May 22, 2006 – Molecular diagnostic tests are the essential tools needed to closely match a more careful diagnosis at an early stage with new drugs that are designed to precisely target disease in carefully identified patient groups. That kind of personalized medicine is expected to greatly increase the response rate that patients have to a drug, which today is often a hit-and-miss approach, and advance the response time to treating disease. And Nanosphere just raised $57 million from investors who believe that the company’s use of nanotechnology in the ultra-sensitive pursuit of molecular materials can offer a big improvement over the current generation of diagnostic tools on the market.
Nanosphere’s technology platform — the Verigene System — is based on work begun at the Nanotechnology Institute at Northwestern University in Chicago. It relies on the use of nanoparticles to detect nucleic acids and proteins in minute quantities.
The problem with current systems, says Nanosphere CEO Bill Moffitt, is that they rely on complex technology that is expensive, lab-based and requires relatively large samples that run the risk of contamination.
Verigene, though, relies on gold nanoprobes that are 13 nanometers in size, roughly the size of DNA. “We take the analytical system down to the level of the biology,” says Moffitt. Large numbers of gold nanoparticles can be dispatched to find a genetic mutation, for example, which can be captured on a microarray and put on a slide. “And now I can coat the gold nanoparticles with silver, which are very reflective, shine a white light on it, and I can see it.”
Moffitt says he’s close to gaining regulatory approval to begin the commercialization process.
“We have our first test in clinical trials now and we expect to put them on the market about the end of the year,” says Moffitt. “The first test should be a panel that measures or detects mutations that cause hypercoagulation; a mutation that makes you prone to blood clots and a higher probability of stroke.”
The second test will be for cystic fibrosis and a third will be used to test a family of enzymes — the cytochrome P450 family — that “metabolize about half of all drugs on the market.” Depending on the way you metabolize medicines, genetic mutations could create severe adverse effects or simply make normal dosages ineffective.
Those tests will be critical instruments in the push to advance a new generation of biotechnology drugs.
“If you think about pharma over the last 50 years,” says Moffitt, “they’ve been going after the low hanging fruit. It’s not been easy to develop them, but they’ve been broad spectrum drugs, reasonably effective and for the most part don’t have horrible side effects. But as we understand more and more about the pathways of diseases, you look to affect the biology as soon as possible, with as early detection as possible.”
Biotech drugs are targeted at the molecular level, he adds. “Those drugs will work on some and definitely not on others. They have lots of drugs that failed to make it through, because they’re only 10 percent effective. But they’re not 10 percent effective, they’re 100 percent effective on 10 percent of the people. But how do you know how to pick the population unless you have the diagnostic method to determine which people have the biochemical makeup to make that drug effective?”
Northbrook, Ill.-based Nanosphere has inked a series of pacts with companies that specialize in finding biomarkers that indicate whether someone is susceptible to a disease.
That was the model for Nanosphere’s new work in developing a test to discover Alzheimer’s. Applied Neurosolutions, which has been identifying biomarkers associated with Alzheimer’s, will apply Nanosphere’s technology to finding them in patients suspected of having the disease. Currently, there is no diagnostic test for Alzheimer’s, which can be conclusively proven only in a post-mortem examination. The two companies believe that the nanotechnology can not only provide the first real diagnostic test, but that it can lead to early diagnosis, the possible use of other bodily fluids to be used in tests, and a more targeted therapeutic response.
