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


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-ofcare
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

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

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

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.