The research team's newly developed NanoDisk-MS assay
is the first test that can measure the severity of active TB
infections. It does so by accurately detecting minute blood
levels of two proteins (CFP-10 and ESAT-6) that TB
bacteria release only during active infections. Credit:
Jason Drees, Biodesign Institute at Arizona State University
Tuberculosis (TB), once better known as consumption for the way its victims wasted away, has a long and deadly history, with estimates indicating it may have killed more people than any other bacterial pathogen. Studies have discovered evidence of its human impact going back to as early as 8,000 BCE, and estimates suggest that it has killed a billion people over the past two centuries. Now, a group of scientists from Arizona, Texas and Washington DC has teamed up to develop the first rapid blood test to diagnose and quantitate the severity of active TB cases. The study was published in the Early Edition of the journal
Proceedings of the National Academy of Sciences
Led by Tony Hu, a researcher at Arizona State University's Biodesign Institute, eight research groups, including the Houston Methodist Research Institute and scientists at the National Institutes of Health, are harnessing the new field of nanomedicine to improve worldwide TB control.
"In the current frontlines of TB testing, coughed-up sputum, blood culture tests, invasive lung and lymph biopsies, or spinal taps are the only way to diagnose TB," said Hu, a scientist in the Biodesign Institute's Virginia G. Piper Center for Personalized Diagnostics. "The results can give false negatives, and these tests are further constrained because they can take days to weeks to get the results."
Despite $6.6 billion spent for international TB care and prevention efforts, TB remains a major risk to human health, particularly for the developing world and people with HIV infections. Making matters worse, TB bacteria can lurk dormant in a person's lung tissue, often for decades, before spontaneously producing full-blown TB disease that can then spread to others. Currently, the World Health Organization (WHO) estimates that up to one-third of the world's population may have such dormant TB infections.
In 2016, an estimated 10 million people worldwide still develop TB each year according to the WHO's most recent report, resulting in almost two million deaths. TB treatment has prevented almost 50 million deaths between 2000 and 2015, but TB remains a worldwide epidemic due to the lack of an effective TB vaccine, the rise in drug-resistant strains and the relatively poor performance of available TB diagnostics.
A new and easy way to rapidly screen those susceptible to TB infections was recognized by WHO and other public health officials as the major technological hurdle needed to overcome the disease. The team's newly developed blood-based TB test not only outperforms all others currently on the market but also takes just hours to complete. This is critical since effective TB control requires that patients start treatment as soon as possible to reduce the risk of spreading TB. This test also holds promise for rapid assessment of TB treatment, an important factor in reducing the development and spread of drug-resistant TB strains.
The research team's newly developed NanoDisk-MS assay, could significantly improve TB diagnosis and management because it is the first test that can measure the severity of active TB infections. It does so by accurately detecting minute blood levels of two proteins (CFP-10 and ESAT-6) that TB bacteria release only during active infections.
"We are particularly excited about the ability of our high-throughput assay to provide rapid quantitative results that can be used to monitor treatment effects, which will give physicians the ability to better treat worldwide TB infections," said Hu. "Furthermore, our technology can be used with standard clinical instruments found in hospitals worldwide."
Current TB assays often demonstrate reduced performance with HIV-positive TB patients or those with TB infections in non-lung tissues, and these patients can require tissue biopsies for diagnosis. The NanoDisk-MS assay, however, detected lung- and non-lung-resident TB cases with similar sensitivity (about 92 percent) regardless of patient HIV status, and revealed good specificity to distinguish patients with related disease cases (latent TB and nontuberculous mycobacterial infections; 87 and 91 percent, respectively) and healthy subjects (100 percent).
The strategy used to generate this assay may also be adaptable to other infectious diseases. Hu is now developing the current TB assay for clinical approval in the fight against TB.
Millions of joint replacements are performed every year. Unfortunately, more than 50,000 patients in USA alone have their prosthetic joints fail due to infection, costing the healthcare system billions of dollars every year. Infection onset happens in days, and most patients don’t even realize they have a problem because they are unable to distinguish the pain of the surgery from infection. By the time symptoms present it is often too late to treat with antibiotics, leading to invasive and unreliable surgeries.
The Philadelphia-based startup
is developing an implantable sensor that actively detects infection after joint replacement surgery and wirelessly communicates and alerts the patient and their physician through the Synotrac smartphone app in real-time. Activated and operated using the app, measurements are automatically taken at regular intervals and securely transmitted via Bluetooth to the patient’s phone. The recorded data analyze the body’s immune response and is automatically plotted and compared with other measurements taken to give a dynamic picture of the joint’s healing process. It is further stored directly in the patient’s electronic health record, giving the patient’s surgeon and primary care physician the ability to track the healing progress over time and intervene immediately in the case of an infection.
The device, made entirely from biocompatible components and sealed with protective coating, is installed intraoperatively during joint replacement, adjacent to the synovial cavity, ensuring no additional surgery is required. The batteries of the device will last for the initial postoperative period, up to 6 months post surgery, when the patient is at the highest risk for infection. The startup is, however, working on a future solution where the phone will charge the device as it is taking measurements, so it will work indefinitely.
Currently, patients are tested with a combination of blood tests, x-rays and bacterial culture if general symptoms of an infection is developed. However, x-rays and blood tests are prone to false negatives, and cultures can take several days. And since it is often too late to treat infections with antibiotics by the time symptoms present, the current diagnostic options are unacceptable. Synotrac’s innovative technology help detect infection early, and enable treatment with antibiotics rather than invasive, costly revision surgeries. The following app communicate with both patients and physicians to not only enable less invasive and costly treatment options, but to minimize the need for postoperative appointments, significantly reducing healthcare costs. Most importantly, Synotrac can save implants, prevent revision surgery, allowing patients to resume normal activities faster and improve quality of life.
The technology has been extensively tested with in vitro models and Synotrac is in the process of obtaining FDA clearance, as well as preparing for their first in vivo studies. The startup is
Venture for America
alumni-founded, and won UBS Venture Catalyst Award in 2016. They have also been part of the
, and have so far raised $250,000 in pre-seed funding.
Millions of people worldwide suffer from retinal degenerative disorders, a group of debilitating conditions with a major impact on quality of life and tremendous socioeconomic consequences.
Common to all these conditions is the damage to photoreceptor cells of the retina, which malfunction and disappear, causing a continuous decline in vision. A number of approaches have been explored to slow down the rate of degeneration and reverse loss of vision, including genetic, pharmacological, surgical and cellular interventions, but there is currently no options available that can restore the lost vision.
The La Jolla-based startup
is determined to restore sight to blind patients afflicted with retinal degenerative disorders. They offer a novel nanotechnology approach to retinal prosthesis, an engineered device that replace lost photoreceptors. The technology is based on arrays of silicon nanowires that simultaneously sense light and electrically stimulate the retina. These arrays of optoelectronic nanowires are bundled together into small electrodes that forms the core of the neural retinal stimulation system. A wireless device is able to transmit power and data to the nanowire arrays over a single wireless connection at record speed and energy efficiency. The entire device is packaged in biologically compatible material, which is then surgically implanted into the space created by the degenerated photoreceptors.
In contrast to existing retinal prostheses, Nanovision’s approach does not require a remote vision sensor to record visual data and convert the gathered information into signals. Instead, the silicon nanowires mimic the retina’s light-sensing cones and rods to directly stimulate retinal cells. In addition, the nanowires give the prosthesis higher resolutions than anything achieved by other devices.
In a proof-of-concept study, published in the
Journal of Neural Engineering
, the wirelessly powered nanowire array was inserted beneath a rat’s degenerated retina. The test showed promising results, and the startup is now working to transition the technology towards clinical trials, helping those who suffer from severe retinal degeneration. Animal tests are already in progress, with clinical trials following.
With a growing aging population, the number of people suffering from retinal degeneration disorders is set to increase dramatically. Hand in hand with the high prevalence and growth of retinal degenerative disorders, the treatment costs are soaring. It is
that the global cost of visual impairment due to Age-related Macular Degeneration (AMD) alone is $343 billion, including $255 billion in direct health care costs. Nanovision is developing an innovative type of retinal prosthesis that could revolutionize the treatment of retinal degenerative disorders. Although still early, the technology could help people with impaired vision and significantly improve quality of life for millions around the world. And although there is no estimate of cost at this point, a cure is likely to reduce the global cost of retinal degenerative disorders.
The groundbreaking technology stems from research at
, and the startup was founded in 2012 by Scott Thorogood, William Freeman and Gabriel Silva. Nanovision has previously received commercialization support and funding through the
TATRX/Qualqomm Wireless Health Innovation Challenge
, which aims to nurture and accelerate the commercialization of selected wireless health technologies. Research of the technology has, besides Nanovision, been funded by
. and the
Institute of Engineering in Medicine
Clinical and Translational Research Institute
A smartphone-based semen analyzer can be used
to test for male infertility. Credit: Shafiee Lab
More than 45 million couples worldwide grapple with infertility, but current standard methods for diagnosing male infertility can be expensive, labor-intensive and require testing in a clinical setting. Cultural and social stigma, and lack of access in resource-limited countries, may prevent men from seeking an evaluation. Investigators at Brigham and Women's Hospital and Massachusetts General Hospital set out to develop a home-based diagnostic test that could be used to measure semen quality using a smartphone-based device. The research was published in
Science Translational Medicine
"We wanted to come up with a solution to make male infertility testing as simple and affordable as home pregnancy tests," said Hadi Shafiee, PhD, a principal investigator in the Division of Engineering in Medicine and Renal Division of Medicine at BWH. "Men have to provide semen samples in these rooms at a hospital, a situation in which they often experience stress, embarrassment, pessimism and disappointment. Current clinical tests are lab-based, time-consuming and subjective. This test is low-cost, quantitative, highly accurate and can analyze a video of an undiluted, unwashed semen sample in less than five seconds."
The analyzer consists of an optical attachment that can connect to a smartphone and a disposable device onto which a semen sample can be loaded. The new test utilizes the advancements in consumer electronics and microfabrication. A disposable microchip with a capillary tip and a rubber bulb is used for simple, power-free semen sample handling. The team also designed a user-friendly smartphone application that guides the user through each step of testing, and a miniaturized weight scale that wirelessly connects to smartphones to measure total sperm count.
To evaluate the device, the research team collected and studied 350 clinical semen specimens at the MGH Fertility Center. Overall, the smartphone-based device was able to detect abnormal semen samples based on WHO thresholds on sperm concentration and motility (sperm concentration < 15million sperm/ml and/or sperm motility < 40%) with an accuracy of 98 percent. The team also evaluated how well both trained and untrained users performed the test using the smartphone-based device.
The 3-D printed setup costs less than $5 and can analyze
most semen samples in fewer than 5 seconds.
Credit: Shafiee Lab
"The ability to bring point-of-care sperm testing to the consumer, or health facilities with limited resources, is a true game changer," said John Petrozza, MD, a co-author of the study and director of the MGH Fertility Center. "More than 40 percent of infertile couples have difficulty conceiving due to sperm abnormalities and this development will provide faster and improved access to fertility care."
Shafiee's team, which focuses on developing new technologies using microfluidics, sees many applications for the technology. In addition to at-home male fertility testing for couples trying to conceive, the device could also be used by men who have had a vasectomy. Usually, men must go to office visits with a urologist for several months after the surgery to ensure that the operation was successful; the new test may allow them to be monitored at home. The test could also be used by animal breeders to confirm the virility of a sample. Beyond semen analysis, the device is also compatible with testing blood and saliva samples. Shafiee looks forward to exploring these applications in the near future.
"My job is to try to understand some of the problems patients and physicians face in the clinic and to help develop new solutions. We are always thinking about what's next and how to develop something new," said Shafiee.
The smartphone-based analyzer for semen analysis is currently in a prototyping stage. The team plans to perform additional tests and will file for FDA approval.
Medical treatments are typically designed using a one-size-fits-all approach, often resulting in serious side effects. In USA alone, more than 700,000 people each year experience serious drug reactions, and more than 117,000 die from them, according to the FDA. While the emergence of precision medicine primarily has focused on selecting the right drug for the right patient, drug dosage is often overlooked and rarely optimized for the individual. A more individualized dose could not only help eliminate potential side effects, but boost the drug’s efficacy.
The San Francisco-based startup
is determined to provide an individualized understanding of a patient’s response to treatment, and has developed a software platform that help guide treatment decision-making. The clinical decision support tool leverage mathematical models, patient demographics, physiological characteristics, genomic data, drug concentrations and biomarkers to calculate drug and dose recommendations. Drug concentration and biomarker data are collected over time to get a deeper understanding of patient response, enabling treatment optimization. And as more data is collected, the algorithms that guide the treatment recommendations will learn and become more precise. The technology is available as an easy-to-use, cloud-based web application that can be accessed directly through the electronic medical record at the point-of-care. It is currently being developed for a handful of drugs, but the software will eventually be applied to a broad range of medications.
The ‘one-size-fits-all’ approach to drug design and treatment results in hundreds of thousands of deaths each year, and billions of dollars in costs. That’s because how much of a drug enters the bloodstream and how quickly it exits the body is influenced by multiple individual factors, such as patient demographics or genetics. And with so many variables, choosing the best medication and dose can be a matter of trial and error. InsightRX’s innovative technology help personalize treatment, including how much to take, how frequently, and for how long. For some patients, taking half a dose four times a day might work much better than full doses twice a day.
Although developing these models to optimize dosing is a complex process that needs to be refined and validated through clinical trials, a more precise, personalized approach could have a major impact on patient care and health outcomes. It could improve treatment efficacy, reduce side effects, and prevent thousands of deaths each year. In fact, multiple studies have shown that individualized dosing lead to significantly better survival rates and improved outcomes, and could potentially help reduce associated healthcare costs.
InsightRX is a spin-off from UCSF and was founded in 2015 by Sirj Goswami, Ron Keizer and Ranvir Mangat. The startup has partnered with multiple clinical centers, including UCSF and Stanford Medical Center, to pilot their technology, and has previously received a grant from the
Clinical & Translational Science Institute at UCSF
. They have also raised a seed funding round with an undisclosed amount from
Launchpad Digital Health
, two accelerator programs based in San Francisco and Sunnyvale, CA.
This is an inhaler used to administer oxytocin.
Credit: Monash University
Every year, over 300,000 women in low and low-middle income countries die during pregnancy and childbirth. Postpartum haemorrhage (PPH) is the single largest cause of these deaths. PPH can be prevented by administering a drug called oxytocin, which is recommended by the World Health Organisation and is widely used in wealthy countries. However, as an injection, oxytocin requires refrigeration and a skilled medical professional to administer it safely. In low and low-middle income countries, one or both of these requirements may not be available.
To address this unmet need, researchers at Monash University Institute of Pharmaceutical Sciences (MIPS), in collaboration with GlaxoSmithKline in London, who sponsored the study, have been developing an inhalable, dry-powder form of oxytocin. They presented the results of the first in-human trial of the new formulation at the
Royal College of Obstetricians and Gynaecologists World Congress in Cape Town
The study demonstrated, in a small cohort of non-pregnant female volunteers, that the effects that inhaled oxytocin has on the body are not meaningfully different from its injected counterpart. This gives confidence that the inhaled form of oxytocin will deliver similar effects in prevention of PPH when given to mothers immediately after giving birth.
The results present the possibility that the new medicine will be able to take advantage of a streamlined pathway to registration, meaning that it could reach the mothers who need it much sooner.
Associate Professor Michelle McIntosh, Project Leader at MIPS, said that this first in-human data offers hope to the many women in resource-constrained settings who do not currently have access to this essential medicine.
"These results show that oxytocin can be delivered similarly via inhalation or injection and therefore we are less likely to be required to conduct the extensive and costly trials needed for an entirely new drug. Instead, we should be able to move forward with trials on a much smaller scale, featuring patients numbering in the hundreds rather than tens of thousands, potentially making the medicine available much sooner," Associate Professor McIntosh said.
This positive data has supported the initiation of clinical studies evaluating inhaled oxytocin when given to women immediately after birth, the time at which oxytocin is routinely administered for prevention of PPH.
A majority of healthcare spending is for largely preventable chronic diseases, and we are therefore seeing more and more focus on preventive medicine. The aim is to either prevent the occurrence of a disease or halt and avert resulting complications after its onset.
Most people agree that preventive care is important, and has in fact been key in advancing our health. Just take a look at how clean water and sanitation has added decades to the average lifespan, and vaccination campaigns have reduced infant mortality.
As a result, the search for new public health measures that can improve overall health goes on.
has found that a routine blood test can help measure a patient’s future risk for chronic diseases, including diabetes, kidney failure, dementia, chronic obstructive pulmonary disease and multiple heart diseases. That pretty much sounds like the holy grail of healthcare. Identify patients at high risk of multiple diseases, help them avoid getting sick, while decreasing healthcare costs. While the study provide an interesting solution that could help advance our health, it also highlight key challenges of preventive medicine.
Although there are cultural differences around the world on how healthcare services are used, most people go to the doctor because something specific is bothering them. Then should the doctor spend resources on something that is unrelated to what the patient actually came in for? And do all people want to know their risk of developing certain diseases, or will such a test cause more harm than good? Will it have an impact on insurance? Will it cause anxiety and stress, reducing quality of life, or will it be perceived as an opportunity to improve health? The answer is likely in how effective available preventive measures are. If a preventive strategy for a specific disease is effective, then patients are more likely to use them, adhere to them, and feel less anxiety towards knowing whether or not they are at future risk of a disease.
However, some of the best-known forms of preventive care does not actually improve someone’s health. For example, annual physicals has been found not to lower risk of serious illness or premature death, and some cancer screenings produce essentially no health benefits. In addition, some low-cost strategies proven to be effective, such as lifestyle interventions, might be difficult to adhere to, if people are willing to even try them.
The economic argument,
the assertion that you can cut healthcare spending through preventive care is widely misunderstood. One of the major reasons why so many preventive strategies fail to reduce costs is the large number of people who need to receive a particular preventive service in order to avert a single expensive illness. There are of course prevention programs that do produce net savings, such as childhood immunizations, but these are in fact considered exceptions. The cost of providing them to everyone is less than that of treating the illnesses they prevent. The truth is that, preventive measures can be very expensive, and the number of people that you need to screen in order to prevent one case of illness can be huge.
This is why the new study is so interesting. While introducing the blood test to patients could be challenging, it might in fact have great impact on the future of preventive medicine. Using a blood test to measure a patient's future risk for chronic diseases could help deliver targeted preventive care. Instead of providing services to a large group who will not benefit from it, which is one of the major reasons why so many preventive measures fail to show cost-effectiveness, such a blood test could personalize preventive care.
By using this ‘smart’ approach to specifically identify with a high certainty who will develop a disease, we are increasing our chances of preventing expensive diseases and saving money.
Sandia National Laboratories researchers Aashish Priye
and Sara Bird offers a view into the Zika box prototype.
Credit: Randy Wong
Add rapid, mobile testing for Zika and other viruses to the list of things that smartphone technology is making possible. Researchers at Sandia National Laboratories have developed a smartphone-controlled, battery-operated diagnostic device that weighs under a pound, costs as little as $100 and can detect Zika, dengue and chikungunya within 30 minutes. The researchers describes the rapid-testing prototype in a paper published in the journal
Testing for these mosquito-borne viruses currently requires a laboratory, and patients can wait days for results. The tests require instruments that are roughly the size of a microwave oven and can cost up to $20,000. This makes rapid testing unrealistic for limited-resource clinics in developing countries where the viruses are prevalent.
Smartphone technology is a key feature of the device. "In addition to creating an app that serves as a simple interface to operate the device, we were able to adapt smartphone camera sensors to replace traditional laboratory sample analysis tools, allowing for unprecedented mobility," chemical engineer and lead author Aashish Priye said.
Laboratory in a box
The Sandia team's device is based on the loop-mediated isothermal amplification (LAMP) diagnostic method, which eliminates the need to process a biological sample, such as blood or urine, before testing. Conventional viral testing involves transporting a sample to a laboratory, extracting DNA or RNA from it and then multiplying the genetic materials through a process called polymerase chain reaction (PCR). This process involves heating and cooling the sample many times, so that any viral DNA/RNA in the sample is replicated enough to be detected.
Repeatedly heating and cooling the sample is power intensive and demands the complexity of PCR machines. Detection of the copied viral material also requires expensive components such as fluorimeters. The complexity and expense of traditional PCR machines have been major hurdles in moving PCR devices outside of laboratories and into the clinics where they are most needed.
Like PCR, LAMP copies viral DNA/RNA, but without the heating and cooling cycle, a heavy-duty power source isn't needed. The addition of a few carefully designed biochemical agents allows a LAMP box to test a sample that is heated only once to 65 degrees Celsius (150 degrees Fahrenheit) for half an hour.
LAMP also eliminates the need for extra sample preparation before testing. "We've demonstrated that the chemistry we're using can amplify viral RNA directly from raw, unprocessed samples," said Sandia chemical engineer and project lead Robert Meagher. "That is the ideal for a point-of-care testing scenario because you don't want to have extra equipment for isolating DNA or RNA."
Meagher and his team previously developed a method to combine LAMP with an additional detection technique so they could test multiple viruses simultaneously. This other technique, known as quenching of unincorporated amplification signal reporters (QUASR), involves tagging fragments of synthesized viral DNA called primers with fluorophores -- molecules that emit bright light signals. The primers incorporate into the heated and amplified sample DNA. QUASR then causes samples containing viral DNA/RNA to appear bright, while negative reactions remain dark.
For the Zika project, Meagher's team developed a novel algorithm that allows a smartphone sensor to act as a fluorimeter, detecting QUASR LAMP light signals if they appear. LAMP works so simply that the user need only place the smartphone on top of the LAMP box and open an app. The app turns on the heater to initiate the LAMP reaction.
Once the 30-minute testing period is up, the smartphone photographs the sample. The app then employs a novel image analysis algorithm to accurately determine the color and brightness of the glow emitted from the LAMP reaction. This smartphone-based image analysis offers much greater detection certainty than the lab technician's naked eye.
Zika virus has been linked to severe fetal abnormalities, including microcephaly and congenital blindness, as well as neurological disorders that can strike people at any age. By enabling diagnosis in half an hour, the device could help clinicians make faster decisions about patient care and isolation, and rapidly alert public health authorities so they can take measures to prevent spread of the virus.
Furthermore, Zika, dengue and chikungunya are spread by the same mosquito type and have similar early symptoms. Sandia's prototype diagnostic tool could enable care providers to test quickly for all three at the same time, preventing misdiagnoses. The same tool can also be adapted to detect other human or animal pathogens.
The cost of making a LAMP box prototype to test for these viruses depends largely on the cost of the phone selected for use with it. "There are billions of smartphones in the world, even in developing countries, and this tool doesn't require the highest-end smartphone on the market," Priye said. "It only needs to have an optical sensor and be able to run the app." The smartphone used in Sandia's successful tests of the prototype cost a mere $20. Ultra-accessible and ultra-portable, the Zika box prototype could one day become a staple in point-of-care clinics worldwide.
Millions of individuals suffer from chronic diseases, the by far leading cause of mortality worldwide. These debilitating diseases require continuous monitoring to check on its progress, development of complications, and help adjust treatment. As a result, we are seeing a surge in technological advances that promises to help improve health outcomes, while providing healthcare providers with a cost-effective monitoring platform to help make informed decisions.
The New York-based startup
is determined to disrupt remote medical monitoring, and is developing textile-based nanosensor technology applicable to multiple medical conditions. Their first product, SimplECG, is a remote cardiac monitoring undergarment that continuously collect multi-channel ECG, heart rate and respiratory rate data from the garment. The real-time data captured is transferred wirelessly via Bluetooth to the patient’s smartphone and further to a secure cloud. An accompanying app enables patients to enter real-time symptoms at the push of a button, which can be accessed by a physician for review through a web-based portal.
The burden of chronic diseases is growing rapidly worldwide, and technology play an increasing role in monitoring and managing treatment. It provide physicians with an objective and consistent feedback, facilitating personalized treatment, while increasing access to care for patients in remote areas and reducing the need for clinic and hospital visits. Nanowear and their innovative SimplECG technology represents the next generation of wearables, a potential game-changing disruptor. The technology address the invasiveness of traditional cardiac monitoring, and provides a platform for the future of preventative medicine.
The real-time, continuous data garnered from everyday clothing enable patients to manage their chronic disease without compromising their day-to-day activities. It could improve health outcomes and improve quality of life for millions of people worldwide, while improving efficiency for healthcare providers. And the technology has extensive applications beyond cardiac monitoring. The startup has already prototyped a headband for screening of neurological disorders, including concussions/TBI, epilepsy and sleep apnea, highlighting the huge potential of the technology.
Nanowear has worked in close partnership with the FDA since early 2015 to understand the dynamic of their device, and in December 2016 received FDA Class II 510(k) clearance. The startup announced in September 2014 that they had raised $1.5 million led by
, with several angels also participating in the round.
An algorithm based on levels of metabolites found in a
blood sample has accurately predicted whether a child is
on the Autism spectrum of disorder (ASD).
Credit: Rensselaer Polytechnic Institute
An algorithm based on levels of metabolites found in a blood sample can accurately predict whether a child is on the Autism spectrum (ASD), based upon a recent study. The algorithm, developed by researchers at Rensselaer Polytechnic Institute, is the first physiological test for autism and opens the door to earlier diagnosis and potential future development of therapeutics.
"Instead of looking at individual metabolites, we investigated patterns of several metabolites and found significant differences between metabolites of children with ASD and those that are neurotypical. These differences allow us to categorize whether an individual is on the Autism spectrum," said the lead author Juergen Hahn. "By measuring 24 metabolites from a blood sample, this algorithm can tell whether or not an individual is on the Autism spectrum, and even to some degree where on the spectrum they land."
Big data techniques applied to biomedical data found different patterns in metabolites relevant to two connected cellular pathways (a series of interactions between molecules that control cell function) that have been hypothesized to be linked to ASD: the methionine cycle and the transulfuration pathway. The methionine cycle is linked to several cellular functions, including DNA methylation and epigenetics, and the transulfuration pathway results in the production of the antioxidant glutathione, decreasing oxidative stress.
The research appears in
PLOS Computational Biology
, where the researchers describe an application of Fisher Discriminant Analysis - a big data analysis technique - to data from a group of 149 people, about half on the Autism spectrum. Deliberately omitting data from one of the individuals in the group, the researchers subjected the dataset to advanced analysis techniques, and used the results to generate a predictive algorithm. The algorithm then makes a prediction about the data from the omitted individual. The researchers cross-validated the results, swapping a different individual out of the group and repeating the process for all 149 participants. The method correctly identified 96.1 percent of all neurotypical participants and 97.6 percent of the ASD cohort.
"Because we did everything possible to make the model independent of the data, I am very optimistic we will be able to replicate our results with a different cohort," said Hahn. "This is the first physiological diagnostic and it's highly accurate and specific."
Researchers have looked at individual metabolites produced by the methionine cycle and the transulfuration pathways and found possible links with ASD, but the correlation has been inconclusive. Hahn said the more sophisticated techniques they applied revealed patterns that would not have been apparent with earlier efforts.
"A lot of studies have looked at one biomarker, one metabolite, one gene, and have found some differences, but most of the time those differences weren't statistically significant or the results could not be reliably replicated," Hahn said. "Our contribution is using big data techniques that are able to look at a suite of metabolites that have been correlated with ASD and make statistically a much stronger case."
The full results of Hahn's work on ASD diagnosis are publicly available and Hahn is hopeful his work will lead to a widely available test that can support early diagnosis, although he does not intend to commercialize his results. For Hahn, the next step is to replicate the results with a new cohort working with his clinical collaborators. In the long run, Hahn hopes the model and diagnostic tool will aid in developing treatment options.
Hundreds of millions of people suffer every day from chronic respiratory diseases, a group of diseases, including asthma and chronic obstructive pulmonary disease (COPD), which have tremendous effect on everyday life. While no cure, there are treatments that help control symptoms, and developing new technological solutions could help optimize care and greatly improve quality of life for millions around the world.
The New York-based digital health startup
is determined to transform respiratory disease management through smart mobile technology, and has developed BreatheSmart, a comprehensive respiratory disease management platform. The platform connects with different devices and sensors, including mSpirometer which measure lung function, and HeroTrackers, a '
jacket' that fits over the inhaler to track patient adherence. In December 2016, the startup launched a new inhaler together with H&T Presspart that track medication use in real-time, as well as quality of medication delivery.
The devices wirelessly connects with the BreatheSmart platform, which delivers scheduled medication reminders, smart notifications and timely information and tips. In addition, the platform enable patients to record symptoms and triggers to better understand what’s affecting their health, as well as share information with care providers in real-time.
According to the WHO, an estimated 300 million people live with asthma and COPD worldwide. Many fail to adhere to their prescribed medication, the main reason for hospitalization of patients with chronic respiratory diseases. Cohero is transforming respiratory care, enabling seamless, automated, end-to-end patient to provider integrated respiratory care management. The platform has previously showed an impressive 250% increase in medication adherence, and 100% reduction in hospitalizations.
The technology could lower overall healthcare costs by reducing hospitalizations and help healthcare providers better reallocate resources to where they are needed the most. They are able to track medication adherence, and adjust or change medication if the patient respond poorly, enabling personalized care. Most importantly, the technology empowers respiratory patients to engage in their care, and could significantly improve health outcomes and quality of life for millions of people.
Cohero Health was founded by Melissa Manice and Dan Weinstein in 2012, and has since been part of
Grand Central Tech
and was named the winner of the 2016 SXSW
Interactive pediatric healthcare innovation pitch competition
. The startup has gone through multiple seed funding rounds, with investors including
Three Leaf Ventures
Pacific 8 Ventures
P5 Health Ventures
An experimental malaria vaccine protected healthy subjects from infection with a malaria strain different from that contained in the vaccine, according to a study published today in the
Proceedings of the National Academy of Sciences (PNAS)
. The research was conducted by scientists at the University of Maryland School of Medicine (UM SOM) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The Phase 1 clinical trial is important because in places where malaria is common, there is usually more than one strain of malaria. To be effective in the real world, a vaccine must protect against more than one. The study’s lead researcher, Kirsten E. Lyke, MD, associate professor of medicine at the UM SOM Center for Vaccine Development, said the vaccine’s versatility was promising. “Our study shows that that this vaccine can protect against at least two strains of malaria,” said Dr. Lyke, who has studied malaria for more than a decade. “We need to continue our research, but this is a fantastic finding.”
Malaria is transmitted to humans through the bite of infected mosquitoes, which inject immature malaria parasites called sporozoites into a person’s bloodstream. The parasites travel to the liver, where they mature, multiply and spread via the bloodstream throughout the body causing malaria symptoms including chills, fever, headache, nausea, sweating and fatigue. According to the World Health Organization, 212 million people were infected with malaria globally in 2015 and 429,000 people died, mostly young children in Africa. The species
is the most common cause of malaria morbidity and mortality in Africa. In the United States, travel-related malaria is a concern for international tourists, aid workers and military personnel worldwide.
The PfSPZ Vaccine used in this study was developed by Sanaria Inc., of Rockville, Maryland. The vaccine contains weakened
sporozoites that do not cause infection but are able to generate a protective immune response that protects against live malaria infection. Earlier research with the vaccine found it to be safe, well-tolerated and protective for more than a year when tested in healthy U.S. adults against a single Africa-derived malaria strain matched to the PfSPZ Vaccine.
The study enrolled 31 healthy adults ages 18 to 45 years, and was led by Dr. Lyke and Robert A. Seder, MD, chief of the Cellular Immunology Section of NIAID's Vaccine Research Center (VRC). Participants were assigned to receive three doses of the vaccine over several months by rapid intravenous injection.
Nineteen weeks after receiving the final dose of the test vaccine, participants who received the vaccine and a group of non-vaccinated volunteers were exposed in a controlled setting to bites from mosquitoes infected with the same strain of
parasites (NF54, from Africa) that were used to manufacture the PfSPZ Vaccine.
Nine of the 14 participants (64 percent) who received the PfSPZ Vaccine demonstrated no evidence of malaria parasites; all six of the non-vaccinated participants who were challenged at the same time had malaria parasites in their blood.
Of the nine participants who showed no evidence of malaria, six participants were again exposed in a controlled setting to mosquito bites, this time from mosquitoes infected with a different strain of
parasite, 33 weeks after the final immunization. In this group, 5 of the 6 participants (83 percent) were protected against malaria infection; none of the six participants who did not receive the vaccine and were challenged were protected. All participants who became infected with malaria immediately received medical treatment.
The research team found that the PfSPZ Vaccine activated T cells, a key component of the body’s defenses against malaria, and induced antibody responses in all vaccine recipients. Vaccine-specific T-cell responses were comparable when measured against both of the malaria challenge strains, providing some insights into how the vaccine was mediating protection.
Ongoing research will determine whether protective efficacy can be improved by changes to the PfSPZ Vaccine dose and number of immunizations. Accordingly, a Phase II efficacy trial testing three different dosages in a three-dose vaccine regimen is now underway in 5- to 12-month-old infants in Western Kenya to assess safety and efficacy against natural infection.
Scientists have created a fast, accurate, and versatile paper-based blood test that could be performed without the need for specialized equipment - providing a more cost-effective strategy for blood grouping.
After analyzing 3,550 clinical blood samples, the test demonstrated more than a 99.9% accuracy rate, and the only inconsistencies occurred in trials with highly uncommon blood types, according to the report published in
Science Translational Medicine
Unlike conventional microplate or gel-column blood-grouping tests, which are technically demanding and slow to return results, the easy-to-interpret test classified samples into the common ABO and Rh blood groups in less than 30 seconds after only two simple steps. To create the test, Hong Zhang and colleagues took advantage of chemical reactions between blood serum proteins and the widely-available dye bromocreosol green.
The researchers applied a small sample onto a test-strip containing antibodies that recognized different blood type markers (or antigens). The results appeared as visual color changes - teal if a blood group antigen was present in a sample and brown if not. With slightly more time (but still in less than two minutes) the assay was able to identify multiple rare blood types.
What's more, the researchers incorporated a separation membrane to isolate plasma from whole blood, which allowed them to simultaneously identify specific blood cell antigens and detect antibodies in plasma based on how the blood cells clumped together (also known as forward and reverse typing), all without a centrifuge. The rapid turnaround time of the test could be ideal for resource-limited situations, such as war zones, remote areas, and during emergencies, the authors say.
As our understanding of the genetic complexity of cancer has grown, the dream of a single magic bullet to cure the disease has become outdated. Cancer is made up of many different molecular sub-types and mutations, each of which responds differently to treatment, requiring a combination of targeted therapies to defeat the disease. With more than 4.5 million possible drug combination options, determining the optimal combination therapy to treat a particular cancer is one of the biggest challenges that doctors face.
The San Diego-based startup
has developed a web-based platform that help doctors sort through cancer treatment options. The doctor takes a biopsy of the tumor and sends the sample to a 3
party service provider for sequencing to understand which mutations the tumor has. CureMatch uses its software platform, combing through millions of drug combinations using data from clinical trials, publications and drug interactions, and analyzes them against the patient’s genetic profile. The software then provides a report to the doctor that ranks the best combination therapy options, who can review the information and recommend a treatment plan.
Traditionally, patients have been treated with a one-size-fits-all approach, aimed at fighting a particular type or origin of cancer. However, two patients rarely have the same response to identical cancer treatments due to the genetic variation of an individual’s tumor. With roughly 300 cancer drugs approved by the FDA, CureMatch enable a new approach to cancer treatment. While there are other companies that use tumor DNA sequencing technology to provide doctors with some guidance, the recommended drug therapies still amount to “one size fits all” approach that is based on a single mutation as driving the cancer. CureMatch take this a step further by matching with multiple specific tumor gene mutations.
While many targeted monotherapies are initially successful, tumors often develop resistance. A combination of targeted therapies stand a better chance of delivering sustained effectiveness. CureMatch has developed an innovative platform that meet a growing need, advancing personalized cancer care by aiding oncologists to optimize cancer treatment. They help tailor treatment options specifically for individual patients, and according to the startup, studies have shown that the approach has resulted in higher response and survival rates than traditional chemotherapy or targeted monotherapies.
The software was developed by Razelle Kurzrock, a senior deputy director of UC San Diego Moores Cancer Center, and Igor Tsigelny, a neuroscientist and expert in structural biology at the San Diego Supercomputer Center. Together with cancer survivor and investor Blaise Barrelet, they founded CureMatch. The startup has been recognized as a 2016 Cool Company by the
San Diego Venture Group
and is part of
, a Johnson & Johnson Innovation Center in La Jolla, CA. They have also been part of the
Dubai Future Accelerators
program, and has been provided undisclosed seed funding from angel investors and
ALS patient taking part in fNIRS trial (Credit: Wyss Center)
Functional near infrared spectroscopic (fNIRS) imaging (pronounced f-nears) has led to a breakthrough in communication with ALS patients who are “Locked-In,” meaning they are in advanced stages of the disease where the brain is conscious and functioning, but they are unable to move any muscles, including the eyes.
Using a wearable system developed by SUNY Downstate Medical Center researcher Dr. Randall Barbour, a team of investigators led by Professor Niels Birbaumer at the Wyss Center for Bio and Neuroengineering in Switzerland and University of Tübingen in Germany were able to measure the brain’s hemodynamic response to a series of ‘yes’ or ‘no’ questions, thus allowing these patients to communicate. The results of the trial were published recently in
“For many years the scientific community has attempted communication with these subjects using different neurosensing technologies,” says Dr. Barbour. “Previous efforts using fMRI and EEG had their limitations, so we built our device to detect changes using near infrared spectroscopy.”
Non-invasive and wearable, the fNIRS system may eventually be incorporated into a home environment, allowing family, friends, and caregivers to communicate with the patient for the first time since the onset of this severe stage ALS.
“The portability of this device is critical for the many weeks of training needed to help subjects develop their new form of communication,” Dr. Barbour added. “The device measures the brain’s hemodynamic response, using fNIRS, and the readings are then processed using specialized algorithms to recognize when a subject is responding yes or no.”
The technology was developed by Dr. Barbour and licensed to NIRx Medical Technologies, through the SUNY Downstate technology transfer program. Together with Professor Birbaumer, NIRx and other partners have been awarded a 3-year grant to further advance fNIRS sensing capabilities working toward the development of a version for in-home use.
Anyone who has been waiting for a loved one who is undergoing a procedure know how the shortest of waits seem unbearable. While there has been much focus on physical changes to the waiting room, for example having a pot of coffee available and providing more comfortable chairs, such changes will hardly reduce stress, anxiety, uncertainty and fears that many experience during this difficult time. These psychological stressors often emerge when details of a situation is ambiguous and unpredictable, or when information is unavailable or inconsistent. Although it is impossible to completely eliminate these stressors, developing new strategies to better communicate with family members could help support and reduce uncertainty.
The San Francisco-based startup
is determined to help hospitals vastly improve the waiting room experience. They have developed a cloud-based platform that enable the delivery of surgery notifications and real-time updates to smartphones of family and friends of patients in the hospital. Invited caregivers, trusted friends and family members go to a provided URL where they can easily login using a unique patient number that correlates to the patient in surgery. During the surgical process, hospital staff can with the tap of a single button send templated and pre-approved facts of generic surgical updates to the patient’s loved ones no matter where they are located. These updates can be: “Anesthesia has started” or “The surgeon is performing the operation”, and even notify when the surgeon will be out to speak with them for those who are present at the hospital.
Research shows that lack of information can lead to stress and poor levels of satisfaction for both patients and their families. And often, families must ask directly or call to get updates, an uncomfortable situation that can place a burden on the hospital staff. Medifies has developed an innovative platform that can improve experience and quality of care through engaging family members, while improving efficiency for hospital staff. It gives real-time updates to family members who are not able to be at the hospital, even giving families the possibility to leave with their conscience intact. It gives the family the opportunity to come back in time to talk to the surgeon, or let the staff know when the family is back in the waiting room so they don’t have to spend time looking for them.
The solution might not be for everyone, and cannot and should not replace all communication between the hospital and family members. It is important that hospital staff is available for questions in order to reduce stress and anxiety. However, it could be an options for friends and family members who are not able to be present, or who simply want regular updates during surgery, enabling them to have breakfast, or go outside for fresh air without missing anything. It could significantly ease tension in the waiting room and reduce uncertainties.
Medifies was founded in October 2015 and released the first version of the technology in October, 2016. Multiple hospitals have committed to buy the technology, and the startup is set to launch a pilot with Johns Hopkins. They have previously raised $125,000, with investors including Alta Bates and Stanford Health executives, and the startup has been part of the
Launchpad Digital Health Accelerator
, and the
Texas Medical Center Innovation Institute Accelerator