Singulex Raises $19.1 Million

Singulex, a Hayward, CA, company (with R&D operations in St. Louis) that makes diagnostics for detecting levels of protein biomarkers, has raised $19.1 million in a Series D private financing led by New York, NY-based OrbiMed Advisors, and joined by existing investors Fisk Ventures, Prolog Ventures and Advantage Capital.

The funds will go toward further development of the company’s Erenna Immunoassay System, a molecule detection technology that has been shown to detect, at previously undetectable limits, normal cellular levels of cardiac troponin I (cTnI), a protein biomarker critical to assessing cardiac tissue damage following a heart attack. By establishing a normal concentration baseline, cTnI’s clinical utility can be expanded from a confirmatory marker to an early warning marker, thereby enabling interventional therapeutic options.

In plain English: The system has the potential to help doctors make earlier and more appropriate prescribing decisions, and to equip pharma companies with intelligence for drug development.

But Red Herring points out that regulatory hurdles may slow the impact of biomarker technologies. “The regulatory and scientific communities warn that standards for the emerging biomarker field, which analysts say is being eyed by nearly every large pharmaceutical company, must be developed before technologies can move toward the market,” according to Red Herring.

Singulex is confident in its ability to move forward, however. “This recent financing will enable us to continue to expand our commercial efforts with the biotechnology and pharmaceutical industry, our diagnostic industry expertise and our intellectual property foothold in emerging diagnostic markets,” said Singulex CEO Philippe Goix, in a statement. “We are in an excellent position to provide information with better clinical utility to drug developers and clinicians.”

Whether or not regulatory bodies will facilitate that process of providing information remains to be seen. But there’s less debate when it comes to biomarkers’ potential, from a scientific standpoint. Red Herring quotes a 2007 Frost & Sullivan report, which says, “biomarkers are being accepted as key decision tools in diagnostics and drug development process.”

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