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.”
