NEW YORK – Danish point-of-care diagnostic firm Egoo Health is preparing to introduce itself into the US market by adjusting its commercialization plan and focusing on broadening its slate of at-home tests.
The company, a subsidiary of Swedish medical technology firm Qlife Holding, was founded in 2019 and gained CE-IVD marking in 2021 for a molecular SARS-CoV-2 assay. Since then, it has been selling its point-of-care device as a wellness product to health practitioners in the UK and the Nordic region, CEO Thomas Warthoe said at the 2023 AACC Annual Scientific Meeting and Clinical Lab Expo last month, but with its entry into the US, it plans to make its device available to a broader range of customers, including other companies looking to commercialize their own biomarkers.
The device has multiple components, including a blood-to-plasma filtration device called the Egoo Collect that is inserted into a cartridge — the Egoo Capsule — and placed into the larger Egoo Device, which is controlled via a smartphone or laptop. The patented Egoo Collect device can convert whole blood or capillary blood into plasma.
The Egoo Device has three chambers for reagents and one reaction chamber that combines the reagents with a sample to a test. It can perform multiple types of testing, including molecular and immunoassay testing. The device can purify, heat, and mix samples and reagents and relies on optics technology to provide analysis, including fluorescence measurement for DNA and RNA biomarkers, bioluminescence for high-sensitivity applications, and enzymatic and immunoturbidimetric absorbance for protein biomarker quantification.
Multiple sample types can be used with the platform, including blood, nasopharyngeal, and oropharyngeal swabs. While the platform can perform molecular tests, such as its SARS-CoV-2 test, the company believes the molecular testing market is "oversaturated," so it isn't actively developing molecular tests, Warthoe said.
Egoo is looking for commercial partners to whom it can license its technology.
The company also provides its ILab software that connects to the cloud and can control multiple Egoo instruments, customize a test's reaction time, temperature, measuring intervals, and mixing speed, and transfer test results into an electronic medical record or data analysis program, said Maiken Rosenstierne, the company's director of research and development. She also noted that reaction changes can be activated at different time points, allowing for the use of tests that require an incubation period.
Egoo currently offers a quantitative C-reactive protein test and is developing tests for vitamin D, HbA1c, and lipid levels, and it plans to develop other assays such as cardiometabolic and respiratory panels. The device and 10 CRP tests are offered on its website for about €600 ($656.84). The firm also offers a subscription plan for three CRP tests monthly that costs €75 and a subscription for 20 CRP tests that costs €300.
The device and CRP test do not yet have regulatory approval under Europe's In Vitro Diagnostic Regulations, which is why they are being sold as wellness products, but the company is "in proceedings" for regulatory approval, Warthoe said.
Despite the variety of tests currently in development, the firm "cannot do everything" itself, Rosenstierne said, which is why it has broadened its commercial focus to partnerships. In particular, the company is using its Egoo Innovate program to target firms that want to conduct decentralized clinical trials with patients in their homes. The first phase of the program is laboratory-based, where a partner works with Egoo to create and optimize an assay for a specific biomarker on the Egoo platform, Rosenstierne said.
"We want our partners to be able to choose and develop the biomarker in collaboration with us," Marketing Manager Christopher Lee Dahm added.
The next phase is optimizing the test design for use at home, Rosenstierne said. This involves taking the information related to running the assay, including the calibration parameters and required assay conditions, and attaching it to a QR code that is then put onto the capsule that will go into the device. That QR code, when scanned by a smartphone camera, allows the smartphone to take control of both the instrument and the test and run the assay with the required conditions, she said.
The firm can also help with small-scale production of the test capsules to test the assay's performance and ensure it is feasible for home use. Once its feasibility has been established, Egoo would then assist with scaling up production of test capsules and gaining regulatory approvals if the test is intended to be commercialized, Dahm said.
Warthoe said the company has seen interest from pharmaceutical companies in developing tests to monitor the safety and efficacy of drugs in clinical trials, and the firm is in discussions with undisclosed pharmaceutical partners to develop companion diagnostic tests. It is seeking additional partners that may be interested in using the platform to develop assays, including for use in clinical trials.
According to Dahm, that could boost clinical trial recruitment and reduce logistics concerns, since patients would be able to participate at home and samples wouldn't need to be shipped to laboratories.
In the future, the company plans to market the Egoo test directly to consumers, but right now its marketing focus, particularly in the US, is on working with partners to develop assays and providing tests to healthcare practitioners who are looking for blood biomarker testing.
The company hopes that eventually consumers will use the Egoo platform to monitor chronic conditions "so they can get an idea of whether their condition is progressing" and can coordinate that data with their healthcare providers, Warthoe said.