Rochester, NY-based diagnostics firm Adarza Biosystems announced last week two additions to its board of directors, including Heiner Dreismann, former CEO of Roche Molecular Systems.
The additions come as the company moves to commercialize what it calls its "Arrayed Imaging Reflectrometry," or AIR, analyte detection platform – a label-free, silicon chip-based biosensor that Adarza CEO Rand Henke said offers levels of sensitivity comparable to a standard ELISA but over a substantially larger dynamic range.
"The technology is a completely novel way of imaging analyte binding events on a solid surface," Henke told ProteoMonitor this week. "Our sensitivity is quite broad, down into the picrogram-per-milliliter or sub-picogram-per-milliliter [range] depending on the analyte" and across up to six logs of dynamic range.
According to Adarza's website, the platform can be readily adapted to profile protein biomarkers in blood, urine, or other fluids and is highly multiplexible, capable of running more than 1,000 reactions at once. The chips used in the platform can be produced for less than $10 each.
The company, Henke said, plans to launch the array system for research use sometime next year.
The system is based on an anti-reflective silicon chip technology that enables the detection of probe-target pairs by optically sensing molecular binding at the chip surface. In the case of protein detection, this involves functionalizing the chip surface with antibodies for the target analytes and then introducing the chip to the sample of interest.
The binding of proteins to the bait antibodies changes the reflectance of the chip surface. This change can be correlated to the amount of bound target protein to determine the quantity of protein in the sample.
"What's unique about [the AIR platform] is that we make a completely antireflective coating, a monomolecular layer, so when a laser light is shined almost nothing is reflected off," Henke said, touting the system's simplicity and speed as advantages he believes will drive its adoption for research and, eventually, clinical use.
"If you look at the other array systems, they are much more expensive," he said. "They tend to be more complex and slower. We can image that entire array with an imaging system that has no moving parts. We can actually read the array in microseconds."
"It's a simple sample-in/answer-out [method] to doing the image analysis," he added, suggesting that this made the platform a strong alternative to the conventional ELISA technology commonly used in research applications, as well as for point-of-care diagnostics and drug development and clinical trial work.
In a study published this February in the journal Biosensors and Bioelectronics, Adarza researchers found the platform to be "readily able to profile 14 cytokines and other inflammatory biomarker proteins in a background of buffered bovine serum albumin or 1 percent bovine serum with performance metrics comparable to singleplex ELISA."
According to Henke, the company's strategy for commercializing the system will be predominately focused on selling it as "a life science tool or a biomarker research tool," essentially marketing the technology as an instrument for use in research or assay development.
Henke said the platform is in "beta trials" with first-adopter clinical researchers at the University of Rochester Medical Center. Adarza is working with the Rochester researchers to use the system for protein biomarker validation in prostate and bladder cancers.
"There are several proteins that people have hypothesized or brought up in the literature as potentially good markers for various types of cancer. What we're trying to do is see whether the AIR technology is a good way to evaluate panels of clinical samples to see if they really are good markers for cancer," Benjamin Miller, a University of Rochester School of Medicine researcher and the chair of Adarza's scientific advisory board, told ProteoMonitor.
"What we are looking at are circulating markers of inflammation, angiogenesis, immunomodulatory proteins – a whole series in that general class," he said.
"I think one of the areas where this kind of technology will be very important will be in facilitating clinical trials – not as a diagnostic necessarily, but as a research tool to look at how well a particular therapeutic agent is doing," Miller added. "That's something we can potentially help with quite well."
Henke said that Adarza plans to partner with outside firms to turn research using the platform into assays for both diagnostics and drug development and assessment.
The addition of Dreismann – who held several senior positions at Roche Diagnostics in addition to his work at Roche Molecular Systems – to the company's board "will be extremely valuable" as the company works to commercialize the AIR platform for such purposes, Henke said in statement last week announcing the appointment.
The company is also working to apply the AIR system to measure environmental exposure. This arm of research has been funded by the National Institute of Environmental Health Sciences, Henke said, and is aimed at creating a field-deployable device to "take a snapshot of the immune system" in order to measure protein markers for a person's physiological response to particulate matter in the workplace or environment.
As a result of this work, Adarza has been approached by a company that Henke declined to name but noted "works with the [US] defense department," in order to adapt the platform for "war-fighter readiness" — using it to gauge soldiers' exposure to disease or toxins in the field.
The Rochester researchers have also evaluated AIR as a tool to examine antibody production in the context of influenza vaccination, publishing their results using the AIR array with a panel of hemagglutinins in the journal Talanta this January.
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