This story originally ran on Feb. 23.
Integrated Diagnostics said this week it has secured the third $10 million tranche of its Series A funding upon achieving key milestones in its diagnostic programs.
Specifically, the company has completed clinical trials demonstrating the commercial potential of its proteomic lung cancer diagnostic, InDi CEO and director Albert Luderer told ProteoMonitor.
"The third and last tranche was linked to the demonstration of a commercially performing clinical diagnostic test," he said. The company, he noted, completed a three-center, 242-patient trial for the test at the end of last year and presented the results to its board in mid-December, resulting in release this week of the final Series A tranche.
The trial used mass spec to measure levels of roughly 200 proteins in each patient with the aim of distinguishing between benign and malignant lung lesions ranging in size from .5 cm to 2 cm. With these measurements, researchers were able to distinguish between benign and malignant lesions with an area under the curve exceeding .80, indicating a diagnostic performance of over 80 percent.
Using the newly released funds, InDi now plans to perform additional clinical trials for the test, Luderer said, noting that the company is currently "in the middle of a 600-person trial" that it plans to finish in the third quarter of this year. With the results from that trial, InDi "will be very close" to having the clinical data needed to support the commercial launch of the test in 2013.
The company is also launching in March a 25-center prospective trial that "will run for several years and will provide evidence" complementing the data generated by the completed clinical trials. Such a trial, Luderer said, would support and speed commercialization of the test by providing "much of the incremental evidence" that potential payors may ask for when deciding whether to cover the test.
"Our guess is that by having a good performing test and by having these trials in place, we might be able to take six months to a year – or maybe more – off the [typical] hiatus between the product's launch and getting paid," he said.
The test is intended to help physicians determine whether lesions picked up by imaging techniques like CT scans are likely benign or malignant and whether a patient should be moved on to a biopsy. According to Luderer, US pulmonologists see around 3.3 million such cases per year.
"If you believe it is cancer – and our test is designed to rule that in – then what you would most likely opt for is an invasive biopsy," he said. "And whenever you're biopsying the thoracic cavity, that's always a high-risk site. So you'd like to be sure that you only ask those who really have cancer to be biopsied and you spare all the others."
Currently, physicians rely on patient risk profiles, including age and smoking status, along with the size of the lesion to determine whether or not to perform a biopsy. The recently completed trial didn't compare the effectiveness of InDi's diagnostic to these conventional approaches, but, Luderer said, the test's 80 percent diagnostic performance is encouraging, and, he suggested, the fact that the trial was multi-center adds to the power of that result.
"One of the pitfalls of proteomic tests has been that many times people have only done single-center clinical trials," Luderer said. "This was a three-major-clinical-center trial, so we had variability associated with each one of the centers, and even with center-to-center variability – which we expected – we had this" 80-plus percent diagnostic performance.
The test's within-center performance ranged from the low 90 percent range almost up to 100 percent, he said.
"We believe that as we go deeper into clinical trials, that [the test's performance] will improve," Luderer said. "We can make adjustments to the testing technology and actually build the test to bias performance attributes that we think are most important."
While the researchers generated the clinical trial data by measuring levels of around 200 proteins per patient, the final test panel will probably consist of around 10 to 15 proteins, he said. InDi plans to use multiple-reaction monitoring mass spec for these measurements and, last month, announced a strategic partnership with Agilent to develop and optimize mass spec workflows for protein biomarker diagnostics. (PM 1/13/2012).
Mass spec-based protein biomarker work has typically “been a research discussion,” Gustavo Salem, vice president and general manager of the company’s Biological Systems Division in the Life Sciences Group, told ProteoMonitor in an interview following announcement of the partnership. “For Integrated Diagnostics, [the issue] is how do we prepare a truly operational, high-throughput CLIA laboratory? So they’ve really raised the bar by saying that the new challenge is taking these potential research solutions and really industrializing them into a commercial solution."
The funding announced this week will be put toward this purpose as well, Luderer said, noting that, in addition to clinical trials, it will be used "to finish our commercialization build-out, which includes all the CLIA reference lab performance and licensing elements we need [and] all the software infrastructure we need."
As InDi president and chief scientific officer Paul Kearney told ProteoMonitor last month, the company plans to offer the test as a CLIA-based product instead of taking it through the FDA approval process.
While Kearney acknowledged in that interview the looming possibility that FDA may begin regulating lab-developed tests, he said that “it’s hard to know what’s going to happen [in this regard]. What most people agree on is that it’s unlikely to happen anytime soon.”
“We’ve looked into companies that have gone to FDA and companies that haven’t in this sort of space, and you can lose market share by not being the first to market [because of] taking an FDA approach,” he said.
Indeed, InDi's lung cancer test could face competition from proteomics-based lung cancer diagnostics being developed by company's including Somalogic and Celera, now part of Quest Diagnostics (PM 4/22/2011).
In a study published in the December 2010 edition of PLoS One, Somalogic's 12-protein panel distinguished cases of non-small cell lung cancer from controls with 89 percent sensitivity and 83 percent specificity (PM 12/10/2010). At the 2011 American Association for Cancer Research's annual meeting, Celera presented data showing its six-protein test distinguished between benign and malignant lesions in a cohort of 80 cases and controls with a sensitivity and specificity of 83 percent (PM 4/15/2011). Quest owns rights to both of those tests.
InDi hopes its clinical trial strategy will give it a leg up in the marketplace, Luderer said, noting that the trials have "been done in collaboration with some of the most influential people in lung cancer."
"There's a [key-opinion-leader] network and it's very important for us to bring them along because they'll be pivotal in establishing with their peers that this is a test that should be done," he said.
"The second thing we've done is used our connectivity with the payor network and talked to physician clinical experts about what kind of evidence-based medicine [they will] require to grant us reimbursement," Luderer added. "So what we did from the first clinical trial onward is put the payor's view in mind."
In addition to release of the funding, InDi also announced this week that it appointed Donald Seaton as chief financial officer and James Garner as chief business officer.
Seaton, who was previously chief financial officer at several life science companies including EndoGastric Solutions, Corus Pharma, and Talisma, brings to the firm "great expertise in devices as well as therapeutics," Luderer said.
Garner, who was previously an executive at UnitedHealth Group, has been working as a consultant with InDi on business planning for most of the last year," Luderer said, helping to build the company's business strategy "so that by the time we could show that the clinical data was there, it would be plug-and-play for the commercial piece."
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