PERTH, Australia – Gbs Inc. reported filing an initial public offering on the Nasdaq for $20 million, as the company looks to launch the first noninvasive SARS-Cov-2 test.

A subsidiary of Sydney-based The Iq Group Ltd. (NSX:IQG), Delaware-based Gbs has developed a biosensor platform that enables real-time diagnostic point-of-care (POC) tests, and the funds raised will enable the company to launch its SARS- CoV-2 test and a saliva glucose test.

The saliva biosensor was invented by Paul Dastoor and his team at the Center of Organic Electronics at the University of Newcastle in Australia. The Iq Group Global acquired the biosensor technology in 2016 and has accelerated its development for diagnostic applications.

Self-administered and immediate, biosensors remove the logistical burden and waiting periods associated with laboratory testing of biological samples. Organic electronic sensors are inexpensive, manufactured at large scale using low-cost roll-to-roll (R2R) printing techniques and can be readily tailored to detect a variety of organic targets

Gbs is expediting a collaboration with the Wyss Institute for Biologically Inspired Engineering at Harvard University to develop a more accurate and real time SARS-CoV-2 test.

The collaboration involves a pilot study to integrate the biosensor platform with a special coating developed at the Wyss Institute that can detect IgM and/or IgG antibodies, which indicate a person’s current or previous exposure to the SARS-CoV-2 virus and potential COVID-19 infection.

The aim of this pilot phase is to confirm the technical feasibility and scale to production of the program and provide an estimate of the analytical performance of the SARS-CoV-2 antibody test. Following the pilot study, the company intends to seek FDA emergency use authorization.

Based on preliminary data generated in this pilot study, further development could result in an easy-to-use diagnostic and screening test that can be applied to salivary and/or blood COVID-19 testing at point of care, with the ability to be manufactured at scale at a low cost, and produce real-time results.

Compared with conventional antibody tests, the SARS-CoV-2 antibody biosensor may measure the quantitative presence of antibodies as opposed to the current qualitative monitoring to date, and the sampling methodology may be through saliva rather than blood, which is noninvasive.

According to recent research by the Johns Hopkins Bloomberg School of Public Health, SARS-CoV-2 antibodies detected in saliva “significantly correlate” to those observed in blood.

“Our partnership with the world-renowned Wyss Institute at Harvard University is a landmark collaboration for Australian biotechnology,” Iq Group Global CEO George Syrmalis said.

If the pilot study is successful, further development could mean the creation of a chewing-gum-sized diagnostic strip that could be used for COVID-19 testing at point of care, with the ability to be printed at scale at a low cost, and produce real-time results.

“Dependent on the outcomes of this research, we may be in a position to provide the global health care system with a point-of-care test capable of detecting SARS-CoV-2 antibodies, with the ability to provide results in minutes,” Syrmalis said. “If the pilot study data is positive, this test has the potential to be used as a point-of-care screening and diagnostic tool, and pre-vaccination screening tests for when a COVID-19 vaccine is made available.

“We know that accurate, real-time diagnostic tools are a future of global health care that we urgently need to accelerate into our current reality as COVID-19 takes its toll on people all over the world. This project could not have come at [a] more crucial time,” he said.

Making fingerprick diabetes testing obsolete

Gbs’ flagship product candidate is the saliva glucose biosensor, a point-of-care test expected to make invasive fingerpricking for blood glucose monitoring obsolete for diabetic patients.

The saliva glucose biosensor is comprised of the glucose biosensor unit and a digital health care app. The biosensor unit is a small, disposable strip, which when exposed to an individual’s saliva instantly provides a glucose measurement. The organic thin film transistor (OTFT) technology can be printed at scale for low costs.

The patient places the saliva glucose biosensor in the mouth, and the digital biosensor detects the analyte in saliva and emits a signal to the patient’s smart device, activating the app to display the analyte reading. The app provides real-time data and sends the data to an electronic medical record or physician.

The company has lodged a 513(g) submission with the U.S. FDA.

“This is a key milestone for The Group, as this engagement with the FDA will facilitate our next steps in launching the saliva glucose biosensor in the North America region and, pending further regulatory submissions, the Asia Pacific, so that we can bring this technology to those who need it most – people living with diabetes,” Syrmalis said.

The company had originally planned to launch its diabetes test first, but it has decided to ramp up the COVID-19 test as a priority.

The offering

The public offering will be priced between $16 to $18 per unit. Gbs is offering 8.63 million shares of common stock plus 2.81 million of convertible preferred shares that are convertible to one common share and one warrant exercisable at the IPO price within two years. Dawson James Securities Inc. is the sole bookrunner.

Gbs intends to introduce and launch COV2 diagnostic tests across the U.S., Europe, APAC and the rest of the world through sublicensees and distributors.

Gbs owns a 50% interest in Biosensx, which has been granted a license for North American rights for the biosensor platform, excluding the SARS-CoV-2 biosensor test.

The biosensor platform is being developed to test for more than 130 indications, including tumor markers, allergens, hormones and communicable diseases.

Gbs will trade on the Nasdaq exchange under the ticker GBS.

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