with CT imaging and a biopsy before making a definitive declaration that a tiny cancer is on the move.
“If we can rule in or rule out the cancer, we’ll spare people a lot of grief and waiting,” Luderer says. “We might catch patients when they still have a chance” to cure the disease by surgically removing the tumor.
Because these blood samples already exist, and the trial would look back in time, InDi doesn’t need to spend time enrolling patients, establishing its prediction, and then waiting for a period of time to see whether it was on target. That sort of prospective clinical trial design might be considered more valuable in the eyes of the FDA, and InDi is carefully considering how it may or may not go about doing such a study in the future, Luderer says.
First things first: InDi hopes to have an answer from its first study of 700 or more patients, possibly by the end of 2011, Luderer says. The strength of that data, plus more results from a validation study, could form the basis of an FDA approval. It’s possible InDi could establish what’s known as a central CLIA-certified laboratory without getting FDA approval, although the company plans to consult with the FDA on whether it should get the agency’s blessing first because of the seriousness of the diagnostic conclusions it seeks to reach.
InDi’s second product candidate, an early warning test for Alzheimer’s, is further behind in development, partly because it doesn’t have the same rich set of data to sift through like the blood samples from lung patients. The disease, which robs cognitive ability and memory from people as they age, takes a long time to progress, and there’s no standard blood-based diagnostic for it today. That means doctors and regulators will probably going to want to see a forward-looking study that takes blood samples, and follows people for years to see who gets the disease and who doesn’t. At a minimum, InDi will need to find samples on Alzheimer’s patients over time, which could be hard to do. It plans to start to establish its test through a retrospective study, then follow up with a combination of retrospective studies with a “small” prospective component, Luderer says.
Advancing into clinical trials like these means that InDi is going to need to hire a few more people with medical experience. The company has added an organic chemist recently, and a couple of mathematicians to help with the bioinformatics algorithms needed to offer the predictive value of the test, Luderer says. “That’s where the rubber hits the road for us,” he says.
The proof of this idea will be in the clinic, and InDi says it hopes to be there within a year. If it can generate some evidence over the next year and a half that validates the founders’ vision, then InDi shouldn’t have trouble nailing down the last installment of its $30 million financing, and then some.
