Medical Device Daily

MedMira (Halifax, Nova Scotia) launched a new division, Maple Biosciences, in Toronto on Thursday, saying that it will be responsible for bringing to market the “next evolution in diagnostic instruments that will displace enzyme-linked immunoassays [EIA].“

EIA, a 30-year-old technology, is currently used to conduct routine lab tests in hospitals, laboratories and clinics globally.

“MedMira is very pleased to embark on this new chapter with the introduction of Maple Biosciences,“ said Stephen Sham, chairman and CEO of MedMira, in a statement. “It will be a new phase of growth for our company, which will ensure we remain at the forefront of the diagnostics industry with a product that complements our rapid tests.“

Sham said, “Global healthcare challenges are increasing rapidly, including overburdened systems, labor shortages and new diseases affecting mass populations. Maple Biosciences will bring to market diagnostic solutions that will enable faster and better diagnostics for improved patient outcomes at lower costs.“

At the Toronto press conference, Dr. Michael Thompson, professor of analytical chemistry at the University of Toronto, said that over the years researchers now at Maple Biosciences have “developed a strong interest in the chemistry of protein, various substrates and electronic silicon.“

“We've more recently gotten involved in using small devices in the field of medicine, under the euphemism 'nanomedicine,'“ he said.

MedMira had earlier acquired Thompson's company, SensorChem International, based on his biosensor research. Maple Biosciences will be “heavily involved“ in biosensor technology, he said.

Maple Biosciences will be developing two types of technology: mapleONE, or Electromagnetic Piezoelectric Acoustic Sensor (EMPAS), and mapleTWO, or scanning Kelvin nanoprobe (SKN Technology). EMPAS works by “creating an electromagnetic field“ to begin with, Thompson said.

Maple Biosciences said EMPAS is an “acoustic resonance-based biosensor for real-time measurement of biomolecular interactions.“ mapleONE is based on the EMPAS technology, a “powerful method“ for determining molecular interactions at the surface of a quartz crystal.

“When combined with the appropriate surface chemistry and microfluidic cartridges, mapleONE becomes a sensitive tool for detecting the biomolecular interactions that form the heart of clinical diagnostics,“ the company said.

Thompson said that the company could place proteins, antibodies or DNA on the technology to use them for disease detection.

SKN Technology is more involved with the ability to do multiple tests, Thompson said. mapleTWO is a “biosensor for high-order multianalyte measurement of biomolecular interactions,“ the company said, with SKN a “powerful method“ for determining molecular interactions based on observations of their fundamental material properties.

“When combined with the appropriate surface chemistry and robotic printing techniques, mapleTWO becomes a sensitive tool for detecting the biomolecular interactions that form the heart of clinical diagnostics,“ the company said.

Thompson said at the press conference that the “vision of this technology for the future is that we could be able to detect a number of different clinical situations in what we call scientifically a multiplex fashion.“

He said that the model would be to have a “whole series of these types of devices working in parallel or in a series.“ The devices would provide a signal, allowing the technician to know if there is a positive or a negative result.

Neeraj Vats, vice president of technology and intellectual property for MedMira, said the goal of the technologies is to replace the standard EIA. “We believe that the change that the Maple technology is able to bring will displace that technology,“ Vats said, noting that there will be many competitors attempting to do the same things as Maple Biosciences.

Vats also said that the simplicity of these systems would mean that fewer lab personnel would be required, which is one way to combat the thinning ranks of laboratorians. The level of training required from the necessary personnel also is expected to be less, although he acknowledged that “training is always a very touchy issue in any diagnostic laboratory testing,“ because of the regulatory requirements for documentation of training.

Vats said that over the next 12 to 18 months, the technology would be validated and submitted for regulatory approval, with the expectation being that the products would be approved and commercially available within that timeframe.