The new CEO of Quanterix isn’t afraid to dream big, and say it out loud.
“We participate in an $8 billion market,” says CEO Dave Okrongly, referring to the business of antibody-based diagnostics. “Quanterix can be a platform for that whole $8 billion market.”
Okrongly was named CEO of the Cambridge, MA-based company in September, and now that he’s been settling in for a while, I got a fresh update just yesterday. The company is the latest brainchild of Tufts University chemistry professor David Walt, who previously hit gold with Illumina (NASDAQ: ILMN), the San Diego-based genetic analysis powerhouse. Quanterix hasn’t said much publicly since it raised $15 million in venture capital back in August 2008, so I’ve been curious for some time about the company’s game plan for approaching the first segments of that $8 billion antibody-based diagnostics market.
Before diving into that, I first wanted to know a little about Okrongly. It turns out he’s got a doctorate in chemistry, and a resume with a lot of commercial experience, most recently as the senior vice president of the molecular diagnostics unit at Siemens Healthcare Diagnostics. Earlier in his career, he caught the startup bug at Applied Immune Sciences, an early gene therapy company that was acquired in 1995 by what’s now Sanofi-Aventis.
So while Okrongly, 51, rose in the ranks at big companies, and introduced a number of clinical diagnostic tests around the world, he felt the urge to come back to a startup to create something new. When he first heard about Quanterix, he didn’t think it was for him. “It seemed early and raw,” he says.
Then he met personally with Walt, who changed his mind. “I thought, holy cow, this could change the whole way we do immunodiagnostics. I gotta give this a run. This is a transformative technology with top-notch people around it.”
Walt is equally enthused about the new leader at Quanterix. “Dave has exactly the right blend of diagnostics experience and strong technical background. He has helped push the company’s market strategy forward while helping it achieve its technical milestones,” Walt says.
The initial idea at Quanterix is to find a way to detect trace quantities of proteins in the blood, which could be an early warning sign for cancer or a neurodegenerative disease like Alzheimer’s or Parkinson’s. Quanterix says its test is about 1,000 times more sensitive than the gold standard ELISA assays. The older tests employ specific antibodies that are made to bind with certain biomarkers, known as antigens.
Some of these older tests can be quite cheap and reliable, but they also have their limits. One of the emerging ideas in biology is that tumors and other diseased tissues spill off specific proteins in the bloodstream, but these proteins generally come in trace amounts too small to be detected by the standard ELISA tests. The Quanterix system is designed to detect thousands of single molecules simultaneously, with proprietary chemistry and what the company calls “a relatively simple” instrument with a light source, optics, a digital camera, and an automated handling system. Software is then used to analyze the images.
Quanterix is betting that its ultra-sensitive tests can fill some of the gaps that ELISA tests struggle with. One well-known example is the prostate-specific antigen (PSA) screening test that is commonly used to detect signs of prostate cancer in the blood. This test is used to screen an estimated 7 million men each year for prostate cancer in the U.S., and gives results that are worrisome enough to prompt 200,000 surgeries to remove the prostate annually, Okrongly says.
Quanterix doesn’t want to pursue that initial screening market—partly because the PSA is notoriously unreliable and controversial. But because the Quanterix system should be more sensitive, it may be more useful for detecting prostate cancer recurrence after a man has had surgery to remove the prostate and trace PSA markers are harder to find in the blood, Okrongly says.
The company is also taking a hard look at the neurology field, Okrongly says. Stroke, Alzheimer’s, Parkinson’s, depression, traumatic brain injury, and bipolar disorder were just a few of the opportunities he ticked off. Many of these conditions are currently diagnosed based on clinical questionnaires, and involve physician judgment, with no way of quantifying the disorder through a biological sample. The blood-brain barrier, which makes a lot of pharmaceuticals inaccessible to the brain, is a big reason why no one has been able to develop blood-based diagnostic tests that are sensitive enough to spot early signs of brain illness.
But more evidence is emerging that signature proteins related to neurological disease do actually get into the blood, despite the blood-brain barrier. And if they are there, that means “we can measure them,” Okrongly says.
One of the big questions I had, and that Quanterix will certainly hear from physicians, is whether all this trace detection could lead to setting off false alarms, or “false positive” results that encourage unnecessarily aggressive treatment. And the early strategy, like with almost all diagnostics, is to run tests on diseased samples and look back for the presence of the protein biomarkers. That can be valuable information, but it’s not the same as a study that hypothesizes a certain biomarker is trouble, detects the biomarker in trace quantities, and follows up patients for a long time to see if those early warning signs in the blood really justified an aggressive treatment strategy or not. This is time-consuming and costly work, and Okrongly acknowledges “there’s no getting around some prospective” analyses further in the future.
In the early days, Quanterix plans to build up its own in-house capability to run these ultra-sensitive tests, and it will ask researchers and physicians to ship their samples to the company for analysis, Okrongly says. That capability should be up and running for clinical trials in late 2010, he says. After establishing the technology’s credibility in-house, Quanterix over the next five to seven years will start selling instruments to central labs, that perform lots of sophisticated analyses for researchers at hospitals around the country.
“We want these tests eventually to be everywhere, but it’s necessary for us to stage it in order to create the market,” Okrongly says. “We’re not delusional that we can create five new markets, but we think if we pick one or two areas and do a good job, we’ll be rewarded. I think this company can stand with the best of them in value creation.”