NanoDx
Reimagining Point-of-Care Diagnostics

After a year into the COVID-19 pandemic, we finally see a transition to normalcy in the U.S. COVID-19 cases have gone down to about 25,000 a day - a significant dip given that the country reported about 230,000 cases a day earlier this year. A recent study from Johns Hopkins University highlights that the share of tests with positive results has reduced to nearly three percent for the first time since mass testing began. This reduction in positive cases, however, has also decreased the number of daily tests conducted. As per the same report, tests have gone down to fewer than one million as of May from two million in January 2021.

According to experts, this change in attitude is alarming since the virus is still far from being deemed “manageable.” People with compromised immune systems—and even immunized people—are still susceptible to the virus, especially to the emerging, contagious variants. In this scenario, it is essential to increase the number of tests and improve the time required to generate results in the event the COVID-19 pandemic reoccurs.

Although the in-vitro diagnostics tests available in the market can effectively detect the presence of the virus, the process is time-consuming. The extensive task of collecting test specimens from patients, examining them in a central lab, and providing the results can take several hours or even days. At a time when every second is crucial, a real-time, point-of-care diagnosis to quickly identify and trace infections is important.

This is precisely where Massachusetts-based NanoDx makes a world of difference. This innovative medical device company is developing a simple, low-cost system that includes a portable handheld for rapid and accurate assessment of nasal, throat, and saliva specimens in a two-minute test. “Our system is based on proprietary nanotechnology biosensors that rapidly detect and accurately measure protein biomarkers that are present in patients with an active virus – like COVID-19 or released from the brain immediately following a head trauma,” says Sharad Joshi, President and CEO, NanoDx.

Valuing the Essence of Time

As of today, the NanoDx System has two applications: Traumatic Brain Injury (TBI) and COVID-19. “On the TBI side, the solution represents an opportunity to help diagnose 69 million patients worldwide. It addresses existing TBI diagnostic challenges by providing a quantitative assessment of injury from a finger stick of whole blood, with no reagents, and a direct measurement of the analytes in a two-minute test,” says Joshi. He goes on to mention that the system will first detect the presence of biomarker proteins (S100B & GFAP) in the blood. Then, the level of biomarkers will be correlated to TBI severity and displayed on a scale from mild to severe. In a preclinical Institutional Review Board (IRB) study, the company tested 100 patient blood samples, which resulted in 100 percent sensitivity and 0 false negatives.

“We are truly transforming in-vitro point-of-care diagnostics by developing products that have the potential to give healthcare providers a novel way to test patients quickly and accurately in any location,” says Joshi.

Our system is based on proprietary nanotechnology biosensors which rapidly detect and accurately measure biomarkers in a small patient specimen in just 2 minutes

“Time matters in caring for patients. Understanding the difference between two minutes and 20 minutes, we are developing a product that helps healthcare providers take fast actions to improve patient outcomes and save lives. Our system’s ability to test a person right on a soccer field or in an elderly care facility or on the military field is extremely valuable.”

The company demonstrated the flexibility and scalability of the NanoDx System by rapidly developing the detection of SARS-CoV-2 with high levels of sensitivity. The modified biosensor produces the test result within two minutes from a small nasal, throat or saliva specimen at the testing site with no central laboratory involvement. “Being able to test fast and accurate is important, but being able to deliver the test results anywhere, meaning at the side of a road, a remote lab, a patient’s home or any kind of remoteness is really important for this point-of-care delivery.”

Bespoke in the True Sense

What truly stands out in NanoDx’s revolutionary system is its Internet of Things (IoT) compatibility. The system also supports WiFi and Bluetooth connections to help potentially trace infected individuals’ movements. This supports multiple use cases. For example, a university with thousands of students can easily run rapid tests across the student population in classrooms, libraries, hotels, cafeterias and provide results in a couple of minutes. The rapid assessment can help identify the infected individuals, trace their movements in real-time, and warn the students who came into contact with infected people using a simple phone notification.

NanoDx’s unique diagnostic abilities have already grabbed the attention of airlines, amusement parks, large corporations, hospitals, and elderly care facilities. “NanoDx’s fast and accurate testing along with the ability to track people in an effective way, while respecting their privacy, is exceptional in the market,” Joshi adds.

Route to Commercialization

Currently, NanoDx is working tirelessly to apply for an Emergency Use Authorization (EUA) for their NanoDx System for SARS-CoV-2. They plan to get a Point-of-Care (POC) clearance on their system for a saliva test to allow expansion of their technology to clinics, urgent care facilities and remote testing sites. The company is also working on high volume manufacturing of affordable, reproducible, highly sensitive, and specific biosensors for many applications beyond COVID-19 and TBI. “We are looking to diagnose stroke, migraine, epilepsy, and cardiac issues with our solution as rapid test options are unavailable for these diseases at the moment. In such fields, remote testing would essentially result in cost savings along with effective and safe diagnosis,” explains Joshi. In the meantime, NanoDx is ramping up its manufacturing capabilities to meet the massive demands of both COVID-19 and TBI testing.

In summary, NanoDx aims to be a world leader in Nanosensor

-Based, Real-Time, Point-of-Care Diagnostics for a wide variety of diseases. “Wherever there is a strong correlation between a biomarker and a disease, we aim to make the diagnosis process faster and more personalized,” concludes Joshi.