On its surface, the recent partnership between Indianapolis-based giants Eli Lilly and Company and Roche Diagnostics may look like a standard big-business arrangement, but executives say it’s much deeper—and could revolutionize how Alzheimer’s Disease is diagnosed. Detecting the devastating illness is more complicated than it may seem, because other diseases with similar symptoms must first be ruled out. By working together to create a better diagnostic method, millions of patients could slow Alzheimer’s progression—before its trademark mental decline.
Diagnosis of Alzheimer’s relies largely on noticed memory or mental decline, but when this symptom surfaces, the disease has already progressed to a moderate or severe stage. The only way to definitively diagnose Alzheimer’s is to detect the presence of tau tangles or amyloid, which is plaque, in the brain. A recent technology allows doctors to do this; tracers are injected that bind to amyloid and “light up” in an image of the brain.
Of the three tracers on the market, Lilly owns one, called Amyvid. However, patients must live close to a manufacturing facility, because it biodegrades quickly after production. As result, a sizable population of patients are missing out on this method.
Lilly and Roche are now combining efforts to develop an alternative test to detect amyloid. Because amyloid is free-floating in the body, Lilly Vice President of the Global Alzheimer’s Platform Team Phyllis Ferrell says it can also be detected in spinal fluid.
“In clinical research, we draw that spinal fluid and are able to do a lab test, kind of like you do a cholesterol test,” says Ferrell. “You run it through a test and it comes back positive or negative. We’re working with Roche to take this research tool and make it commercially available, so that the ability to detect amyloid can be done much more broadly than today.”
Lilly says detecting Alzheimer’s earlier is a critical factor for the drugs that are currently in development.
“You have to catch someone much earlier in the disease than we’re catching them right now,” says Ferrell. “We want to make it as simple and easy as possible to detect this pathology.”
It also makes good business sense for Lilly, because it owns one of tomorrow’s potential disease-modifying therapies: solanezumab, which aims to destroy amyloid buildup in the brain. Currently in Phase 3 human clinical trials, it could be a breakthrough drug for Alzheimer’s patients. In the most recent study, it showed better results among patients in the earlier stages of the disease. Logically, sales of solanezumab will be better with easier—and earlier—Alzheimer’s detection.
“We want to have [the diagnostic] available at the time of a potential solanezumab launch,” says Ferrell. “We think there’s benefit to patients and their families to know as soon as possible. If you’re trying to slow the progression of the disease, the best way to do that is to detect and treat it early.”
Roche says its expertise in developing such large-scale diagnostic “kits” would make the test rapidly scalable.
“We are the leading diagnostic company, so that means we have more instruments and more technology in more labs than any other diagnostic player; patients are never too far away from a lab that can run the test,” says Roche Companion Diagnostics International Business Leader Bruce Jordan.
“It’s our instrumentation already available today that allows us to place new and innovative kits into an already existing hospital laboratory.”
Because the spinal fluid diagnostic involves taking something out of the body—rather than putting a drug in—it will have a faster regulatory path, making Lilly and Roche certain that their teamwork could soon break new ground in how doctors find, and ultimately treat Alzheimer’s disease.
Jordan says Roche is hopeful a spinal fluid diagnostic could be less expensive than the current method that involves brain imaging.
Ferrell says, with current diagnostic methods, valuable time is lost in slowing the progression of Alzheimer’s.
Ferrell says a spinal fluid diagnostic test will make it easier for doctors to detect Alzheimer’s with certainty.