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In-Home Strep Test: Diagnose without leaving your couch!

by Angela Fusaro, MD

Patients need a convenient, cost-effective way to diagnose and treat low acuity conditions, like Step Throat. Now you can diagnose and treat Step from your couch!

Atlanta, GA Patient Power Tools!

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About this project

The problem we solve:
Patients need a convenient, cost-effective way to diagnose and treat low acuity conditions, like Step Throat. There are more than 40 M cases of sore throat each year. Currently, your options for diagnosis include a PCP office visit, but average wait time to see a PCP is between 1.5 and 19 days (varies with geography). You need to miss work, and school, while you take sick Johnny to the pediatrician. The average nonmedical cost of one case of Strep throat is $87. Urgent Cares and ERs cost exponentially more; average co-pays are hundreds of dollars in addition to insurance company expense. You could call a telemedicine company, but physicians are naming the correct diagnosis, viral pharyngitis and Strep pharyngitis, in only 70-75% of cases. And 45% of the time, antibiotics were prescribed inappropriately or tests were not ordered, so you end up at the PCP anyway! Use our patient-friendly, one-step, in-home Strep test. It’s an objective, reliable, convenient way to know if you have Strep

About our solution:
Imagine the home pregnancy test, but for Strep. All the patient does it touch the cotton swab to their tonsil and then place it in the test reader. Our unique design has greatly increased the sensitivity, as compared to other rapid detection tests. Our sensitivity is almost as high as a culture! And within 5 minutes, you have your result! The test kit will display a numerical code that will also be sent directly to your smartphone, and your physician. You will speak briefly on the phone with the doctor, so if there are any other questions or concerns, they can be addressed. If you have Strep, a prescription will be waiting for you at the nearest pharmacy. It’s that easy! Our product allows diagnosis to occur, on average, 24 hours sooner than a traditional PCP office visit. For every case of Strep, this prevents a lot of contagion, essentially decreasing approximately 4.8 new cases of Strep. And you also don’t have to miss work or school!
Progress to date: We have a minimum viable product, and have continued to make modifications to our prototype, based on performance and customer feedback. We have handfuls of beta testers, mainly parents, who have used this product with their kids, and love it! They find the design to be easy and prefer it to the current options. We are currently modifying our business model to ensure that the product can be available on-demand. We have met with the FDA and are actively in the regulatory process for obtaining pre-market approval, and raising funds for clinical trials. We have filed patents on our design.

About Our Team

Dr. Angela Fusaro, MD
Emergency Medicine, Practicing Physician
Medical school: New York Medical College
Bio: Angela Fusaro is an emergency medicine physician who is passionate about healthcare innovation. She is currently designing tools for remote diagnostics, so that high quality urgent and emergent care can be conveniently practiced in your living room. Successful entrepreneur interested in collaborating with other physicians to help translate their clinical insight into marketable products that can save, and improve the quality of, patients' lives.
Title: Co-Founder, Physician 360
Twitter: @fooseMD

About Team Members

Robert Rankins
Co-Founder, Physician 360, MD
Biography: Robert C. Rankins, MD, an Emergency Medicine physician and entrepreneur in McKinney, TX had a recent successful exit from the Freestanding Emergency Room business, which he founded in 2003. Dr. Rankins currently holds patents on two medical devices, one designed and used to remove foreign bodies from the ear and nose, and a second which attaches a tongue blade to an otoscope. He served as President of the County Medical Society for 5 years.
Rob Lapporte
Co-Founder, Physician 360, MD
Biography: Dr. Rob Lapporte has been practicing in emergency rooms and urgent care centers for many years. Dr. Lapporte's clinical acumen has been instrumental in designing our proprietary algorithms which enable medical professionals to treat patients in a timely manner with highly sensitive and specific suggestions with regards to diagnosis and treatment. Dr. Lapporte's background also includes a medical directorship of one of the most successful free-standing emergency rooms in the Dallas area.

About Our Company

Physician 360
Location: Atlanta, Georgia
Twitter: @Physician360
Product stage: proto
Sales: Working on it
Employees: 1-2

How We Help Patients

We want to empower patients. We want to make this process (Strep Throat diagnosis and treatment) as easy as taking an Uber, because we know that folks are busier than ever, and there is never a convenient time to get sick. We are preventing time missed at work and school (opportunity cost). No more waiting in long Emergency Department lines just to find out 'it's only a virus'. No more waiting for days to see your primary doctor. And sitting in the waiting room at the PCP office, exposing others, and being exposed yourself to worse germs than you already have. Not to mention that all this delay to diagnosis, increases risk of serious outcomes like heart disease, all from a simple sore throat! Help us, help you. Let's keep simple things simple. So you focus on important things.

How We Help Physicians

Many physicians are already offering their patients an option for virtual visits; some insurance companies are even requiring it. Our product can serve as an adjunct for telemedicine, increasing physician adoption of virtual visits, by increasing confidence in their remote diagnostic ability and decreasing liability. Our product can also be utilized by primary doctors to decompress their waiting rooms. It also allows them flex to accommodate high-volume seasons. With an ever growing and aging population, and an increase in the percentage of patients who are insured, the physician shortage continues to worsen. Patients will always outnumber us! Let’s free up time and energy for physicians to focus on complicated medical conditions, by empowering patients to handle the simple stuff at home.

Challenge Mission

Mission: We are Emergency Medicine physicians who identified an unmet need, and using clinical insight, created a product that empowers patients with sore throat. This product benefits all stakeholders.
Use of funds: Our next step is the human factors trial. We would use the $25k to begin that process. While we recognize that a multi-centered trial will be on the cost magnitude of hundreds of thousands of dollars, this would allow us to hire a dedicated Research Programs Associate who can manage patient recruitment and logistics. Once we raise our seed round, we would then built the molds necessary to produce the hundreds of devices we will need for the clinical trial. We anticipate the entire trial will take 1 year and cost $1M.
Intellectual Property Status: One of our founders (sole inventor) has assigned the intellectual property for the device to our company. Patents have been filed. We are in a patent-pending status. There is no academic affiliation with this patent.
FDA Status: We have already had one pre-submission meeting with the FDA. We are actively submitting a FDA-requested supplement to our pre-submission. We anticipate a 510k pathway, using previous rapid Strep tests as a predicate device, with a robust human factors trial.
Personal Message: Time is what we value most. We will feel successful if we can help each patient avoid one unnecessary doctor visit. There is never a convenient time to get sick. Help us help you get diagnosed and treated with minimal disruption to your day-to-day. Let's make treating Strep Throat as simple as calling an Uber! So you and your doctor can focus on more complicated things.


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    05/21/2016 Jason Ribeira - Physician

    Liked the project.

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    05/21/2016 Dr. Ryan Ribeira - Physician

    Liked the project.













Angela Fusaro, MD
Co-Founder, Physician 360
New York Medical College

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