FDA Approves Macular Degeneration App

If you are at risk for retina-related eye problems, you probably see your eye doctor at least once or twice a year. Now you can have your doctor monitor your vision twice a week, and from the comfort of home. An app that allows this has just received FDA approval.

The new app is called mVT, which stands for myVisionTrack. It allows people who have diabetes or a family history of macular degeneration to easily monitor their vision. The app displays a series of four circular ‘Gaussian’ patterns and requires that you tap the screen on the one that is not truly circular. It can be used with both wet and dry age-related macular degeneration. http://www.myvisiontrack.com/mvt

To get the mVT app, you need to first see your eye doctor. Mike Bartlett, President of Vital Art and Science LLC, the company that produces mVT, says that since the app is considered a medical device, “the FDA specified that our test should only be supplied “by prescription” from a licensed eye care professional, which means from ophthalmologist or an optometrist. “

From Vital Art and Science website

Test results are uploaded to the doctor’s portal which can also be programmed to send the alerts by e-mail or text of any significant changes in vision. The office staff then contacts you to set up an appointment to review the test results and suggest treatment.

On approval of the mVT App, the FDA stipulated that people could not receive the results directly. Bartlett said, “They were afraid that patients might use home test results to decide that they don’t need to go back for their scheduled appointment, and by supplying the results only to the doctor they would keep this from happening.” This FDA requirement is apparently common with newly approved medical devices and is expected to be eliminated in time. People with diabetes monitor their glucose and those with hypertension use blood pressure devices at home, but they still visit their doctors.

The mVT app is convenient to use and provides easier long term vision monitoring but is not a substitute for the traditional Amsler Grid. If you are at risk of retinal issues, you should regularly be using the Amsler Grid to check your vision. But instead of looking at what looks like a graph on a piece of paper that you often forget at home, now these grids can always be viewed on the screens of all smartphones.

– Jack Klausner

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Irritable Bowel Syndrome Home Test Approved

April 15, 2015 – April marks National Irritable Bowel Syndrome Awareness Month. Coincidentally, last week, BÜHLMANN,  a Swiss medical laboratory company received EC’s regulatory approval to distribute its home test for irritable bowel disease. The test kit, IBDoc, will allow for testing at home and provide immediate results which can then be shared digitally with a medical provider. BÜHLMANN reports that trial participants’ feedback has been “phenomenal.” IBDoc requires a smartphone and an internet connection.

Enthusiasm at  the Swiss company is apparent. Chris Moore, CPO, states “never before has such a sophisticated biologic test system been brought to patient’s homes,” and predicts that IBDoc will have the same impact on irritable bowel disease, as monitoring blood sugar levels at home had on diabetes over a generation ago.

IBDoc smart phone app display of results

IBDoc smart phone app display of results



The test name, IBDoc, is an acronym for Irritable Bowel Doctor and measures calprotectin, a biomarker for gastrointestinal inflammation, which is used as indicator for severity of gastrointestinal conditions such as Crohn’s disease and ulcerative colitis. Patients with chronic irritable bowel conditions measure their calprotectin levels normally every three months.  BÜHLMANN claims that IBDoc is “superior to classically used blood biomarkers, such as C-reactive protein, erythrocyte sedimentation and others.”

  • Smart phone required
  • * Non-invasive
  • * No laboratory needed
  • * Stool testing simplified
  • * Results in minutes
  • * Patient empowerment
  • * Results shared by internet


As of now, Christian Reinhard, IBDocs product manager, is focusing on European distribution, but plans on future trials to meet FDA approval. When contacted about US distribution, Reinhard responds, “As for all FDA approvals, this can be a long process, especially for a new product category like this — smartphone based diagnostic tests — but we hope that we can launch in the US in the next two years.” Although this time frame may be average in the medical industry, it likely feels like eternity for those who make up the more than 20 percent of the estimated US population who have to live with irritable bowel disease.

-Jack Klausner

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A Glimpse Into the Future

We recently have witnessed the smartphone and its various add-ons increasingly being used in diagnostic home testing. This trend will no doubt continue, but are there any clues as to where else we may be heading?

As with the recent introduction of smart watches and Apple glasses, it often seems that technological advances that are literally revolutionary, are being introduced at such a rapid pace, that we are becoming blasé, even before we have fully incorporated the technology into our lifestyle.

A Glimpse into the Future Flickr account Garry Knight. License CC BY 4.0.

A Glimpse into the Future
Flickr account Garry Knight. License CC BY 4.0.

So where are we heading with home medical testing? Without access to a crystal ball, perhaps we’ll get a clue by following the money trail?

Let’s pick up the trail at the University of Melbourne, where plans are being drawn to integrate the departments of medicine, life sciences, physical sciences and engineering – all this in an attempt to develop medical technologies that will allow citizens in remote areas to participate in health care currently available only in major cities.

In order to fund this effort, the university plans to raise $500 million by the end of 2017, in its venture entitled, Believe: the Campaign for the University of Melbourne – it has only $100 million to go. A recent donation of $5 million from an alumnus, Leigh Clifford, will serve to create a ‘chair’ that will combine education with research efforts in medicine, engineering and the sciences.Let’s pick up the trail at the University of Melbourne, where plans are being drawn to integrate the departments of medicine, life sciences, physical sciences and engineering – all this in an attempt to develop medical technologies that will allow citizens in remote areas to participate in health care currently available only in major cities.

In the Melbourne Engineer, Mr. Clifford is quoted as saying: “The gift will allow researchers to concentrate on progressing their pioneering and collaborative work ensuring people across Australia, and the region, have access to healthcare. The idea of small, low cost and easy to use devices for the best patient management is only one example of what is possible in the future.”

The inter-disciplinary cooperation is aiming at improving diagnostic and therapeutic capabilities in conditions such as:

* Epilepsy

* Parkinson’s Disease

* Spinal Injuries

* Psychiatric Disorders

Outcome expectations from collaborative efforts among the disciplines are high, as Mr. Clifford has stated “This is an exciting challenge as we work together to create not only portable diagnostic tools, but the next generation of bionic devices and implants.” At the current rate of technological advances, we’ll know soon enough if these expectations are justified.

Jacob Klausner

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Monitor Your Vital Signs at Home

You finally made it home after a long commute and an especially stressful day at work. Suddenly, you are aware of a discomfort in the chest, unlike anything you’ve experienced before. You sit down to relax but breathing becomes more difficult. What to do? Call 911? Ask someone to drive you to the ER or maybe just the local Urgent Care center? In a state of heightened anxiety and confusion, critical decisions need to be made… and quickly.

Sensors are located on top and sides of Scout

Sensors are located on top and sides of Scout

A California firm, Scanadu, has developed a device, called the Scandau Scout, that can instantly determine critical physiological data in such situations. The company has just begun field testing the Scout – an easy to use device that determines vital signs, displays and then stores them on a smartphone. An ultra-sleek looking gadget, about 2 inches in diameter and half an inch thick, its functioning is dependent on several physiologic sensors.

To use the Scout, it is simply held to the left forehead for about a minute to establish temperature, blood pressure, respiration rate, pulse, variability in heart rate and EKG. The information can instantly be transmitted to medical personnel for assessment and further instructions. The triage that normally begins in the ER, has just started at home. Just as interesting, is that the concept of developing the Scout, first occurred to Scandau founders following a family tragedy and the experiences that followed in the medical center.

Although it may be used in emergency situations, developers hope that the Scout will find even greater usage in daily settings. They propose that with such simple access to physiologic measures, individuals will be able to better monitor circumstances or individuals that give rise to vital signs associated with heightened emotional distress and then avoid them. Could this mean that before having the day’s fourth cup of Java or deciding on a congested route option preferred by the GPS, you check the stress level on the Scout?

Scandau gained financial support for the research and development of the Scout through crowd funding. Recently it has begun distributing the device to its share holders, at a cost of about $200, partly in an attempt to gather usage data required by the FDA. So confident is Scandau of FDA approval, that it has already begun developing its next home testing device, the Scanflow, which will provide urine analysis on as much as a dozen urine values.

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Smartphone Diagnoses HIV and Syphilis

I have written recently on the use of smart phones for various medical tests, but lingering doubts relate to their accuracy as compared to traditional laboratory testing. In addition, the F.D.A. has viewed such diagnostic Apps as ‘new medical devices’ and has required that they undergo extensive testing prior to their approval. Now, we hear about an amazing new technology that aims at addressing existing reservations.

A recently published study, by a team of researchers at Columbia University’s School of Engineering and Applied Science, reports on a smartphone accessory that claims to be as accurate as traditional medical laboratory testing, in detecting HIV and syphilis antibodies. The researchers claim that their device “replicates, for the first time, all mechanical, optical and electronic functions of a lab-based blood test.” This accessory, also known commonly as a “dongle”, is so small and lightweight, that it can be held in one hand and costs only about $34 to produce. This is in contrast to traditional and much larger diagnostic equipment used in medical laboratories which costs tens of thousands of dollars.

In their study, the device was tested in Rwanda among 96 pregnant women, in order to prevent them from passing these diseases to their offspring. With this test, all that’s required is that a drop of blood resulting from a finger prick be applied to a disposable plastic cassette which fits onto the device. The cassette houses chemical reagents that are mixed by simply applying digital pressure. Since the dongle does not contain its own electric current, it relies on the phone’s audio jack through which it receives power and through which it also transmits the results to the smartphone within 15 minutes, where they are then kept on file.


Diagnostic device easily attaches to smartphone

Diagnostic device easily attaches to smartphone


It’s anticipated that with time, this technology will be expanded to cover more diseases and be consumer oriented and user-friendly. Providing this level of accuracy in disease testing, especially in settings located far from the barest essentials, no doubt will have a major impact on the health and lives of millions who currently live in remote areas. Thanks to this new dongle and similar other developments, the smartphone has just become a little smarter, and all indications are that this trend will continue and bring with it novel applications that will result major changes in the delivery of healthcare.

by Jacob Klausner

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Home Testing for Jewish Genetic Conditions

In the U.S., it’s estimated that about 1 in 4 Ashkenazic Jews is a carrier for genetic diseases more common in that population. Carriers typically have no symptoms of the disease and unless they undergo genetic testing, may remain unaware of their carrier status – this despite a 25% risk of producing offspring with the actual disease if their mate is also a carrier. When considering starting a family, most Jewish couples know that Tay-Sachs disease commonly runs among Ashkenazic Jews and they will often get tested. But what about testing for other genetic diseases, such as Cystic Fibrosis or Spinal Muscular Atrophy, which are also more commonly found in those of Jewish descent?

Despite also being a public health concern, until recently, there has been no readily accessible resource providing testing information for various Jewish genetic conditions. This is no longer the case. An effort by an Atlanta based non-profit group JScreen, in collaboration with Emory University School of Medicine, has taken on the task of making it much simpler for anyone of a Jewish genetic background to have a saliva home-test prior to starting a family. JScreen will also provide phone counseling to the couple regarding available options. Where results are more involved, JScreen will suggest a consultation with a local genetic counselor.

Participants are mailed a “spit kit” directly to their home. The saliva sample is returned to a certified lab in a pre-paid envelope and results are ready in a few short weeks. An analysis for more than 85 diseases is done, 40 of which are common in people with Jewish ancestry and over 45 of which are common in the general population. JScreen is currently available in the U.S. and its cost is often covered by commercial medical insurance policies as well as Obamacare plans purchased on government exchanges.

med jack

JScreen Kit for screening Jewish genetic disorders

JScreen claims that depending on the medical insurance policy, the maximum out of pocket costs would be $99, even if the insurance plan does not cover genetic testing or has a high deductible. For those who have no health insurance or have Medicare or Medicaid coverage, the current cost for the test is $999. Couples who need help paying for the test, are required to fill out a financial application for assistance determination. JScreen’s Project Coordinator, Rachael Gates, says that due to the generosity of donors, they’re generally able to subsidize balances of over $99 that insurance does not pay. In addition, they have set up a gift certificate program called JGifts which allows friends or family members to offset the cost of testing for aloved one.

While saliva genetic testing can accurately detect up to 99% of carriers for some conditions, they typically average 94% accuracy, which is comparable to blood testing. Anyone over age 18
with at least one Jewish grandparent and planning on having children, should request a genetic screening kit by going to their website, www.JScreen.org. They are also encouraged to view a brief video explaining the screening process as well as sign a consent form. The test request is normally coordinated with a physician. Test results are sent to the couple in approximately four weeks and a followup consultation with a genetic counselor is arranged to review results.

Jacob Klausner


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Saliva Fertility Monitors

Women traditionally track their fertility on a calendar. Those experiencing difficulty conceiving have used other means, including urine-based ovulation monitoring strips – despite their messiness and cost, to improve their chances of conceiving. More information about these kits can be found on: http://www.hometest4.com/pregnancy-test/female-fertility-test.

Less widely known, are saliva-based monitoring kits, which we report on here. Although such kits have been around many years, they have gained little market share despite their lower cost, reduced messiness and earlier notification of estrogen surge – correlating with ovulation. Utilization stands to increase due to recent European research findings reporting high efficacy and renewed marketing efforts by manufacturers.

Interestingly, both type tests rely on the same biology. As ovulation approaches, estrogen levels surge, leading to higher sodium levels in saliva and cervical fluids. Increased salinity leads to microscopic crystal formation in dry saliva — fern-like patterns (ferning) detected with a handheld microscope and a light. The units have a lipstick case design and testing takes about five minutes.

Currently two companies produce multiple-use, saliva-based kits; Hilin Life Products of Newark, N.J., and Fairhaven Health of Bellingham, Wash. It’s reported that German firm, Geratherm Medical AG, plans to enter the U.S. market with OvuControl. While the companies advocate the kits for conception purposes, they advise against their use for birth-control.

Hilin Life ProductsHilin Life ProductsKnoWhen60X$59.99
Fairhaven Healthwww.fertile-focus.comFertile-Focus55X$27.95
Geartherm Medical AGTBDOvuControl50XTBD

While the major benefits to these tests relate to convenience and cost, there are some reservations. They include research findings that fail to demonstrate any link between ferning and ovulation, variability in ferning timing which compromises its utility, and ferning is completely absent in some women. In addition, there is a learning curve in being able to recognize ferning. Apparently, women with difficulty conceiving should still rely on more than a single ovulation monitoring system in order to improve their chances.

Jacob Klausner

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Google Video Chats With Doctors

If you’re one of millions of people who has done a Google search of your symptoms to try to figure out why you’re not feeling well, Google now hopes to be more helpful in getting you an answer. In an attempt to benefit from the extensive searches being done to self diagnose, Google is testing a new program that allows you to video chat with a physician and supposedly receive better information. It is widely claimed that researching symptoms on the web, frequently leads to misdiagnosis. If the false diagnosis is a serious condition, it can elicit unfounded anxiety, a condition that’s been termed “cyberchondria.”

At the present time, only individuals in Massachusetts and California have access to this trial service where Google will pick up the tab for the chat. To help in the launch, Google has teamed up with licensed physicians from Scripps Medical and One Medical. Though similar services exist, Google believes it’s got an edge by allowing the physician to view the individual. If they’re correct, its official launch will likely impact this field.

Although several headwinds to this platform may be cited, my main concern relates to tremendous reliance on sophisticated technology in current medical practice. It’s common today for a physician, despite being fully aware of the medical history and the patient standing before them, to request a series of laboratory tests and/or radio-graphic imaging before proposing a diagnosis.
With this practice playing a part in Google platform’s, aside from the straight forward case, the best a clinician could provide is a list of several possible diagnoses. Will individuals be inclined to open their Google Wallet for a list of conditions? Time will tell.

The way the Google platform now works is fairly straight forward. When doing a search of symptoms, a pop-up icon appears with the message:“Based upon your search query, we think you are trying to understand a medical condition. Here you can find healthcare providers who you can visit with over video chat. All visit costs are covered by Google during this limited trial. Talk with a doctor now.”

Since last year, Google has employed some health video chats in its Google Helpouts platform. Here “providers” schedule a time to teach or offer advise for a predetermined fee. In the US, the health care industry is over $3 trillion in size and in developed economies it regularly makes up 10% of the GNP. If Google is able to succeed with the platform, then even tapping into a fraction of the health care market, could be very beneficial for the company and hopefully patients as well.

Jacob Klausner

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Anemia Home Test Shows Promise

 The hemoglobin of our red blood cells carries oxygen to tissues throughout the body and is normally taken for granted until the level drops and anemia results. This may cause mild symptoms such as dizziness, tiredness and weakness or far more serious cardiac symptoms and even permanent cognitive deficits in children.

 It is estimated that as much as one third of the world’s population are at risk of developing anemia. In the U.S., this translates to 85 million people being at risk while 5 million actually are affected. Managing anemia, requires the drawing of blood by a skilled phlebotomist, followed by analysis by a trained laboratory technician. Since all this requires specialized equipment, testing until now has been limited to hospitals, medical offices or laboratories. Further negatives may include the need for blood drawing on a periodic basis, which can sometimes be painful.

 A just published study out of Georgia Institute of Technology and Emory University, reports on an at home, self-administered, inexpensive, disposable, simple plastic device that measures hemoglobin without even needing electricity. The study involved 238 adults and children with various levels of anemia who also underwent standard blood testing for comparison.

 The device draws up a small drop of blood by capillary action, similar to the way a diabetic performs a finger stick. Exactly 5 micro liters of blood is mixed with a precise amount of a reagent solution to produce a characteristic color that is determined by the hemoglobin level. In less than a minute, test results are achieved by matching colors ranging from blue to red. For those who are color-blind or simply color-challenged, an optional smart phone app has been developed which estimates the hemoglobin level and can then transmit the information.

 Individuals who will benefit most from hemoglobin home testing are those who require ongoing management of blood anemias, including sick-cell anemia, aplastic anemia and thalassemia. In addition, cancer patients receiving chemotherapy, individuals with kidney failure and those with chronic inflammatory-immunologic disorders will also benefit.

 The results of the FDA supported study demonstrated that the device has sensitivity levels greater than 90% in individuals with mild and severe anemia. While the device currently costs only half a dollar to produce, it still requires FDA approval and is expected not to make it to market shelves until 2016.


Photo shows the two parts of the anemia test device assembled.

Jacob Klausner

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FDA Approves New Colon Cancer Screening Home Test

We first reported this past April on a large scale study of Cologuard, a new multiple target home test for colon cancer. The DNA and blood-based test was shown to be more accurate than any screening test currently on the market. Last week, Exact Sciences, the company behind Cologuard, announced FDA’s decision to approve the test.

 In an unprecedented move, the Centers for Medicare and Medicaid Services (CMS) concurrently proposed that Cologuard be covered nationally by these programs. Normally, CMS begins its evaluation for coverage of new technology, only after the FDA submits their approval. It is anticipated that by November, Cologuard will receive final approval for coverage by other medical insurance programs. Cologuard will be available to patients without insurance at a cost of $599.

 The CMS has proposed that medical insurance companies cover the test for individuals aged 50 to 85 who are of average risk and have no signs or symptoms of colon disease. It still remains to be determined how often the test should be performed, how to deal with false positives or how to correlate it with a colonoscopy procedure.

 Exact Sciences has created the website www.CologuardTest.com and is planning to make the test available in select European markets once it receives CE Mark approval. The test which is conveniently performed at home, will be available to patients through their medical providers who will also receive the results. More information about the importance of colon cancer screening can be found on the company’s website, www.beseengetscreened.com. According to the U.S. National Cancer Institute, almost 50,000 people died of colon cancer in the U.S. last year and although it is considered the most preventable cancer, it is also the least prevented due failure in following screening guidelines.

 Jacob Klausner

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