a warning sign of a malignancy in its early days. Pulmonologists, Luderer says, “are scared they’ll miss the call.”
The idea at InDi is to provide new information to help doctors determine if they’ve made the right call.
InDi is specifically looking to help doctors tell the difference between benign and malignant lesions. InDi’s service takes a blood sample from the patient and runs it through a mass spectrometer from Agilent Technologies that identifies the presence of certain proteins based on their molecular weight. InDi’s scientists, using some heavy-duty math, narrowed down a list of 50,000 human proteins to a group of about 200 that could consistently be found in blood, and might offer a clue toward malignancy, Luderer says.
The company hasn’t yet published any of its findings in peer-reviewed scientific literature, or identified those proteins, Luderer says. But InDi put its technology to the test last year in a study of samples from 240 patients at three medical centers. Researchers had detailed medical histories on these patients, which included things like CT scan results, biopsy findings, and how sick the patients got over time. The InDi test was able to tell the difference between benign lesions, and malignant ones, when researchers performed the blood-protein analysis and then looked at what the pathology tests said.
InDi is currently running a similar study, this time with samples from 600 patients, that the company hopes will confirm that earlier result, Luderer says. The company will look to publish after the results from its second study come in, he says, which should happen by late this summer.
Taken together, those two studies should help form the basis for a panel of 10-15 “sentinel proteins” that will be the key to diagnosing benign or malignant lung tumors, Luderer says. Once that data is hand, InDi will be in position to start marketing its test to pulmonologists. The company plans to establish a centralized lab, in which pulmonologists will send patients’ blood samples in for analysis, and InDi will send them back a report on the patients’ risk. This type of operation, known as a CLIA lab, doesn’t require FDA approval.
InDi currently has about 30 employees, and plans to hire another 10 or so this year as it scales up for its commercial phase, Luderer says. The new financing will enable the company to complete the next steps in clinical development, but by the second half of the year, it expects to raise more money through a Series B financing to help it go commercial.
Because InDi’s test is based on complex new protein analysis, the company plans to build its own specially trained sales force of about 35-50 sales reps, who will make their pitch to about 6,000 pulmonologists in the U.S., Luderer says. He didn’t say what he expects the test to cost, but it will be in the same range as high-priced molecular diagnostic offerings from companies like Genomic Health, XDx, and Agendia.
InDi has put together a seasoned executive team to carry out this vision. Ken Fang, the chief medical officer, previously worked at XDx; Guy Seaton, the finance chief, worked at Corus Pharma and SonoSite; and Jim Garner, the chief business officer, has experience as a senior vice president at UnitedHealth, the leading private health insurer.
No other company is believed to be a competitive threat in analyzing blood proteins for lung cancer diagnosis, Luderer says. Maynard, MA-based Allegro Diagnostics, however, is using genomic analysis of biopsied tissues to help doctors answer this same question about benign-vs.-malignant lung tissues. Luderer says InDi’s advantage is in that it’s easier to get a blood sample, and his company’s scientists believe they get more information from looking at proteins rather than nucleic acids.
There are plenty of hurdles to clear before something like this can be widely adopted. Researchers may balk at the data, wondering if it is really predictive, or at least withhold judgment until they see long-term follow-up data from patients who enroll in a prospective study. Doctors will want to be sure not to set off a lot of false alarm bells that lead to unnecessary and aggressive interventions. Payers will want to be sure that they are getting their money’s worth by paying a lot up-front for a diagnostic test that should save money down the road by treating cancer before it’s too late. If InDi is successful with this initial rollout in lung cancer, then investors will surely want to see proof that it can reproduce the feat in early detection of other forms of cancer.
Luderer spent some time on an IPO roadshow with his last company before selling it to Life Technologies. Earlier this month, he renewed some of those Wall Street acquaintances during a trip to the Leerink Swann Global Healthcare Conference. He says it’s possible that InDi could have something of interest to investors at conferences like that, just four years after the Series A financing arrived to support a “whiteboard” idea.
“If we hit our objective, by launching the product this time next year, it will be one of the fastest-from-scratch stories in the venture space we’ve seen in some time,” Luderer says.
