PERTH, Australia – In response to the COVID-19 pandemic, Trajan Scientific and Medical Ltd. and Synexa Life Sciences Ltd. have developed and validated a SARS-CoV-2 serology assay that enables more efficient, population-based monitoring of the longevity of COVID-19 vaccines being deployed and to help determine the timing and deployment of booster vaccinations.

“We’re focused on how you deliver quality information and how you start with a validated quality measurement tool that is more than a gimmick,” Trajan founder and CEO Stephen Tomisich told BioWorld.

“The rollout of COVID-19 vaccines signifies the need for accurate data points for the long-term monitoring of COVID-19,” he said.

The Trajan-Synexa collaboration has demonstrated that blood microsamples collected remotely using Trajan’s Hemapen are as accurate as blood samples collected using traditional phlebotomy when measuring the diversity of antibodies that are produced following infection with SARS-CoV-2.

The Synexa assay’s primary purpose is to provide data that will help answer important questions following the rollout of approved SARS-CoV-2 vaccines, such as: How long does immunity last? How well does the population respond to the vaccines? What is the variation in immunity among the population?

The SARS-CoV-2 serology assay combines two elements, providing a streamlined solution for sample collection and testing: Trajan’s Hemapen, which is a pen-shaped microsampling tool that enables the collection of four volumetrically fixed, accurate and precise dried blood samples from a single source; and Synexa’s SARS-CoV-2 serology assay, which is capable of detecting anti-SARS-CoV-2 IgM, IgA, IgG and neutralizing antibody response.

Cape Town, South Africa-based Synexa’s assay, which uses Trajan’s sample collection capabilities, is not designed to replace the current “positive-negative” COVID-19 testing process. Rather, it is designed to measure a patient’s response to SARS-CoV-2 exposure using blood microsampling technology, and whether the patient’s immune system is responding effectively. The assay is designed to support therapy and vaccine surveillance.

The Hemapen is a self-administered blood sample collection using a simple finger-prick that can serve market needs in a new world of socially distanced patient care. The Hemapen technology can be applied to large-scale screening and monitoring after the rollout of vaccines.

“The assay can inform pharmaceutical companies and governments in determining how long COVID immunity lasts in patients and when booster shots should be administered. This type of testing will better prepare the community for subsequent waves of new variants of the virus,” said Tomisich.

“The assay will help ensure that large-scale screening and sero-surveillance studies following the rollout of vaccines can be conducted safely and efficiently, while maintaining social distancing protocols and providing comfort and convenience for patients.”

The SARS-CoV-2 serology testing kit measures antibodies that bind to the SARS-CoV-2 virus and block infection. These “neutralizing” antibodies make up a fraction of the antibodies that a person’s immune system will generate following vaccination.

An advantage of Hemapen is its integrated dried blood spot storage format, so blood samples can be collected in a patient’s home, in remote areas or anywhere in the world, and then mailed to Synexa’s testing facilities in Europe and North America without the need for refrigeration.

Mom and Pop early venture

Tomisich started Trajan with his wife, Angela, in 2011. The Melbourne-based company started out in analytics.

“We had a bit of a mid-life crisis, and we wanted to translate science into something that would benefit people,” he said.

“We see ourselves as a catalyst for measurement technologies playing a role in health care.”

“You can see this happening already, particularly in the fields of mass spectrometry and some of the chromatography techniques leading into mass spectrometry.”

“We’re continuing to grow and to invest in expertise in these areas.”

He and his wife are the sole shareholders of the private company that now has 450 employees around the world and manufacturing sites in Australia, the U.S. and Malaysia.

“Our view of the future is around de-centralized health care,” he said. “A few things will drive that. The cost structure of the Western health care systems are such that the meter starts running the minute people show up, and often people are turning up for monitoring services, Tomisich said.

“If you can develop a way to take analytically credible samples outside of that clinical setting, then that helps to break that cycle.

“Secondly, if we think the world is moving toward personalized and preventative health care, then it has to be measurement-based, and you have to measure the healthy, because it they’re sick you’ve missed that preventative window.”

When designing the company’s Hemapen device, “we knew it had to be intuitive and be able to be used by an unskilled person, but it also needed to allow an unskilled person to take a microsample with the accuracy and integrity beyond what you would do in a lab.”

“The key linkage for us is that it’s about monitoring and looking for change. Once you’re able to have reproducible accurate measurement taken from a remote sample, then the changes you see are real,” he said.

The Hemapen can also be used to measure other processes. For example, athletes have used the Hemapen to understand how their training regime affects their metabolic processes.

“Ultimately, we’re going to see machine learning/artificial intelligence work with these measurements and start to do correlations between genetic profiles, metabolic profiles and your likely health outcomes,” Tomisich said.

Trajan received numerous grants from the Australian government to develop its manufacturing capability. It received a A$2.1 million (US$1.6 million) grant in 2013 to fund a new Australian Research Council Industrial Transformation Training Center for Portable Analytical Separation Technologies.

And, in 2015 Trajan was one of 11 Victorian businesses receiving a total of A$27.4 million to establish or expand high value manufacturing operations under the Next Generation Manufacturing Investment Program.

In 2020, the company received TGA approval for its Hemapen as the first blood microsampling device for use in Australia. The device is supplied for therapeutic or IVD use in Australia, New Zealand, the U.K., Europe, and the U.S., and the Synexa assay has been validated according to EMA and FDA guidelines.

Hemapen is supplied for therapeutic or IVD use in Australia, New Zealand, the U.K., EU and the U.S. Outside of these territories, the Hemapen is supplied for research purposes only. The Synexa assay kit is supplied for research purposes only.

Synexa Life Sciences was founded in 2003 as an early pioneer in the field of biomarker science. It is a privately held company, backed by Gilde Healthcare, a specialized European health care investor.