ECG monitor AliveCor granted OTC status

BY Michael Johnsen

SAN FRANCISCO — AliveCor on Monday announced that the Food and Drug Administration has granted the company over-the-counter clearance for the AliveCor Heart Monitor, a single-channel ECG (electrocardiogram) recorder, previously available by prescription only. The device is available now for pre-order purchase with shipments beginning in March.

The AliveCor Heart Monitor provides people with suspected or diagnosed heart conditions, and those at risk of heart conditions, the ability to track their heart health anytime, anywhere, at an affordable cost. Health professionals and patients have reported using the device to detect, monitor and analyze irregular heart rhythms. 

“Over-the-counter access to mobile health devices has the potential to change the way consumers manage their overall health, facilitate preventative medical care and save both patients and healthcare professionals time,” stated Euan Thomson, president and CEO AliveCor. “We are pleased to now provide easier access to our innovative Heart Monitor and with the help of healthcare professionals provide timely analysis of data to all users.” 

The AliveCor Heart Monitor’s medical grade ECG recordings can be shared directly with a user’s physician, or sent to a U.S. board-certified cardiologist or a U.S. based cardiac technician through AliveInsights, an analysis service that offers expert review of ECGs directly through the free AliveECG app. Recordings are then reviewed and analyzed providing users with a more complete picture of their current heart health.

The AliveCor Heart Monitor is the only FDA-cleared mobile ECG recorder that supports both iPhone and Android smartphones. It records, displays, stores and transfers single-channel ECG rhythms wirelessly, using the free AliveECG app. With secure storage in the cloud, users can access their data confidentially anytime, anywhere, and can grant access to their physician. 

The AliveCor Heart Monitor can now be purchased at at a cost of $199.


Leave a Reply

No comments found



Q&A: Genetic profiling with Dr. Anita Goel of Nanobiosym

BY Jim Frederick

A new and possibly transformative technology for rapidly diagnosing and evaluating patients based on their specific genetic profile may soon begin appearing at retail pharmacies and clinics, giving pharmacists and clinicians another tool for advancing patient health outcomes and their own practice capabilities.

Dr. Anita Goel, M.D., Ph.D.

The new tool, called Gene-RADAR and developed by Cambridge, Mass.-based research institute Nanobiosym, is now undergoing review for multiple applications at the Food and Drug Administration. In October, the technology won the $525,000 grand prize in the inaugural Nokia Sensing XCHALLENGE as a breakthrough, rapid disease diagnosis and wellness testing technology.

The Gene‐RADAR platform analyzes a drop of blood, saliva or other body fluid placed on a nanochip and inserted into a mobile device, which then detects the presence or absence of a disease’s pathogen in less than an hour. According to Nanobiosym founder, chairman and CEO Dr. Anita Goel, M.D., Ph.D., a Harvard-MIT-trained physicist and physician, it provides the same accuracy now available only in a diagnostic lab at a fraction of the cost.

In January, DSN spoke with Dr. Goel on the Gene-RADAR technology, and on its potential use in the pharmacy and retail clinic setting. Here are excerpts from that interview.

DSN: What led to the development of Gene-RADAR?
Anita Goel: This has been a 20-year journey … to break down the silos between fundamental physics, biomedicine and nanotechnology. I call it nanobiophysics — the nexus of these industries. By bringing physics into medicine and biology, we can understand biological systems at a whole new level. On a practical level, I’ve been looking at nanomachines that read and write information in DNA, using tools from physics, quantum optics and nanotechnology. We’ve found … that by manipulating the environment, we can modulate how these little nanomotors read and write information that’s embedded in DNA. By playing with the knobs in the environment, we can actually turn the genes on and off… We’re essentially modulating these little motors, which are like tiny Xerox machines crawling up and down the DNA.

DSN: How does that ability to manipulate nanomotors translate into a diagnostic tool?
Goel: Gene-RADAR is a nanotech-enabled platform [for] … mobilized diagnosis in real time of any disease or wellness biomarker that’s based on DNA or RNA. It harnesses these nanomachines to weed out information in a genetic DNA or RNA marker. You take a drop of blood or saliva … and insert it into a nanochip, and it’s placed into our Gene-RADAR mobile device. The first-generation system we are planning to deploy is about the size of an iPad.

DSN: How would a retail pharmacist or clinician employ the system?
Goel: With Gene-RADAR, a health care worker — or even consumers themselves — will be able to genetically profile the patient. You would get information in real time, with gold-standard accuracy, to … start personalizing your meds, your nutrition, diet, exercise protocol, drugs and many more things.

DSN: What could this diagnostic tool mean for a pharmacy that incorporates it?
Goel: A pharmacy is the place where people go to not only get prescription medicines, but also OTC medicines, vitamins, healthcare products, wellness products, beauty products, consumables and personal care products. The pharmacy has really become an ecosystem for all those things. And all these products could be tailored to the needs of a particular individual, based on their DNA and RNA signatures. That’s what Gene-RADAR can do. We could stick a platform in every pharmacy, with a disposable chip that would be used to figure out what vitamins a person should take or what OTC meds are better for them. You can even personalize skin care, beauty care and personal care products because not all people react the same.

DSN: Based on that person’s genetic footprint?
Goel: Exactly. The key is you have to customize the chip [to read] the markers to go with various consumer products. So we’re building an ecosystem of these partners [for whom] we customize. For example, pharmaceutical companies are in discussions with us to build companion diagnostics to their prescription medications. We’re working with them in a collaborative fashion to customize our chip reader and software so it becomes a companion to one of their therapies.

DSN: Give us an example of how that would work.
Goel: Imagine a cancer chemotherapy they’re trying to get through the FDA. We can help to streamline with a chip which patients are more likely to respond to that chemotherapy, vs. which will be resistant to that therapy. So you do a more personalized therapy to maximize the efficacy and decrease the side effects for the patient. The pharmacist could take the patient and help determine if they’re a candidate for one therapy over another. Right now, that’s done at the doctor or at the hospital level. But in the future, you can envision this fine-tuning being done at least in part at the pharmacy level. Or the calibration of drug dosing, or using our devices because it’s quantitative as a drug-monitoring tool to see if the patient is responding to the drug, or whether they need to take alternative [therapy] because, for instance, they’ve become resistant to a certain antibiotic.

DSN: What about Gene-RADAR applications beyond prescription drugs – say, for instance, for OTC meds or supplements?
Goel: We can apply the same focus for OTC medications, vitamins, consumables, nutraceuticals, wellness products — all of these also can be personalized and customized to the patient. For example, someone deficient in vitamin D levels can use that data to help them choose the right products to … optimize their levels.

DSN: It also dovetails with the movement to empower and engage patients more effectively in their own health and wellness.
Goel: Exactly. It’s really putting the patient at the center, … taking care of his or her own health and wellness. They’re part of the same spectrum, and all these personal care products could be more tailored and more effective if you have real-time diagnostics to help you focus on which products help you the most — and also see their efficacy. Another example is … the development of a chip to monitor inflammation. Inflammation is the foundation of many of the diseases of the modern world, from cancer to diabetes and heart disease. Even the fundamental process of aging itself is thought to be linked to inflammatory pathways. So if we have a system where people can go into their pharmacy and measure their inflammatory levels in real time, and then go back and change their diet, cut out … stress levels, get into a better exercise protocol, take the right vitamins and anti-inflammatory nutraceuticals, then come back and see a direct effect on their inflammatory levels, you can start to track and — even in a preventive health care basis — get people into better wellness long before they suffer a heart attack or some other condition the health system would register. And the pharmacy can be a center for that community care.

DSN: So these chips can be customized to look for certain markers indicating conditions or pathogens — or even monitor the impact of a nutraceutical or prescription regimen?
Goel: Yes. To be more precise, we actually customize the chip, the reader and the software to [track] a particular condition. One example we’ve developed is a point-of-care HIV viral load chip. That test traditionally takes $200 and two weeks at a centralized lab in the United States, and six months in sub-Saharan Africa because they have one centralized [lab] in the whole country.

DSN: Tell us how the Gene-RADAR tool actually works to diagnose and track, say, HIV.
Goel: You put a drop of blood in the nanochip, insert it into our iPad-sized device, and within less than an hour you get a real-time quantification of the viral load. You can use that to figure out your … therapy … [or] to tailor [prescription regimens] and monitor the response from the patient over time, to see if they’re taking their meds. So … they can come back to the same pharmacy and check to see if their viral loads are dropping.

DSN: And these chips are customized to be able to detect different pathogens or therapeutic progress?
Goel: We build different apps on our platform. As a corporation, we have both a company and a research institute. Our research arm works with the leading science, technology and healthcare players around the world to identify their biggest needs, and we collaborate with them to develop apps [for which] there’s a big need. The commercial company right now is commercializing the HIV viral load chip because we found that, in … parts of the developing world, [diagnosing and treating such conditions as] HIV, TB and malaria … are real unmet needs. And the gold-standard way of testing them is in a centralized lab. Our technology enables you to get out of that centralized lab and decentralize, mobilize and personalize that gold-standard health care. There are quick-and-dirty tests now that can be done at the pharmacy and point-of-care level, but those have a lot of false positives and negatives. HIV oral test pulled and restored… They all require PCR as the gold standard; our technology will benchmark against that.

DSN: How far is Nanobiosym away from actually deploying the technology on a large scale? And in terms of global reach, does it depend on first forming partnerships with NGOs and other groups to distribute these on a broad scale?
Goel: Exactly. What we’re finding in the developing world is we have to build … collaborations with NGOs and industry stakeholders on the ground. We’ve started doing that in a few countries, and that’s led us to get awards from the USAID, government of Canada and so forth to help mobilize some of this on the ground to get this technology out there. But there’s a lot of steps between our labs in Cambridge, Mass., and deploying on large scale.

DSN: How about in the United States?
Goel: Domestically, there’s even a bigger opportunity. However, the challenge here is it’s a very well-differentiated market. We’re collaborating with the FDA, but for each app the FDA has a separate process. So that creates a lot of [work] that has to be done.

DSN: So each app of the chip and the gene-mapping technology requires separate documentation and applications with the FDA?
Goel: Correct. Now, there are some products that don’t require FDA [approval], like nutraceutical or personal care products. We’re collaborating with the FDA to figure out the best approach. At a very fundamental level, this represents a technological capability that we’ve never had before to provide gold standard-level diagnosis outside of a centralized health facility, like a hospital or a pathology lab, and bring it into a decentralized environment, in a mobile setting at the point of care — like the patient’s bedside, doctor’s offices, a pharmacy, people’s homes or even rural villages. This is a paradigm shift that our health system is not prepared to handle overnight. So we have to build an ecosystem of partners and collaborators who have a vested interest in the success of this kind of game-changing technology coming to scale. I believe that pharmacies could be a key partner in this mission because they have only to gain with the ability to diagnose and monitor patients and consumers in real time, at the pharmacy itself. There is some movement in this direction. We just want to take it to the next level, where all pharmacies could benefit from these next-generation diagnostic platforms. And as we build more chips and more apps, the pharmacy would have more to offer. The pharmacy could share revenues with us by providing the service.

DSN: How would that revenue-sharing model work, and have you had discussions yet with any pharmacy chains or pharmacy organizations?
Goel: We are being approached by a number of pharmacies. They seem very enthusiastic, and some of them … want to play a role in helping shape some apps. One of the revenue-sharing models we’ve looked at is where we provide the chip reader and software and any upgrades and new apps, and set up a Nanobiosym kiosk at each pharmacy, and there’s a revenue share based on the users who interact with that kiosk. The pharmacy becomes a distribution partner. Not only would they make the revenue on the chips and testing, it enhances their ability to sell their products — whether prescription or OTC meds, nutraceuticals, vitamins, personal care, beauty care, it gives them a very personalized way of serving their clientele. It empowers consumers to feel like they’re taking ownership of their own health and wellness, and the pharmacy becomes the support ecosystem where they can go and find all those needed products.

DSN: So the kiosk would be a self-actuated product, or would it require intervention by a pharmacist or clinician to walk a patient through the finger stick or saliva test?
Goel: In our original vision for the U.S. military and the developing world environments, we knew we wouldn’t always have the luxury of having a healthcare worker available to run the device. So … somebody with minimal training … could get an answer. We tried to keep it simple. But there are other bells and whistles we can add to software that can be interpreted for the pharmacist who wants to then guide the patient to other options or products … to help personalize the program. For example, you could personalize a nutrition or nutritional supplement program.

DSN: When will this technology be widely available here?
Goel: It’s not far off. In the developed world, it’s very dependent on having the right distribution partner because this kind of game-changing technology disrupts the traditional supply-chain alliances of healthcare diagnostics. We need partners to reach the consumers. It’s not enough for us to have these next-generation technologies; we have to figure out the distribution channels. I believe pharmacies, in particular, could be excellent partners in scaling up this mission because they have a direct access to the consumer and patients. And this could be tailored to go into this environment in a way that supports the maximum number of products the pharmacy is selling. I would envision some visionary pharmacies out there would be the early adopters of this technology and set up the ecosystem — a place where people could come in and interact with … doctors and nurses available for consultation [and to] … build excitement around our product.

DSN: And this will be a product that could be purchased by consumers for use in the home?
Goel: We’re basically an enabling platform, so we can partner with weight loss companies, nutritional companies, wellness programs and other groups to provide information and tools to them to make more informed decisions. We’re even in discussion with fitness clubs that want to use this to help their members achieve better wellness by genetically fingerprinting themselves to figure out their right fitness protocol. Different people have different metabolisms, and you can watch that with our DNA/RNA markers.



Leave a Reply

May-09-2014 10:42 am

This is the real thing - will totally revolutionize diagnostic testing.



Study finds probiotic strain Cardioviva helps reduce cholesterol

BY Michael Johnsen

WINNIPEG, Manitoba — A new study published in the January issue of Nutrition Reviews found that the probiotic L. reuteri NCIMB 30242 (Cardioviva) was found to significantly reduce LDL cholesterol and total cholesterol. 

Elevated LDL-cholesterol is a major risk factor in heart disease. Most adults (91%) say they care about maintaining a healthy cholesterol level for heart health, but less than half (37%) routinely get their cholesterol tested. 

"People know probiotics for digestive health. They don’t associate them with heart health," stated Doug DiRienzo, lead author of the review. "It’s time to recognize their potential role as a simple and natural tool in cholesterol management."




Leave a Reply

No comments found