Nextgen Biomed Ltd. has begun a clinical trial of a breath test to monitor antibody levels in individuals vaccinated against COVID-19. Be'er Ya'akov, Israel-based Shamir Medical Center authorized the trial for test developer Scent Medical Technologies Ltd. (Scentech Medical), which is in the midst of merging with Nextgen. The merged company will be called Scentech Medical.

“Nextgen has helped to fund Scentech Medical and is providing access to the public markets that is needed to continue to fund the ongoing operations and future endeavors. We have ambitions that extend beyond the coronavirus, extending into the identification and diagnosis of a wide range of diseases and medical conditions,” Nextgen CEO Yaniv Hevron told BioWorld.

“We believe that Scentech is at the ideal point to enter the public markets because the company is projecting significant income in 2021,” Hevron added. “The public markets allow us access to funds when we will need them for growth while also providing an ideal incentive system to reward the company for its growing revenues.” Nextgen trades on the Tel Aviv board as NXGN.M.

Clinical trials underway

The company believes its trial is the first to attempt to demonstrate the ability to monitor antibody levels and types of antibodies activated by COVID-19 vaccination. The trial will use a rapid breath test to identify the presence of biomarkers for IgM and IgG antibodies associated with the vaccines approved around the world to date. The researchers expect the test to be able to differentiate between the vaccines and determine their efficacy.

They are simultaneously conducting a trial to detect infection with SARS-CoV-2, also at Shamir Medical Center. Scentech Mdical previously identified biomarkers that indicate COVID-19 positivity in a trial with 784 participants. In discussing results of that trial, Hevron said, “while we cannot share preliminary data or specific numbers during ongoing clinical trials, our sensitivity and specificity are higher than existing commercial tests,” including both PCR and antigen types.

The company expects the VOX system developed by the company to discern between individuals who are positive (even if asymptomatic), negative, and negative with antibodies.

Device development

The test requires a patient to blow through a simple, disposable, straw-like apparatus into a system that captures a sample of exhaled breath and then analyzes it. “The device is a proprietary system that includes a unique ionization source but that operates in a similar fashion to the devices that are used in airports to detect explosives,” Hevron explained.

Currently the test takes a few minutes, but the company hopes to get the process completed in under 30 seconds before it rolls out.

The trial will include several hundred subjects for each vaccine studied over the next few months.

The system’s underlying algorithm has been tested on more than 1,000 individuals so far. That preliminary research identified specific biomarkers in breath produced directly by SARS-CoV-2, a process which can also be performed with other infections or pathologies, Hevron noted.

After analyzing the breath sample for these biomarkers, the system returns a positive or negative result that is presented on a screen or sent to the individual’s mobile device, depending on the systems with which the test is integrated. “We are currently working with airport security systems for the device’s integration with other technologies like ID verification technologies and border security checks,” Hevron said. “Each implementation has its own method for presenting the final result.”

Scentech plans to make the test available after finalizing the validation studies and obtaining final regulatory approval. “While we would love to project timelines for both of these events, regulatory approval timelines are always difficult to project and the validation studies are subject to variables like the availability of suitable subjects, hospital staffing, and regulatory requirements,” Hevron noted. “For these reasons we are not currently providing timeline projections at the moment but it is highly likely that it will be available in the near future.”