New Superconducting Coil Improves MRI Performance

A multidisciplinary research team led by University of Houston scientist Jarek Wosik has developed a high-temperature superconducting coil that allows magnetic resonance imaging (MRI) scanners to produce higher resolution images or acquire images in a shorter time than when using conventional coils.

Wosik, a principal investigator at the Texas Center for Superconductivity at UH, said test results show the new technology can reveal brain structures that aren’t easily visualized with conventional MRI coils. He also is a research professor in the UH Department of Electrical and Computer Engineering.

The cryo-coil works by boosting the signal-to-noise ratio (SNR) – a measure of the strength of signals carrying useful information – by a factor of two to three, compared with conventional coils. SNR is critical to the successful implementation of high resolution and fast imaging.

Wosik said the cryo-coil reveals more details than a conventional coil because of its enhanced SNR profile. Where a conventional coil does not have enough sensitivity to “see,” a superconducting coil can still reveal details. These details will remain hidden to conventional coils even when image acquisition is repeated endlessly.

For the initial tests, the probe was optimized for rat brain imaging, useful for biomedical research involving neurological disorders. But it also has direct implications for human health care, Wosik said.

“Research in animal models yields critical information to improve diagnosis and treatment of human diseases and disorders,” he said. “This work also has the potential to clearly benefit clinical MRI, both through high quality imaging and through shortening the time patients are in the scanner.”

Results from preliminary testing of the 7 Tesla MRI Cryo-probe were presented at the International Symposium of Magnetic Resonance in Medicine annual meeting in May. The coil can be optimized for experiments on living animals or brain tissue samples, and researchers said they demonstrated an isotropic resolution of 34 micron in rat brain imaging. In addition to its use in MRI coils, superconductivity lies at the heart of MRI scanning systems, as most high-field magnets are based on superconducting wire.

In addition to Wosik, collaborators on the project include Ponnada A. Narayana, director of the Magnetic Resonance Imaging Center and a professor in the Department of Diagnostic and Interventional Imaging at the University of Texas Health Science Center at Houston; Kurt H. Bockhorst, senior research scientist at UT Houston; Kuang Qin, a graduate student working with Wosik; and I-Chih Tan, assistant professor in the Department of Neuroscience at Baylor College of Medicine.

Compared to corresponding standard room temperature MRI coils, the performance of the cooled normal metal and/or the high-temperature superconducting receiver coils lead either to an increase in imaging resolution and its quality, or to a very significant reduction in total scan time,” Wosik said.

More information can be found from University of Houston website by following this link.

Soberlink real-time mobile-breathalyzer FDA approved

Soberlink announced that the Soberlink Breathalyzer has received 510(k) premarket clearance from the U.S. Food and Drug Administration (FDA) for medical use by healthcare providers to remotely measure alcohol in human breath, for the purpose of aiding in the detection and monitoring of alcohol consumption in those who suffer from alcohol use disorders.

Soberlink and Sober Sky Web Portal act as an accountability tool that allows recovering individuals to conveniently and discreetly share blood alcohol content (BAC) results with their treatment providers and recovery circle from almost anywhere in the world. Soberlink has worked for over five years with the top treatment facilities and addiction experts to develop a protocol for using the Soberlink System in clinical monitoring of alcohol use disorders.

“It is great to see the FDA clearing a remote monitoring device for recovery management by healthcare providers. Remote clinical monitoring has been used successfully in the treatment of other chronic diseases such as diabetes and hypertension to monitor key disease progression indicators and has provided the kind of information that healthcare professionals can use to adjust and improve their patients’ care,” says Tom McLellan, Founder and Chairman of the Board of Directors at Treatment Research Institute. “It is about time that we have the same kind of technology to provide personalized, continuing care for alcohol use disorders.”

The longer a person stays involved with consistent monitoring, the better the long-term outcome. The traditional standard of care for alcohol monitoring has been urinalysis testing. With the Soberlink Cellular Device and Sober Sky Web Portal, testing is no longer confined to a laboratory environment. The flexibility of the Soberlink System and partnership with Verizon Wireless empowers individuals to test from nearly anywhere and at any time.

“According to studies from the Centers for Disease Control and Prevention, nearly 88,000 people die from alcohol-related causes annually, making alcohol the fourth leading preventable cause of death in the United States,” stated Brad Keays, Founder and CEO of Soberlink. “Further attesting to its prevalence, the Foundation for a Drug-Free World cites that out of the 3.9 million Americans who received treatment for any kind of substance abuse problem in 2005, 2.5 million of them were treated for alcohol use.

“Improved outcomes are the mandate in all of healthcare, and Soberlink is at the forefront of this movement,” Keays said. “Soberlink is working hard to advance technology to improve outcomes in addiction treatment. These advances encourage transparency and flexibility and reinforce trust between the patient and treatment provider. FDA clearance is a significant milestone for our company and paves the way toward continued growth in the healthcare space.”

A press release can be found from Soberlink website.

Cheap paper strips for cancer testing at home

Chemists at The Ohio State University are developing paper strips that detect diseases including cancer and malaria—for a cost of 50 cents per strip.

The idea, explained Abraham Badu-Tawiah, is that people could apply a drop of blood to the paper at home and mail it to a laboratory on a regular basis—and see a doctor only if the test comes out positive. The researchers found that the tests were accurate even a month after the blood sample was taken, proving they could work for people living in remote areas.

The assistant professor of chemistry and biochemistry at Ohio State conceived of the papers as a way to get cheap malaria diagnoses into the hands of people in rural Africa and southeast Asia, where the disease kills hundreds of thousands of people and infects hundreds of millions every year.

But in the Journal of the American Chemical Society, he and his colleagues report that the test can be tailored to detect any disease for which the human body produces antibodies, including ovarian cancer and cancer of the large intestine.

The patent-pending technology could bring disease diagnosis to people who need it most—those who don’t have regular access to a doctor or can’t afford regular in-person visits, Badu-Tawiah said.

“We want to empower people. If you care at all about your health and you have reason to worry about a condition, then you don’t want to wait until you get sick to go to the hospital. You could test yourself as often as you want,” he said.

The technology resembles today’s “lab on a chip” diagnostics, but instead of plastic, the “chip” is made from sheets of plain white paper stuck together with two-sided adhesive tape and run through a typical ink jet printer.

Instead of regular ink, however, the researchers use wax ink to trace the outline of channels and reservoirs on the paper. The wax penetrates the paper and forms a waterproof barrier to capture the blood sample and keep it between layers. One 8.5-by-11-inch sheet of paper can hold dozens of individual tests that can then be cut apart into strips, each a little larger than a postage stamp.

“To get tested, all a person would have to do is put a drop of blood on the paper strip, fold it in half, put it in an envelope and mail it,” Badu-Tawiah said.

The technology works differently than other paper-based medical diagnostics like home pregnancy tests, which are coated with enzymes or gold nanoparticles to make the paper change color. Instead, the paper contains small synthetic chemical probes that carry a positive charge. It’s these “ionic” probes that allow ultra-sensitive detection by a handheld mass spectrometer.

“Enzymes are picky. They have to be kept at just the right temperature and they can’t be stored dry or exposed to light,” Badu-Tawiah said. “But the ionic probes are hardy. They are not affected by light, temperature, humidity—even the heat in Africa can’t do anything to them. So you can mail one of these strips to a hospital and know that it will be readable when it gets there.”

The chemists designed ionic probes to tag specific antibodies that extract the disease biomarker from the blood and onto the paper chip. Once they are extracted, the chemicals stay unchanged until the paper is dipped in an ammonia solution at the laboratory. There, someone peels the paper layers apart and holds them in front of a mass spectrometer, which detects the presence of the probes based on their atomic characteristics—and, by extension, the presence of biomarkers in an infected person’s blood.

Badu-Tawiah and postdoctoral researchers Suming Chen and Qiongqiong Wan successfully demonstrated that they could detect protein biomarkers from the most common malaria parasite, Plasmodium falciparum, which is most prevalent in Africa.

They also successfully detected the protein biomarker for ovarian cancer, known as cancer antigen 125, and the carcinoembryonic antigen, which is a marker for cancer of the large intestine, among other cancers.

They worked with former doctoral student Yang Song in the lab of colleague Vicki Wysocki, professor of chemistry and biochemistry, to study how the probes stick to the antibodies with a high-resolution mass spectrometer. Wysocki is the Ohio Eminent Scholar of Macromolecular Structure and Function and director of the Campus Chemical Instrument Center at Ohio State.

After confirming that their tests worked, Badu-Tawiah and his team stored the strips away and re-tested them every few days to see if the signal detected by the mass spectrometer would fade over time. It didn’t. The signal was just as strong after 30 days as on day one, meaning that the disease proteins were stable and detectable even after a month.

Since the antibody strips survive more than long enough to reach a lab by mail, they could open up a whole new world of medical care for people in rural communities—even in the United States, Badu-Tawiah said. Even for people living in the city, testing themselves at home would save money compared to going to the doctor.

In the US, he said, the tests would be ideal for people who have a family history of cancer or have successfully undergone cancer treatment. Instead of waiting to visit a doctor every six months to confirm that they are still in remission, they could test themselves from home more frequently.

In the case of malaria, the human and financial costs are high, especially in Africa.

Malaria is a mosquito-borne disease caused by parasites. The infection starts with flulike symptoms that can develop into kidney failure or other complications. The Centers for Disease Control and Prevention estimates that there were 214 million cases of malaria worldwide in 2015, and 438,000 people died—mostly children in Africa.

“In Africa, malaria is so common that whenever you get feverish, the first thing you think is, ‘Oh, it’s probably malaria,’” Badu-Tawiah said.

While the prototype test strips at Ohio State cost about 50 cents each to produce, those costs would likely go down with mass production, he said. The greatest cost of using the strips would fall to urban medical facilities, which would have to purchase mass spectrometers to read the results. Model portable instruments can cost $100,000 but less expensive handheld mass specs are under development.

Still, Badu-Tawiah pointed out, an initial investment in mass specs would be more than offset by the potential boon to Africa’s economy. UNICEF estimates that malaria costs the continent $12 billion in lost worker productivity every year.

In the United States, where mass spectrometers are more common, the cost savings would come in the form of reduced insurance use and fewer out-of-pocket expenses from going to the doctor less often.

“Although this approach requires an initial investment, we believe the low-cost paper-based consumable devices will make it sustainable,” Badu-Tawiah said. “We can set one small instrument at a grocery store, then sell the paper strips for just 50 cents per test. The same for Africa, and perhaps much cheaper there.”

The university will license the technology to a medical diagnostics company for further development, and Badu-Tawiah hopes to be able to test the strips in a clinical setting within three years. In the meantime, he and his colleagues are working to make the tests more sensitive, so that people could eventually use them non-invasively, with saliva or urine as the test material instead of blood.

Full story can be found from The Ohio State University website.

CFDA issues the Decision on Amending Good Supply Practice for Pharmaceutical Products

In order to further strengthen the quality management of drug distribution, and ensure drug safety, the Decision on Amending Good Supply Practice for Pharmaceutical Products was adopted at the executive meeting of China Food and Drug Administration (CFDA) on June 30, 2016, and shall go into effect as of the date of promulgation. CFDA issued the newly amended Good Supply Practice for Pharmaceutical Products on July 20, 2016.

Medtronic Continuous Glucose Monitoring (CGM) System CE Approved

Medtronic announced it has received CE Mark for its new Guardian(TM) Connect mobile continuous glucose monitoring (CGM) system for people with diabetes using insulin injection therapy. Guardian Connect is the first smartphone-enabled CGM system from Medtronic to receive CE Mark and further demonstrates the company’s intent to provide solutions for people across the diabetes care continuum. The system will be launched on a country-by-country basis in the second quarter of fiscal year 2017, beginning with select countries in Europe, Asia Pacific, and Latin America.

With Guardian Connect, people on insulin injections will be able to check their current glucose level anytime on their mobile device, as easily as checking other information sources such as email, the weather or social media. They can also be alerted of high and low glucose levels on their mobile device, helping them confidently avoid or address high and low glucose situations. Guardian Connect is the first and only mobile CGM system with customizable SMS text alerts enabling care partners to receive high and low glucose alerts on any connected mobile device. The system also features the option to automatically upload the data daily into CareLink(TM) therapy management software, which reduces the burden of data upload for both people on insulin injection therapy as well as their healthcare providers.

“Having continuous, real-time access to glucose values and being alerted to important trends and events is key for people with diabetes. With our new Guardian Connect system, we’ve continued to innovate so we can deliver these insights for people with diabetes on insulin injection therapy,” said Annette Brüls, president, Diabetes Service and Solutions at Medtronic. “Guardian Connect is also compatible with our CareLink® diabetes therapy management platform and arms healthcare providers, their patients and care partners with actionable data to help improve day-to-day diabetes management and make long-term therapy adjustments. Expanding our solutions to help more people with diabetes no matter where they are on the care continuum is central to our goal of transforming diabetes care for greater freedom and better health.”

The Guardian Connect system consists of a small wearable CGM device that takes glucose readings every five minutes (288 times a day) and sends these glucose values directly to a smartphone app. People on insulin injection therapy can use the system to check glucose levels on their mobile phones, enabling them to see highs and lows in real-time, understand the trends and help improve their daily management of diabetes. Alerts can also be set up if glucose levels go above or below preset levels, helping patients prevent or address potentially dangerous high and low glucose events. All of this information can be shared with care partners via SMS text messages and via access to the real-time CGM tracing from any web-enabled device. In addition, healthcare providers can leverage automatic daily data uploads via CareLink.

The Guardian Connect smartphone app will initially be available with iOS devices. Medtronic is currently developing an Android version of the Guardian Connect app for release at a later date. The Guardian Connect system is not yet available for sale in the United States.

A press release can be found from Medtronic website.

3D weaving technique to grow a living hip replacement

With a goal of treating worn, arthritic hips without extensive surgery to replace them, scientists have programmed stem cells to grow new cartilage on a 3-D template shaped like the ball of a hip joint. What’s more, using gene therapy, they have activated the new cartilage to release anti-inflammatory molecules to fend off a return of arthritis.

The technique, demonstrated in a collaborative effort between Washington University School of Medicine in St. Louis and Cytex Therapeutics Inc. in Durham, N.C., is described July 18 in Proceedings of the National Academy of Sciences.

The discovery one day may provide an alternative to hip-replacement surgery, particularly in younger patients. Doctors are reluctant to perform such operations in patients under age 50 because prosthetic joints typically last for less than 20 years. A second joint-replacement surgery to remove a worn prosthetic can destroy bone and put patients at risk for infection.

“Replacing a failed prosthetic joint is a difficult surgery,” said Farshid Guilak, PhD, a professor of orthopedic surgery at Washington University. “We’ve developed a way to resurface an arthritic joint using a patient’s own stem cells to grow new cartilage, combined with gene therapy to release anti-inflammatory molecules to keep arthritis at bay. Our hope is to prevent, or at least delay, a standard metal and plastic prosthetic joint replacement.”

The technique uses a 3-D, biodegradable synthetic scaffold that Guilak and his team developed. The scaffold, molded into the precise shape of a patient’s joint, is covered with cartilage made from the patient’s own stem cells taken from fat beneath the skin. The scaffold then can be implanted onto the surface of an arthritic hip, for example. Resurfacing the hip joint with “living” tissue is designed to ease arthritis pain, and delay or even eliminate the need for joint-replacement surgery in some patients.

Additionally, by inserting a gene into the newly grown cartilage and activating it with a drug, the gene can orchestrate the release of anti-inflammatory molecules to fight a return of arthritis, which usually is what triggers such joint problems in the first place.

“When there is inflammation, we can give a patient a simple drug, which activates the gene we’ve implanted, to lower inflammation in the joint,” said Guilak, also a professor of developmental biology and of biomedical engineering. “We can stop giving the drug at any time, which turns off the gene.”

The 3-D scaffold is built using a weaving pattern that gives the device the structure and properties of normal cartilage. Franklin Moutos, PhD, vice president of technology development at Cytex, explained that the unique structure is the result of approximately 600 biodegradable fiber bundles woven together to create a high-performance fabric that can function like normal cartilage.

“As evidence of this, the woven implants are strong enough to withstand loads up to 10 times a patient’s body weight, which is typically what our joints must bear when we exercise,” Moutos said.

Currently, there are about 30 million Americans who have diagnoses of osteoarthritis, and data suggest that the incidence of osteoarthritis is on the rise. That number includes many younger patients — ages 40 to 65 — who have limited treatment options because conservative approaches haven’t worked and they are not yet candidates for total joint replacement because of their ages.

Bradley Estes, PhD, vice president of research and development at Cytex, noted, “We envision in the future that this population of younger patients may be ideal candidates for this type of biological joint replacement.”

Guilak, who also is the director of research at Shriners Hospitals for Children — St. Louis, and co-director of the Washington University Center of Regenerative Medicine, has been collaborating with Cytex on this research. The scientists have tested various aspects of the tissue engineering in cell culture, and some customized implants already are being tested in laboratory animals. He said if all goes well, such devices could be ready for safety testing in humans in three to five years.

More information can be found from Washington University School of Medicine website.