Widespread point-of-care (POC) and at-home diagnostics have long been widely held goals. However, that hasn’t been widely translated into reality. Startup Nanodiagnostics Inc. has been working for years toward a panel of POC tests, helmed by one for traumatic brain injury (TBI) that was quick, simple and accurate enough to use at the sports stadium or on the sidelines of a soccer field.

Now, it has raised an $18 million series C round to get both a SARS-CoV-2 test and a TBI test to market on the same device. The Boston-based company, which was formerly called Biodirection Inc. and is also known by the shorthand moniker Nanodx, pivoted with the onset of the unfolding pandemic. It adapted its nanotechnology platform that originally was in-licensed from Harvard University to develop a test to identify active SARS-CoV-2 antigen from a drop of blood or saliva.

Dx platform pivot

“We're a platform device company that started off in [TBI], being able to use small samples of blood in a dropper to be able to detect whether there are biomarkers associated with head trauma,” Nanodx President and CEO Sharad Joshi told BioWorld. “We had a whole pipeline of products, including influenza and other things. In just the last several months, we've been working on a COVID virus test.

“It turns out [that] it works really well. We can get a result, just like in [TBI] in under two minutes with really high levels of accuracy,” he added. “We're currently ramping up in our manufacturing processes and validating our work, and then we'll be launching toward the marketplace.”

Nanodx said that it already has partnered to get the SARS-CoV-2 test system to various outlets – such as airlines and sports leagues – that could use the device, which is about the size of a toaster. People could be assessed prior to participation in such characteristically crowded activities. The company expects to submit for an emergency use authorization (EUA) from the U.S. FDA within about a month after completing testing to establish the sensitivity and specificity, which it anticipates will be quite high based on early results.

The company already has been in conversations with the agency and anticipates a review only would require a few weeks to a month or so. Nanodx also aims to launch in Europe this summer. Next, it plans to complete testing and an FDA submission for its TBI offering, which won a breakthrough device designation early last year. The test works on the same diagnostic device but with a separate type of cartridge, each of which is about the size and shape of a business card.

After that, it will pursue a separate regulatory go-ahead for the Nanodx system to be used by a layperson, rather than administration via a health care professional. That would enable its widespread use to screen people for active viral infection in the workplace, for large gatherings and at home. Nanodx also expects to develop a SARS-CoV-2 antibody test.

How it works

“We designed this for initial use in the emergency room,” Joshi said. “But then we made it simple enough so that we could eventually get approvals to deploy it to the side of a football field or in the military application or a first ambulance responder or Coach Joe on the side of the soccer field. That was our vision. So, we made this product super simple to use. We did a lot of human factors design and development. Then, eventually, we were going to get to some of these new applications.

“But the demand for COVID testing is massive, and it's one of the major reasons why our country is not back to work, back to school, or even back to flying on airlines again,” he continued. “Because it's a two-minute test, it allows you to test while people are queuing up in line – with appropriate distancing – for example. They can spit into a tube cap; the tube dispenses into the cartridge.”

The nanowire-based Nanodx system is designed to work by sending an electrical current through a circuit. The nanowires are so thin that it would take 70,000 of them to comprise the width of a single human hair. The system is functionalized with an antibody particle that attracts the designated biomarker in the blood. When exposed to the sample of blood or saliva, the nanowire circuit changes the resistance to the current going through the circuit, allowing for measurement of that biomarker.

The system conducts a direct measurement of the biomarker that does not require an amplification or reagents like those needed with common testing methods, such as PCR or ELISA. It’s also conducted in real time as the molecules attach to the nanowire. Because the system is largely chip-based, the manufacturing is expected to be straightforward, inexpensive and easily scalable. Nanodx R&D and manufacturing facilities are in the U.S., an issue related to access that has emerged as global supply chains and trading relationships have become frayed in the current context.

Eventually, Nanodx aims to pick up where it left off with tests for its system, such as for sepsis and stroke. A wide swath of various tests is key for POC testing platforms and would work to ensure its relevance even after the immediate pandemic needs ease. Still, even with a COVID-19 vaccine or widespread immunity testing likely will prove necessary for some time, particularly for at-risk individuals.

The recent series C financing was led by the alternative investment unit of Boston-based wealth and asset management firm Shepherd Kaplan Krochuk LLC (SKK). This round made the firm the largest investor in Nanodx.

"The global need for rapid, definitive and efficient diagnostic technologies has never been greater than it is currently,” summed up Steve Brackett, president and managing member of SKK. “Nanodx fits SKK's investment strategy, which focuses on cutting-edge, proprietary technology platforms addressing large endemic issues and conditions in the global markets. We are impressed by the depth and breadth of Nanodx's current products and development plans."

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