23andMe granted authorization by FDA to market first direct-to-consumer genetic test

Limited to Bloom Syndrome and autosomal recessive disorders
February 23, 2015

23andMe, Inc., a personal genetics company formerly forced by the FDA to halt sales of its direct-to-consumer Personal Genome Service, has now been granted authority by the FDA to market the first direct-to-consumer genetic test under a regulatory classification for novel devices.

The new permission is limited to Bloom Syndrome and autosomal recessive disorders.

The approval came in under the FDA’s “de novo classification option” for “novel devices of low to moderate risk that are not substantially equivalent to an already legally marketed device,” explained 23andMe in a statement.

The FDA is also reclassifying autosomal recessive carrier screening tests, with the intention to exempt such carrier tests from FDA premarket review.

More work to do first

However, 23andMe will not immediately begin returning Bloom syndrome Carrier Status test results or other health results to customers until it completes the regulatory process for additional test reports and can offer a more comprehensive product offering, according to the statement.

“This is a major milestone for our company and for consumers who want direct access to genetic testing,” said Anne Wojcicki, 23andMe CEO and co-founder. “We have more work to do, but we remain committed to pursuing a regulatory path for additional tests and bringing the health reports back to the US market.”

Bloom syndrome is a rare disorder that is more common in people of Central and Eastern European, or Ashkenazi, Jewish background. One in 107 people of Ashkenazi Jewish descent is a carrier for Bloom syndrome. The disorder is characterized by short stature, sun-sensitive skin changes, and an increased risk of cancer. According to the National Institute of Health, this condition is inherited in an autosomal recessive pattern, which means both copies of the gene in each cell have mutations.

23andMe says it has more than 850,000 customers worldwide with more than 80 percent consented to participate in research, including learning about your ancestry, which is not covered under FDA regulations.

 

http://www.kurzweilai.net/23andme-granted-authorization-by-fda-to-market-first-direct-to-consumer-genetic-test

A wearable, 3D-printable temperature sensor

February 23, 2015

University of Tokyo researchers have developed a “fever alarm armband,” a flexible, self-powered wearable device that sounds an alarm in case of high body temperature.

The flexible organic components developed for this device are well-suited to wearable devices that continuously monitor vital signs including temperature and heart rate for applications in healthcare settings.

The new device combines a flexible amorphous silicon solar panel, piezoelectric speaker, temperature sensor, and power supply circuit created with organic components in a single flexible, wearable package.

Constant monitoring of health indicators such as heart rate and body temperature is the focus of intense interest in the fields of infant, elderly and patient care.

A design challenge

Sensors for such applications need to be flexible and wireless for patient comfort, maintenance-free, cheap enough to permit disposable use to ensure hygiene, while not requiring an external energy supply.

Conventional sensors based on rigid components are unable to meet these requirements, so the researchers to developed a flexible solution that incorporates organic components that can be printed by an inkjet printer on a polymer film.

The researchers say the fever alarm armband is the first organic circuit able to produce a sound output to provide audible information when the flexible thermal sensor detects a pre-set value within the ranges of 36.5 ºC to 38.5 ºC. It’s also the first to incorporate a power supply circuit, which increases illumination by more than 7 times in indoor lighting conditions.

“Our fever alarm armband demonstrates that it is possible to produce flexible, disposable devices that can greatly enhance the amount of information available to carers in healthcare settings,” said research group leader professorTakao Someya.

“We have demonstrated the technology with a temperature sensor and fever alarm, but the system could also be adapted to provide audible feedback on body temperature, or combined with other sensors to register wetness, pressure or heart rate.”

Could Apple be on the Cusp of a New Era of Remarkable Innovation?

1AF 2 JONY IVE

Close to a year ago we posted a report titled “Jonathan Ive: We’re at the beginning of a remarkable time.” The report was based upon a Time’s article. The most interesting moment in that article was when Ive stated that Apple was at the beginning of a remarkable time, when a remarkable number of products would be developed. Ive further added that when you think about technology and what it has enabled us to do so far, and what it will enable us to do in future, we’re not even close to any kind of limit. It’s still so, so new.

 

Who could have ever imagined at that very moment in time that Jonathan Ive was already hard at work designing a future electronic car? In fact, Apple was in the process of hiring close to 200 people — both from inside the company and from potential competitors like Tesla — to develop technologies for an electric car. Some of those technologies came to light in a series of 2014 patents that we covered in last week’s report titled: The iCar: It’s Popcorn for your Mind.

 

This week we posted an extensive Patently Legal report titled “Apple Sued by Advanced Lithium Battery Maker on Several Counts Including Employee Raiding & Misappropriation of Trade Secrets.” The company suing Apple is known as “A123” and our report was based on their formal complaint filed with a Massachusetts court. The lawsuit was the closest thing to a smoking gun that Apple was indeed on the fast track to developing a next generation electric car battery.

 

2 AF 2 - A123 SUES APPLE

 

When reviewing the company’s web site it’s evident that 99% of what A123 develops is advanced electric car batteries. Only a tiny slice of their work is dedicated to developing batteries related to portable and medical devices.

 

On another front this week we posted a report titled “Former GM CEO Doesn’t Think Apple’s Move into Cars is Wise.” While former GM CEO Dan Akerson was making his statements about Apple, a report filed two days earlier noted that GM was actively hiring 8,000 programmers.

 

While the majority of GM’s new programmers are reportedly working on a new online store for selling cars and options, it’s clear that Detroit fully understands that future cars are going to be more about delivering quality consumer gizmos, super advanced sensors, high-end Heads-Up-Display systems, electric batteries and beyond. They’re racing to catch up and come to grips with the changes and challenges that will be knocking on their doors over the next decade.

 

In that context, Dan Akerson’s commentary this week was really more about the fear of Apple entering the auto industry. Yet knowing Apple, they’ll reinvent the development cycles of car manufacturing and place priority on finding and delivering breakthrough technologies so that a U.S. car company can once again lead in this sector instead of  following the likes of Toyota, Nissan and others.

 

2ASF 2

USA TODAY reported yesterday that Thilo Koslowski, vice president and automotive practice leader with tech advisors Gartner Inc. was on record stating that “Cars are the ultimate mobile device, and anyone that’s in technology should get more serious about this space,” noting that the automobile has ceased to be defined as a mechanical device and is now viewed “as a software and IT-designed machine that happens to have four wheels.”

 

Koslowski sketched out a near future where perhaps fleets of sleekly designed and likely autonomous cars pick up and drop off passengers in dense urban centers. If that comes to pass,traditional automakers such as Ford and GM will be competing for those contracts with the likes of Google and Apple … Or collaborating.

 

In the background this week was also the lunacy of hunting down mini vans with LIDAR systems that were rented by Apple. It was like watching a UFO cult going mad photographing these vans. Then again, there’s always a circus-like side show to news stories like this. One percent fact, ninety-nine percent speculation.

 

The whole thing blowing up in the press as it did this week about Apple entering the electric car was surreal. Think back to just a few weeks ago when Apple’s CEO Tim Cook was so proud to announce during their Financial Conference Call that CarPlay would be rolling out with 30 automotive brandslater this year.

 

With this week’s rumors and quasi facts bouncing around about Apple racing into the electric car business – I kept wondering to myself, why would any car company want to support CarPlay going forward with this latest news on the table? Why would Nissan or Toyota who make electric cars want to support Apple’s infotainment system when Apple’s larger business plan is to compete with them directly for the whole car itself?

 

In the end, do we really know what Apple’s plans are for an electric car? While the news blitz was exciting to read about with speculative dates thrown around like 2020, we really don’t know what Apple is up to. It’s just interesting noise like last year’s short-lived buzz about Apple TV.

 

In late 2013 Apple’s CEO was trying to enter 2014 with everyone buzzing about Apple TV and how Apple would take it to the next level. His first big media push began with Brian Williams on NBC.

 

3af Tim Cook on TV

Then Cook added fuel to the fire about Apple TV when talking to Charlie Rose. Apple was definitely banging the war drum that Apple was going to take TV into a whole new era of innovation. What has happened since? Nothing.

 

That was Cook’s first concerted effort of bringing back the “vision” thing to Apple after Steve Jobs passing. Yet after giving two major TV network interviews psyching up the market about Apple TV, it disappeared into the night without a trace. All of that marketing momentum, lost. All that Apple delivered in 2014 was a few more Apple TV channels that were primarily for the U.S. market.

 

So as the Apple Watch launches in April, can Apple actually be working on the next leap for Apple TV and an electric car at the same time realistically? On the one hand Jony Ive’s statement last year in Time magazine about Apple being at the beginning of a remarkable time, when a remarkable number of products would be developed confirms that they can indeed juggle multiple major projects.

 

On the other hand, Apple’s new way of talking-up internal projects like Apple TV so publicly on television and then failing to deliver it in a timely manner is oddly new. The same can be said about having news of an electric car exploding in the press without control. In contrast, Steve Jobs was a master of keeping Apple’s mystique at a very high level so that he could control and build interest and momentum about a new product prior to launch. He never talked about projects that were too far into the future.

 

In the end could Apple be on the cusp of a new era of remarkable innovation? Yes of course and they’re likely already beyond the cusp at this point in time. The only disconcerting element surrounding recent news events is how Apple isn’t controlling the news of their vision as they once did.

 

Talking about what’s to come too early is a set up for sure disappointment like vaporware was in the 1990’s. That’s why Jobs stayed clear of that trap. Why Cook and Ive seem to be jockeying for popularity in the press as being the visionary guy at Apple is an oddity lately.

 

We’re seeing long interviews with Apple’s Tim Cook (Charlie Rose) and Ive (with the New Yorker) and rarely interviewed together. Although it would serve Apple better if there was a single strong voice for the company like it use to be, it was Steve Jobs who set up the company so that Ive would be able to be independent of Cook. We’re now seeing how the two are on different tracks publicly. Whether that’s good or bad for Apple is something that we’ll only understand over time.

 

In the meantime, get ready for Apple to take us into a new innovative era where a stream of new products will excite us over and over again. It all starts with Apple Watch in April followed by a possible new iPad Pro and Apple’s new music streaming service. And that’s only for the first half of 2015. It’s sure shaping up to be a great year for new Apple products.

http://www.patentlyapple.com/patently-apple/2015/02/could-apple-be-on-the-cusp-of-a-new-era-of-remarkable-innovation.html

Statins Do Not Lower Risk Of Parkinson’s Disease: Study

Millions of people across the world take statins to lower their cholesterol level and reduce the risk of heart disease and stroke. Statin use, however, may not reduce the risk of Parkinson’s disease, reveals a new study.

Previous research studies suggested that the use of statins also helped in lowering the risk of Parkinson’s disease. However, a joint study conducted by researchers at the National Institute of Environmental Health Science and Penn State College of Medicine showed that statins may not actually protect a person from Parkinson’s disease.

Xuemei Huang, a professor of neurology at the Penn State College of Medicine, who is also the vice chair of the research, cited the findings of prior studies and suggested that low levels of low-density lipoprotein (LDL), or bad cholesterol, are linked with reduced risk of Parkinson’s disease. However, previous studies did not take into consideration the cholesterol level of patients prior to statin use.

The researchers took into account the level of blood cholesterol, Parkinson’s disease status and medication taken by the patients from an ongoing and long-term Atherosclerosis Risk in Communities study.

Levels of cholesterol were noted every three years after 1987 to 1989, right before statin started to be used widely.

The researchers observed that levels of total cholesterol and bad cholesterol were linked to Parkinson’s disease. However, statin use did not reduce Parkinson’s disease, but instead increased the risk for the ailment in the long term.

Even though the analysis was based on a small number of Parkinson’s disease cases, the researchers claimed, the preliminary findings contradict that statins provide a protection against Parkinson’s disease. Statin may be beneficial for the heart, but it does not benefit the brain.

“One possibility is that statin use can be a marker of people who have high cholesterol, which itself may be associated with lower PD risk. This could explain why some studies have found an association between use of these medications and low incidence of PD. Most importantly, this purported benefit may not be seen over time,”said Huang.

More than 1 million Americans suffer from Parkinson’s disease and it also affects between 4 million and 6 million people across the globe. The actual cause of the disease is unknown and it does not have a cure. However, medicines are given to patients to control the symptoms of the disease.

The findings of the latest study was published in the journal Movement Disorders.

http://www.techtimes.com/articles/34497/20150222/statins-do-not-lower-risk-of-parkinsons-disease-study.htm

Does Unemployment Change Your Personality?

Brain area for speech shuts down when talking

A brain area, long recognised as the command centre for human speech, actually shuts down when we talk, scientists have found.

Broca’s area of the brain has been recognised as the command centre for human speech, including vocalisation.

Scientists at University of California, Berkeley and Johns Hopkins University in Maryland have now challenged this long-held assumption after they found that Broca’s area actually switches off when we talk out loud.

The discovery has major implications for the diagnoses and treatments of stroke, epilepsy and brain injuries that result in language impairments.

“Every year millions of people suffer from stroke, some of which can lead to severe impairments in perceiving and producing language when critical brain areas are damaged,” said study lead author Adeen Flinker, a post-doctoral researcher at New York University who conducted the study as a UC Berkeley PhD student.

“Our results could help us advance language mapping during neurosurgery as well as the assessment of language impairments,” Flinker said.

Flinker said that neuroscientists traditionally organised the brain’s language centre into two main regions: one for perceiving speech and one for producing speech.

“That belief drives how we map out language during neurosurgery and classify language impairments,” he said.

“This new finding helps us move towards a less dichotomous view where Broca’s area is not a centre for speech production, but rather a critical area for integrating and coordinating information across other brain regions,” he said.

Flinker and fellow researchers found that Broca’s area – which is located in the frontal cortex above and behind the left eye – engages with the brain’s temporal cortex, which organises sensory input, and later the motor cortex, as we process language and plan which sounds and movements of the mouth to use, and in what order. However, the study found, it disengages when we actually start to utter word sequences.

“Broca’s area shuts down during the actual delivery of speech, but it may remain active during conversation as part of planning future words and full sentences,” Flinker said.

The study tracked electrical signals emitted from the brains of seven hospitalised epilepsy patients as they repeated spoken and written words aloud.

Researchers followed that brain activity – using event-related causality technology – from the auditory cortex, where the patients processed the words they heard, to Broca’s area, where they prepared to articulate the words to repeat, to the motor cortex, where they finally spoke the words out loud.

The findings are published in the Proceedings of the National Academy of Sciences.

(This article was published on February 22, 2015)

Microsoft OneNote gets handwriting support on the iPad, OCR everywhere

  • Feb 20, 2015 6:14 AM

Google isn’t the only company furiously adding improvements to iPad apps. Microsoft recently announced a major feature update to OneNote for Apple’s slate, adding a standard feature found on OneNote’s other platforms: digital pen support. The latest version of OneNote for iPad brings handwriting and drawing, allowing you to make sketches on your slate or just doodle during Physics 101.

All handwriting and drawing operations are kept under the Draw tab, which is available in each note. Just hit that tab and you can annotate notes, highlight text, or draw over an image. Microsoft offers sixteen different pen colors for compulsive color coders.

onenoteipad2
OneNote for iPad now features handwriting detection.

The iPad’s new drawing feature also has palm rejection for anyone who likes to put their palm to pad when writing or drawing. To customize this feature to your writing style, click the hand icon in the upper right corner under the Drawtab. You’ll have six choices (three each for righties and lefties) for how you hold a pen to help OneNote adapt to you.

For anyone opposed to the use of a stylus, you can also draw, highlight, and annotate with your finger—although results may be a bit messier than with a pen.

If you want to scroll through a note, remember to go back to another tab such as Home or View, as the Draw tab is all about scribbling around the content currently on-screen.

Beyond handwriting for the iPad, Microsoft says optical character recognition is now available across its entire range of OneNote apps from Office Online to iOS. Just snap or scan a picture that includes some text, give Microsoft’s cloud a few minutes, come back to your image, and the text should be fully searchable.

The impact on you at home: The updates to the iPad and widening OCR to all of Microsoft’s apps makes it much easier to pick-up where you left off on the device of your choosing. That’s especially true for handwriting, which is a popular use case for Microsoft’s note-taking app. It also shows that Microsoft is serious about cross-platform development, ensuring its software works just as well on an iPad as on a Microsoft device like the Surface Pro 3 or a Lumia phone.

http://www.pcworld.com/article/2886664/microsoft-onenote-gets-handwriting-support-on-the-ipad-ocr-everywhere.html

New study reveals mobile phone ‘dependency’ issue with users

February 20, 2015 09:57 PM

LONDON, Feb 20 — It’s no secret that smartphones and other screens can be addictive, but a recent survey of US and UK smartphone owners sheds some light on the extent of this dependency. Conducted by the Apigee Institute and the Sandford University Mobile Innovation Group, the study places a particular emphasis on the importance of the device in users’ social lives.

In order to explore the effects of smartphones on those who use them the most, researchers honed in on “top app users,” a category defined in the study as the top 25 per cent of smartphone owners based on their frequency of use of apps in 12 different categories. The signs of dependency were especially strong within this group of heavy users.

There’s no denying that Facebook and Twitter have become important vectors of 21st-century social life, but some of the survey findings are nonetheless surprising. Twenty-one percent of top app users said they would be unable to maintain a relationship with a significant other without the apps on their phone, while 19 per cent said they would not be able to make new friends.

The smartphone has become a familiar companion for top app users, 55 per cent of whom say they check at least one app hourly or more, even if it gets in the way of face-to-face social interactions. A majority of them even admit to engaging with their phones “nearly all the time,” including when they are having dinner with others.

Far from wanting to curb their screen time, 90 per cent of the users in this category say they intend to download just as many apps next year as they did over the past 12 months, while 45 per cent expect to download even more.

The authors of the study suggest that top app users described as “a sharp tip to the mobile use spear” exhibit behaviors that are likely to extend to all smartphone owners over time. They note that 30 per cent of all users surveyed said they plan to increase their smartphone usage in 2015, while 32 per cent said they plan to download a higher number of apps than in the previous year.

For now, it is clear that smartphones have already modified a number of their owners’ social behaviors: 92 per cent of people surveyed say the device has changed the way they connect with their friends, while 49 per cent said it has changed the way they date. But other aspects of everyday life are also affected: 58 per cent of respondents say smartphone apps have led them to manage their health differently, while 84 per cent say the device has changed the way they shop.

On a related note, the study found that the majority of smartphone users expect many of the businesses and organisations they interact with to offer “key products and services” through apps over the next two years. Smartphone owners are particularly likely to expect this from banks (92 per cent), restaurants (91 per cent), grocery stores (90 per cent), educational institutions (86 per cent) and even doctors (75 per cent).

The study is based on a survey of 1,000 US and UK smartphone owners carried out between September 30 and October 7, 2014. — AFP-Relaxnews

http://www.themalaymailonline.com/tech-gadgets/article/new-study-reveals-mobile-phone-dependency-issue-with-users#sthash.ecszRTeD.dpuf

One of the coolest things about the Apple Watch may be a feature no one really talks about

LISA EADICICCO0FEB 21, 2015, 11.06 PM

Apple flooded us with information about what its first smartwatch will be able to do when it announced it back in September.

It will be able to share your heartbeat, prompt you to stand up when you’ve been sitting all day, and, of course, show you the time in a bunch of different ways.

But, one of its most interesting capabilities is a somewhat minor one that’s easily overlooked.

Apple’s industrial design chief Jony Ive talked about the company’s upcoming watch in a recent interview with The New Yorker.

Ive described how the Apple Watch’s screen will be different than that of a phone – it won’t light up the same way the iPhone’s display does when it turns on.

According to Ive, the screen for the watch uses deeper blacks than that of the iPhone. Ive thinks that an entire display, especially for something as small as a watch, shouldn’t have to light up. Rather, the screen should only highlight the specific thing you’re looking at.

“The whole of the display comes on,” he said to The New Yorker in reference to the iPhone 6. “That, to me, feels very, very old.”

But since the Apple Watch’s screen shows deeper and darker blacks than the iPhone’s, it’ll make the screen look like it has very little, if any, frames surrounding it. The New Yorker cited the neon jellyfish images Apple showed on the watch during its launch as an example. Since the display would be so dark and it would blend into the bezels, it would make it seem like the jellyfish is suspended in space rather than just being pictured on a screen.

AppleButterfly

Apple

 

Here’s how The New Yorker described it:

On a current iPhone screen, a jellyfish would be pinned against dark gray, and framed in black, and, Ive said, have “much less magic.”

It’s a small detail, but an interesting one, and it’s something that could differentiate the Apple Watch from its competitors.

Throughout the smartwatch category in general, there’s been some question as to whether or not a small screen on your wrist could serve any real purpose. It’s unclear whether or not the Apple Watch will answer that question, but based on Ive’s words it at least seems like Apple is trying by thinking about screens differently on watches versus phones.

This radical air-filter design could help Beijing and L.A. residents breathe easily

February 20, 2015

Stanford’s Yi Cui and his students have turned a material commonly used in surgical gloves into a low-cost, highly efficient air filter that could be used to improve facemasks and window screens, and maybe even scrub the exhaust from power plants.

Finding himself choked by smog from produced by automobiles and coal power plants on trips to China, Yi Cui, an associate professor of materials science and engineering at Stanford, and his graduate students set to work designing an inexpensive, efficient air filter that could ease the breathing for people in polluted cities.

Using surgical-glove material in an air filter

Cui’s team works on batteries, not air filters, so they were able to think differently. They started by looking for polymers that would have a strong attraction to the main components of smog — especially, particle matters that are smaller than 2.5 microns, known as PM2.5. These pose the greatest risk to the human respiratory system and overall health; current filtration systems that can remove them from the air are very energy-intensive.

It turned out that polyacrylonitrile (PAN), a material commonly used to make surgical gloves, met these requirements. Using a technique called electrospinning, the researchers converted liquid PAN into spider-web-like fibers that are just 200 nanometers in diameter (about a thousandth the diameter of a human hair).

They applied a high voltage to the tip of a syringe containing a polymer solution and grounded the fibers on a metallic screen. By a simple static-electricity principle, the resulting electrical force pulled the polymer solution into the polymer nanofibers that lie across the mesh holes, forming an effective network for air filtration.

Built into a window

As a bonus. the final material also allows about 70 percent transparency and yet collects 99 percent of the particles. “The fiber just keeps accumulating particles, and can collect 10 times its own weight,” said Chong Liu, lead author on the paper and a graduate student in Cui’s lab. “The lifespan of its effectiveness depends on application, but in its current form, our tests* suggest it collects particles for probably a week.”

The first two immediate applications, Cui said, would probably be simple passive systems, such as personal masks and window screens, or possibly hospital air filtration systems.

“The transparency and distance between the fibers means that light and air can pass through very efficiently, which makes it a very good application for windows,” Cui said. “It might be the first time in years that people in Beijing can open their window and let in a fresh breeze. We think we could use this material for personal masks, window shades, and maybe automobiles and industrial waste. It works really well, and it might be a game-changer.”

The material might also be useful for filtering exhaust from cars, or from the smoke stacks of power plants and industrial complexes. These applications, Cui said, would require additional testing of the material to ensure that it is robust enough to withstand other acidic or toxic compounds in these types of exhaust.

The work is published in the current issue of the journal Nature Communications.

* In the study, the researchers approximated Beijing’s smog by flowing smoke from burning incense over different densities of the fiber, and later performed a field test in Beijing.


Stanford University | Stanford researchers develop new filter to combat air pollution


Abstract of Transparent air filter for high-efficiency PM2.5 capture

Particulate matter (PM) pollution has raised serious concerns for public health. Although outdoor individual protection could be achieved by facial masks, indoor air usually relies on expensive and energy-intensive air-filtering devices. Here, we introduce a transparent air filter for indoor air protection through windows that uses natural passive ventilation to effectively protect the indoor air quality. By controlling the surface chemistry to enable strong PM adhesion and also the microstructure of the air filters to increase the capture possibilities, we achieve transparent, high air flow and highly effective air filters of ~90% transparency with >95.00% removal of PM2.5 under extreme hazardous air-quality conditions (PM2.5 mass concentration >250 μg m−3). A field test in Beijing shows that the polyacrylonitrile transparent air filter has the best PM2.5 removal efficiency of 98.69% at high transmittance of ~77% during haze occurrence.