NEW YORK – After finalizing its manufacturing strategy, point-of-care diagnostic firm NanoDx is working to commercialize its traumatic brain injury (TBI) and COVID-19 tests.
The firm's reagent-less NanoDx System, which uses electrical currents to detect biomarkers for different diseases, uses technology developed and patented at Harvard Medical School and IBM and licensed by the Southborough, Massachusetts-based company, which was formerly known as BioDirection, Chief Commercial Officer Mike Sampson noted. The development came from the "desire … to get very simple, very fast, very accurate tests really to the point of care … so that decisions can be made right away," he said.
The difference between the NanoDx System and other point-of-care devices is that the NanoDx System "doesn't rely on the reaction between the reagents and the sample," Sampson said. "Instead, it just directly measures whatever target it grabs, and so, it gets a very specific result in a very short amount of time."
To use the device, a sample is applied to a single-use cartridge that is then placed in the reusable analyzer. The sample is moved over the two nanosensors within the analyzer, which run small electrical currents through the sample via nanowires coated with antibodies that bind to the target biomarkers. As the biomarkers attach to the antibodies, the electrical resistance changes, and that change is measured and sent to an algorithm that correlates the measurement to the concentration of biomarkers in the sample. The algorithm then provides a result that can be sent via the cloud within two minutes, whether to a smartphone or an electronic medical record.
The first two applications are for COVID-19 and traumatic brain injuries, and the process is similar for both, Sampson said. However, rather than providing a positive or negative result, the readout for the TBI test provides a general recommendation depending on the presence of two biomarkers: S100 beta, and glial fibrillary acidic protein. The company chose the biomarkers, specifically S100 beta, from multiple previously published studies that suggest they are important markers for evaluating TBI, Sampson said.
The levels of the biomarkers present in the blood sample — obtained via finger prick for ease of use at the point of care — correlate to TBI severity, and the result of the test will be on a scale from mild to severe and will include a recommendation for further screening via a computerized tomography scan if necessary.
The COVID-19 test, meantime, provides a positive or negative result from multiple sample types, including nasal and saliva samples, and is intended to determine whether someone is actively infected, Sampson said. The antigen test is directly measuring the surface protein of the virus using an antibody with high specificity for detecting the protein, he noted.
Both tests are in the process of regulatory approval and commercialization — clinical trials for the TBI test for submission of the assay for US Food and Drug Administration 510(k) clearance are beginning soon, with plans to submit the screening test in the next year, Sampson said. The platform has already received breakthrough device designation from the agency.
A preclinical study of the TBI test drawing on 100 patient blood samples found 100 percent sensitivity and no false negatives. The goal, at least for right now, is for the test to be used as a triage tool to understand whether someone — such as a football player or member of the military — is safe to continue their activities or if they need to go to a hospital and "follow up with other standard procedures to assess TBI," such as a CT scan, Sampson said.
For the COVID-19 test, the company is involved in discussions with the FDA about both emergency use authorization and full 510(k) clearance, although it is also looking at regulatory approval outside the US. There are "still a lot of countries struggling" with the virus that NanoDx is aiming to help, Sampson said, and clearance and commercialization for the COVID-19 test is expected outside the US "in the very near term." Marketing trials for both the COVID-19 and TBI tests are expected to start in the next few months, he added.
The firm has plans for a variety of distribution methods, including both direct sales and working through distributors, although nothing is in place yet. And while Sampson declined to disclose the exact cost of the device, he noted that the platform is intended to be the "next step" of point-of-care devices and will likely be "on the high end" of the spectrum of point-of-care testing prices. Sampson said he sees the system being used by any medical provider, such as in a hospital emergency room or doctors' office. The firm also may consider its potential for home use in the future, he noted.
Optimizing its manufacturing processes to scale up capacity has been a key part of the move toward commercialization of its platform. Working with semiconductor manufacturer SkyWater Technology, NanoDx implemented a new manufacturing process to improve the consistency and quality of manufacturing, preparing it for large-scale distribution efforts, Sampson said.
The two companies worked for about a year to optimize the semiconductor manufacturing and final device, said Steve Kosier, SkyWater's chief technology officer. The firms had to create a manufacturable structure that allowed the sample fluid to contact the nanowire in the device without the semiconductor processing damaging the nanowire itself, Kosier said. He added that the sequence of steps in the process flow is "different than for any other semiconductor process flow in the world."
Bloomington, Minnesota-based SkyWater will also optimize the manufacturing process and workflow to run without engineering intervention. SkyWater and NanoDx already have thousands of working samples, but Kosier said the timeline for when it will begin manufacturing in high volume depends on the rest of NanoDx's commercialization process.
In light of the changed manufacturing process, the company plans to publish new data on the system's performance in the coming months as clinical trials begin, Sampson noted.
Once the TBI and COVID-19 tests are on the market, Sampson said that the company also will look at tests for other infectious diseases, as well as biomarkers for stroke and sepsis.