Theranos, Inc.

JUPITER, Fla., Feb. 28, 2025 /PRNewswire/ -- In a stunning revelation that will reshape the conversation around Elizabeth Holmes and her work at Theranos, one of the largest Specialty Labs in the Nation has confirmed that Holmes' diagnostic technology was in fact Accurate—and that her suppressed Test Result findings regarding Avastin®, a cancer drug were very accurate during the 15 month Pfizer study in 2007. In 2007 and 2008, Holmes conducted a study for Pfizer investigating the angiogenesis process and the effect of Bevacizumab, an anti-VEGF antibody therapy used in cancer treatment under the brand name, Avastin® See page 0012 of Trial exhibit 0143. – bottom half of 0012 shows the Avastin® affect. The Pfizer contract with Theranos was executed on December 12th 2006 worth $900,000.00. The study took place in clinics and in patient homes with her machine wirelessly transmitting Results to Theranos servers and the Pfizer portal during the course. Her research demonstrated that while the drug initially appeared to suppress VEGF levels, that was only true using another companies reagent that is used by LabCorp and many labs across the nation called, R&D Systems VEGF ELISA. Avastin® is a monoclonal antibody that attaches to VEGF in the body to prevent the body from making blood vessels (angiogenesis) so the cancer will not spread. The problem is, ELISA testing using Antibodies, in fact the same antibody as Avastin, Anti-VEGF or better known as Bevacizumab. This causes a problem when testing for VEGF because you cannot detect it due to the same antibody being present. It doesn't know VEGF is present, it is being blocked by Anti-VEGF. She also discovered that Avastin causes what's called a VEGF complex, which means the body starts creating TONS of VEGF. VEGF levels spiked dramatically—showing an alarming surge from an average of 140 pg/mL to over 8,000 pg/mL. This post-treatment VEGF REBOUND effect signals a rapid increase in blood vessel formation, which could exacerbate cancer proliferation rather than control it. Her study was also confirmed independently in 2023 by JAMA open network. Despite Holmes' findings, Pfizer and Dr. Shane Weber who testified against Elizabeth Holmes in court, rejected the results on December 31st 2008. Holmes' research was originally conducted using the Theranos Edison (TSPU - Theranos System Processing Unit), which ran proprietary assays to measure both free and total VEGF levels. Unlike traditional laboratory methods—which only detect unbound VEGF—the Theranos approach provided a complete picture, revealing the dangers of VEGF suppression therapy when treatment is discontinued. Holmes' Study was originally conducted using the Edison or aka the TSPU - Theranos Systems Processing Unit, which ran proprietary assays developed in house at Theranos and commercially available test kits used by Lab Giants, LabCorp and Quest. In this case of VEGF, she used her proprietary test measure both free and total VEGF levels. Unlike traditional laboratory methods—which only detect unbound VEGF—the Theranos approach provided a complete picture, revealing the dangers of VEGF suppression therapy when treatment is discontinued because she could detect the TOTAL VEGF. Today, Access Medical Labs has demonstrated that: Holmes' technology was indeed Accurate. Conventional testing methods, such as those used by LabCorp may underreport the true impact of anti-VEGF drugs. When Bevacizumab exits the bloodstream, a VEGF rebound may occur and CANNOT be detected early enough due to VEGF being blocked which could drastically increase the spread of cancer. Our lab testing proves that Elizabeth Holmes did not lie. Her tests & machine worked. Ryan ElHosseiny Access Medical Labs 954-494-1664 SOURCE Access Medical Labs WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Just more than a decade after CMR Surgical ‘s founding, the surgical robotics developer won FDA de novo authorization for its multi-port, soft tissue Versius platform in October 2024 . When announcing the regulatory milestone, CMR Surgical said Versius (which had a CE mark since 2019) was already the world’s second-most-utilized surgical robotic system, with more than 26,000 procedures completed. CMR Surgical sought marketing authorization in the U.S. after conducting clinical trials in Poland and India. “It’s a great relief as you can imagine, and a lot of work — my goodness,” CMR co-founder Dr. Mark Slack said in a recent interview with Medical Design & Outsourcing. We asked Slack for advice that could help other device developers navigate the FDA de novo pathway, meet new cybersecurity standards and successfully launch their own products. The following has been lightly edited for clarity and length. MDO: What did you learn taking your Versius surgical robotics system through the de novo platform that you and your team wish you knew when you started on that journey? Slack: “Pick very carefully who you work with, and you have to pick very carefully somebody who’s got the right background to do it. And then you need to absolutely match it with in-house capability as well. You cannot just go out to consultants and leave out a real skill in your internal, because otherwise you just get caught. To me, the biggest problem with regulation at the moment is that they are trying to prevent things that occurred due to criminality rather than things that occurred just by chance. Theranos is a good example. They were lying, making it up. Regulation’s not going to catch that. We have the same with the doctors. If you have a bad doctor who maims and kills people, then they change the appraisal process and they change the paperwork, but that won’t catch them. We are at the very critical point where regulation expenses are becoming an issue, and it is an issue for us in medtech, because Medtronic — they make $30 billion a year , they’ve got 800 products. An average drug [maker might bring in] $20-$30 billion a year for the blockbusters. They can afford the regulatory process, and I think we can’t. So one, you’ve got to pick your person really, really well. Number two, you mustn’t self-complicate. I have a a line with my team: ‘We’re not here to set the standards. We’re here to meet them.’ … We have absolute chaos in Europe with the MDR. It is not fit for purpose. It is harming the industry more than you can imagine. At the moment, it is easier to work with FDA than with Europe and and a lot of companies in Europe will be making a decision to go to the FDA.” MDO: What are the advantages you would note of working with the FDA? Slack: “I can do a Q-Sub (Q-Submission), I can get to know the team. I can get meetings, I can ask questions, I get answers. The Q-Sub process is a very good one … but you’ve got to be very careful to make sure that you create Q-Subs correctly, because otherwise you waste a hell of a lot of time. Sometimes you also have to take some risk as well, and sometimes just do it and and depending on the size of it or what that particular issue is. The de novo process is so big, it was scary. MDO: What about cybersecurity standards and regulations? Slack: “The other area that I think probably we weren’t anticipating was cybersecurity, but we did do that very, very well, and have learned a lot, and are now very well prepared going into the future for that. And we did that largely in-house, using external test houses as well. You’ve got to get the people to come and try and hack you. But our software people largely did our cyber themselves, which was really good. We did very well. We got a very high score and it’s just such a delight to see.” MDO: Do you have tips for finding a cybersecurity partner? How would you vet somebody to hack into your systems? Slack: “We went through legitimate companies, and there are plenty springing up at the moment. I would be very scared of using a hacker. I wouldn’t know where they would be coming from, or where they’d be going and so on. … The software team went up pretty quickly. We got one or two involved. They came in with their teams. It was a very set process for cyber, but anything cyber is money. It’s how many hours can you afford.” MDO: Any other advice for navigating the regulatory process? Slack: “The other bit of advice I’ll give with the FDA is working out how much they will tolerate outside of the U.S., and that remains a problem. FDA want U.S. data, and it cost us quite a lot of effort trying to justify that our surgical population was similar to the U.S. one and that the patient population was similar to the U.S. And that’s a very difficult one, because what is the normal American in 2024? I think the white population is going to be in the minority relatively soon. You’ve got people of Indian origin, people of Far Eastern origin, you’ve got your traditional Black Americans, you’ve got your traditional white Caucasian. It’s not dissimilar to Europe. But we definitely got pushed quite hard on matching. They are not keen on OUS (outside of the U.S.) data still. So I think going into the U.S. you need — depending on the depth of your pocket — to think very carefully about doing U.S. studies.” MDO: If you had to do it over again, would you have paid to do trials in the U.S.? Slack: “Yeah, 100%. An even bigger question — it depends on your depth of pocket, you know — would it not be better to, from the outside, do an IDE? I think the U.S. finds that very comforting. I suspect it’s congressional pressure to make people do de novos and so on. But you know, if you can afford it and you come and you do an IDE, well you’ve got all the same questions. You’re getting the data. You’re getting it in the right place. You’re getting it with the right surgeons. I think that would solve, for many people, quite a lot of problems.” MDO: What are your thoughts on real-world data? Slack: “It’s frustrating, and I’m not sure what the way forward is. At the moment, people mustn’t be fooled. If you go into the FDA and you get to use the term real-world data, make absolutely certain that your real-world data matches the criteria stipulated in the FDA document from around 2018. It’s out of date, it’s not accurate, but if you don’t use that they will argue with you about your real-world data as well. The FDA is very concerned about clinical acceptance criteria. And when you go to real-world data rather than a curated trial, the chance that you will get to those conversion rates and so on are quite small. The fact that instead of dealing with 50 people, you have a data set of 12,000 doesn’t seem to impact them. I’m a great believer that the future is real world data, but you have to curate your real world data particularly well. You have to have auditable standards.” MDO: Any other advice you’d like to share with device developers? Slack: “When you start a company like this, be very careful not to over commercialize too quickly. Get yourself solid, get your basis done. And if I did it again, I’d probably sell 50 systems and then stop, and then work those 50 systems to massively improve, get it to as strong as you can, and then go back out commercially. I think that’s a sensible move. Unfortunately, you get pressure from investors and so on. And we’ve basically done that now. We’ve matured the system and it’s giving performance to doctors that are coming back saying, ‘This is as good as, if not better than.’ That’s what I’ve always wanted. Co-founder Luke Hares used to say to me, ‘Mark, you’re always whinging, you’re always moaning. You always want things better. So when are you going to be happy?’ I said, ‘It’s got nothing to do with me. It’s when the surgeons tell me they’re happy.'” We’ll have more from our interview with Slack in the coming weeks. Subscribe to our free email newsletter to make sure you don’t miss it.

The Food and Drug Administration is defending the record of Jeff Shuren, former director of the agencys medical device center, after The New York Times reported on how his role intersected with his wifes work as legal counsel for medtech companies.Shurens wife, Allison Shuren, is co-chair of the life sciences and healthcare regulatory practice at law firm Arnold & Porter, and represented medical device companies. Shuren led the FDAs Centers for Devices and Radiological health for 15 years and, in July, announced he would retire. Shuren will stay with the agency as it finds and transitions to a new leader.The CDRH authorizes new medical devices to enter the U.S. market and monitors product safety through postmarket surveillance and recalls.The FDA defended Shuren in an email to MedTech Dive amid the ethics controversy raised by the Times and a patient safety advocate.FDA has no indication that any FDA regulatory decisions were impacted by Dr. Shurens wifes employment nor that Dr. Shuren made any decisions in the interest of parties other than the public served by the FDA, agency spokesperson Shannon Hatch said in the statement.The Times article examined potential overlap between the work of Shuren and his wife in cases involving the discredited blood testing company Theranos, Allergens breast implant recall, which came after the devices were connected to a specific form of cancer, and a proposal to strengthen regulation of LASIK eye surgery.The FDA, which reviewed the information raised by the Times, found no evidence Shuren violated the criminal conflict of interest statute, according to Hatch.Still, it appears there were certain instances from about 10 years ago for which Dr. Shuren should have either recused himself or sought ethics authorization to participate to avoid any potential appearance of bias, said Hatch.As a result, Shuren has been advised to exercise greater caution in matters concerning recusal obligations and is being provided additional administrative support to ensure future compliance, Hatch wrote.A spokesperson for Arnold & Porter said the law firm has long had strict protocols in place to assure compliance with the FDAs requirements governing financial conflicts of interest and impartiality.We are confident that Allison Shuren has acted in compliance with all such requirements dictated by her husbands affiliation with the FDA, the spokesperson wrote in an email.Advamed, the medical device industrys largest lobbying group, did not return a request for comment from MedTech Dive.Shuren retiresThe Times article comes two months after Shuren announced his retirement as CDRH director in an email to staff. Michelle Tarver, the FDAs deputy director for transformation, was named acting director of the center.In a separate July email, FDA Commissioner Robert Califf told agency staff that Shuren would transfer to the commissioners office and assist in the leadership transition at CDRH while the FDA searches for a permanent successor. Shuren is expected to leave the agency later this year.The FDA is proud of Shurens commitment and integrity in serving the public over the course of his government career, said Hatch. Senior leadership is required to adhere to ethics requirements that include filing annual public financial disclosure reports. Guidance on recusal obligations and reminders of those obligations are provided during financial disclosure reviews, the spokesperson added.The agency stands by his science-based public health decisions and those made by others within the Center for Devices and Radiological Health, including those that were discussed in the recent New York Times article, Hatch said.Shurens ethics documents also were vetted by the FDAs Office of Ethics and Integrity and ethics attorneys in the Department of Health and Human Services Office of General Counsel over multiple administrations, added Hatch.Patient advocate groups and lawmakers have called for improvements to the FDAs medical device safety system to better protect people from faulty products. In recent years, the FDA has faced criticism amid several high-profile product safety events that have involved patient harm tied to breast implants, Bayers Essure birth control device, Medtronics heart pump, and Philips years-long recall of more than 15 million respiratory machines.The Government Accountability Office is reviewing the agencys device recall process after a request from Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn. The Times article said reports of device-related injuries rose to 900,000 in 2023 from about 190,000 in 2012, citing an analysis of FDA data by the company Device Events.Robert Steinbrook, director of consumer rights group Public Citizens health research arm, called on the HHS Office of Inspector General to launch an investigation into allegations in the Times article that Shuren did not fully recuse himself from working on matters involving clients of his wifes firm.There are long-standing concerns that the FDAs regulation of medical devices has been too friendly to industry under Shurens leadership and has not prioritized patient safety and the effectiveness of novel medical devices, Steinbrook said in a statement, calling the report very troubling.An HHS-OIG spokesperson declined to comment on the matter when contacted by MedTech Dive. '