Two years after acquiring diagnostic developer SynX, Nanogen is on the verge of launching its first product based on that company's work: a point-of-care test for diagnosing congestive heart failure.
"It's designed to help physicians diagnose people with symptoms of chest pain and shortness of breath in the emergency room," said Rod Wilson, the president of Nanogen's Point-Of-Care Diagnostics division, and the former president and chief operating officer of SynX. "You can very quickly, in 15 minutes, determine if it's congestive heart failure, versus, for example, an asthma attack or a pulled muscle, and take appropriate intervention."
When it was founded five years ago, SynX was focused on using proteomics technologies to discover biomarkers for therapeutics and diagnostics, especially in the areas of congestive heart failure, insulin resistance, and Alzheimer's disease.
"We took biological samples like blood, and we would look at non-diseased people and people with the disease we were targeting, and look for biomarkers that were lower or higher in quantity in one versus the other," said Wilson. "We were getting very good at finding novel biomarkers."
After identifying biomarkers, researchers at SynX would develop their own antibodies in-house and create ELISA tests against selected biomarkers.
"Now we're really in the commercialization phase."
But even though SynX was successful at finding biomarkers, and at developing a few ELISA tests, the company realized about two years ago that it did not have the resources to move the biomarkers through the next steps: product development, clinical development, regulatory approval, and sales and marketing.
"It's very hard to fund basic research and development," said Wilson. "Venture capitalists and investment bankers are looking for near commerciability. It's difficult for small biotech and proteomic companies to compete for dollars when they're saying, 'Fund our proteomic discovery, and in five, 10 years, you might have a drug or diagnostic product in the market.'"
SynX then began looking for a partner that could bring in the resources that it lacked.
"Nanogen has a lot of expertise in development and regulatory affairs. They have a track record of success that enables them to raise the funds to move a product like [the] congestive heart failure [test] through the clinical and regulatory phases," said Wilson. "SynX had intellectual property rights. We had discovered some biomarkers and validated them."
Once it was acquired by Nanogen, SynX shifted its focus from proteomics research to developing point-of-care diagnostic products.
"Now we're really in the commercialization phase," said Wilson.
Though SynX has discovered many disease biomarkers on its own, the peptide biomarker that is the basis of the soon-to-be-released congestive heart failure test proBNP was actually licensed from Roche before Nanogen acquired it. SynX developed antibodies against proBNP and used them to develop the new point-of-care test.
The point-of-care test is based on lateral flow of samples across a nitrocellulose membrane, Wilson explained. Biomarkers are placed on the nitrocellulose strip. If the sample interacts with the biomarkers, then a line becomes visible, and the intensity of the line is an indication of how much of the marker is present in the sample.
The US Food and Drug Administration approved the congestive heart failure product in plasma testing in February. Nanogen decided to further develop the test so that it can be used with whole blood. The company now expects to launch the whole-blood product in the second half of the year.
"Whole blood will be easier for our customers so they don't have to go through the centrifugation step," said Wilson. "Our customers are in the emergency room, so we want to make it as fast and easy as possible."
Aside from gearing up to launch the proBNP-based test, Nanogen is also working on combining troponin I a biomarker for congestive heart failure that was discovered by SynX with proBNP to create a second congestive heart failure test that would provide further diagnostic information for monitoring and risk stratification of heart failure patients.
"That's an area that we're going to look to in the future combining proBNP with other cardiac markers," said Wilson.
Also at the front of Nanogen's pipeline for development is a point-of-care test for stroke and traumatic brain injury.
"In the emergency room there is an unmet need for diagnosing stroke and traumatic brain injury," said Wilson. "You can have an MRI or CAT scan done, but that's a seven- or eight-hour process to get someone onto those machines. We're trying to give them a quick biomarker test so they can distinguish if it's a bad bump, a migraine, [or] a stroke."
Nanogen has already commercialized ELISA tests for stroke and traumatic brain injury that were developed based on biomarkers discovered by SynX. The company is currently in the process of clinically validating the ELISA tests, and developing an optimized point-of-care test based on validated biomarkers.
"If you're going to test 200, 300 patients, it's much easier to put those samples onto a 98-well ELISA instead of 98 point-of-care tests," said Wilson. "But for where our customers are in the emergency room, there are no lab techs, so ELISA is not the format the works well."
Wilson estimated that a point-of-care test for stroke and traumatic brain injury could be out on the market within 18 to 24 months.
In addition to developing point-of-care tests, Nanogen is also looking for partners who would like to license or co-develop biomarkers that are at the back of the pipeline. The company was recently granted two new patents: one for an Alzheimer's therapeutic that works by removing from serum an Alzheimer's-associated protein, called human glial fibrillary acidic protein; and another for a biomarker that could be useful in diagnosing metabolic syndrome.
"Those particular patents are quite far back in the pipeline for development," said Wilson. "We look at what has the biggest commercial market available, and there's a queue for development. We're trying to pick our best chances of success. But if there's some other companies that might want to fund development [of those biomarkers], that would move it up in our queue for development."
Tien-Shun Lee ([email protected])