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Singulex’s Recent Collaborations Using Its Erenna Tech Push Shop Toward Dx Market

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Singulex this week announced a second collaboration in less than a month that will use its Erenna protein- and metabolite-quantification technology, a deal that takes the Hayward, Calif.-based firm one step closer to planting roots in the crowded low-abundance protein-detection space.
 
The deal, with Wyeth Pharmaceuticals, calls for the companies to use Singulex’s flagship platform to co-develop immunoassays for a broad range of diseases. Singulex has installed the system at Wyeth and has begun optimizing assays that the drug maker will use to measure specific biomarkers in human blood.
 
A Singulex official declined to disclose financial terms of the deal. Wyeth did not respond to requests for an interview.
 
The collaboration comes less than two weeks after Singulex said that the Washington University School of Medicine will use the platform to develop assays for validated and putative biomarkers in certain disease areas [See PM 11/15/07].
 
Also this month, the firm said it had received a $900,000 Phase I/II Fast Track Small Business Innovation Research contract with the National Cancer Institute to create cancer biomarker assays. Washington University and Sigma-Aldrich will be Singulex’s collaborators on the grant.
 
According to the company’s website, its Erenna platform integrates “capillary flow to manage fluidics, laser-induced fluorescence, a highly sensitive detection optics module, and a 384-well immunoassay plate format for the specimen-antibody reaction.”
 
The system also uses a digital molecule-counting module that Philippe Goix, the company’s president and chairman, said increases the ability of the system to quantify proteins.
 
“We get a digital signal on every antibody,” Goix told ProteoMonitor this week. “Every time there is a labeled antibody passing by the detector, it’s generating a very strong peak and it’s counted.
 
“That’s what’s exquisite — the quantitation, the ability to digitize and quantify one by one every antibody passing by the exquisitely sensitive detection platform,” he said.
 
Identify and Quantify
 
Founded in 2003 as a DNA-analysis shop, Singulex switched its focus to the low-abundance protein-detection space a year later after determining that the high demand for products that detect such proteins, coupled with a market with few such products, equaled a business opportunity.
 
The DNA market “is a very crowded market, and I believe there is a lot of opportunity and a lot of unanswered questions, clinical questions that need to be answered on the protein side,” according to Goix.
 
Indeed, proteomics researchers repeatedly cite detecting and identifying low-abundance proteins in biological samples as being one of the most common and difficult obstacles to their work because high-abundance proteins such as albumin and IgG tend to hide the presence of low-abundance ones.
 
In human serum, for example, the six most abundant proteins represent about 90 percent of the total protein mass. The task is to filter out those proteins to unearth the less-obvious ones. Singulex’s solution is the Erenna system.
 
The company is not alone in the market, which is flooded with reagents, workflows, columns, and instruments designed to deplete high-abundance proteins while enriching low-abundance proteins. Earlier this month, for instance, Bio-Rad Laboratories launched its ProteoMiner reagent kit for protein enrichment [see PM 10/11/07].
 

“That’s what’s exquisite — the quantitation, the ability to digitize and quantify one by one every antibody passing by the exquisitely sensitive detection platform.”

But Goix said the Erenna platform is distinguished from the competition by both its high sensitivity and ability to quantify proteins at low levels. According to the company Erenna uses 10- to 20- fold less biological sample than other ELISA 96-well plate formats, allowing it to capture 20 to 100 times more data from a 100 microliter serum sample.
 
Also, Singulex does its in-house work for customers in small volumes with samples measured in microliters, and with one assay per well.
 
“That’s important because we don’t have complex metrics in terms of multiple analytes, antibodies that will compete with each other,” Goix said. “We just basically do one analyte per sample on small volume with high sensitivity.”
 
He said the Erenna system has a dynamic range 10 to 50 times greater than the conventional immunoassay platform used to mine low-abundance proteins, which allows researchers to detect proteins on the fentogram level.
 
As a result of the Washington University School of Medicine’s collaboration with Singulex, researchers at the school will be part of Singulex’s Erenna Technology Access program, allowing them early access to Erenna.
 
Samuel Stanley, vice chancellor of research at the university, said that the school and Singulex had been working together in various capacities for several years, and when it decided to pick a low-abundance protein-detection platform, the school was “impressed [with] the system and its promise.”
 
The university will use the Erenna system to assess the efficacy of drug treatments. “We’re interested in really assessing the Singulex system to see whether it really improves our sensitivity and specificity … and allows us to improve our ability to detect responses to chemotherapy, for example,” Stanley said.
 
While the Erenna system is commercially available, much of Singulex’s revenue derives from its services business. Goix declined to provide financial details about the company, saying only that revenue is in the “seven digits.” The company has never recorded a profit.
 
For the future, it is looking at the diagnostics field, specifically to develop point-of-care tests for areas such as cardiovascular diseases and cancer. The collaborations announced during the past few weeks are meant to push the company in that direction, Goix said.
 
In June, the company also announced it had raised $19.1 million in private financing to develop a pipeline of diagnostics based on low-abundance protein markers. Orbimed Advisors was the lead investor while Fisk Ventures, Prolog Ventures, and Advantage Capital also participated.
 
“What we offer is a brand new diagnostic capability in molecular or novel diagnostics that will generate high clinical value,” Goix said. “At this point in time we are working at building that diagnostic menu on a platform that will eventually be cleared by the [US Food and Drug Administration]. We have not started that yet, but we are in the planning stage.”