compliant with them.

“Thousands of Arizonans are struggling to afford the high cost of traditional lab tests. Others are forced to go to an emergency room for lab testing since locations and hours for labs are so inconvenient. This law gives Arizonans the freedom to get these tests done in a transparent, cost-effective way to engage with their own health and begin working with their doctors preventatively,” said Ms. Holmes.

Doctors in Arizona have reinforced Theranos’ positive impact on healthcare in Arizona. Dr. Matthew Baral, who testified on behalf of the new direct access testing legislation in front of the Arizona State Senate said, “I have already experienced Theranos as a great new partner for physicians in Arizona. I recently had several patients who were reluctant to get lab tests I ordered because of financial constraints. This factor effects patient compliance across all medical disciplines that utilize lab testing as part of their diagnostic process and treatment management. In order to provide the best care, physicians need real-time data in order to engage and make informed diagnostic decisions, without having to worry about whether the patient will go in for the test. The transparency that Theranos offers by listing their prices increases the likelihood of patient compliance, and every dollar counts with health care costs and deductibles going up,” he continued, “Theranos offers testing at a fraction of the typical price, and holds the same certifications as conventional labs. Plus, the ease of collecting blood from a finger-stick makes it a no-brainer to utilize Theranos’ technology for my pediatric patients.”

Other doctors in the state reinforced Thernos’ commitment to innovation, accessibility, quality, and affordability, “Theranos brings a much needed innovative technology to the healthcare industry. An upfront, transparent pricing, with a fraction of the cost of traditional laboratory tests offers value to the patients, and payers alike, and significant cost savings to the industry as a whole. Patients appreciate finger stick over venipuncture, the ease of access with locations throughout the Valley, and flexibility of available times at their Wellness Centers,” said Dr. Jagdish Patel, a gastroenterologist in Sun City.

Lab test data drive more than 70% of health decisions. Yet, the majority of lab test orders don’t get filled in the U.S., likely due to the inconvenience and unpredictable costs of getting tests done. Theranos charges the same prices – clearly posted on its website and in its Wellness Centers – for everyone, regardless of insurance status. Theranos Wellness Centers are open nights and weekends, giving doctors and individuals the information they need at the time it matters.

About Theranos:

Theranos, Inc. is a consumer health technology company founded in 2003 by Elizabeth Holmes. Theranos’ mission is to make actionable health information accessible to people at the time it matters, enabling early detection and prevention of disease, and empowering people with information to live the lives they want to live. Theranos offers a comprehensive menu of lab tests in convenient locations in its Walgreens Wellness Centers in Arizona and California, with plans to expand throughout the country.
Visit us at theranos.com. Follow us at @theranos.

[Bundi]

Re: Breakthrough Of Instant Diagnosis

This is a dream come true! My veins are so terrible, "routine" blood tests have always been an agony for me. Plus, now I can frequently monitor some things that tend to fluctuate a lot. I'm no longer dependent on seeing a doctor to beg them for another test, then wait for my next visit to get the results.

[Polish_Silver]

Re: Breakthrough Of Instant Diagnosisp--it's real!

A bit more on the regulatory front...

Theranos Receives CLIA Waiver, Paving the Way for GreaterAccessibility of Health Information at the Time and Place it Matters
First-Ever CLIA-Waived HSV Test and Test System

PALO ALTO, CA (July 16, 2015) – Theranos, Inc. todayannounced that its test and Theranos test system for the herpes simplex 1 virusIgG (HSV-1), . . .

. . .

About a year ago there wan an interview on NPR/science friday with a guy from Columbia university. They have a very similar technology they are aiming at third world countries. It works off a smart phone dongle. For $2 they can test for 6 diseases in 15 minutes. It will do wonders for public health, and I think will contribute to a paradigm shift in sexual relations.

[shiny!]

Duplicate

[shiny!]

Big Problems at Theranos

The Wall Street Journal is reporting serious problems are about to be revealed at Theranos. They've halted all but one of their 1-drop blood tests and Walgreens has stopped expansion of their in-store blood draw centers. Was it all bio-tech vaporware?

Deficiencies Found at Theranos Lab
Federal inspectors will soon release details on problems at blood-testing facility

U.S. health inspectors have found serious deficiencies at Theranos Inc.’s laboratory in Northern California, according to people familiar with the matter.

The problems were found during an inspection by the Centers for Medicare and Medicaid Services, the chief federal regulator of clinical labs, at the blood-testing company’s facility in Newark, Calif. Failing to fix the problems could put the Theranos lab at risk of suspension from the Medicare program...

... The problems observed by regulators were far more severe than those cited by CMS following its last inspection of the same lab in December 2013, according to the people familiar with the matter. The previous inspection cited infractions that Theranos said it promptly resolved.

It isn’t clear exactly what regulators have faulted Theranos for in their latest inspection, which took several months. Adverse findings would be another regulatory setback for one of Silicon Valley’s highest-profile startups, valued at about $9 billion in 2014. More...

[ProdigyofZen]

Re: Big Problems at Theranos

It seems like it may have been.

Another Silicon Valley darling/unicorn (no pun intended) about to go under?

[Woodsman]

Re: Breakthrough Of Instant Diagnosis

The next Steve Jobs or Bill Gates wound up being an (alleged) fraudster and extortionist. Who knew Silicon Valley would give Wall Street and DC a run for the money in the @sshole race?

2016 has not been too kind to Elizabeth Holmes, the Steve-Jobs wannabe in charge of fraudulent Theranos. She has thus far been banned for 2 years from operating labs, removed from hosting fundraisers for Hillary and lost her entire net worth. And now, the Wall Street Journal has published the "tell-all" story of the whistle-blower, 26 year old Tyler Shultz, who brought the the whole Theranos farce crashing down. It's a sordid tale complete with all the expected twists and turns of a Jason Bourne thriller including intimidation, coercion and private detectives.

Tyler Shultz is the grandson of George Shultz, 95, who was President Richard Nixon’s Treasury and labor secretary and secretary of state for President Ronald Reagan, with whom he had a close relationship. The elder Shultz also happened to be a Theranos board member in 2013 when his grandson accepted a full time position there.

Fresh out of Stanford with a degree in biology, it didn't take long for Shultz to discover deficiencies in the accuracy of Theranos' testing equipment. After Shultz's complaints to Theranos executives, including Elizabeth Holmes, fell on deaf ears, he decided to blow the whistle to a state regulator instead. Using an alias, Tyler Shultz contacted New York state’s public-health lab and alleged Theranos had manipulated a process known as proficiency testing, relied on by federal and state regulators to monitor the accuracy of lab tests.

Theranos Whistleblower Tells All On Intimidation And Coercion Tactics Employed To Silence Him