Medical Device Daily
Earlier this month, Pfizer (New York) reaped a large number of negative headlines when it reported that it had to stop its Phase III ILLUMINATE trial of a new drug that it had expected to raise good cholesterol, the halt due to an increased rate of death in those receiving only the investigational drug torceptrapib.
Singulex (Hayward, California), a small biotechnology company, is working on a troponin assay that a new paper demonstrates has promise in detecting the well-known biomarker for heart damage in normal patients. The company plans ultimately to offer the assay both to pharmaceutical companies for clinical trial monitoring of adverse heart events and therefore to avoid disappointments, such as those by Pfizer, at a late stage in drug development —within two to three years — for clinical diagnostics.
Additionally, pharmas are increasingly calling for such assays for testing of patients to determine potential adverse reactions to an approved drug — a development their liability attorneys probably are actively urging.
Current assays, can typically detect a heart attack four hours or more following a heart attack.
The paper on this assay, the Erenna Bioassay System, just published in Clinical Chemistry, features research by Alan Wu, PhD, professor of laboratory medicine at University of California, San Francisco . Singulex evaluated Erenna’s performance in specimens from healthy individuals and patients with chest pain.
Study findings showed the presence of cTnI in the blood of healthy individuals, established normal baseline concentrations of cTnI, and demonstrated that Singulex’s Erenna assay platform was able to detect small changes in concentration levels of cTn1, which could be an early indicator of AMI that is below the current and standard detectable limit of 350ng/L.
Restated, the assay is designed “to incorporate direct, single-molecule detection technology with customized clinical assays that are capable of quantitatively detecting ‘therapeutically significant’ biomarkers at sub-picogram concentration levels,” the company said.
Singulex plans to offer the troponin assay along with an “assay menu” to pharma companies in Q107 via its Erenna platform, Philippe Goix, president/CEO of the company, told Medical Device Daily.
“We need to continue to expand on the ... clinical value of troponin,” Goix said, saying that the company’s strategy will be to enter into a collaboration with a “top medical institution” to further investigate the biomarker.
Singulex also hopes to develop its troponin assay for clinical diagnostic use, and it will “definitely be available for collaboration tied to the diagnostic focus,” Goix said.
The company already has developed more than 75 assays for protein and metabolite biomarkers. Singulex also has developed customized assays for pharma companies. All of these assays are available now to pharma companies and universities through the companies Early Technology Access Program, or eTAP.
The Erenna Bioassay System, to be launched next year, will feature a menu of assays derived from these.
The research conducted by Wu and his colleagues “offers preliminary clinical results for the use of Singulex’ customized Erenna assays in the early detection” of heart attack, or acute myocardial infarction (AMI) and demonstrates diagnostic capabilities that meet recently redefined criteria for AMI diagnosis as outlined and recommended by the European Society of Cardiology (Sophia Antipolis, France) and the American College of Cardiology (ACC; Bethesda, Maryland).
According to Wu, results of this preliminary clinical study show that with the use of a high-sensitivity assay, there are detectable troponin concentrations in the sera of health individuals in a “Gaussian distribution” (essentially a normal bell-curve distribution somehow associated with German mathematician Carl Friedrich Gauss).
He also noted that the data suggest that a high-sensitivity assay can detect the presence of AMI earlier than with a conventional cTnI assays. It may also identify more subjects at risk for future adverse events, particularly important not only in a clinical setting but in the clinical trial procedures of pharma companies.
“During this collaboration, I was very excited ... that we were able to measure troponin I in normal [people]. And no one has been doing that before — no one,”Goix told MDD.
Still, he acknowledges that Singulex does not have all the answers yet, but he said the company wants to continue to expand on this academic study and demonstrate results in a larger trial.
Goix said he was “intrigued and excited” by the potential of the company’s technology to “add the clinical utility in a diagnostic setting.”
In a nod to the many and much-discussed efforts characterized as personalized medicine, Goix said, “The reason why we want to bring this capability ... is that if you develop a diagnostic along with a drug,” there would be a clinical action “tied to the diagnostic, so we feel that would be even more powerful.”