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Novartis Niji System May Provide Earlier Diagnosis of Severe Allergic Asthma

Trending Now:  Point-of-care testing is gaining significance.

pv1016_nijiNovartis has unveiled a novel in-office point-of-care diagnostic tool: the Niji System and Total IgE Test. This first-ever test delivers quantitative total IgE (Immunoglobulin E) levels in about 12 minutes using only one to two droplets of finger stick blood, allowing for quick in-office diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings.

“Point-of-care testing is an important tool for healthcare professionals to make informed treatment decisions within a single appointment, thus helping to ensure patients are not lost to follow-up and ultimately improving patient management and outcomes,” says Vas Narasimhan, M.D., global head of drug development and chief medical officer for Novartis. “The Niji System provides a platform for fast and easy blood tests that could potentially be applied across a variety of disease areas.”

Novartis recently completed all requirements for the CE Mark of the point of care diagnostic platform Niji System as well as the Total IgE Test. The system is now cleared for sale within the European Union and in all countries recognizing the CE Mark and the company intends to launch the system in Europe in Q4 2016.

The Niji System does not require any sample preparation, lengthy setup, or any calibration procedures. Clinical and nonclinical performance evaluations conducted with the Niji Total IgE Test demonstrated performance comparable to currently marketed reference laboratory tests. The test may be a useful tool for healthcare professionals as an aid in the diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings in their office setting.

Takeda Launches Wearables Pilot for IBD Management

Takeda has launched a pilot digital technology program to support patients and physicians with the management of inflammatory bowel disease (IBD). This program, iBData, is designed to intersect healthcare and digital technologies. In partnership with Texas Digestive Disease Consultants (TDDC) and Vanderbilt University Medical Center (VUMC), this pilot program will allow patients with IBD to track their symptoms and lifestyle factors with wearable watch technology. The data will be collected and translated into reports intended to help enhance patient-physician interaction with the goal of improved care.

The initial rollout of the program will involve about 100 patients. “iBData leverages the remarkable capabilities available today when wearable technologies and medicine converge, in an effort to help overcome these challenges,” says Stephanie Brown, VP, head, specialty business unit, Takeda. “This innovative pilot program will explore new ways to transform care by generating novel insights into the patient experience that physicians can directly utilize.”

USC Takes a Closer Look at mHealth-Enabled Eyeglasses

Dr. Leslie Saxon, head of the University of Southern California’s Center for Body Computing (CBC), is directing a new study to determine whether sensor-embedded eyeglasses can accurately collect biometric data. She’s also interested in knowing whether they promote consumer engagement, and whether mHealth devices can actually compel users to become more philanthropic.

“There’s a lot you can build onto in that form factor,” says Dr. Saxon, whose organization has been at the forefront of the “contextual health” movement for several years. “It’s going to be all about the experience for people.”

For the study, the CBC is partnering with VSP Global, whose West Coast-based innovation shop, called The Lab, created a set of eyeglasses with an embedded gyroscope, accelerometer, and magnetometer. The Level glasses, which debuted in an early form in 2015 and have since been modified, can track steps, calories burned, and activity time.

USC employees will wear the Level and track their activity through a smartphone app. They’ll also accumulate points, working toward a free eye exam and the donation of a pair of eyeglasses to someone in need through VSP Global’s Eyes of Hope program.

The challenge will be in getting people to use the glasses on a regular basis, and without a second thought. That hasn’t been the case with other wearables, like activity bands.

“Unprecedented numbers of people have been buying activity trackers, but it doesn’t tend to be a durable experience,” Dr. Saxon says. “We need to find a way to make this durable … and for (people) to continue using them long after the novelty wears off.”

Studies indicate some 65% of the nation’s adults wear glasses, and another 19% use contact lenses with glasses as a backup. Dr. Saxon says that’s a natural entry point for mHealth, because it leverages something people are already wearing anyway.

In addition, mHealth experts say the head is a better location for biometric detection than, say, the wrist.

New Class of Insulin Delivery Receives FDA Clearance

Companion Medical, focused on developing advanced technology to improve diabetes care, has gained FDA clearance for its InPen system, a wireless-enabled insulin pen and proprietary mobile application.  The InPen can calculate and recommend optimal dosing, track history and timing of doses, monitor insulin temperature, display last dose and insulin-on-board, and track and report to the healthcare provider.

InPen is cleared in the U.S. for use with Eli Lilly & Company’s Humalog or Novo Nordisk’s Novolog, both rapid acting insulins.  The InPen app is cleared for Apple iOS with an Android version planned for late 2016.  The company has also filed for CE Mark.

“FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care,” says Sean Saint, CEO, Companion Medical.  “The product combines the benefits of sophisticated insulin pumps with the simplicity and affordability of pens and syringes, providing patients, physicians, and caregivers increased confidence that diabetes is being managed optimally.”

Apple Acquires Personal Health Data Startup

Apple acquired Silicon Valley-based Gliimpse under the radar earlier this year, to bolster its digital health portfolio and signaling an increased interest in applications for chronically ill users. Gliimpse has built a personal health data platform that enables any American to collect, personalize, and share a picture of their health data. According to its LinkedIn profile, Gliimpse began with a simple idea — everyone should be able to manage his or health records, and share them securely with those they trust. Currently in stealth, Gliimpse is healthcare’s platform for building patient-centric apps. By unlocking hospital silos, it can aggregate fragmented data into Medicare mandated patient summaries.

While mum about what it plans to do with Gliimpse, Apple has made it known that it is looking to expand its presence in the health industry. It already offers a range of services such as, HealthKit, CareKit, and ResearchKit that allow patients, clinicians, and researchers to access important health and wellness data via a range of mobile devices.

Study: Schizophrenia-spectrum Disorder Patients Handle Digital Therapy Intervention

Pear Therapeutics, the creator of prescription digital therapies called eFormulations, recently completed the study mHealth for Schizophrenia: Patient Engagement With a Mobile Phone Intervention Following Hospital Discharge. The study, supported by a grant from the Department of Health and Human Services, Centers for Medicare & Medicaid Services, is to date the largest and longest study examining the interaction of patients with schizophrenia with a digital therapy. The study examined the engagement of patients with schizophrenia-spectrum disorders with the digital therapy intervention for a period of three to six months post hospital discharge.  The study evaluated 342 participants between 18-60 years of age, who had been diagnosed with a psychotic disorder and were discharged from a psychiatric hospitalization within 60 days.

The study demonstrated robust usage of and engagement with the research version of a digital therapy for treating patients with schizophrenia, schizoaffective disorder, and bipolar disorder.  Seventy-four percent (73.6%) of patients were successfully able to use the digital therapy three to six months after discharge, and on average, participants used the digital therapy for 82% of the weeks they had a mobile phone. The study found that patients engaged with the app every other day, and when engaged, they used on-demand features more than once per day. Patients who used the app for the entirety of the study averaged 4.3 days of use per week. Researchers say this study debunks the concern that patients who are not clinically stable are not capable of using mobile interventions.

Cancer Battles Take on New Life in Upcoming Xbox Game “I, Hope”

pv1016_ihopeI, Hope is a strikingly designed 3D adventure game on ID@Xbox, Microsoft’s self-publishing platform for indie game developers, aimed at helping young patients take their mind off long hospital stays and difficult treatments — all while having fun.

“I wanted to bring uplifting virtual experiences to people who really need it — and that’s kids fighting for their lives in hospitals,” says creator Kenny Roy.
Developed specifically with combating cancer in mind, 100% of the profits generated by I, Hope will go to supporting children with life-threatening illnesses and their families. The game is set to be released in 2017 on Xbox One.

With I, Hope, Arconyx and GameChanger hope to motivate, encourage, and give hope to children in the fight of their lives. Adventurous, enchanted, yet emotionally rooted in reality, I, Hope tells the moving story of a young girl called Hope, struggling to defeat “cancer”; a mysterious evil creature that has ravaged and scorned her beautiful island home. In order to attain the weapons, knowledge and courage needed to defeat the monster, Hope travels through five different floating fantasy islands in which she’s confronted by various perils.

The initial idea behind I, Hope was straightforward: come up with a story, design the game and donate it to a charity. After a Kickstarter campaign, huge support from Unity and GameChanger on board, Mr. Roy submitted the game to ID@Xbox.
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