St. Louis, Mo.-based biotech firm Mediomics announced this week that it has received a $460,000 renewal of an STTR Phase II grant from the National Institute of General Medical Sciences to develop its Pincer product, a homogeneous antibody-based protein detection assay.
The company will use the grant primarily to fund efforts to increase the sensitivity of the Pincer assay, and to use it to develop a six-protein biomarker panel for cardiovascular disease, Mediomics founder and president Yie-Hwa Chang told ProteoMonitor.
Chang launched the company in 2001, commercializing an aptamer-based protein-detection method developed in the lab of St. Louis University School of Medicine professor Tomasz Heyduk. Called Bridge-it, the technology — which Mediomics licenses from SLU — uses pairs of fluorophore-labeled aptamers to detect DNA-binding proteins.
Each aptamer pair consists of a fluorophore donor and a fluorophore acceptor. In the presence of the target protein, the aptamers attach to their respective binding sites on the protein, bringing the fluorophores into close proximity, which leads to energy moving from the donor fluorophore to the acceptor. Presence of the target protein can be quantified as a function of this exchange of fluorescence.
Mediomics' Pincer product works in essentially the same way, but where Bridge-it used only aptamers, Pincer works with a variety of binding molecules including ligands, peptides, and antibodies. Presently the company is focused on developing antibody-based assays, Chang said, hoping to get "a niche in the ELISA-based assay market."
The primary advantage of Pincer technology lies in its simplicity, Chang said. While conventional ELISAs involve multiple binding and washing steps that generally take several hours, the Pincer method is a single-step homogeneous assay wherein researchers combine the sample containing the target protein with the fluorophore-labeled antibody pairs and then incubate them for 30 minutes before taking a measurement.
"It's just mix and measure," Chang said. "No binding, no washing, none of those things. It's much more straightforward."
It's also potentially more sensitive than an ELISA assay, he said. Currently the method can detect proteins present at low picomolar levels — roughly the same as an ELISA. Chang hopes, though, to improve the assay's sensitivity by 10 to 100 times, he said.
Chang said the company is also developing versions of the assay using non-fluorophore-based detection techniques, although he declined to elaborate, saying that it involved proprietary technology. It can also be converted, he said, for use with bead and microarray platforms.
Since its launch nine years ago, Mediomics has operated largely on money from government grants, receiving Small Business Innovation Research grants from the National Science Foundation, STTR grants from the National Institutes of Health, and subcontracts from the Department of Homeland Security. In all, Chang estimated, the company has taken in roughly $3 million in federal funds.
"At the beginning [the technology] was just a simple concept, and we've extensively developed these products through government funding," he said. "With a lot of university inventions the major problem is in the early stages. You have a good idea and you patent it, but then you have to have a small biotech company to bring it to the next level, and also during this stage it's hard to find investors because it's so early. We're lucky in a way because we've been very successful in getting government funding."
Mediomics currently has no outside private investors – although Chang said that he's open to potential venture capital – but has raised around $1 million internally.
He added that the company plans to have finished sensitivity improvements to the Pincer platform and development of the cardiovascular biomarker panel by late spring of next year and will release new products based on this work — including Pincer assays for cytokine detection – shortly thereafter.
In addition to the STTR Phase II grant, the company recently received two new SBIR contracts that it plans to use in part to develop a handheld companion device that can run the Pincer assays in point-of-care testing settings.
"Researchers can use it, manufacturers can use it for onsite [quality-control testing, and] food processing companies can use it for the quick detection of pathogens," Chang said, noting that while the first generation of the device consists basically of a handheld fluorometer, the next generation will likely be a chip-based platform.
With regard to the cardiovascular biomarker panel, the company plans to develop it first for the research market and then for use in clinical trials within two to three years. It's currently in talks with several companies about partnering to develop the panel for clinical use, Chang said.
He added that, after years of lying low, the time is now right for the company, which has six employees and generated roughly $1 million in revenues last year on sales of Bridge-it and Pincer assays, to begin a serious commercial push.
"Our technology has really matured," he said. "It's time to move to that next phase, to commercialize the products and put a lot of effort into marketing. It's time for us to really let people know who we are and what we have, and we're going to spend a lot of energy and investment in marketing."