ORLANDO, Florida – Point-of-care instrument developer iAssay has formally unveiled its latest product, a point-of-care device that extracts data from diagnostic tests, highlighting its data management and interoperability features.
The firm chose to debut the instrument called SimpleTest 2 at the annual Healthcare Information and Management Systems Society (HIMSS) conference, held here this week, in order to tout its capabilities — after extracting data from diagnostic tests, SimpleTest 2 sends the information to the cloud and connects it to the IT systems of labs and healthcare providers, said iAssay CEO and Founder Lonnie Adelman.
"It brings the functionality of a reference lab to the point of care," said iAssay Scientific Director Edward Strong.
While the firm presented the SimpleTest 2 concept at a US Air Force innovation event last year, it formally introduced the product for sale at HIMSS.
The instrument records the image of a test inserted into a drawer on a cartridge, automatically interprets the results, creates a report, and transmits data to the firm's data hub.
The new device differs from an earlier product, another universal reader called CyberReader, in that it has two drawers rather than one to run tests simultaneously and has the cloud connectivity. As with the CyberReader, the SimpleTest 2 is adjustable, thanks to an adapter module the company designed to run test cartridges from many different manufacturers on a single, universal instrument.
The iAssay cloud stores test results as well as images and automated analyses of optical, electrical, and magnetic lateral flow immunoassays. With SimpleTest 2, the company is trying to take human error out of the interpretation of POC tests and eliminate the need for manual data entry of results.
Adelman said that point-of-care testing usually is a "dead end" when it comes to workflow. The testing device returns a value and someone has to manually enter the data into a laboratory information system or even a spreadsheet, he explained.
"This meeting is showing that the cloud part of what we're doing is extremely important," Adelman said. "The cloud is more important than the [instrument] you hold in your hand."
The firm, founded in 2014, has been able to validate the SimpleTest 2 technology during the COVID-19 pandemic using PCR technology testing for SARS-CoV-2 as testing based on that technology proliferated, according to Adelman.
The company plans on leasing SimpleTest 2 with monthly fees, a per-test charge, and data service charges, according to Adelman. The cloud platform is open to other devices, and iAssay said that it is adhering to the FAIR (Findable, Accessible, Interoperable, and Reusable) data principles promoted by the US National Institutes of Health.
According to Adelman, SimpleTest 2 will allow smaller care providers to be able to offer point-of-care diagnostics by making it easy for them to get data from tests. A sample use case is allowing clinics to have a single medical director remotely overseeing sample collection by lab techs at multiple sites.
Strong said that the device helps organizations operate more efficiently and even extend their brands. He said that it would have made it easier for health systems and even lab startups to put their names on pop-up COVID-19 testing sites without having to station a medical director at each location.
Adelman said that a seed funding round is in process, and that the firm has gotten a commitment from an individual investor, Deen Wong, a pathologist in Kealakekua, Hawaii.
Adelman's first company, Ericomp, was an early producer of programmable PCR machines. Adelman said that no investment banker ever approached him while he ran that company in the 1980s and '90s, but at HIMSS, iAssay has attracted the interest of several institutional investors.
The company is also pursuing a Small Business Innovation Research Phase II grant from the US Air Force after receiving a Phase I award a year ago. Adelman said that iAssay will end the seed round early if it wins the grant.
Adelman said that iAssay will pursue both 510(k) clearance from the US Food and Drug Administration as well as CE-IVD marking in Europe. In the meantime, the firm will concentrate on corporate and parolee drug screening, which can be done in the US without FDA clearance.
The company said that it has collected data showing that results read by SimpleTest 2 meet or exceed accuracy and precision promised by test manufacturers. That data, which is not yet public, will be part of FDA 510(k) and CE-IVD applications.
If iAssay does receive regulatory clearance, it will market SimpleTest 2 to physician offices and urgent care centers. Adelman said that the firm eventually would like to get the instrument into clinics in pharmacies and supermarkets.
The firm has applied for a US patent for its technology for automated processing of multiple test types in a common drawer like the ones on the new device. It said in January that it expects to receive the patent midyear.