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Singulex to Seek FDA Clearance for Sgx Clarity; Aims for Point-of-Care Prototype by Year End

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NEW YORK (GenomeWeb) – Singulex plans to list its single-molecule counting Sgx Clarity instrument as a CE-marked in vitro diagnostic in Europe at the end of March and plans to submit it for US Food and Drug Administration clearance in the second half of the year, according to Singulex CEO Guido Baechler.

In an interview at the recent JP Morgan Healthcare conference in San Francisco, Baechler provided an update on the firm's activities in the immunodiagnostics space and in developing its single-molecule counting (SMC) technology for various applications.

Singulex is currently about halfway through clinical studies in the US at sites in Minneapolis, Albuquerque, and at its own laboratory in Alameda, California. The firm also plans to have a prototype version of a point-of-care instrument by the end of the year.

In addition, it is beginning to work with Grifols, which invested $50 million for a 20 percent stake in the company last year, on using its SMC technology for blood screening applications. And, Baechler said, the firm is considering areas outside of immunodiagnostics for applying its technology, such as food safety.

For both the CE-IVD listing and FDA clearance, the company is developing assays that measure levels of the protein cardiac troponin-I. Elevated levels of troponin can indicate a risk for myocardial infarction, heart failure, or cardiovascular death.

However, the indications for Singulex's test will initially be slightly different in Europe and the US. The first test in Europe will be to rule out cardiac ischemia in patients in order to avoid unnecessary cardiac stress tests. In the US, the first indication will be to rule in a heart attack. Though, eventually, Singulex plans to have clearances for rule-in and rule-out claims in both countries.

A major focus of the company has been on developing a point-of-care device. It has brought new people on board to help in the research and development of that device, and Baechler said the company would have a prototype by the end of the year and eventually pursue FDA clearance.

"Once we go through that with Clarity, for the point-of-care device it will be more simple," he said. The two systems are essentially powered by the same technology, and the point-of-care system will have the same sensitivity as the Clarity, he added.

Last year, Grifols invested $50 million in Singulex and licensed rights to use its SMC technology for blood screening and plasma donations. Baechler said that the two companies have now begun work on developing immunoassays to screen blood that has been donated for infectious pathogens, including HIV, hepatitis C virus, and hepatitis B virus.

Baechler said that Singulex is essentially serving as Grifols' R&D arm, while Grifols is providing the "specification and engineering partners to develop the system." He did not provide a timeline for the launch of a product from that work.

Singulex also struck a recent deal with Qiagen to codevelop companion diagnostics by combining Singulex's SMC technology with Qiagen's molecular testing services. Baechler said that the idea is for Qiagen to work with pharmaceutical companies to develop companion diagnostic markers on the Clarity instrument. He added that Qiagen was interested in partnering with Singulex because it does not have an immunoassay platform.

In addition, a number of pharmaceutical companies already have Singulex's technology in house, Baechler said. EMD Millipore, a unit of Germany's Merck KGaA, purchased Singulex's life science research business in 2015, enabling it to further develop and commercialize the SMC technology for research applications.

Under the agreement with Qiagen, though, the companies will work with pharmaceutical companies to develop the SMC technology for diagnostics. Baechler said that the fact that some pharmaceutical companies already have experience using the SMC technology in research would help in their future discussions. Also, partnering with Qiagen will provide the opportunity to incorporate not just immunoassays, but also molecular markers in the diagnostics.

Baechler said that one potential outcome of the collaboration is that tests developed under the partnership that run on the Clarity system could be brought through FDA clearance and distributed on the Clarity. Baechler said it is still early in the partnership though, so the details have not been worked out.

Recently, Baechler said that the company started an initiative to look at opportunities for applying SMC technology outside of human diagnostics. For example, he said, there are potential food safety, veterinary, and environmental applications.

"Especially in the food safety space, there's a large market," he said. Currently, most tests are microbiology based and require culturing of organisms. So, using the SMC technology to detect things like antigens produced by Escherichia coli, could differentiate it from other tests.

The company only recently began to explore that opportunity, but he said it would likely pursue an outlicensing strategy to partner with companies already in the food testing market. The goal would be to "find alternatives to use what we've already built in other areas that aren't core to our business strategy," he said. 

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