NEW YORK (GenomeWeb) – Researchers at Virbio are developing technology that enables the visualization of cellular structures to reveal the presence of cancer, dysplasia, or benign tissue.
The technology, optical biopsy, combines a low-cost endomicroscopy probe with a magnetic tracker that fits inside a standard endoscope. While the probe gathers high resolution images, artificial intelligence analyzes the images to provide a view and understanding of a cell's structure.
The technique aims to enable physicians to more precisely locate where to biopsy, and as a result patients would require fewer biopsies, Rob Toth, CEO of Virbio, told GenomeWeb. "The whole idea behind this technology is to get a virtual preview of the cell and to be able to view the cellular structure to help you determine where to biopsy."
In February, New Brunswick, New Jersey-based Virbio secured an exclusive license to the technology from Rutgers University.
Toth is working with a group of advisors that includes Mark Pierce, an assistant professor of biomedical engineering at Rutgers. Pierce presented a protocol for the design and assembly of a high-resolution microendoscope that can be built in a day using off-the-shelf components for under $5,000 in a paper that he co-wrote and published in the Journal of Visualized Experiments in 2011.
"Confocal endomicroscopy is emerging as a safe, minimally invasive means of improving the accuracy of endoscopic screening and surveillance for Barrett’s esophagus and colorectal cancer," Pierce and colleagues wrote in a separate paper that was published in The American Journal of Gastroenterology in 2011. "When used alongside 'red flag' techniques such as autofluorescence imaging or narrow-band imaging, endomicroscopy enables the gastroenterologist to evaluate the gastric or colonic mucosa with cellular-level resolution in a real-time optical biopsy."
Virbio plans to first target the market for Barrett's esophagus testing and later for colon cancer screening. The company is seeking seed funding that would allow it to further develop artificial intelligence algorithms and navigate the path through clinical trials to FDA clearance.
Mauna Kea Technologies, which has a commercially available optical biopsy system, reported €8.5 million ($9.2 million) in revenues in FY 2015. Its Cellvizio optical biopsy technology received FDA clearance in 2011, the same year in which the company went public.
The firm's technology allows for real-time characterization of polyps and identification of lesions at risk for cancer during colonoscopy screening. The optical biopsies provide physicians with microscopic images of tissue in a minimally invasive manner.
According to the firm, more than 20,000 patients have benefited from use of its optical biopsies. The system has received regulatory approvals in China and Japan, and in May, the firm received US Food and Drug Administration 510(k) clearance covering confocal miniprobes used with its near-infrared platform for urological and surgical applications.
Among the applications for optical biopsy technology are Barrett's esophagus, gastric disease, bilio-pancreatic strictures, pancreatic cysts, inflammatory bowel disease, and colorectal lesions.
There are many newer molecular technologies that have been developed or are in development for detecting Barrett's esophagus. For example, in 2013, Diagnovus launched a real-time PCR-based assay that measures methylation of eight biomarkers in biopsied tissue from Barrett's esophagus patients to determine their risk of progression to high-grade dysplasia or esophageal adenocarcinoma.
And just last month, researchers at Case Western Reserve University and Medical Center won $850,000 in funding from the National Cancer Institute to develop a methylation-based biomarker test for the condition. The team is also developing a novel balloon device to obtain samples from the lower esophagus, potentially eliminating the need for endoscopy and biopsy, and making the test useful for low-cost screening.
Toth sees his firm's technology as complementing rather than competing with many existing and emerging molecular diagnostic technologies within its target markets.
"I see optical biopsy as one piece of the information puzzle making up a proper diagnosis of certain diseases, bridging the gap between macro analysis — such as narrow-band imaging — and micro analysis — such as molecular technologies — and my guess is that most medical doctors will use all the available information available to make the most accurate diagnosis," he said.
For Virbio, its near-term target markets also are influenced by insurance and reimbursement policy. A CPT code already exists specifically for optical biopsies that would allow reimbursement for Barrett's esophagus tests, so that will be the company's first target application. Colon cancer screening would follow as the next target market.
"We now see a unique opportunity for this technology to emerge," Toth said. "There's been some good work on getting CPT codes to allow reimbursement for the technology over the past few years."
Virbio has filed a provisional patent application for the hardware portion of its optical biopsy technology. The company continues to develop the artificial intelligence algorithms that give it the capability to analyze images.
"Part of the reason we are looking to raise money is for algorithm development and the acquisition of images," Toth said. "The more images you feed the algorithms, the more they can generalize and find patterns that are not necessarily obvious."
Generating the most accurate algorithms will translate into economic value, driven by the need for greater efficiency in medical applications, he added.
"Lower cost and less time — those are scarce resources that we have to optimize, and this will be enabled by artificial intelligence. AI has been developed in fields outside of medicine. … The technology, hardware, and algorithms are at a point where we have come to expect artificial intelligence to help us out with our diagnoses. It's not a scary thing that we don't know about any more. It's prime time for artificial intelligence to take its leap into medicine."
Virbio is looking to attract funding from angel investors and from venture capital sources, Toth said.
The firm also is working with gastroenterologists and other clinicians at Robert Wood Johnson University Hospital, which has signed a non-binding letter of intent for clinical trials related to the Virbio optical biopsy system.
"Once we get a larger amount of funding, we will look to conduct institutional trials in which we can work with multiple hospitals and get data from multiple centers," Toth said. FDA clearance could take between one and two years and depend on a lot of factors, he added.
The firm has plans to initially work with distributors to sell its optical biopsy system and later build a direct sales force, and it is also considering selling its system in veterinary markets, which do not require FDA approval. In addition, an accurate deep-learning algorithm will allow for software licensing opportunities, according to Virbio.
The company has set a price of $100,000 for each optical biopsy device, but said it would be possible to reuse detachable probes a limited number of times.