Lewis Carpenter, a running back for Vince Lombardi’s NFL-champion Green Bay Packers, had stopped playing football for decades before his relatives were confronted by obvious signs that his health was in decline. He showed mood swings, memory loss, erratic behavior, and poor motor skills that are characteristic of chronic traumatic encephalopathy (CTE), a disease that can be definitively diagnosed only at autopsy. Early in 2011, postmortem test results confirmed that Carpenter had indeed suffered from CTE.
The first chapter of that story was told late last year at the debut of the award-winning documentary, Requiem for a Running Back. The next installment involving this progressive, degenerative brain disease is being written in the scientific literature now, featuring technology developed by Quanterix.
New technology has shown promise for detecting CTE and the approximately 150 protein biomarkers linked to conditions in neurology, oncology, cardiology, inflammation, and infectious disease. Called Simoa™, it is a single-molecule array on a fully automated digital immunoassay platform that detects single proteins or panels of proteins in the blood, saliva, and other biofluids and tissue.
“We and our partners have invested some $150 million in developing the technology,” says Kevin Hrusovsky, Quanterix executive chairman and CEO. The company expects to raise more than $64 million from the IPO it filed in December 2017.
“Following the IPO, we have some very exciting things planned for the future of Quanterix and precision health, including expanding our commercial base, improving our Simoa technology, and supporting the launch of the new SR-X instrument, as well as expanding our corporate headquarters,” Hrusovsky says. “We’re also looking to expand into areas outside of life science research, including potentially lab-developed tests, in vitro diagnostic tests, and other markets.”
“The technology only becomes more magical as we see its evolution through third-party publications,” he continues. That magic has been reported by independent researchers in more than 129 journal articles so far.
The ultimate benefits aren’t just at the bedside. While it is being developed as a diagnostic tool, Simoa is being used by leading drug developers to determine efficacy and identify autoimmunity issues.
For example, Hrusovsky says, drug makers are using Simoa to determine whether a drug affects such critical markers as amyloid beta, tau, and neurofilament light (NF-L). Companies also are using the technology for patient stratification and to identify secondary markers that could be used to characterize a drug’s specificity, efficacy, and side effects. Eventually, it may be used to monitor patient progress and as a health screen to identify diseases at their earliest stages, when they are most treatable.
“When I joined Quanterix in 2014, it was focused on becoming a diagnostic company,” Hrusovsky recalls. Gaining FDA approval for a diagnostic takes up to seven years, however. The company didn’t want to wait. Therefore, it repositioned its technology for drug developers, offering a noninvasive way to determine whether a drug was having the desired effect—and generating a revenue stream in the process.
To make that happen, the company executed a three-step plan. First, Quanterix focused on the engineering to ensure the product could deliver on its promise. Second, it secured biopharma validation, which meant putting the assay platform in the hands of scientists working in their own, independent labs.
“We’ve gone from having no commercial instruments placed in early 2014 to having nearly 160 in use today,” he notes. Quanterix also runs customer studies on the eight instruments it maintains in house, to help biopharma clients learn whether the technology can be of value in their development programs. So far, it has run approximately 400 separate customer studies.
The third step may have been the hardest. The company had to wait for results to be published in peer-reviewed journals. During that time, Hrusovsky renegotiated Quanterix’ diagnostics contract to increase the company’s long-term opportunities.
“It’s a good growth model,” Hrusovsky says. “Quanterix has grown 40–50% per year since January 2014. [In 2016], our revenue was nearly $18 million. By the end of the first half of 2017, we’d collected $11 million,” demonstrating continued growth of more than 40% annually.
Independent Research is Prized
To support independent research using Simoa, Hrusovsky launched the Powering Precision Health Summit (October 24 and 25, 2017). The summit brought together leading scientists in the fields of neurodegenerative disease, oncology, and infectious disease.
“We’re really excited about the coming ability to see CTE in living humans, by detecting the CCL11 and other brain health biomarkers. There’s interest in our technology from the NFL, military veterans, and others concerned with head trauma and head health. The NIH presented new data indicating that biomarkers in the blood can show whether individuals have suffered concussions.” With those data, it may be possible to determine the severity of those injuries and project recovery times.
“We’re also very excited about MD Anderson Cancer Center’s concept to team its new exosomal enrichment technology with Simoa to identify pancreatic cancer much earlier, potentially as early as stage two—before metastasis—when surgical intervention has a greater chance of impacting survival [time],” he continues. Other projects are trying to identify lung cancer patients with PD-L1 over-expression. This could help identify positive responses among the 15% of the patients given a checkpoint inhibitor who also did not exhibit PD-L1 overexpression in microscopic analysis.
“Investigators are also beginning to look at environmental factors like radiation from mammograms or CT scans. Today, reports say only 10% of CT scans for head trauma reveal positive lesions, but they emit an estimated 100 times more radiation than a chest X-ray,” Hrusovsky says. “Digital biomarkers also may molecularize environmental factors to learn, for example, how sleep helps clear toxic biomarkers from the body or to understand the health impact of excessive sugar, growth hormones, antibiotics, and pesticides in the food chain.”
The ability to identify single proteins and DNA molecules in the blood—potentially doing with a blood test what once required a biopsy—seems unbelievable and sets Quanterix’s technology apart, according to Hrusovsky.
That strength is also its greatest weakness, conferring a “too good to be true” aura that gives some potential adopters and the scientific world pause. The alternatives, however, are to wait for tumors to grow to sizes that can be detected by imaging or less-sensitive assays, or continue deploying more invasive methodologies like biopsies. “Those options are expensive and invasive, and may delay detection and early intervention,” Hrusovsky says.
To overcome that “too good to be true” perception, “We took an extra two years,” he says, to develop the technology. That time enabled independent investigators to demonstrate the benefits of the technology and for their outcomes to be validated in respected, peer-reviewed journals.
The NFL (and Soccer Moms) Have Hope
In the near future, even the invasiveness of a blood draw may be eliminated.
“Eventually, a blood test may be replaced by a fingerpick, and a fingerpick replaced by a saliva or urine test, using our technology,” Hrusovsky says, citing a recent NIH study that detected biomarkers in saliva using Simoa. In addition to continuing to advance its technology for research and diagnostic applications, Quanterix’s long-term plan calls for addressing consumer needs for testing at local pharmacies or at home.
Someday, soccer moms may test their header-prone children with a simple saliva test to get the first early warnings of concussions or CTE.
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