iAssay Point of Care Testing: The Square of Healthcare: Any patient test, Anywhere

by lonnie adelman

The iAssay® Device is a wireless, hand-held, Smartphone-based, point of care test system. Any POC test cartridge can be used via a plug-in adaptor. Test/patient/wearables data is pushed to The Cloud.
San Diego, CA United States Medical Device BigData MedStartr Ventures challenge

All Team Company Patients Physicians Mission Innovation Details Supporters Comments Updates

About our project

The problem we solve: The “Providers’ Pain” is addressed head-on by iAssay. In the U.S. and developed countries, today’s healthcare system demands dramatic cost decreases while improving patient care. Patient test results take too long, and testing (especially outside of hospitals) costs too much. Patient information, test results, and interconnected records don’t coexist real-time in a common database. In the US, enter Value based Payment System (VPS) in 2017: Hospital and physicians will be tracked by tax id, they will get paid more if they are more efficient. Overspending is also tracked. VPS will drive care providers to iAssay’s low cost of entry, immediate cost reductions by eliminating patient sample transportation, immediate test results (stored in The Cloud) to quickly diagnose and reduce readmissions, and a Cloud-based database to enable activities such as auto population of EHRs, auto billing for the provider.

About our solution: Battery-powered, the patent-pending iAssay® System is wireless, hand-held, Smartphone-based, point-of-care (POC) clinical diagnostics system that provides central lab quality, but at the patient's bedside. The system accommodates any POC test cartridge using a plug-in adaptor, leading some to call the iAssay System “The Square of Healthcare.” This Open Platform gives care providers choices: choose the best test cartridge (already in the marketplace) based upon performance and price, plug it into iAssay device, and run the test. Test results are available in minutes! Perform a panel of tests on a patient at point of care in minutes by the patients’ bedside. Store all the data in The Cloud, and autopopulate patient healthrecords, enable automatic billing for the provider, push data into the BIG Data stream for an unlimited number of uses. The Solution image shows two test strips for cardiac markers. These were inserted into the device and the concentration of cardiac marker found.

Progress to date:* Developed a prototype, and are performing validation testing with patient samples * Experienced corporate team & acclaimed advisory board guidance * Successful testing & validation underway * Have initial external seed investments * IP Portfolio Growing * Agreement signed to pilot iAssay with National University Clinic; Other pilots in planning Working with Health IT partners to HIPAA-compliantly capture test results and auto-populate EHRs Looking for more strategic partners in Health IT and Test Cartridge manufacturers

About Our Team

Creator: lonnie adelman

Location: California

Education: California State University, Northridge

Bio: Lonnie is a 30 year veteran of the Biotechnology, Medical Device, high tech, & Consumer Products Industries. He is iAssay’s CEO, & acting CTO. As founder of Ericomp, Inc. he was first to ship a programmable PCR machine, then a line of 6 models. 12 years with HP focused on technical innovation, mentoring, & managing cross-functional teams focused on high-volume product development. He always seeks to share his experience, solicit input from the team, & then win together.

Hospital Affiliation: N/A

Title: CEO

Advanced Degree(s): N/A

About Our Company

iAssay, Inc.

Location: 9921 Carmel Mountain Road
suite 777
San Diego, CA 92129

Founded: 2014

Website: http://www.iAssay.net

Twitter: @iAssay

Other link: http://www.iAssay.net

Product Stage: Prototype/MVP

YTD Sales: Working on it

Employees: 3-5

How We Help Patients

The “Providers’ Pain” is addressed head-on by iAssay.  In the U.S. and developed countries, today’s healthcare system demands dramatic cost decreases while improving patient care.  Patient test results take too long, and testing (especially outside of hospitals) costs too much.  Patient information, test results, and interconnected records don’t coexist real-time in a common database.  In the US, enter  Value based Payment System (VPS) in 2017: Hospital and physicians will be tracked by tax id, they will get paid more if they are more efficient.  Overspending is also tracked.  VPS will drive care providers to iAssay’s low cost of entry, immediate cost reductions by eliminating patient sample transportation, immediate test results (stored in The Cloud) to quickly diagnose and reduce readmissions, and a Cloud-based database to enable activities such as auto population of EHRs, auto billing for the provider.

iAssay provides a mechanism for care providers to conveniently, immediately, and cost effectively test patients within the newest Healthcare regulations.  Removing the barriers that might lead to care providers to "wait till the next visit" to test patients will undoubtedly improve patient care, and save lives.

Saving all patient test data in The Cloud to automatically and accurately populate electronic health records will lead to delays associating with need to retest the patient because test results are lost.

How We Help Physicians

Beyond the Patient Protection and Affordable Care Act, a wide range of reforms is necessary to address intransigent problems in healthcare delivery in the United States and worldwide. These include inequities in the availability and access to health services for significant segments of the population, inefficiencies in the prevailing modes of healthcare delivery and financing, uneven distribution of quality, escalating cost, and the prevalence of adverse lifestyles that tend to exacerbate these problems. Concurrently, dramatic advances in the capabilities of information and communication technology (ICT) and its expanding vital role in all sectors of modern society present a compelling case for a thorough examination of the underlying evidence and its appropriate deployment in healthcare.

Home monitoring/wireless point-of-care testing intervention by iAssay in disease management promises to involve patients in their own care, provide continuous monitoring by their healthcare providers, identifies early symptoms, and also allows for prompt responses to exacerbations in their illnesses. Generally, the benefits of home monitoring/wireless point-of-care testing include reductions in use of service (hospital admissions/readmissions, length of hospital stay, and emergency department visits). It includes the collection of clinical data from the patient and the transmission, processing, and management of such data by a healthcare provider through an interface system. As such, it represents an innovative paradigm for the medical management of chronic illness, which aims at providing appropriate care at the appropriate time and place in the most appropriate manner.

Challenge Mission

Market Size

iAssay's addressable market is $8.8Bil Addressable market: Professionally-Administered tests, which is expected to increase to $10.5Bil by 2019. This is a small segment of the more than $20B Point of Care market ( http://www.marketsandmarkets.com/Market-Reports/point-of-care-diagnostic-market-106829185.html?gclid=Cj0KEQjwhvbABRDOp4rahNjh-tMBEiQA0QgTGuDc0BM4q5vjhQVPpOyv7zRhKm_tLYdlWO-D8OSglkYaAqTk8P8HAQ)

Projected 3 Year Growth

In 3 years, iAssay will generate $36M in device revenue and $17M in "Click Charges" -- we receive a small commission for every test run on the iAssay device. iAssay projects an EBITDA of $40MM.

How We Will Make Money

iAssay will sell devices at a gross profit, then receive "Click Charges" (commission) every time a test is run on our device. Sometimes the commission will come from the manufacturer of the test cartridge, sometimes the commission will come from the customer.

About our Competition

iAssay's primary competition is Abbott iSTAT and Alere Epoc. Neither of these companies are interested in the home care market because it's too small for them at $0.5Bn, but large enough for us to start off. Abbott iSTAT has 18 test cartridges and Alere has 2, and neither can run any other cartridge but their own. Neither of these companies can run all the tests that a provider would need point of care, but iAssay can because its device can accomodate all kinds of test cartridges regardless of format or technology. The universal nature of iAssay's patent-pending device is its biggest advantage: nobody else can do a full patient panel at point of care.

Innovation Details

Intellectual Property Summary

•PCT/US2013/074209, Published June, 2014,

     National Phase June, 2015

•Two provisional patents in process:

      Filed 7/1/16: Protects additional configurations and functionality

      In Process: supporting medium/high-complexity assays outside the hospital and lab

Corporate and Intellectual Property CounselLegal: Wilson Sonsini Goodrich & Rosati

Patent Link
PCT/US2013/074209

Clinical Information

iAssay plans to begin testing patients in ad hoc clinics in January, 2017 after IRB approval ( http://iassay.net/national-university-nurse-managed-clinic-in-watts-los-angeles-collaborates-with-health-net-connect-and-iassay-to-expand-access-to-virtual-health-care-services/ ). 

We are in the planning stage for other clinical trials.  We need to raise $50K to participate in a trial to prove clinical efficacy for post-transplant patients.

We will have 3 pre-production models ready for FDA 510k clearance by Q4 of 2017.

Regulatory Status

iAssay expect to file an FDA presubmission in early 2017.  The company expects to begin the FDA 510k clearance process by Q4 of 2017.

How we will use the funds raised

iAssay is looking to raise a total of $700K from all souces ASAP.  $500K will be allocated to R&D (including clinical trials and product development), $100K will be allocated to Marketing (Strategic partner agreements; initial deals with regional/national labs, distributors, Payors; Tradeshow attendance), $100K will be allocated to G&A

As funding is available, it will be allocated to functions that allow iAssay's business plan to stay on track.

Thank You

Many in the US are worried about the state of healthcare. More people are discharged from hospitals earlier & earlier, & are seen at home by visiting nurses.  I saw this as a global problem, not just in the US.  I looked for a way to develop a product that provided better services at a lower cost. 

Typically blood’s drawn, & the sample driven from a home to the hospital.  What happens if a patient’s hours away from a blood lab, & only has hours to live?  Solution: iAssay’s universal tester will provide test results in minutes, & the patient diagnosed immediately.  All test data is stored in The Cloud.  We are going to SAVE LIVES! I’ve invested over $100K.  Now you have an opportunity to participate by funding this project. Thanks, iAssay team.

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lonnie adelman
CEO
California State University, Northridge

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