If the consumer-doctor connection is the window to early prevention, diagnostic testing is the early biological warning system for some easily treatable illnesses. But discovering fixable problems often happens after the doctor’s visit.  That’s “closing the barn door after the horse has escaped.”

The process assumes that everyone is committed – or worried enough – about their health to follow through quickly and follow their physician’s request to obtain needed diagnostic information.  It doesn’t always happen that way!  Almost 70% of medical decisions use lab test results. The problem is that 40% of physician diagnostic prescriptions are never filled.

Could a change in how consumers access diagnostic data impact the tragic trend that more than 70% of US deaths (41 million annually) are related to often treatable non-communicable diseases? In this Medika Life exclusive, we talk with health-tech innovator Pouria Sanae of ixlayer about why he is working to shake up the current “sick care” system by empowering consumers and the health system through affordable, reliable, reliable and accessible home-based testing.

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Gil Bashe: Tell me about the genesis of ixlayer and your vision to make it easier for physicians and patients to work together around the convenience of diagnostic testing. What problem did you set out to solve?

Pouria Sanae: Two stories explain how ixlayer got started. Several years before I launched ixlayer, my mother was selected to participate in a clinical trial. The clinical site’s onboarding process included diagnostics that revealed abnormal blood levels.  The follow-up testing found a malignant tumor in her neck. She was operated on a month later and is alive and healthy today. This was a time-sensitive discovery; had she missed the tumor – until even six months later – it would have been too late. After that experience, I knew I needed to do something in the health sector that could help other people and families. Survival cannot be left to serendipity. 

Our co-founder, Dr. Poorya Sabounchi, lost his father to a medical condition that could have been prevented if detected earlier. His professional passion became genomics and genetic testing, and he first joined Illumina to pursue that mission. When we met, we immediately connected on this idea that so many people are ‘hosts’ to a disease without knowing it – many people need screening but don’t get it.  How many lives are lost because the information isn’t available? That is core to why we advocate for consumer engagement in diagnostic medicine.  Ixlayer is more than a company. It is a catalyst for long-awaited change that will benefit providers, payers, and, most importantly, patients and their families.

Bashe: Unfortunately, you’re right – the stories you shared happen too often. Your and Dr. Sabounchi’s experiences – harnessing diagnostic information within us as a preventive strategy – should be the standard of care. How did you transform life-changing family experiences into ixlayer? What were the operational steps?

Sanae:  I made the change very quickly – I left my job in the tech sector and moved to the health sector. First, I joined Helix, a promising sequencing lab providing the same concept for genomics.  There, I realized that the hurdle to better, frequent diagnostic testing is the difficulty in operationalizing or shifting the process itself. This is a very fragmented market.

I was involved in launching the lab testing platform for Geisinger, Mt. Sinai, Invitae, and National Geographic. On top of Helix – they were all spending millions of dollars and 18 months on development. They were inventing the same wheel over and over! We saw what was missing: infrastructure and patient experience layer on top of the lab work.  The observation and need were the basis for ‘ixlayer.’  I for infrastructure and X for the experience.  Suppose we could equip the industry with this missing piece. In that case, we could increase lab testing volume and offer preventative options, affordability, patient experience, and in-home convenience.

Bashe: When we look across the lab testing sector, even as some assays or technologies evolved, the patient experience for diagnostic testing has remained unchanged. Would you say that’s true? 

Sanae:  Yes. There are three issues when it comes to the consumer experience of diagnostic testing. One is convenience, the second is affordability, and the third is the ease of use.

For example, if I want to go and get my thyroid checked, I first need to go to a doctor and discuss the need for the test. I need to get a requisition or “req” form. Then go to drive to a lab like LabCorp or Quest. Then, return to the doctor to discuss the results. Once the test is ordered, this clinical journey requires at least two physician visits and a lab visit. Let’s also add in the scheduling and drive time. 

Another issue is affordability. Based on my current insurance, I pay $60 for this, out of pocket – two $20 copays for the doctor visits and another $20 for the lab. It adds up.

On top of it all, consider time constraints. I don’t have the time to see a doctor. Most people don’t have the time. This system assumes you have complete power over your schedule – put the employer aside. Get someone else to handle childcare. 

So those are the three things that need to change within the system. It’s not the doctors’ or labs’ fault.  No one is to blame. The system is the system, and it is failing us.

Bashe: You mentioned a thyroid test as an example. How does a consumer access a consumer-oriented diagnostic test like this?  

Sanae: The beauty of partnering with a national retail pharmacy is that we provide something the end consumer can pick up off the shelf. CVS calls this “symptom to treatment in a box.” Once you pick up a test, scan a QR code and begin a digital experience. A telehealth physician oversees the process on the back end. You get instructions on how to collect your sample. You ship it back to the lab, which processes the test, and you get a result. If your results are abnormal, a physician calls you and explains the result and next steps. And in this case, CVS owns the process; if your results are abnormal, you’re sent back to Cvs Minute Clinic for continuity of care.

Bashe: Tell me a little bit more about the tests themselves. What types of samples are used in your tests?

Sanae: We cover everything when it comes to at-home testing. Depending on the type of test, our services support all samples for at-home tests, including saliva, blood – whether finger-prick and dried blood spot or tube – and we also do stool and urine. The first one we started with for the four Cvs tests is blood.

Bashe: There seems to be a major movement to make pharmacies more accessible in personal health management. I’m curious to get your take – with the rise of at-home testing and telehealth during the COVID-19 pandemic, do you see a behavioral shift in consumers wanting more accessible care?

Sanae: Yes. We entered the market before the pandemic, back in 2018. Initially, the feedback from the industry was that the end user – the consumer – wasn’t ready. The Covid era has changed the concept of in-home care, and people realize how easy it is to engage with their health on their terms. CVS, Walgreens, Walmart, and Amazon are entering the market and have financial models where they feel they can add value. On top of that, consumers – especially Gen Z, Millennials, and Gen X – seek improved home care.

Bashe: It sounds like you’re talking about sparking a movement of health-conscious consumers – those who say maybe I should check my thyroid function or my cholesterol proactively. Is that your hope?

Sanae: A future of at-home health testing is key to preventive care. It provides a snapshot of personal health information over time. The doctor already knows that 133 million Americans have chronic conditions that often require ongoing lab testing. But 60 million Americans have a chronic condition and don’t know it. What if we could help more of those people get diagnosed sooner – maybe even before their condition becomes a serious problem? Suppose we manage to test that individual more often. In that case, we can identify high-risk patients and hopefully, get them the treatment and support they need before their condition becomes a problem.

Through the CVS partnership and others, we can help more pharmacy and health system partners realize the significant value of empowering consumer health.

Bashe: Could you share with me a little bit about ixlayer technology itself? How does your technology differ from other systems?

Sanae: Oneof the challenges for the diagnostic space and in-home testing is that it is a very fragmented market, with different regulations for each state. We developed a technology layer, a cloud layer, that integrates into forty different services, and we keep adding services daily. This includes 27 different labs, a physician network in all 50 states, fulfillment services, picking and packaging, in-home mobile phlebotomy, insurance, Emr, and so forth. On top of that, we combined this into a very easy-to-use patient experience layer, transforming a complex, segmented ecosystem into a patient-friendly flow.

We can launch our customers within six to eight weeks. It might take years if a retail company or provider network wanted to do this themselves. We are making it possible to operationalize the shift from sick care to self-care and support the medical practice of preventive care.

Bashe: When you look at the future, share with me what you think might happen realistically a year from now.

Sanae: Consumer adoption of these tests will increase. The goal is to have lab testing be like a toothbrush. If toothbrushes were invented for the first time today, your dentist would tell you that you don’t need that thing. Come in when you have a cavity. That is what health care is today.  We wait for people to have pain instead of giving them preventive tools to monitor and maintain their health. Our vision is that lab testing can and should be like that toothbrush – the preventive care in-between visits. You should test yourself every quarter, should monitor yourself, and then, when you come in for your checkup, you can show the results and discuss them with your doctor. That’s preventive engagement.

Bashe: What are your thoughts about how physicians understand this change as a fulfillment of their vision to be healers and address the needs of people who need healing? Will the fragmented health ecosystem realize that a smarter, educated, engaged consumer is the Holy Grail of wellness?

Sanae: I’m glad you brought that up because many disagree with this industry topic. Many primary care physicians are against patient-initiated testing, where an individual patient goes to a lab on their own.  They are concerned that the patient won’t get the correct information or support without guidance from a physician. In reality, there is demand for that kind of access, and we all need to find the balance between what we do and what physicians do.

This type of service benefits providers, too. If we can work together to prevent healthy people from coming into the hospital, it may reduce physician fatigue.  That means doctors will have more time and energy for patients with pressing needs. If physicians adopt in-home testing, which they are, it reduces the cost of a hospital bed and the cost of care. ixlayer adds value to preventive care, disease management, and the chronic condition diagnosis journey.

Bashe: You have a diagnostic business model, but it feels like you also have a public health model. When people are actively engaged in conditions that could be well-managed and engaged at the earliest stages, we can improve people’s survival outcomes.

Sanae: We are an ally to public health. The public health system needs to know that this is available to make lab testing more straightforward and accessible. For example, the Netherlands provided an in-home lab test for colon cancer for every household because they realized the significant benefit of pre-screening and early detection. This is a catalyst to have consumers recognize that they have the most at stake – healthy longevity.

We are a platform that powers consumer and public health. The provider network, retailer, payer, or government agency can tap into the ixlayer platform to set up their offering. They can utilize their health system lab because we’re lab agnostic. They own the data. They own the patient relationships. ixlayer is just the pathway.

Attempting to manage a person’s health without regular diagnostic data is like putting your ear on the car’s hood to understand if the engine is functioning correctly. Suppose we get more people to check more often. In that case, our system supports the medical community that seeks longer, healthier lives for everybody.

With chronic non-communicable illnesses on the rise, detecting health issues early enables health professionals to guide the course of treatment – to adjust diet, offer medication options and engage other medical specialties.  Creating this “pre-patient” model of care empowers consumers to be better informed and engage in their health. Suppose we encourage frequent lab testing by reducing cost, access and convenience barriers. Can we also reduce obstacles to lowering system costs and shift emphasis from sick care to preventive care?  Pouria Sanae and his ixlayer team are long-awaited catalysts for these changes.

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AUSTIN, TEXAS AND FRANKLIN LAKES, N.J. (May 11, 2022) – Babson Diagnostics, a science-first, health care technology company, and BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the expansion of a strategic partnership to move blood sample collection into new care settings, including enabling patients to collect blood samples at home for diagnostic testing.

Since 2019, the two companies have collaborated to create a capillary blood collection and testing system, now in advanced development, to enable laboratory-quality, small-volume capillary blood collection at retail settings by team members with no previous experience in blood collection. Plans under the expanded agreement include continuing research and development to enable self-collection, mobile services and at-home collection. Babson and BD also will expand the types of blood tests that are possible through small-volume blood collection beyond primary care-oriented tests, and they also plan to develop diagnostic tests for pediatric use.

“Today’s agreement expands our long-standing partnership with BD and builds on our shared passion of making convenient blood testing accessible to all, not only in the U.S., but also globally,” said David Stein, chief executive officer of Babson Diagnostics. “Extending the medical home is critical in today’s health care environment. We believe that retail convenience is perfect for today’s consumer, but because the Babson service is well-suited to many settings with no need for a phlebotomist and an easier collection experience, we see many opportunities for future expansion.”

Over this long-term collaboration, Babson and BD are advancing development of the blood testing ecosystem, which includes BD’s next generation capillary collection technology and Babson’s proprietary automated sample-handling and analytical technologies. These have been designed to work together to enable blood testing that requires only one-tenth the sample volume of traditional venipuncture methods without sacrificing quality, accuracy, or the number and types of tests that are possible.

“This is a paradigm-shifting solution that addresses multiple unmet needs within the current health care system,” said Brooke Story, president of Integrated Diagnostics Solutions for BD. “Because it is less invasive and more convenient than the traditional venous blood draw method, capillary blood collection may lead to an improved patient experience, which in turn could help health care providers see better compliance among patients for routine blood testing.”

BD brings 70 years of specimen management experience to the partnership and is a leader in blood collection technology, including the development of the new, state-of-the-art capillary collection device[i]. Babson provides deep instrument analyzer expertise and is building an ecosystem for blood collection in the pharmacy setting as well as designing the systems and workflows to analyze small volume capillary blood in a central lab. Babson continues to work with local and national pharmacy chains to conduct extensive clinical studies of its service platform in preparation for commercial launch.

[i] The capillary collection device is an investigational device under 21 C.F.R. 812 and requires additional studies to make any definitive conclusions about safety or efficacy

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Dr. David Stein, CEO of Babson Diagnostics, is a recognized leader in the diagnostics innovation category. Dr. Stein has been a pioneer working with medical technology giants such as Siemens Healthineers, Roche Diagnostics, Becton Dickinson, other leading global companies on the field of consumer care diagnostics. What does one of the sector leaders believe is the line between imagination and reality — between sales and science?

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Gil Bashe: We are all following the Elizabeth Holmes trial closely. It captivates us. While there is a lot of debate focused on the person in the spotlight, we all agree that Theranos had a great idea. I think the real question is, “can a drop of blood give us THAT much information?” Dr. Stein, you’ve been at the forefront of looking at this. Is it possible?

Dr. David Stein: When I first started in this field 20 years ago, people asked if we could do broad panels from small volumes of blood. That was always a goal that everybody was trying to attain. We looked at a very narrow menu based on capillary samples or those that were easy to collect. Then in 2015, we started asking if technology had evolved enough that you could do broad panels from small volumes of blood.

I’m not saying one drop; I’m saying a few drops. We saw that it was possible, but you couldn’t do it via point-of-care locations. You had to totally reimagine the end-to-end process, from collection to the way we automate, making it easier for the person collecting a sample to do the pre-analytics, to the way you maximize the clinical utility of the blood you collect. Then, you need to consider how to approach the analytics, so you get economies of scale and breadth of menu.

In short, the answer is “yes.” From a small volume, it’s possible; however, only through taking a very rigorous, science-first approach and reimagining the end-to-end process can it be achieved.

Did Theranos Cast a Shadow on the Entire Sector?

Bashe: Dr. Stein, you seem so clear that it’s possible, it’s doable. I know, looking at the science that you’re championing, you are demonstrating successful results in large numbers of people. So why did Theranos fail? Where did they go wrong? Can you explain that for us?

Stein: I will not claim to be an expert on what Theranos was doing nor how they approached it. What I do know is how we are approaching that same challenge. We’ve had the great opportunity to partner with Becton Dickinson and Siemens on this journey and really break down this problem from collecting a very reliable, small sample of blood from somebody’s finger to automating all the analytics around it.

When we looked back at when Theranos was doing this, I think it is likely they tried to pull together discrete technologies to make this happen and you can’t do that. Everything has to fit together seamlesslessly. If you look at methods for hematology, comprehensive metabolic panels, immunoassays, lipids, there’s a gold standard, and that’s what we’re adhering to. We’ve looked at how you maximize the clinical utility of the blood you collect and how, on the analytic side, you can use less blood volume to do these broad panels. There are no dilutions or cheats or anything like that in what we are doing. We’re truly using global, gold-standard methods.

Why Consumer Blood Test Matter and How Convenience Saves Lives

Bashe: We’re all occasionally guilty of not following through. A doctor writes a prescription, tells us to go to a phlebotomist or a diagnostic center. Then one year later, we still haven’t done it. What’s the danger of that? Can you talk to us a little bit about the imperative, the importance of timely blood testing?

Stein: We’re doing what we’re doing largely for this reason — to hopefully, help people have a longer lifespan. For me, this is a deeply personal mission. More than 70% of all clinical decisions are informed or powered by diagnostic lab testing. But as you’ve mentioned, a lot of people don’t get it done. What we’ve seen in this new economy is that people want choice. They want convenience. They want to be empowered in their health journey. We believe people should have convenience and accessibility when it comes to their diagnostic blood testing without having to sacrifice quality, menu breadth, cost or any of these aspects.

With the rise of telemedicine, you can sit with your doctor, with your blood tests in front of you and say, how do they look? How could I improve results? Just by looking at somebody, you can’t tell how healthy they are, but a blood test gives you an incredible amount of information about their metabolic state and other risk factors. I can tell you that somebody who’s pre diabetic can take actions a lot more effectively than if they have diabetes already. It’s the same for other diseases. That’s the goal of everything we’re doing: make the information accessible and timely so that your clinician can take action and you can treat conditions before they become chronic disease.

Everybody wants a long life, but the most important thing is that you enjoy a healthy life. That’s my mission: make diagnostic blood testing more accessible and convenient so people can be empowered to take hold of their health care journeys.

Bashe: When we look at take-home COVID-19 antigen assay tests, we’re seeing how easy it is for consumers to engage. Correct me if I’m wrong, but it’s really high-tech made very simple. To your point, I think consumers want to be involved in conveniences that this Amazon-like economy makes possible. The possibility of me easily taking that blood test where I pick up shampoo or prescriptions is very appealing. Share some thoughts about the process that that you imagine for putting into practice convenient diagnostics at the consumers’ point of purchase — a process that Theranos clearly wanted to pursue.

Stein: Retail in general is a great place to get diagnostic blood testing done. Pharmacies are trusted places; when you walk or drive by one, why couldn’t you get your diagnostic blood test done? COVID testing showed that retail is a preferred, convenient way of getting health testing handled. Most COVID testing was done by going to the pharmacy quickly and getting results that day or the next.

That is our approach: a consumer-focused, health-system-compatible path. Go to your pharmacy. No HIPAA or payment going back and forth. It’s transactional, accomplished within five to seven minutes by a pharmacy tech or customer care representative. A phlebotomist doesn’t need to be onsite. The process would be completed using a device we are developing in concert with Becton Dickinson. The pharmacy customer’s sample would go directly into a small device that automates all pre-analytic processes and does everything according to the medical chain of custody. Then once a day, or multiple times a day if volume requires, couriers pick up samples and brings them to a highly automated microsample lab. Patients and providers get results that day or the next. We plan to offer a broad menu of tests, so this service covers what you need for your routine testing.

Bashe: I want to go back to the Theranos situation. The book has come out. The trial is happening. Countless newspaper articles are being written. in the wake of all this reporting and speculation, a core concern is the possibility that the technology has been disadvantaged because people are looking at it through the lens of the Theranos failure. When there’s so much public health need for this idea to be realized, what are you and others doing to overcome communal skepticism?

Stein: The need for accessibility and convenience is real. People want it. I think the no-brainer is that our work is driven by science. We made a very conscious effort to always lead with science, always lead with transparent data. We have a scientific advisory board made up of luminaries in the industry to ensure that we always follow the science. I feel like my first 20 years in diagnostic science and patient care was to help me advance the category to this point. It’s not just me. The leaders of the category are also dedicated to addressing patients’ needs and bring advances to market. But we cannot do that by side-stepping the science.

First and Foremost Validated Science

Bashe: Despite the shadow Theranos cast on the sector, there are a core group of dedicated companies working on blood diagnostics, and that’s a huge public health benefit that investors are recognizing. Among those companies, you are clearly a front runner. You have the right partners, have the science behind you, published peer-to-peer data, you’re developing partnerships: it’s all very exciting. Let’s look at the future for a second. Can you give me a sense, without committing, when you think we could see this in the market? And what are your next steps?

Stein: I won’t give you a definitive timeline because we’re a regulated industry and science is something we take seriously; you can’t push it. The data have to support the concept. I can tell you that we have about a dozen people coming in through our retail partners directly to our facilities each day when we’re running clinical studies and we’re constantly running clinical research with retail partners. Having been in diagnostics for two decades with leaders such as Eric Olsen and industry pioneers as partners, we know we need to be in the field, testing people. That’s what we will continue doing between now and launch, which will be sooner than later. With retail partners, we are ensuring that when a patient walks into a retail space, they have an incredible customer experience, that the collection process is easy and intuitive for all sides, and that people truly get their results same day or next day.

Bashe: I’m glad to see that, in the wake of the Theranos controversary, you and your amazing partners are mobilizing the technology and essential science to address a pressing public health. You’re providing further proof that by engaging the consumer, we have the best chance to use technology to benefit people. I want to thank you and the Babson Diagnostics community for doing your part. Thank you for clarifying the differences between imagination and reality when it comes to consumer-centered testing, and reminding us success is dependent on good science, transparency, and staying true to the regulatory process.

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