Curtailing a ‘diagnostic odyssey’

SEATTLE—Molecular diagnostic company Indi (Integrated Diagnostics) recently secured $30.25 million from the closing of a Series B financing round and an additional $17 million in non-dilutive debt financing provide by Life Sciences Alternative Funding.

Baird Capital led the financing round, with existing investors InterWest Partners and the Wellcome Trust also participating. Alexandria Venture Investments, the strategic venture arm of Alexandria Real Estate Equities Inc., has also joined the Series B as an investor. In conjunction with this financing, Dr. Michael Liang, a partner with Baird Capital’s venture capital group, has joined Indi’s board of directors.

Indi plans to use the funds to further commercialize Xpresys Lung, its molecular diagnostic blood test that aids physicians in dealing with indeterminate lung nodules. The test launched late last year.

“We are very pleased to help Indi take their early commercial success with Xpresys Lung to the next level,” said Liang. “Indi has taken their innovative proteomic technology and applied it to a massive unmet need: the high costs associated with over-diagnosing lung nodules. Their strategy is a perfect fit for Baird Capital’s focus on investing in companies who produce innovative technologies that address expanding market needs.”

Dr. Albert A. Luderer, CEO of Indi, says that some three million nodules are discovered every year in the United States, and of those, there is a subset of about 600,000 patients per year that he calls “the real problem.”

“The easiest way to characterize those patients is that they fall in a size nodule range of about 8 mm to up to 30 mm,” Luderer explains. “If you have a nodule of that dimension, we’ve estimated through our clinical trials that the prevalence of cancer is about 23 percent in that group. Many of those patients are benign. So the real question is, who is benign? Who can you rule out? As we did more and more research on this, we found that those 600,000 patients consume on average about $35,000 each in terms of diagnostic workup. Because the lung is so difficult to get at and to try to biopsy, you go through a graded series of more and more invasive procedures. And so patients … go through an honest-to-goodness diagnostic odyssey.”

Indi’s approach in developing Xpresys Lung—work that began four years ago, says Luderer—was based on systems biology, as they looked to see if certain proteins in a patient’s plasma “could reflect a state of pathology.” Xpresys Lung measures the relative abundance of proteins from several pathways associated with lung cancer, through the use of multiple reaction monitoring mass spectroscopy.

“Our premise was that if you could look broadly across the expression of the more or the less abundant proteins, that you might be able to see a disturbance in networks as expressed by differential protein expression,” Luderer tells DDNews. “And that’s exactly what we found in patients with lung nodules; we found a very good cancer signal that switches on very early that allows us to discriminate a benign from a malignant nodule. And the work we did was all stage 1 cancer; we know how aggressive lung cancers are, but they’re potentially curable at that stage, so we think we’ll get some benefit there—not only in terms of finding people who don’t have disease, but those who do have disease, they’re going to be found earlier, I believe.”

“Many people are trying to address the lung cancer question. I think we’re the only ones that have approached it from a ‘rule out cancer’ and a lung-nodule management point of view,” he adds.

Luderer identifies this as a multibillion-dollar marketplace in the United States, one of the “rare blockbusters in diagnostic medicine,” and more growth is expected. Luderer points out that in looking at most cancers, nearly all of the molecular diagnostics are focused in what could be called the late stage of diagnosis: when a patient has proven disease and the diagnostic is concerned with determining disease aggressiveness and a patient’s potential response to various therapeutics. As such, he says there is a larger market opportunity earlier in the process.

Pulmonology is not the only area Indi is interested in, according to Luderer, as the company is also looking into developing diagnostics for certain neurological conditions. Areas related to traumatic stress disorders, multiple sclerosis and aging disorders such as Alzheimer’s disease are all fields the company is investigating.