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Harvard home testing kit for male fertility uses a smartphone app to count sperm

Harvard Develops a Cheap Smartphone Test for Male Fertility

Talk of semen and sperm is anything but a giggling business for the more than 45 million couples worldwide dealing with infertility—and more than 40 percent of those cases involve male infertility. To help such couples, Harvard medical researchers have developed a smartphone attachment that could enable easy and inexpensive home fertility tests for men. 

The new device, which resembles a chunky smartphone charging case or cradle, has a slot for a disposable microchip slide containing the semen sample. That enables men to quickly load up a sample and get back results from a custom smartphone app within five seconds. The low cost and convenience could prove revolutionary for many couples who otherwise must rely on pricey and time-consuming lab tests to get the most accurate fertility test results—an option that is often out of reach for many low-income families in both industrialized and developing countries.

“This can make home fertility testing for men as simple as home pregnancy testing for women,” says Hadi Shafiee, an assistant professor in medicine at Brigham and Women's Hospital, Harvard Medical School.  

Testing of 350 patient semen samples—including both fresh and cryopreserved samples—showed how the new smartphone device can detect abnormal semen samples with almost 98 percent accuracy. It judges semen based on two of three key indicators used by the World Health Organization: sperm count per milliliter of fluid, or concentration; and how many sperm are moving, known as motility. (The third, unused indicator, how many sperm have normal shapes, is referred to as morphology.) Additional details appear in the 22 March 2017 online issue of the journal Science Translational Medicine.

Home use seems pretty easy. Once a man has, um, downloaded his DNA package into a small cup, he simply dips the end of the microchip slide into the cup, and squeezes a small rubber bulb on the slide in order to draw the sperm sample up into the microchip. The contaminated disposable tip of the slide snaps off easily so that the microchip sample can be loaded into the slot on the smartphone attachment.

The smartphone attachment is made from materials costing just $4.45 total. These include: a 3D-printed case with a white LED to provide lighting, two extra lenses to boost the optical power of the smartphone's existing camera, a low-cost battery and some electronics plus wiring. Initial tests used Moto X, Moto G4, and LG G4 handsets, but slight device modifications could probably allow it to accommodate most phones.

The easy-to-use smartphone app relies upon proprietary software algorithms to count individual sperm and detect their movements. The app's analysis of each sample takes less than five seconds and runs entirely on the smartphone hardware, which means it does not need to spend time sending the data to a more powerful laptop computer or to cloud computing resources.

“It was challenging for us from a software perspective to do the whole analysis on the phone and to measure both motility and total sperm count in a very rapid manner,” Shafiee says.

The Harvard researchers hope to improve the software so that it can eventually detect abnormal sperm shapes and disregard similar-size cells in the semen sample. Shafiee declined at this time to comment on whether the software relies on popular and powerful machine learning techniques. (His only comment on that subject came during a marathon session of back-to-back phone interviews: “You're the first reporter to talk about that.”)

Shafiee emphasized that the new smartphone-based test could fill a “gap” that exists in terms of home fertility tests for men. Products such as FertilMARQ and SpermCheck use a chemical staining approach. Trak, another product approved by the U.S. Food and Drug Administration (FDA), uses a small spinning centrifuge to measure sperm concentration in a microfluidic device. But all these products only measure sperm concentration, whereas the Harvard device can also measure motility.

Perhaps the closest competitor for the Harvard smartphone device is the YO Home Sperm Test developed by Medical Electronic Systems. The $49.95 home testing kit became available for purchase in early 2017 and is marketed as “the first FDA-cleared Smartphone based solution for testing your motile sperm.”

But Shafiee seemed skeptical of Medical Electronic Systems’ test after looking at the documentation filed with the FDA. He pointed out that the YO test relies on a new measure called “motile sperm concentration” that describes a “normal” cutoff point of 6 million motile sperm per milliliter. By comparison, WHO standards measure normal motility as having greater than 40 percent motile sperm in each semen sample. That leaves open the possibility that the YO test could rate certain samples as “normal” that would be considered abnormal under WHO standards.

“Imagine a sample with 100 million sperm per ml and the motility is 10 percent,” Shafiee explains. “Based on clinical practice and WHO guidelines, this is abnormal because it falls below 40 percent on motility—but YO would identify it as healthy.”

The YO test’s accuracy was also mainly compared with that of another proprietary Medical Electronic Systems lab test that relies upon the same, somewhat questionable “motile sperm concentration” measure. The Harvard team compared its smartphone device’s results with the current standard methods used to diagnose male infertility: manual microscope-based testing, and computer-assisted semen analysis (CASA). And last but not least, Shafiee also pointed out that the Harvard team's research has just been published in a peer-reviewed journal. 

There may be plenty of market opportunities for the Harvard device in any case. Besides couples dealing with infertility, there are more than 33 million couples with male partners who underwent vasectomy as a form of contraception. Vasectomy procedures in the U.S. number between 175,000 and 550,000 procedures per year. The Harvard smartphone device or similar devices could help such men regularly check their semen samples to make sure that their vasectomy holds up—a follow-up practice that is highly recommended but often ignored because of the inconvenience of current testing methods.

Animal breeders might even benefit from a similar form of smartphone-based testing kit that lets them perform fertility tests for livestock on the spot instead of waiting on time-consuming transfers to equipped labs. But “considering the differences between human semen and animal semen in terms of sperm concentration, motility, and sample volume, the current version of the smartphone-based semen analyzer would need to be augmented for applications in animal breeding,” say the Harvard researchers. In other words, we're going to need a bigger sampling device.

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DIY Lego Robot Brings Lab Automation to Students

In an attempt to get robotics-minded kids more interested in life sciences—and vice versa—Stanford researchers have designed DIY robot kits for automating chemistry experiments. Using a Lego Mindstorms EV3 set and some plastic syringes, students can build robots that measure and transfer liquids, automating their their classroom laboratory assignments. Instructions for building the robot were published Tuesday in the journal PloS Biology.

“What’s key for me is that we merge robotics education—which is loved by kids and teachers—and life sciences education,” says Ingmar Riedel-Kruse, a bioengineer at Stanford who led the project. “Learning should be playful. And maybe it’s more fun to engage in chemistry or biology experiments if you do it with a playful robot.”

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Headshot of a smiling woman with blond hair.

Why Mary Lou Jepsen Left Facebook: To Transform Health Care and Invent Consumer Telepathy

Mary Lou Jepsen has done well for herself in the tech industry. Most recently she was an engineering executive at Facebook working on its Oculus virtual reality gear; before that she spent three years at Google X, running advanced projects on display technology.

These were good jobs, and Jepsen liked them. “I said, never again, not another startup!” she told IEEE Spectrum in an interview at SXSW Interactive. “But then I had a big enough idea that I had to leave my extremely cushy job at Facebook,” she says. “The VR stuff was pretty cool. But transforming health care and telepathy… there’s no contest.”

Yep, transforming health care and telepathy, those are the items on her to-do list. Jepsen plans to achieve both goals with a cheap wearable device that her engineers are now tinkering with in the lab. And then there’s the side benefit of reinvigorating the tired consumer electronics industry, which Jepsen thinks is due for the next big thing. 

Jepsen was at SXSW to give a talk about Openwater, her new startup. While the company is still conducting R&D to decide on its first products, Jepsen feels the need to speak out now about what she’s building and how she thinks her technology could radically change society. She wants to give people fair warning and time to think about what’s coming. “I know it seems outlandish to be talking about telepathy, but it’s completely solid physics and mathematical principles—it’s in reach in the next three years,” she says.  

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A man with thin legs sits in a chair while a nurse stands nearby.

One Small Step for a Paraplegic, One Big Step Toward Reversing Paralysis

In a hospital in Switzerland, permanently paralyzed people are now learning to walk again with the help of stimulating electrodes implanted in their spines. For Grégoire Courtine, professor of neuroprosthetics at the Swiss Federal Institute of Technology Lausanne (EPFL), this day has been a long time coming. “It took us 15 years to get from paralyzed rats to the first steps in humans,” he says. “Maybe in 10 more years, our technology will be ready for the clinic.”

Courtine has made it his mission to reverse paralysis. He started 15 years ago with those paralyzed rats, putting tiny electrical implants into their spines to stimulate nerve fibers below the site of their spinal cord injuries. When the implant’s electrodes were powered up, Courtine’s team could train the rats, using a harness to support the animals while encouraging them to walk forward. “After two months of training, a rat that was completely paralyzed walked to the delicious piece of Swiss chocolate that we put at end of track,” Courtine remembers.

A rat held upright in a harness walks forward on its back legs.
Photo: EPFL
Gregoire Courtine's early studies enabled rats with paralyzed hind limbs to walk.

This miraculous feat was possible because the rat’s nervous system adapted to its injury with the help of the stimulation and training; the few nerve fibers around the spinal cord injury that had been spared from damage regrew and reorganized to bring commands from the rat’s brain to its legs. 

But Courtine had no intention of stopping with rats, and worked to optimize the technology in monkeys. Now his research has reached an important milestone, as the first human clinical trial of the spinal implant system has just begun at the Lausanne University Hospital. Courtine described the new trial and the research that led to it at a talk at SXSW Interactive, the massive tech festival underway in Austin, Texas, and after the talk he sat down with IEEE Spectrum to get into the technical details. 

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An illustration shows many twisting DNA double-helices

With Synthetic Biology Software, Geneticists Design Living Organisms From Scratch

The first time geneticist Jef Boeke designed a synthetic chromosome, he sometimes wrote and edited its DNA sequence in a Microsoft Word document. 

His goal was to create a slightly altered version of yeast chromosome 9, the shortest of the 16 chromosomes that make up the organism’s genome and contain all the operating instructions for life. He started with the short chromosome’s right arm, but even this task was daunting. Its DNA code consisted of 90,000 “letters,” the molecules referred to as A, C, G, and T that are arranged in particular sequence to encode biological function.

Painstakingly, Boeke went through the code, making changes that he thought would be scientifically interesting or that would make the chromosome more stable. This misery drove him to seek help from student Sarah Richardson in his neighbor Joel Bader’s lab, who wrote scripts to automate some of the most tedious steps. This was the embryonic beginning of what was to become the genome design software called BioStudio.

DNA molecule shows the letters that pair up to form the rungs on a twisted ladder, with G pairing with C, and A pairing with T.

Once Boeke finished his design, the synthetic chromosome was constructed by taking short snippets of manufactured DNA and stringing them together. Then Boeke’s team checked the design by taking a normal yeast cell, swapping out its natural chromosome 9, and looking to see if it would keep functioning with a manmade chromosome inside. Nobody knew if it would work. 

It did. The results were published in Nature in 2011, and the quest to build synthetic critters from scratch took a big step forward. Boeke’s team prepared to design the other 15 chromosomes to make a completely synthetic yeast—and the world’s first completely synthetic complex organism.

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A patient lies in a hospital bed in the ICU, surrounded by machines and monitors

In Hospital ICUs, AI Could Predict Which Patients Are Likely to Die

Hospitals have an understandable goal for their intensive care units: to reduce “dead in bed” events.  

With streams of data coming from equipment that monitors patients’ vital signs, the ICU seems the perfect setting to deploy artificially intelligent tools that could judge when a patient is likely to take a turn for the worse. “A lot of hospitals are interested in developing early warning systems that can predict life-threatening events like sepsis, cardiac arrest, and respiratory arrest,” says Priyanka Shah of the ECRI Institute, a nonprofit that evaluates medical procedures, devices, and drugs for the health care industry.  

Both academic researchers and medical device companies are now trying to figure out which combinations of measurements can provide the best indication of patient deterioration, Shah says. Once that technical challenge is met, researchers will still have to prove “clinical relevance,” she says—not just proof that the technology works, but also that it can be integrated into a hospital’s workflow and that it will save money. 

Dealing with FDA regulators, set-in-their-ways clinicians, and money-conscious hospital administrators may be the more daunting part of the mission to smarten up the ICU. Because on the technical front, the research is promising. 

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Amoeba-Like Robot Programmed With DNA

Living things: They’re most inspiring, but also difficult things to try to replicate in robotics. With that aim, researchers in Japan have managed to design a tiny robotic system that moves like a living cell. The scientists described the robot last week in the journal Science Robotics.  

The system, called a molecular robot, is about the size and consistency of an amoeba. It is a fluid-filled sac containing only biological and chemical components—about 27 of them, says Shin-ichiro Nomura, a bioengineer at Tohoku University in Sendai, Japan and one of the robot’s inventors. The molecular components work in concert to stretch and change the shape of the sac, propelling it with cell-like motion through a fluid environment. The motion can be turned on and off with DNA signals that respond to light.

Other than puttering around, the amoeba-like robot can’t do much. But that’s the beauty of the invention, says Nomura. The bot serves as a vehicle to house whatever researchers can dream up: tiny computers, sensors, and even drugs. Outfitted with those tools, the system could then be used to explore the biomolecular environment. It could seek out toxins or check the surface of other cells or the content of a Petri dish. 

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Drawing of four nanobots

The Tiny Robots Will See You Now

Over the past week, we’ve highlighted a lot of big, impressive robots. Now it’s time to pay homage to their teeny, tiny counterparts.

It’s science-fiction-turned-reality: Researchers are developing micro- and nanoscale robots that move freely in the body, communicate with each other, perform jobs, and degrade when their mission is complete. These tiny robots will someday “have a major impact” on disease diagnosis, treatment, and prevention, according to a new review in Science Robotics from a top nanoengineering team at the University of California, San Diego.

The review highlights four areas of medicine where tiny robots have been successfully used in proof-of-concept studies: targeted delivery, precision surgery, sensing of biological targets, and detoxification. Of those, “active drug delivery is primarily the most promising commercial application of medical microrobots,” said paper co-author Joseph Wang, chair of nanoengineering at UCSD, in an email to IEEE Spectrum. In December, for example, researchers at ETH Zurich in Switzerland showed that a wire-shaped nanorobot could be wirelessly steered toward a location and then triggered by a magnetic field to release drugs to kill cancer cells.

To get to know these little machines better before we meet them in the doctor’s office, here are five things to know about micro- and nanorobots:

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Gold colored film atop a pink rabbit heart

Flexible Sensor Might One Day Monitor a Heart for Decades

During surgery, a heartbeat doesn’t just tell whether a person is dead or alive— it can warn of big problems that come up quite suddenly. Keeping watch for subtle irregularities in the heart’s electric activity can help save a patient’s life. But today’s technology can’t give as much detail as doctors want because it degrades too easily—which can cause serious harm to the patient. That’s why John Rogers, professor of materials science and engineering at Northwestern University, collaborated with a team of researchers to develop a new type of sensor that is much safer and more refined, and could likely survive in the body about 70 years.

These paper-thin devices are an array of 396 voltage sensors set in a 9.5- x 11.5-millimeter multilayer flexible substrate that’s meant to attach to the outside of the heart, covering a significant portion of the organ. Previous sensors arrays picked up signals through direct contact between a metal conductor and human tissue, but the new array is covered with an insulating layer of impermeable silicon dioxide. The researchers described the invention this week in Nature Biomedical Engineering.

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ALS patient uses brain-computer interface to type responses to Stanford researchers' questions

New Record: Paralyzed Man Uses Brain Implant to Type Eight Words Per Minute

“What did you enjoy the most about your trip to the Grand Canyon?” the Stanford researchers asked. 

In response, a cursor floated across a computer screen displaying a keyboard and confidently picked out one letter at a time. The woman controlling the cursor didn’t have a mouse under her hand, though. She’s paralyzed due to amyotrophic lateral sclerosis (also called Lou Gehrig’s disease) and can’t move her hands. Instead, she steered the cursor using a chip implanted in her brain.

“I enjoyed the beauty,” she typed. 

The woman was one of three participants in a study, published today in the journal eLife, that broke new ground in the use of brain-computer interfaces (BCIs) by people with paralysis. The woman who took the Grand Canyon trip demonstrated remarkable facility with a “free typing” task in which she answered questions however she chose. Another participant, a 64-year-old man paralyzed by a spinal cord injury, set a new record for speed in a “copy typing” task. Copying sentences like “The quick brown fox jumped over the lazy dog,” he typed at a relatively blistering rate of eight words per minute. 

That’s four times as fast as the previous world’s best, says Stanford neurosurgeon Jaimie Henderson, a senior member of the research team. Further improvements to the user interface—including the kind of auto-complete software that’s standard on smartphones—should boost performance dramatically.  

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The Human OS

IEEE Spectrum’s biomedical blog, featuring the wearable sensors, big data analytics, and implanted devices that enable new ventures in personalized medicine.

 
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