Executive Summary

Ionica Sciences, based in Cornell University’s Kevin M. McGovern Family Center for Venture Development in the Life Sciences, has developed a high-sensitivity platform for the detection of infectious disease in human blood serum.  The 7-year-old company currently is focusing on Lyme disease with the revolutionary IonLyme test, which has undergone proof of concept and could be on the market within a year.

Ionica turned to FuzeHub for help in finding a partner to produce the specialized plate surfaces needed for its test, and was introduced to Square One Coating Systems of Oriskany, N.Y.  Then, in 2019, it received a $35,000 grant from the Jeff Lawrence Innovation Fund, which FuzeHub administers. It used the grant to purchase a 96-well Raman spectrometer to help transition the IonLyme test from the research laboratory to a clinical reference lab, a crucial step in preparing it for future sale to physicians.

Situation

Joel Tabb, a biochemist, and chemist Omar Green founded Ionica Sciences in 2013, with the goal of merging technology from biology and chemistry to target infectious disease.  Tabb, who holds the title of President while Green is CEO, said that since both men were scientists, “it took us a little time to figure out how to run a company.”

The company got a financial boost from the U.S. Department of Defense with a $148,000 SBIR/STTR grant in 2013 and two additional, similarly sized grants, in 2015 and 2018.  It also received an investment from the Global Lyme Alliance (GLA) a research and philanthropic organization.  In 2014, it moved into the McGovern Center at Cornell University, giving it the laboratory facilities it needed to begin its R&D.

Louis Walcer, director of the McGovern Center, said the incubator is extremely selective in admitting companies into its program. An advisory committee of Cornell alumni with experience investing in life sciences ventures evaluates applicants as it would any prospective investment, asking three main questions: Is the technology potentially groundbreaking?  Is there a business plan in place to help realize that goal? Is there a management team that has the basic skills to carry out the business plan?

“Ionica appealed to us because of the breadth of their platform, and the cleverness with which they combined a number of known technologies in a unique way to create a diagnostic platform that could be deployed at bedside and in doctors’ offices to yield a rapid diagnosis for things that were exquisitely difficult to diagnose,” Walcer said.

Tabb said the partners decided early on to focus on Lyme disease, which is not only common in the Northeast but is the fastest-growing vector-borne infectious disease in the United States. He explained that the illness, which is caused by the bacteria deer ticks pass on to humans, is not hard to treat but can be difficult to diagnose if the doctor does not see the telltale bullseye rash. Early symptoms are often nonspecific and include fever, headaches and muscle pain, which can relate to many conditions. These initial symptoms fade quickly, with more serious symptoms appearing in about four weeks. Therefore, the current antibody test, which looks at the body’s response to the bacteria, can produce a false negative result as much as half the time.

“Antibody testing just does not work well for Lyme,” Tabb said. “There has really been a need for a new form of testing.  And that is what we came up with–a rapid, easy-to-use test for the bacteria that causes Lyme disease.”

He said Ionica has demonstrated that the test works with both lab developed samples and human samples, and is now in the process of finishing up development.  The goal then would be to begin commercialization of the test.

“Ionica Sciences has been working diligently on their diagnostic testing project in collaboration with the McGovern Family Center,” said Julianne Clouthier, who monitors project outcomes as Director of Industry Engagement for FuzeHub.

Walcer noted that incubator companies are required to achieve certain goals, including advancing their technology and developing a product, with the center’s help. Ionica has worked closely with Cornell researchers, utilizes undergraduates from the Dyson School of Business as interns and uses graduate students in management, hospital administration, and statistics as consultants. It also was aided in securing capital and received help fleshing out its management team with the addition of Chief Business Officer Dean Koch.

Although the company is starting with IonLyme, what it has developed is a platform, which can easily be adapted for a number of infectious diseases, including new illnesses like COVID-19.

“It can be rapidly adapted and that is where we hope this will play a really strong role in the future,” Tabb said.

Needs

Despite the support from Cornell, Ionica faced two main needs in its quest for the commercialization of its platform, both relating to its use of surface-enhanced Raman spectroscopy to identify certain proteins in serum samples.

The technology requires the test to take place on a specialized surface for maximum resolution. Green developed the surface, but the company needed someone to produce it.

“The materials we work with are gold and silver, and not everyone understands using them in these conditions,” Tabb said. “Only a few people have this expertise–certainly in the state, maybe in the country and even internationally.”

The second need was a spectrometer, an instrument that uses light to enable highly sensitive measurements, almost down to the detection of a single molecule. This would be vital in putting Ionica’s platform in a standard format for high-throughput testing in a clinical setting.

Engagement

Ionica was introduced to FuzeHub through the Cornell Center for Materials Research (CCMR) a state- and federally- funded research center with which the company worked on its initial testing.  The partners were told FuzeHub could assist them with their manufacturing issues.

“As a relatively new company that was doing research, what we lacked experience with was having materials manufactured, getting supply chains up and running, things like that,” Tabb said. “So CCMR put us in touch with FuzeHub.”

Tabb and Green asked if FuzeHub might be able to use its vast network to find it a New York company to work on the specialized surfaces needed for its test.  The answer was Square One, which had just the expertise that was needed.

“Their knowledge of metals has been crucial for us in developing these surfaces,” Tabb said.

Lloyd Ploof, who founded Square One in 2012, said the company does metal finishing—including zinc, tin, gold, silver and nickel—for a variety of industries including aerospace, defense, medical and OEM.  He had known people at FuzeHub for a few years, having attended the organization’s Solutions Forums and other events, before the introduction to Ionica.

Ploof said Ionica had worked with a few other companies who took different approaches to producing the specialized surface needed to improve resolution, but “we came up with a much easier, much more economical, much more repeatable, much more scalable way of doing it – and  we’ve been moving ahead with them ever since.”

With its relationship with Square One set, Ionica returned to FuzeHub seeking the funding it needed to buy equipment.  It was suggested that the company apply for a Jeff Lawrence Innovation Fund award. The McGovern Family Center applied for and received $35,000 to purchase a 96-well Raman spectrometer that Ionica uses.

Tabb explained that the commercialization of technology aimed at physicians and laboratory technicians requires making it fit easily into their normal workflow.  The spectrometer does this by enabling the individual conducting the test to put 96 samples down on a plate and read them all in just a few minutes.

“That is the format in which assays are done in labs all the time,” he said.  “This 96-well reader takes our highly sensitive method and puts it in a standard format for high-throughput testing.”

Outcomes

While some things were put on hold due to the COVID-19 pandemic and resulting lab closures, Ionica is back at work and moving closer to commercializing its technology. The company now has certain testing milestones to meet with the new spectrometer—which was delivered right before the start of the pandemic—to complete its work with FuzeHub.

Clouthier said the project is expected to be completed in early 2021 and “it will be exciting to see the results stemming from the utilization of the new spectrometer.”

She noted that research findings made possible by FuzeHub’s support for Ionica are expected to help the company increase revenue and attract investment, which will allow it to expand staff as the test moves through validation and FDA clearance.

“Ionica Sciences expects to add approximately 10 new technical and management jobs over the next 3 years,” Clouthier said.

Ploof said there is also some “down the road potential” for Square One. The company has a patent pending on its particular method of producing the surface, which it hopes to commercialize, and is in the process of working on a second patent while negotiating exclusivity rights with Ionica.