Usually, detecting cancer is done through a combination of physical exams, imaging tests, blood tests, and biopsies. A biopsy, where a tissue sample is taken and examined under a microscope. This process is time-consuming and often relies on parts of the health system working together quickly, which does not always happen. Some cancers, like brain, pancreatic, and ovarian cancers, are difficult to detect, which can slow diagnosis even further.

By contrast, liquid biopsies can detect cancer more quickly. This type of testing looks at bodily fluids (typically blood) for evidence of cancer cells by finding biomarkers that are shed by cancer cells into the bloodstream. Liquid biopsy technology is advancing fast and with new technologies emerging, such as using light to detect these signals. This is a similar approach to that used when small swabs are passed over luggage and analysed at airport security.

By combining this spectral analysis with artificial intelligence (AI), it is possible to speed up cancer detection at a significantly lower cost. At the forefront of this revolution in cancer detection is Dr. Holly J. Butler. Dr Butler is the co-founder and CTO of Dxcover, the company behind the award-winning multiomic spectral analysis platform. Grounded in biophotonics and driven by an unwavering dedication to improving patient outcomes, Dr Butler is striving to bring about a new era of non-invasive diagnostics; one where a couple of drops of blood and a beam of light might one day save millions of lives.

Dr Butler, alongside an award-winning leadership and research team, has been developing methods to analyse blood samples using infrared spectroscopy. What they discovered was a way of ‘reading’ the biochemical fingerprint of disease in a standard blood test. This research became the foundation of an award-winning proprietary platform that leverages a unique combination of AI and spectral analysis to detect patterns in small blood amounts, allowing clinicians to find cancer earlier, more accurately, and far more affordably than many existing techniques.

The potential is enormous. Unlike conventional liquid biopsies, which rely on picking up fragments of tumour DNA, this platform is more wide-ranging in its approach. It uses a multiomic strategy – looking at proteins, lipids, metabolites, and more – through a process known multiomic spectral analysis. It translates to even tiny tumours, sized at just 0.2 cm, being capable of leaving a detectable trace. And it’s all done with just nine microlitres of blood.

Dr Butler’s drive to transform scientific ideas into reality started early. After her Ph.D., she took on a Scottish Enterprise-funded project to translate laboratory-based research into clinical diagnostics. Her entrepreneurial endeavours were making waves as early as 2017 – she was ‘Young Entrepreneur of the Year’ at the Scottish Women’s Awards and received the Women in Innovation award at the Global Game Changers Awards. She has continued to be a vocal advocate for women in STEM and an active mentor to early-career scientists and entrepreneurs via the Strathclyde Inspire network in the intervening period.

“I’ve always been drawn to problems where science can make a real, tangible difference in people’s lives,” she says. “To me, early detection for the most difficult to detect cancers is one of the biggest, most urgent problems we face – and one we hope to solve.”

Dr. Butler’s role in bringing this innovation along is as much practical as it is strategic. She is part of a team that spans lab operations, data, software, quality and regulatory affairs, pushing the science to clear the bars for real-world medical use. “You can’t just invent a technology,” she says. “You need to prove that it works, scale it with safety, meet stringent quality specifications, and prove how it fits into clinical pathways. That is the challenge.”

For Dr Butler, it is about the impact on lives. “Cancer still kills nearly 10 million people a year,” she says. “The difference between early or late detection can be life and death. We want to make early detection routine – not something that’s just for some individuals or comes too late.”

Now pursuing an Executive MBA, Dr. Butler is expanding her leadership credentials. “Science gave me the means to innovate,” she says. “But the MBA is teaching me to lead, to strategise, to build something that can last.”

That ecosystem, she hopes, will be one where innovation and inclusion go hand-in-hand. She’s particularly passionate about ensuring that diagnostic breakthroughs become accessible across communities. “We’re aiming for a future where your GP can run a test like this early—long before you’re even referred to a specialist,” she explains.

Dr. Butler’s work remains patient-centred and personal. “Every time we detect a cancer that would have been missed – that’s the goal,” she says. “And every time we improve the technology is a step closer to a world where fewer people have to hear the words, ‘if only we’d caught it sooner.'”

The post Shining a Light on Early Cancer Detection appeared first on Medika Life.

Early Detection Poses Challenge

Glaucoma may strike individuals of any age, but it is most prevalent in people over the age of 60. For Black Americans, the rate of prevalence ticks up much earlier, at about 40 years of age, and people with diabetes or a family history of the condition are also more susceptible. Because glaucoma is asymptomatic in initial stages, early diagnosis is challenging.

The disease occurs when the optic nerve and the retinal ganglion cells — which relay visual inputs to the central nervous system — are damaged; elevated pressure in the eye, or intraocular pressure, is the main culprit. When fluid accumulates in the eye, such as from overproduction or improper drainage, it increases intraocular pressure and also the risk of developing glaucoma. Symptoms appear slowly, with changes in peripheral vision occurring before forward-facing vision becomes compromised.

Comprehensive eye exams can catch glaucoma in earlier stages, as these screenings involve optic nerve examination, intraocular pressure measurement, visual field testing and risk factor assessment. Patients must be proactive about regular screenings because once vision is lost, it cannot be repaired or restored. Available therapies can stop glaucoma’s progression and generally focus on alleviating intraocular pressure, but early diagnosis remains key.

Building on Existing Diagnostic Tools

Advances in diagnostic tools can give clinicians more and better information for treating glaucoma. Optical coherence tomography (OCT), for instance, uses light-wave imaging to help assess the optic nerve’s structural integrity. More recently, OCT angiography (OCTA) has been adopted to consider the optic nerve’s support system, such as blood supply. Functional imaging may be the next wave, as it should enable clinicians to identify cells under oxidative stress and take corrective action before irreversible damage is done.

Understanding a patient’s visual field is critical to identifying ocular diseases, and virtual reality goggles are emerging as a user-friendly, portable device. Doheny Eye Institute, dedicated to vision science, is investigating VR to enhance existing field vision testing and foresees future assessments that could bypass patient response. With its predictive powers, AI should also have a diagnostic role; AI may identify factors that clinicians could overlook when determining the risk of disease, progression, and aggressiveness so that patients can be treated early and accordingly.

Treatment Options Keep Evolving

Patients have various treatment options for glaucoma and generally take one of three paths: medication, laser or surgery. In the past five years, two new medications have surfaced, each with a novel mechanism of action that is additive to clinicians’ arsenals. The rho kinase inhibitor works to lower intraocular pressure, while a nitric oxide medication has dual action, reducing pressure and improving blood flow and oxygen to the optic nerve head. Research organizations like Doheny Eye Institute are also investing in the drug delivery arena, seeking ways to reduce patient error in medication administration and improve outcomes.

Laser treatment is nothing new in treating glaucoma, but techniques and instruments are constantly being refined. Laser trabeculoplasty has gained more acceptance, and as a minimally invasive procedure, it provides relief by reducing intraocular pressure. A more recent introduction, micropulse transscleral laser therapy also relieves intraocular pressure but by delivering energy in short pulses, which appears to minimize collateral tissue damage.

Should patients be beyond medication or non-invasive procedures, incisional surgery remains an option to improve natural drainage of the eye or insert an implant to create an accessory drainage pathway. Advances in surgical procedures, implants and devices continue to be sought after in research circles.

The Future Lies in Neuroprotection

Glaucoma research is a dynamic field, and an emergent focus is neuroprotection, where treatment extends beyond decreasing intraocular pressure to intervention in the chemical pathways that lead to the death of retinal ganglion cells. This exciting area considers protective effects, such as a drug therapy that could prevent cells from dying. It also explores how cells could be resuscitated, or what interventions could return damaged cells to their full functionality. Ultimately, this field of study is working toward neuro regeneration, where neural pathways may be fully restored so that lost vision may be regained.

With continued advances in glaucoma-related research and development across the board — from diagnostics and devices to pharmaceuticals and drug delivery to laser and surgical procedures — the future for patients is looking brighter. Maintaining momentum will be key for researchers to achieve the ultimate goal and find a cure for existing and future glaucoma patients.

The post Envisioning a Future with Reversal of Glaucoma-Related Vision Loss appeared first on Medika Life.

Along that difficult road is support – a place of respite from the complex environment innovators face – the community of HITLAB, the Health Innovation Technology Lab.  HITLAB is a leading academic research institution focused on improving global healthcare through innovation and technology and housed within Columbia University in New York City and Chaired by Stan Kachnowski, Ph.D. MPA, HITLAB has become a haven for health, technology, and design champions to find common ground.

“The HITLAB Innovation Summit is a dynamic platform where healthcare leaders, entrepreneurs, and innovators come together to forge groundbreaking solutions,” reflects Dr. Kachnowski.  “It fosters collaboration, sparks creativity, and drives healthcare transformation through the power of technology and innovation.”

HITLAB academic roots at Columbia set a tone for research and training.  New York City has emerged as a hub for digital health innovation. It is home to more and more startups drawing on the resources of the nation’s financial capital, a close connection to academic medical centers and talent. The Big Apple – like Bean Town Boston – is a strategic epicenter to explore how emerging technologies such as augmented intelligence (AI) and virtual reality (VR) find a meeting point with telehealth and remote patient monitoring through rigorous research, analysis, and design thinking.

Centered Around Cutting-Edge Solutions

At its annual HITLAB Innovators Summit 2023, conversations center around cutting-edge solutions for the digital health community to overcome social determinants of health and unite disparate hospitals’ information systems. The gathering is a digital health sector roadmap to advance health access, address challenges, and improve patient outcomes.

Attendees of this intimate Summit that combines keynotes, panel conversations and scheduling networking are fans!

“The HITLAB Innovation Summit is a game-changer for the healthcare industry. The convergence of technology, innovation, and expertise creates an electric environment that fuels groundbreaking ideas and fosters meaningful collaborations,” says John Anderson, chief technology officer HealthTech Innovations.

While other like-forums have evolved into co-counseling sessions on how to survive EHRs and the heavy life to onboard the 500-pound EPIC gorilla, attendees at HITLAB also learn about “EPIC envy” – where small and community health centers that don’t have the resources to afford this state-of-the-art software find alternative paths tapping into technologies to piece together other ways to track patient care and outcomes.

Also, in hearing from major biopharmaceutical companies such as Merck, Novo Nordisk, and others, digital health innovators can reflect on the importance of ample science to shift the conversation from hype to hope and fact-based cautious optimism.  In turn, big pharma share openly on the main stage how science alone – absent of technology – can fall short in meeting patient information, adherence and care needs. 

As in previous years, the HITLAB Innovation Summit 2023 brings together experts across the health innovation ecosystem, including clinical trials, pharma, private equity, public health, engineering, design, and data science. The diverse community is seeking solutions that integrate health tech – digital therapeutics, health information, and smart devices meaningfully. The gathering’s success lies in bridging the gap between patients, payers, product innovators, policymakers and providers. It enables these communities to connect and accelerate practical solutions that can be implemented in real-world settings.

Presenters are Category Leaders

Presenters are bold and blunt. From Bill Taranto, President, Merck Global Health Initiative Fund, to Dr. David Berger, CEO, SUNY Downstate Medical Center, to David Klein, CEO and Co-founder, Click Therapeutics, to Tim McCarthy, Head of Digital Sciences & Translational Imaging, Pfizer and representatives from public health, venture capital finance, legal and regulatory; the three-day gathering offers a bolus of category knowledge.

“The time is now for this space – a revolution in medicine is about to happen that will shift care to center around patients,” emphasizes Click Founder and CEO David Klein. 

Klein was among the key voices discussing integrating therapeutic choices and that physicians would look more holistically in treating patients with drugs, digital therapeutics and behavioral guidance – focusing on people care satisfaction.  Digital therapeutics must model its efforts akin to biotechnology driven by evidence-based clinical outcomes looking beyond the 510K regulatory milestone for approval.

Actionable Insights

The insights shared will guide business planning decisions among newcomers and veterans to the category.  Among the noted attendees at this year’s HITLAB Innovation Summit is Amir Kishon, Ph.D., CEO of Twig Health. Kishon was among the early pioneers in the sector.

“Healthcare as a regulated industry is somewhat apprehensive about innovation. It is in its DNA. Digital health is challenging this predisposition and the question I ask myself is when this industry will tip to appreciate that innovation is a friend. We are getting there,” notes Kishon.

The program conducts studies and clinical trials that set out the scientific methodology to assess digital health interventions’ efficacy, usability, and safety.  It’s now acknowledged that Food and Drug Administration 510K approval to market for digital applications and therapies is a necessary regulatory threshold; the barrier to success is convincing science as a solid foundation for access that requires payer and provider support and a clear pathway to reimbursement.

Bottomline – it’s about reimbursement and ease of use. In the session What’s Needed for Sustainable Adoption of Digital Health American Medical Association Vice President for Digital Health Strategy, Meg Baron, offered very clear insight into how digital health enterprises can better integrate into the physician’s workflow – the “return on health” to show value.

Beyond the Summit, HITLAB promotes entrepreneurship and innovation in the digital health space. HITLAB is multi-faceted – professional development, accelerator and crowd-sources community for startups and early-stage companies, helping them navigate the complex healthcare landscape, access funding opportunities, and refine their product or service offerings.

In incubating promising ideas, HITLAB fuels the growth of the digital health ecosystem, fostering the development of transformative solutions that address unmet needs and drive positive change. Put the fall meeting on your calendars!

The post HITLAB Innovation June Summit is a Power Hit for Digital Health Change Agents appeared first on Medika Life.

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.

The post Can At Home-Health Dx Testing Move Primary Care Back into the Preventive Care Front-Seat? appeared first on Medika Life.

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We’ll come back to that awful statistic, but we need to keep such findings in context: Randomized clinical trials show that screening mammograms save lives.

Today, I look forward to exploring breast cancer screening, including the pros and cons of the various imaging approaches.

Mammograms

Mammograms remain central to screening for breast cancer. Systematic reviews of randomized clinical studies for women ages 40 to 69 years show a long-term drop by up to one-fifth in the risk of dying from breast cancer.

Unfortunately, these are primarily historical; most screening mammograms studies began before 1990. Since then, there have been changes in imaging, and there have also been tremendous treatment advances.

Full-field digital mammography

Today, many patients have full-field digital mammograms. These images are similar to traditional film-screen mammograms, except now the image is captured by an electronic detector stored on a computer.

In the United States today, virtually all of the mammography units accredited by the Food and Drug Administration are full-field digital units. Are these newer digital mammograms better than the old film ones?

The most extensive study, the Digital Mammographic Imaging Screening Trial (DMIST), discovered that while the overall diagnostic accuracy of the film and digital mammograms appear similar, digital mammography is more accurate for women less than 50 years of age, for premenopausal and perimenopausal women, and women with dense breasts.

Tomosynthesis

This digital approach produces three-dimensional (3D) images using a moving X-ray source with a digital detector. Multiple studies suggest that tomosynthesis mammograms increase cancer detection rates modestly compared with historical 2D digital mammograms.

A 2018 analysis of a collection of studies showed a gain of 1.6 cancers (per one thousand screening studies) detected with the addition of tomosynthesis, compared with traditional mammograms alone. The tomosynthesis rates also appeared lower.

Alas, no studies have examined whether tomosynthesis cuts breast cancer mortality chances.

Mammograms — Still the gold standard

Mammograms continue to be the primary imaging modality for screening women at average risk of getting breast cancer.

Ultrasound sometimes supplements mammogram screening for those with dense breasts, even though we don’t have high-level evidence to show improved outcomes.

Magnetic resonance imaging (MRI), in combination with mammograms, is being increasingly used for those at high risk of getting breast cancer. However, we have some data that incorporating MRI for those with extremely dense breasts (and normal results on mammograms) results in fewer interval (between studies) cancers than mammograms alone.

Mammograms — New findings

A University of California, Davis-led study, published 25 March 2022 in the Journal of the American Medical Association Network Open, reports these findings:

Half of women will experience a false-positive mammogram after ten years of annual breast cancer screening with 3D mammograms. The risk appears lower for women who have mammograms every other year.

The 3D mammogram approach modestly dropped the odds of having a false-positive result compared with standard digital 2D mammograms.

These groups had a lower false-positive risk:

• Women with non-dense breasts
• Older women
• Those who screened every other year

Writing in sciencedaily.com, the first author Dr. Michael Bissell writes that the “screening technology did not have the largest impact on reducing false positives.”

Dr. Bissell adds that the findings from our study highlight the importance of patient-provider discussions around personalized health. It is essential to consider a patient’s preferences and risk factors when deciding on screening interval and modality.

The researchers analyzed data collected by the Breast Cancer Surveillance Consortium on 3 million screening mammograms for over 900,000 women aged 40–79 years.

I am surprised that the innovative 3D mammogram approach for breast cancer screening did not lower the chances of having a false positive after ten years of screening. Still, mammograms save lives.

The post 3-D Mammograms — Worth It? appeared first on Medika Life.

It’s a tool by which we expand the human sensory experience, and very much like today’s sophisticated technology such as the transistor, night vision goggles, and even artificial intelligence and allowed us all to become even “more human.”

It might even be fair to say that the stethoscope was one of the first technologies available to the clinician.  But that technology has seen little change in over 200 years when it was first introduced by the French physician Rene Laennec in 1816.   But like many aspects of medicine, driven by technology, that’s about to change.

In a recent paper in Lancet, a clinical study gives us a look into the future of Laennec’s stethoscope and its utility as more than just a “sound amplifier” but a powerful tool that combines an ECG-enabled stethoscope examination and artificial intelligence to detect low cardiac function or heart failure. In the case of this trial, an ejection fraction under 40%.  The results indicated that, with some variation around device position, that detection was about 90%. The authors concluded:

“A deep learning system applied to single-lead ECGs acquired during a routine examination with an ECG-enabled stethoscope can detect LVEF of 40% or lower. These findings highlight the potential for inexpensive, non-invasive, workflow-adapted, point-of-care screening, for earlier diagnosis and prognostically beneficial treatment.”

The implications are significant—for clinical care and also the evolution of “technologically empowered” tools to enhance care.  And in addition, the direct contact of the device eliminates the need for ears and sounds transfer via air.  The cardiac sounds are digitized and recorded to establish a reproduceable and visual tracing of what used to be those subtle sounds “lub dub”.

It’s actually a classic technological transformation and follows the pattern of digitization that we’ve seen many. Our camera and even our phones were once clunky and hardly optimized for convenience and utility. But once these devices were digitized, they provided a disruptive transformation in the marketplace. Digitization was followed by dematerialization and demonetization. And after that, democratization emerged.

Today, we see almost everyone with smart phones in their pockets and the application of these technologies to life are seemingly endless and transformative in expected and unexpected ways. That similar dynamic is beginning to happen with the stethoscope. It’s been two hundred years and very little has changed with respect to the underlying mechanism. But today the stethoscope is a tool that is enhanced by technology to provide powerful insights for diagnosis and care. But here’s something that is very interesting and rather unusual.

While the stethoscope was generally the domain of the physician, we now see an interesting shift where consumers make use of this tool to enhance their own care. The domain of the stethoscope may expand to include patients and caregivers and provide a simple and accessible tool to evaluate cardiac function in the comfort and convenience of your home.  It’s these new tools that help expand the role of home care and even telemedicine as the path from digitization to democratization becomes a powerful reality.

Here’s the very good news.  The technology isn’t just an idea or abstract prototype. The stethoscope of tomorrow is available today.  EKO Health, the study sponsor, has a range of tools that expands clinical awareness and leverages technology to improved care. 

Rene Laennec would be proud.

The post It’s Not Your Father’s Stethoscope appeared first on Medika Life.

The Silicon Valley startup Theranos acquired near-mythical status in part because of the charisma of its young leader, Elizabeth Holmes. Unfortunately, the promise — that vital health information could be obtained from a small drop of blood using handheld devices — appears to have been a lie.

Not a reader? I’ve got you covered. You should soon have a new feature film from “The Big Short” writer and director Adam McKay. The future movie stars Jennifer Lawrence as Theranos founder Elizabeth Holmes.

Now comes a proof-of-concept for the ability of a single blood drop to detect lung cancer in individuals who exhibit no symptoms of the disease.

Metabolomics — An emerging science

Let’s look at the study, recently published in Proceedings of the National Academy of Sciences. The Harvard-affiliated researchers built a lung-cancer predictive model based on metabolomics profiles in blood. What does that mean?

Metabolomics analyzes cell metabolite flows to discern healthy and pathological states by focusing on the metabolome — the dynamic biochemical system found in all of our cells, fluids, and tissues. This exciting emerging field is new to me, too.

The way I see it, with metabolomics, scientists are comprehensively measuring all metabolites and smaller molecules in a biological specimen. A kind of systemic engineering at the most granular level.

Now things are about to get more interesting. When lung cancer is present, the altered physiology of the cells can lead to changes in blood metabolites made (or consumed) by cancer cells in the lungs.

Metabolomics — Finding lung cancer

The Harvard researchers examined metabolomic profiles in blood using high-resolution magnetic resonance spectroscopy. This tool can examine a massive array of compounds inside living cells by measuring the collective reactions of the metabolites.

Researchers screened tens of thousands of blood samples saved at hospital biobanks. They found 25 patients with non-small cell lung cancer with stored blood specimens obtained at diagnosis and at least six months before diagnosis.

Here’s how the scientists did their work:

1. Trained their statistical model to recognize lung cancer by measuring metabolomic profile values in blood samples from 25 patients during their lung cancer diagnosis.
2. Compare #1 to blood samples from 25 healthy controls.
3. Validate the model using blood from the same patients but obtained before a lung cancer diagnosis.

It worked. For the third, the predictive model gave results between the healthy controls and the patients at diagnosis.

For additional validation, the researcher applied the model to a different group of 54 patients with lung cancer, using blood obtained before their diagnosis. The model’s predictions again appeared accurate.

Metabolomics — Into the future

As a doctor involved in cancer care, I find this preliminary research extraordinarily exciting. In addition to creating the potential to detect cancer early, the researchers also showed that values from the predictive model measured from prior-to-diagnosis blood samples could also predict five-year survival for patients.

Previously, the investigators had shown the potential for magnetic resonance spectroscopy-based metabolomics to differentiate cancer types and stages of diseases. They have also shown some ability to distinguish between indolent prostate cancer (which can be monitored) and cancer requiring treatment.

The same group will apply metabolomics to look for Alzheimer’s dementia clues in spinal fluid and blood samples.

AT RISK OF SOUNDING LIKE someone in Silicon Valley creating secrets and lies about the promise of a drop of blood, I share this: Harvard researchers may have a new diagnostic blood test that opens the door to the early detection of lung cancer.

You probably got the Silicon Valley (USA) reference, but if not, here is your go-to book (full disclosure — I would love it if you bought it from your local bookseller):Bad Blood: Secrets and Lies in a Silicon Valley StartupBad Blood: Secrets and Lies in a Silicon Valley Startup – Kindle edition by Carreyrou, John. Download it once and read…www.amazon.com

The Silicon Valley startup Theranos acquired near-mythical status in part because of the charisma of its young leader, Elizabeth Holmes. Unfortunately, the promise — that vital health information could be obtained from a small drop of blood using handheld devices — appears to have been a lie.

Not a reader? I’ve got you covered. You should soon have a new feature film from “The Big Short” writer and director Adam McKay. The future movie stars Jennifer Lawrence as Theranos founder Elizabeth Holmes.

Now comes a proof-of-concept for the ability of a single blood drop to detect lung cancer in individuals who exhibit no symptoms of the disease.

Metabolomics — An emerging science

Let’s look at the study, recently published in Proceedings of the National Academy of Sciences. The Harvard-affiliated researchers built a lung-cancer predictive model based on metabolomics profiles in blood. What does that mean?

Metabolomics analyzes cell metabolite flows to discern healthy and pathological states by focusing on the metabolome — the dynamic biochemical system found in all of our cells, fluids, and tissues. This exciting emerging field is new to me, too.

The way I see it, with metabolomics, scientists are comprehensively measuring all metabolites and smaller molecules in a biological specimen. A kind of systemic engineering at the most granular level.

Now things are about to get more interesting. When lung cancer is present, the altered physiology of the cells can lead to changes in blood metabolites made (or consumed) by cancer cells in the lungs.

Metabolomics — Finding lung cancer

The Harvard researchers examined metabolomic profiles in blood using high-resolution magnetic resonance spectroscopy. This tool can examine a massive array of compounds inside living cells by measuring the collective reactions of the metabolites.

Researchers screened tens of thousands of blood samples saved at hospital biobanks. They found 25 patients with non-small cell lung cancer with stored blood specimens obtained at diagnosis and at least six months before diagnosis.

Here’s how the scientists did their work:

1. Trained their statistical model to recognize lung cancer by measuring metabolomic profile values in blood samples from 25 patients during their lung cancer diagnosis.
2. Compare #1 to blood samples from 25 healthy controls.
3. Validate the model using blood from the same patients but obtained before a lung cancer diagnosis.

It worked. For the third, the predictive model gave results between the healthy controls and the patients at diagnosis.

For additional validation, the researcher applied the model to a different group of 54 patients with lung cancer, using blood obtained before their diagnosis. The model’s predictions again appeared accurate.

Metabolomics — Into the future

As a doctor involved in cancer care, I find this preliminary research extraordinarily exciting. In addition to creating the potential to detect cancer early, the researchers also showed that values from the predictive model measured from prior-to-diagnosis blood samples could also predict five-year survival for patients.

Previously, the investigators had shown the potential for magnetic resonance spectroscopy-based metabolomics to differentiate cancer types and stages of diseases. They have also shown some ability to distinguish between indolent prostate cancer (which can be monitored) and cancer requiring treatment.

The same group will apply metabolomics to look for Alzheimer’s dementia clues in spinal fluid and blood samples.

The post Detecting Cancer With a Blood Drop appeared first on Medika Life.

With a sealed user interface and revolutionary ZONE Sonography® Technology+, the new ME8 Ultrasound System combines best-in-class image quality with an intuitive user experience

MAHWAH, N.J., Oct. 23, 2020 /PRNewswire/ — Mindray, a global leader in the development of innovative healthcare technology, today announced the launch of a revolutionary new product, the ME8 Ultrasound System. With a weight and thickness of just 6.6 pounds and 1.7 inches, respectively, the ME8 System’s main unit is one of the lightest and thinnest laptop-based machines in the industry. In addition, this compact, durable, and powerful System houses advanced software and hardware built to maximize performance in all applications.

“Since its founding, Mindray has been dedicated to developing innovative and accessible ultrasound solutions for the point of care environment,” said Wayne Quinn, President of Mindray North America. “Given the continuous evolution of the healthcare industry as a whole, and the ongoing fight against COVID-19, we are proud to be able to provide state-of-the-art solutions like the ME8 that address the pressing challenges of today, while supporting our partners’ long-term goals.”

The ME8 Ultrasound System has been thoughtfully designed to overcome the obstacles clinicians face in today’s challenging healthcare environments. With a sealed user interface for ease of cleaning and disinfection and revolutionary software-based ZONE Sonography® Technology⁺, the ME8 Ultrasound System combines best-in-class image quality with an intuitive and customizable user experience to help ensure reliable and efficient diagnosis during the most challenging exams.

Using AI-powered smart tools (Smart B-Line, Smart VTI, Smart IVC), this portable ultrasound system can help assess volume status and fluid responsiveness in critically ill patients. With groundbreaking technologies like eSpacial Navi^TM and iNeedle+^TM, the ME8 offers the most advanced suite of needle guidance and enhancement technologies. Additionally, when used with the U-bank, the System provides up to eight hours of battery life allowing for all-day scanning.

“As point of care ultrasound continues to break through barriers in a variety of clinical settings, it is our responsibility here at Mindray to continue to push ultrasound technology forward,” said Maher Elhihi, Director of Marketing, Ultrasound. “At the end of the day, our goal is to provide greater access to leading-edge imaging technologies that enable better patient care, and we are confident that the ME8 System addresses these evolving needs.”

Through innovative solutions like the ME8 Ultrasound System, Mindray continues to drive its mission forward, advancing medical technologies to make healthcare more accessible. Click here to watch the launch event.

About Mindray

Mindray is a leading developer, manufacturer, and supplier of medical device solutions and technologies used in healthcare facilities around the globe. We believe we can change lives by making the most advanced healthcare technology attainable for all. We do this by empowering healthcare professionals through innovative, high-value solutions that help create the next generation of life-saving tools across three primary business segments: medical imaging, patient monitoring and life support, and in-vitro diagnostics. Mindray maintains its global headquarters in Shenzhen, China; Mindray North America is headquartered in Mahwah, New Jersey. Our Ultrasound Innovation Center is located in San Jose, California, with additional facilities in major international markets around the world. For more information, please visit http://www.mindray.com. 

SOURCE Mindray North America

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Several methods can be used to detect antibodies and antigens, including ELISA, agglutination, precipitation, complement-fixation, fluorescent antibodies and more recently chemiluminescence. Serological testing features prominently in Covid-19 testing.

It is used to test a patients sample for the presence of antibodies to the SARS nCoV2 virus that causes Covid-19. The presence of these antibodies tells us that the patient was infected with the virus. The test cannot be used to determine if you are currently or newly infected, that requires a NAAT based test that searches for actual viral material rather than antibodies and antigens

What do we use Serological Testing for?

Blood typing is typically performed using serologic methods. The antigens on a person’s red blood cells, which determine their blood type, are identified using reagents that contain antibodies, called antisera. When the antibodies bind to red blood cells that express the corresponding antigen, they cause red blood cells to clump together (agglutinate). These clumps can then be identified visually.

Serologic tests also play a key role in transfusion medicine. Prior to a blood transfusion,the test is used for crossmatching, a process that ensures a donor and recipient are compatible. The direct antiglobulin test is performed to detect if antibodies are bound to red blood cells inside the person’s body, which is abnormal and can occur in conditions like autoimmune hemolytic anemia, hemolytic disease of the newborn and transfusion reactions.

In Immunology, Serologic tests can help to diagnose autoimmune disorders by identifying abnormal antibodies directed against a person’s own tissues.

The importance of Serology

Serological surveys are often used by epidemiologists to determine the prevalence of a disease in a population. Such surveys are sometimes performed by random, anonymous sampling from samples taken for other medical tests or to assess the prevalence of antibodies of a specific organism or protective titre of antibodies in a population.

These surveys are potentially the most direct and informative technique available to infer the dynamics of a population’s susceptibility and level of immunity. The emergence of the tests usefulness in tracking viral outbreaks and measuring prevalence in communities across the globe has been made evident by the Coronavirus Pandemic of 2019/20

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