Release date: 2015-07-23 Elizabeth Holmes, the world's youngest female billionaire, and her company, Theranos, based in Palo Alto, are aiming to replace it with a cheaper, faster, less painful solution. The traditional blood test method, this vision has inspired the public's imagination. Theranos aims to replace traditional blood tests with a simple finger-fitting approach, which is slowly expanding from its original locations in California and Arizona, while the company's technology is still shrouded in mystery and controversy. in. Compared to giants such as the Laboratory Corp of America and Quest Diagnostics, Theranos offers the same tests, but with less money and faster processing. In the past, blood tests required a small tube of blood to be drawn with a needle and a syringe, and the company said it needed a drop of blood from a pricked finger to detect it. The blood test will go to the pharmacy – the company has partnered with Walgreens and sent it to a nearby laboratory facility for analysis through patented technology. More and more groups are joining, including Wednesday morning, an insurance company called AmeriHealth Caritas focused on the US Medicaid market. How many of them are real materials, how much is in speculation? I am not going to make a point here. I still don't know how Theranos technology works. But after a day of discussions with the company's partners, I was more confident. This confidence comes from the following aspects: The Food and Drug Administration (FDA) has just announced that it has decided to approve one of the tests of Theranos. In my opinion, this does give some confirmation of its technology. . On Wednesday, I talked with Holmes about 50 minutes by phone and talked to her three partners for an hour. They are, Capital Blue Cross Pennsylvania, a local large insurance company; the Carlos Slim Foundation, which is working with Theranos in Mexico; and an insurance company that specializes in Medicaid underwriting. AmeriHealth Caritas has just entered into a partnership with Theranos on Wednesday. They have thoughtful considerations about what they are engaged in and the potential to change their inherent practices. I hope that this is true, because Holmes’s ethical challenge to the way the health care system works has become obvious and convincing. I would like to hear her views on the pricing practices of the medical laboratory industry: “The people in need find you, just because there is no suitable insurance to make the test price lower. As a result, you charge them thousands of dollars for the test. It is a bit wrong. We firmly believe that these tests should be very affordable, no Depending on the operator, the price is transparent and affordable for the average person." Anyone who has tested blood may agree with this statement. The following is what I learned during the conversation. FDA approval The suspicions surrounding Theranos continue. Investment bank ISI Evercore analyst Michael Cherny wrote in a recent briefing to investors: We have repeatedly heard from the insiders (people who have a lot more degrees than me) that the reason for this secrecy is that there is no special "patent" in this technology (this is Their words are not what we said). At the Executive War College meeting in May, a clinician pointed out that "The only thing that Theranos really changed was pricing transparency and excellent public relations activities." A recent review article published in the scientific journal Clinical Chemistry and Laboratory Medicine asserts that “most of the company’s claims are exaggerated.†The author of the article, from Mount Sinai Hospital in Toronto In Toronto, Eleftherios P. Diamandis believes that Theranos may be superior in cost or speed to the prior art, but without further reliable testing, "Theranos The quality and reliability of technology is still questionable." Outsiders criticized Theranos for not publishing enough data. In response, Holmes responded that her approach is more standard and strict than the published data: FDA approval for 120 different Theranos tests. This is not a standard practice in the industry. Many blood testing methods have not been approved by the FDA, because the testing methods developed by the laboratory itself and used by itself are not subject to many regulations. Holmes believes that the FDA-approved threshold is much higher than simply publishing a conclusion in a medical journal. The move by Theranos is commendable. Having said that, Theranos tends to exaggerate its meaning for a single test that was approved by the FDA earlier this month. The approval was a single detection technique for herpes simplex virus type 1 (which can cause cold sores and, in rare cases, genital herpes). Theranos tends to use it as a confirmation of the company's technology – a press release simply claims that the company's “laboratory testing technology is approved by the FDA†rather than emphasizing the only technology approved for detecting herpes virus. There are important differences: each test requires its own approval. But the FDA has just announced a decision letter to Theranos and a far more detailed memo. The 29-page memo revolves around the agency's thinking, which does not explain how Theranos's system works, but does have a sample comparison of existing technology and Theranos technology. Not only did the test results be basically the same, but Theranos's equipment really replaced the needle with a drop of blood, as it was advertised. Holmes agrees that the company's speed and cost savings come from logistics in addition to technology. Theranos has begun to provide tests that are not yet integrated into the company's system, that is, traditional blood draws, but the charge is still only 50% of the Medicaid reimbursement quota, sometimes it will be lost. If large laboratories have the same low-cost test drugs, how can their laboratory fees be so high? “It seems that no other vendor offering laboratory testing wants to charge a fee below the Medicaid reimbursement rate!†Holmes said. Test water test The medical insurance company Capital Blue Cross Pennsylvania entered into a partnership with Theranos on July 8. Among the three companies I interviewed on Wednesday, the executives of the company had the most thorough review of Theranos technology. Chief Executive Gary D. St. Hilaire said he and his team have been following Theranos for four years. Four years ago, they invested in a venture capital fund with other Blue Cross/Blue Shield insurers. “Our people have spent a lot of time at their company headquarters,†Hiller said. "We are confident in their team, and the show they've seen is not a natural one." He added that he had confidence in Itranos before he got FDA approval. Aji Abraham, senior vice president of Capital Blue Cross, said he even ran to use Theranos for a test and then compared it with the most recent blood test. Neither he nor his doctor found any significant differences. Abraham said that because of the patient's privacy laws, he could not disclose in detail his tests on Theranos. Right now, Capital Blue Cross is using Theranos as a complement to other detection providers, rather than replacing it with the former. But Hiller said he expects the agreement will save them money, on the one hand because the test will be cheaper, and on the other hand because more patients will choose a blood test. About half of the blood tests performed by doctors will be abandoned, which is detrimental to the health of patients and may bring greater costs in the long run. Theranos is committed to setting up a laboratory near the Capital Blue Cross's new pharmacy, where a Theranos testing center is in operation. Before the new lab is put into use, the sample will travel across the United States and be airlifted to California for testing. Even so, Hiller said, the test results can be released in only 24 to 48 hours - faster than he can do a test at the nearby Capital Blue Cross Hospital. Mexican side Ricardo Mujica Rosales, executive director of the Carlos Slim Foundation, is also attracted by the prospect of cost reduction. The Slim Foundation is working with first-line clinics across Mexico to try blood tests for cholesterol, proteinuria and other test results for 1 million people, with the aim of combating the health problems caused by obesity to some extent. Some of these tests will now be conducted on Theranos devices. "Our detection efficiency will be greatly improved," Rosales said. “It’s easier to operate and cheaper, and it’s faster than the current practice.†However, the Slim Foundation did not test too much about Theranos’ technology. "We trust them," Rosales said. Given that Theranos is still trying to gain a foothold in several states in the United States, building a large number of testing centers in Mexico seems a bit embarrassing for it. However, Holmes said that the type of testing involved in the project is limited and therefore cheaper and easier to manage. Medicaid patient Medicaid is a medical insurance system set up by the US government for poor patients. Usually, Medicaid patients are the last to enjoy new technologies. But Theranos is an exception: on Wednesday morning, the company announced a partnership with AmeriHealth Caritas. AmeriHealth is a for-profit company that manages Medicaid Health Insurance, owned by two non-profit Blue Cross/Blue Shield agencies, covering approximately 7 million people. Paul Tufano is the CEO of AmeriHealth. He said that he contacted her after reading Holmes's news. What he saw was not so much an opportunity to cut the cost of laboratory testing, but rather a way to draw the Medicaid patient. He said that these patients usually only enter the medical system through the emergency room. Andranos is a new way of getting test results without being scary. "Just use a needle instead of a tight blood pump," Tufano said. “And just walk into a retail store – a place they may already be familiar with. This is an easy way to change the overall relationship between the Medicaid population and the health care system.†He also said that he believes that all the rhetoric about Theranos detection is just a matter of words - the results of these tests are quite accurate. “Our people have had a lot of interaction with Theranos,†Tufano said. “If we are not satisfied with the basic technology, we will not provide this product to member institutions.†AmeriHealth does not have a timeline to promote Theranos. Does this mean that Theranos will definitely change the way we test blood? Not necessarily. The revolution is not easy. It would be better if you could learn more about the Theranos "black box". But as far as we are concerned, the future is bright. Among all the hot start-ups, how many are determined to cut medical expenses? I want to know more, but the news I have heard has made me more convinced that Holmes is running a real company - A company worthy of our continued attention. 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