Singulex Expands Diagnostics Partnerships, Looks for FDA Approval of Sgx Clarity System Next Year

Published: Sep 05, 2017

Singulex Expands Diagnostics Partnerships, Looks for FDA Approval of Sgx Clarity System Next Year September 5, 2017
By Alex Keown, Breaking News Staff

ALAMEDA, Calif. –The next six months will be critical for the growth of Singulex as it looks to change the face of rapid diagnostics with its Sgx Clarity system.

Singulex is developing a number of tests for a variety of diseases, including Clostridium difficile and heart health through the measure of the biomarker troponin.

In the case of troponin, the Singulex Sgx Clarity cTnl Assay quantitatively measures the biomarker troponin at levels far lower than existing technologies, which means it can be used with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease.

Clostridium difficile infection is the leading cause of gastroenteritis-associated death and has become the most common cause of health care associated infections in U.S. hospitals. Costs associated with Clostridium difficile are estimated to be about $4.8 billion annually.

To stem that expense, hospitals and other care facilities may face Clostridium difficile, Singulex has developed its diagnostic tool as a method to help rule out various diseases or other infections a patient may be suffering – and at a faster pace.

“There’s no other systems that have this level of sensitivity,” Guido Baechler, president and chief executive officer of Singulex, told BioSpace in an exclusive interview.

Baechler said the system is able to generate results within an hour, which can be indispensable for patient care. By providing rapid results Baechler said that means health care professionals can rule out unnecessary procedures, which is more efficient for busy doctors and does not add to the stress many patients are already under.

“That’s a very important part of the story,” he said.

Currently, Singulex has 10 of its systems operating in Europe. Baechler said the company is getting positive feedback from European physicians who tout the efficacy of receiving clinical information so fast in order to rule out diseases.

Now the company is hoping to bring the system to the United States. Baechler said the company will approach the U.S. Food and Drug Administration by the end of September and hope it will be cleared to market the system here by June 2018.

If approved, Baechler said it should not prove too difficult to expand its manufacturing and logistics to the United States. In preparation of global expansion, Baechler said the company has hired a sales director who will lead the expansion when the time comes. If approved in the U.S., Baechler said the company will begin hiring a sales force to handle that domestic expansion from its current level of about 230 employees.

“Right now, it’s a little too early to predict what we’ll need in the United States,” he said.

Singulex is already working with several domestic healthcare companies and biotechs. He noted that Kaiser is looking at the Sgx Clarity technology for use within its closed system. The system will be invaluable for a healthcare group like Kaiser due to the significant savings it can bring the organization, Baechler said.

In December 2016, Singulex forged an agreement with Thermo Fisher Scientific for a biomarker used to diagnose systemic bacterial infection and sepsis and in the United States. The BRAHMS PCT (Procalcitonin) biomarker can provide aid in assessing the risk of critically ill patients for progression to severe sepsis and septic shock, and the risk of mortality in patients diagnosed with sepsis, another area of diagnostic need, Baechler said.

“This will allow doctors to rule sepsis out, saving them money,” he said.

In January, Singulex struck another deal with Germany-based Qiagen N.V. to develop companion diagnostics through Singulex’s Single Molecule Counting immunodiagnostic platform. Qiagen invested $50 million to own 20 percent of Singulex. Baechler said it was a big deal for the company and a big validation of the product

Singulex also has deals in place with Merck and Millipore. Last year, Singulex licensed technology to Spanish pharmaceutical company Grifols, a leader in donor screening testing and plasma testing. Baechler said approximately half of blood tests conducted worldwide are done with Grifols’ platform, which makes it a key partnership.

“There’s a lot of opportunities out there and we’re looking where to go next,” he said.

The Clostridium difficile test isn’t the only product in Singulex’ diagnostic arsenal. Currently, the Singulex Clinical Laboratory offers more than 60 blood tests that primarily focus on the assessment of chronic conditions such as cardiovascular health, inflammation, diabetes, abnormal cholesterol, or hormone imbalances, as well as cancer monitoring.

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