Theranos

[BrianMDelaney]

Check out the prices here:

 

http://www.theranos.com/test-menu?ref=for_providers

 

Backstory:

 

http://www.wired.com/2014/02/elizabeth-holmes-theranos/?cid=18964974

 

If this pans out, it will revolutionize medicine -- and will certainly make our citizen science projects more doable!

 

If anyone is near Palo Alto, s/he could even give it a spin!

 

Brian

[Michael R]

I note that they have no IGF-1, IGFBP3, or reverse T3, and it's not clear that their testosterone test has an option for LC/MS for people with low T or just gives everyone the regular ELISA; for the moment, that makes them pretty much useless as a lab center for CR folk, even if they're around the corner and can really deliver on acccuracy.

 

Aside from being cheap (and, for people who have a hard time physically getting enough blood into vials due to CR), what is the basis for your enthusiasm?

[BrianMDelaney]

Anyone in the Bay Area or Arizona (only locations so far open) tried Theranos?

 

http://www.theranos.com/

 

This looks to be an amazingly useful service: really cheap, accurate (I gather) blood tests. It looks like you need a doc to order the tests, but even paying a doc out of pocket would be worth it, given their prices.

 

Brian

[Michael R]

As I said in response to your previous Theranos post,

 

I note that they have no IGF-1, IGFBP3, or reverse T3, and it's not clear that their testosterone test has an option for LC/MS for people with low T or just gives everyone the regular ELISA; for the moment, that makes them pretty much useless as a lab center for CR folk, even if they're around the corner and can really deliver on acccuracy.

 

Aside from being cheap (and, for people who have a hard time physically getting enough blood into vials due to CR), what is the basis for your enthusiasm?

 

I also now note that they have no NMR LDL cholesterol particle number assay, either. And, as you say, you seem to need a doc, and they have very few centers available.

 

Are they actually even cheap? They have so few tests that I would bother paying out-of-pocket for (vs. those any insurance plan would cover without a blink) or that aren't so basic and cheap as to make shopping around separately of relatively little value (CBC, chemistry panel, HbA1c) that I don't know how to make a meaningful comparison. Have you actually put together a panel you would want to pay for here and compared it to buying your tests from LabCorp via an LEF membership plus discount, or the Comprehensive Wellness Profile plus other goodies from DirectLabs.com (Dean's preferred choice)?

[BrianMDelaney]

Wow. Our forum software and my computer really do not get along. I thought I'd posted about this but a search came up with zip. And I wasn't notified of your (recent) response (even though my settings say that I should be so notified). In any event:

 

Yes, for me, the tests would be cheap, since I don't have insurance in the U.S. But DirectLabs.com might be nearly as good for my needs. Thanks for the tip! I'm in the U.S. for a few weeks now, so I'll put together a panel and do some comparison shopping.

 

Brian

[Michael R]

So, an update: they do now offer IGF-1, and it's extraordinarily cheap — but still no IGFBP-3, without which it's not very informative; nor do they have IGFBP-1, which is useful for other purposes. They also now have rT3, but not a few other tests I'd like to get.

 

Also, they're using radioimmunoassay for their testosterone test; this is not really reliable for people with very low T, including a lot of CR males as well as most women. What you really need for this is an LC/MS-MS assay, which is either the standard test or an optional specialty test available from the other major labs.

[BrianMDelaney]

Update. Interesting article about Theranos which raises a number of questions, one of which I hadn't heard of: the possible problems with the finger prick method of getting blood (one gets too much interstitial fluid instead of blood):

 

http://www.businessinsider.com/scientist-skeptical-thranos-blood-test-elizabeth-holmes-2015-6

 

- Brian

[Michael R]

I haven't looked at thte article you linked, but the problem of getting whole blood vs. interstitial fluid isn't new and is pretty predictable for Theranos' microsampling method: it's a well-known problem "they" are always warning diabetics about in taking fingerprick blood samples, and are why they warn you not to squeeze in an attempt to get enough blood out of a given prick.

[Michael R]

An exposé in the WSJ, behind a paywall but discussed in several second-party sources with varying additional reporting (Business Insider 1, Business Insider 2, WaPo, TechInsider) alleges that Theranos has struggled to get accurate results for most of its analates, and can currently only actually use their proprietary Edison tech for ~10% of its offered tests — meaning you'd still need to get a conventional blood draw for most rather than being able to order a fingerprick kit and do it from home. Additionally, it cites various researchers criticizing it for nondisclosure of data, so independent researchers can't assess their claims.

 

Theranos' retorts that the criticisms come from disgruntled former employees and that the reporters "even declined ... our offer to send proprietary Theranos devices to their offices so they could have a demonstration of tests conducted themselves, and compare the results to those of other testing providers." (Though a commenter in a YCombnator thread archly reacts: "I can't believe the reporter didn't take Theranos up on its free offer to collect his blood and analyze it for personal health information that might be useful to Theranos...er, I mean, to the reporter.")

 

The WSJ reporter says Theranos tried to kill their story.

[Michael R]

 

Theranos Scales Back to All But One of Its ‘Finger Stick’ Tests

Update, 9 p.m. Oct. 15: A new report from The Wall Street Journal claims that Theranos has stopped selling all but one of its finger stick tests under pressure from federal regulators, citing an unnamed source. The source also said that federal regulators had shown up unannounced at Theranos’ doorstep. Theranos’ CEO spoke on CNBC’s Mad Money to refute the Wall Street Journal’s claims.

 

Update, 3.38 p.m. Oct 16: Theranos issued the following statement this afternoon. The company said the FDA is putting its Nanotainer tube, which it uses to collect blood samples, through a rigorous review process. [The tube is being treated as a medical device for regulatory purposes, and thus it falls under FDA regulation, whatever happens with its testing method -MR]. The statement said the use of its Nanotainer has been cleared for one test for Herpes, and implied that the process would be straightforward:

Now we’re working with them on clearance of just the Nanotainer™ tubes across all tests. But it’s the same tube. We’ve already met their rigorous standards in our first submission on our systems, and we’ll continue to do so.

 

But attorney Bradley Merrill Thompson, who specializes in FDA law with the firm Becker Epstein & Green, said it won’t necessarily be easy for Theranos to get the use of the Nanotainer approved for all of its tests.

“The chemistry of each test is slightly different,” he explained. “And the type of blood impacts the test in different ways for different tests.”

 

[Michael R]

 

Theranos Ran Tests Despite Quality Problems Federal inspection report said a Theranos lab ran a blood test on 81 patients despite erratic results from quality-control checks

By

John Carreyrou and

Christopher Weaver

Updated March 8, 2016 6:53 a.m. ET

A federal inspection report said a Theranos Inc. laboratory ran an important blood test on 81 patients in a six-month period despite erratic results from quality-control checks meant to ensure the test’s accuracy, people familiar with the report said.

 

[Paywall]

 

 

WSJ: How Theranos Put Patients in ‘Immediate Jeopardy’

On Jan. 25, the Centers for Medicare & Medicaid released a letter it sent to the blood-test startup Theranos, informing the company an inspection of its Newark, California lab had found it to be deficient in five areas. CMS said  deficiencies in one of those areas — hematology — put patients in “immediate jeopardy,” which is defined by the agency as a situation likely to cause “serious injury or harm, or death” to patients.

 

Theranos ran a blood-clotting test on 81 patients “despite erratic results from quality-control checks,” The Wall Street Journal reports. ... But what CMS did not release are the actual problems it found in the lab ... Those were detailed on Form CMS-2567, called a Statement of Deficiencies. When we asked CMS for that, a spokesperson would only say the form would become “releasable” after Theranos’ plan of correction was approved.

 

Wall Street Journal ... sources said CMS found that Theranos “ran an important blood test on 81 patients in a six-month period despite erratic results from quality-control checks meant to ensure the test’s accuracy,” the Journal said.

 

The test, called the prothrombin time test, measures how long it takes blood to clot. Inaccurate results “can be especially serious for patients taking blood thinners such as warfarin” (better known as Coumadin), the paper said.

 

Any doctors who received results from tests conducted between April 23 and Sept. 15, 2015, when the quality control problems emerged, should have patients retested as soon as possible,” one academic in laboratory medicine told the Journal. “Those results are not worth anything,” said Timothy Hamill,  professor emeritus at the University of California, San Francisco.

[Michael R]

Report Shows Theranos Blood Tests Fail Even the Company’s Standards

 

By Andrea Kissack

April 1, 2016

 

... A newly released federal inspection report, by the Centers for Medicare and Medicaid Services (CMS), has found that the company’s testing devices often fail the firm’s own accuracy requirements.

 

The 121 page redacted report about Theranos’s Newark laboratory, revealed that the company’s much touted finger-prick blood tests failed quality control checks nearly 30 percent of the time.

 

Theranos may now be facing sanctions that could range from fines to a retraction of the company’s approval to test human samples.

 

John Carreyrou is an investigative reporter for The Wall Street Journal who has been covering Theranos and first reported the story today. ... “This is [government inspectors] going in and looking at data and records from Theranos itself and then reporting that the records show an incredibly high rate of failure during quality checks, incredibly wide variations,” explains Carreyrou.

 

In reviewing the report, Carreyrou described a hormone test that failed 87 percent of quality control tests during one month and a test to help detect prostate cancer failed more than 20 percent of the time.

 

The current report follows an independent study, released earlier in the week, also showing inconsistent lab results. ...

 

Carreyrou said that his understanding is that federal regulators plan to impose sanctions that could range from fines to a retraction of the company’s approval to test human samples.

 

When reached for comment about the government report, Theranos spokesperson, Brooke Buchanan, said, “Quality and patient safety is our top priority. Theranos submitted a Plan of Correction to CMS and related evidence that addressed how the company has actively ensured that our lab operates at the highest standard. We’ve made mistakes in the past in the Newark, CA lab, but when the company was made aware of the deficiencies we have dedicated every resource to remedy those failures.”

 

In KQED’s own interviews with Theranos and government regulators, we have not been able to clarify how many patients have been affected, or what they may have been told about the blood testing irregularities.

 

 

[Dean Pomerleau]

Pretty sad. It looks like the end is near for Theranos:

 

Regulators plan to revoke Theranos’ federal license and ban founder Elizabeth Holmes

 

Theranos might find itself homeless in the next little bit. A federal agency plans to force founder Elizabeth Holmes out of her blood analysis startup for two years and take away the California lab’s federal license.

 

First reported in the Wall Street Journal, the Centers for Medicare and Medicaid Services sent a letter dated March 18 proposing sanctions barring Holmes and company president Sunny Balwani from owning or running operations in labs for at least two years – including in  both California and Arizona – and taking away federal licensing for Theranos’ California facilities in Newark and Palo Alto after Theranos’ continued failure to correct major problems with accuracy and competence.

 

These actions would be a major financial blow to the startup valued at $9 billion. Theranos has the runway to keep working with approximately $700 million in the bank but the two labs make a good portion of the money for Theranos’ operations and a loss of the founder and president would strangle any hope of recovery.

 

The letter has not been released to the public, but you can view a copy given to the WSJ here.

 

CMS gave Theranos 10 days to comply from the time the letter was issued (several weeks ago).

 

Between June 1st and September 21st, Theranos failed to properly hire and train qualified people to run the machines, allowed unlicensed workers to review patient test results, failed to follow manufacturer’s instructions on equipment and did not have a proper, written protocol in place to calibrate the machines to maintain accuracy.

 

Theranos submitted a plan of correction in February but the March 18 letter from CMS indicates it was not satisfied with the actions Theranos has taken so far.

 

Last week Theranos told TechCrunch it had submitted a plan to CMS to correct the problems, including hiring a new lab director in its Newark facility.

 

Theranos now must convince federal regulators it has taken the necessary steps needed and to not impose the penalties associated (a fine of up to $10,000 per day) for non-compliance.

 

According to Theranos spokesperson Brooke Buchanan, CMS has not imposed sanctions at this time and has already responded to the March 18th letter within the ten-day timeframe required.

 

“This is normal practice, normal process,” Buchanan told TechCrunch. “But this is all hypothetical until if and when Theranos receives sanctions.”

 

--Dean

[Michael R]

All:

 

The Theranos fiasco aside: as regards one of the original reasons we started talking about the company, Life Extension has a great sale on blood tests ending today.

[Michael R]

From now thru' Monday (the 28th), WalkIn Lab has a 20%off Black Friday sale on all lab tests, using the code SAVEMORE20%. (Don't be distracted by the November sale specific to diabetes, or other discounts: they can't be combined with the Black Friday sale, so plugging in those codes will lose you the across-the-board 20% off). Requisitions are good for several months, so pick them up now if you want to get labs anytime this winter (including eg. your 25(OH)-vitamin D3).