In the past, medical tests had to be taken at a doctor’s office, hospital, or lab. Yet 70% of diagnoses are based upon diagnostics, and it can be difficult to get regular testing when required to attend an in-person facility. iAssay System, a new patented device that relies on wireless technology and microcomputers, will accept fingerstick blood samples or urine samples taken at a patient’s home. The iAssay System will enter the $30 billion Point of Care (POC) diagnostics market. “Faster test results mean that patients can be treated now instead of later, improving patient outcomes,” said Lonnie Adelman, Founder and CEO of iAssay, which makes the device.
Through the iAssay System handheld medical test reader, flexible testing will become available for cardiology, hematology, OB/GYN, infectious diseases, oncology patient, and drugs of abuse. Most recently, the company added COVID-19 testing capabilities. Test results are then automatically uploaded to the cloud for remote monitoring and reuse of data. “What we do is adapt already FDA-cleared and functioning point-of-care test cartridges to our device,” said Adelman. “That way, we can use the best-in-class cleared test cartridges for optimal test performance.”
In the past year, iAssay System was granted a patent for reflexive testing with the technology, and a related patent is currently pending in the EU. iAssay has developed a clinical study with regulatory consultant MDC Associates to support EUA submission, a PreSubmittal for an FDA 510(K) was filed, and a Joint FDA 510(K) with a COVID-19 partner is currently under an MOU.
The system is being placed on a reagent rental program, with the rental fee being paid by a negotiated cost per click result fee. Initially, there will be fixed annual data agreements with some healthcare providers that are expected to generate $5K-to-$10K per provider per year. Eventually, the anonymized data can be sold across many industries, with sales channeled through well-known and independent distributors, such as Henry Schein and Cardinal Health, and directly to test strip manufacturers. iAssay will apply its IP into bonus markets, such as food safety, water quality, and veterinary medicine.
With the iAssay System, the future of medical testing will be transformed, and patients will have easier access to the tests they need from the comfort of their homes. “Whenever I explain the system to people, it just clicks,” said Adelman. “They understand right away that our device is going to help people get their testing done more conveniently, and it is going to save everybody a lot of time.”