Point-of-Care Diagnostics on Display at HIMSS 2022

Around 2014, I saw a very interesting TED Talk with a woman dressed in a Steve Jobs-like black turtleneck, talking about performing diagnostics for a variety of medical conditions using only a single drop of blood. I was fascinated by the story and, at the time, shared the video with readers. This type of innovation would certainly revolutionize the blood diagnostics industry. Of course, the woman was Elizabeth Holmes and she was talking about technology being developed by her company, Theranos.

I’m now watching the Hulu series “The Dropout,” which shares Holmes’ story and how she rose to such fame, only for it all to come crashing down around her. In an upcoming Editor’s Letter, I will certainly share my thoughts and observations of that series, but I bring this up here because I wanted to illustrate my frame of mind when attending this year’s HIMSS event in Orlando. My skepticism was on high for anyone pushing forward a claim on diagnostic capabilities. That said, I found several exhibitors who seemed to have more realistic goals for their technology than the aforementioned Holmes.

This was my first visit to the annual HIMSS (Healthcare Information and Management Systems Society) event. I had been told for years it was something I should check out, so I went in with somewhat high expectations. I’m happy to report those expectations were met. While the event covers a wide array of healthcare-related innovations, from electronic health record systems, solutions for surgical scheduling, and software for efficient billing, it also houses a good number of medtech providers more aligned with MPO’s typical focus. I met with these companies while attending and saw a bevy of intriguing offerings.

As I mentioned, I saw a number of diagnostics-centric firms with products of varying capabilities. Unlike Theranos, none of them made claims that would cause me to scratch my head wondering just how they were going to go about producing technology to match.

First up was a meeting with ixlayer. This company offers a complete at-home lab testing solution that can be branded with any company’s name and/or logo. The kit can be used to help with remote patient monitoring or decentralized clinical trials. The firm also provides a system to enable employer-sponsored clinical health testing for COVID-19. The options for this include a laboratory test (ixlayer has a number of laboratory partners and can route tests to one that will provide the quickest turnaround time), an antibody test, and a rapid point-of-care (POC) test. The “plug and play” style of ixlayer’s offerings (i.e., “plug in” your logo) was an impressive and comprehensive solution.

At the end of my first day at HIMSS, I met with iAssay, and spoke with them about their “universal” POC reader. The system enables use of a single reader for any test panel (FDA cleared) to provide results to patients in minutes wherever they are located. This eliminates the need to send a sample to a lab. Further, the unit allows the results to be uploaded directly to a cloud system and/or recorded to an electronic health record. The system works in conjunction with a cartridge, which is what identifies the type of test being read. In addition, there are verification systems in place to ensure the cartridge being used is authentic. As we spoke, what became even more interesting was the applications for this type of unit beyond the healthcare environment. For example, a university could have one for COVID testing of returning students. Or it could be used by police for drug screenings. Anyone who has a POC test in development and is seeking to avoid “re-inventing the wheel” in the development of a reader should be curious to look at iAssay.

The last of my diagnostics visits was with Cue Health. Another POC solution (I think that is a well-established trend for diagnostics going forward), Cue provides molecular level testing, which differentiates it from a number of its diagnostics peers. Additionally, the firm is proud to point to the fact that you don’t have to take their word on the system’s accuracy. Rather, in a study conducted by the Mayo Clinic laboratories, the results of the company’s COVID-19 test in the POC setting was set against the centralized lab PCR testing model. According to a press release covering the study, it was found the “overall concordance between the Cue point-of-care test and the reference laboratory tests was 97.8 percent.” While the company’s only product at the moment is for COVID-19, they expect to be able to accommodate other testing solutions.

HIMSS offered a fantastic look at how diagnostic capabilities are changing for the better and it was astounding to see what is capable at the point-of-care. 

Sean Fenske, Editor-in-Chief
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