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Immunodiagnostics Firm Singulex Shutters Abruptly

NEW YORK – Immunodiagnostics maker Singulex will cease operations as of June 28, according to the State of California Employment Development Department.

In a bi-weekly listing, the EED noted that Almeda-based Singulex filed a notice on June 19 that it would shut down, and that the notice was received by the EED on June 24.

The report also states that the company had 71 employees in California and that the closure is permanent.

Executives at Singulex did not reply to repeated requests for comment.

The company was founded in 2003 and its current CEO Guido Baechler took over the position six years ago. He had been with Singulex for five years before his appointment and previously held leadership positions at Roche Diagnostics.

At ASM Microbe in San Francisco this week, clinical microbiologists presenting evaluations of the Singulex Clarity Clostridium difficile toxin detection test said that a planned dinner with the company had been abruptly cancelled. The company was also supposed to have a booth at the conference but it was never set up.

Grifols invested $50 million in Singulex in May of 2016 to acquire 20 percent of the common stock interest in the company. Grifols was also granted an exclusive worldwide license for products related to blood donor and plasma screening.

With Grifols, Singulex was reportedly developing blood screening  immunoassays for HIV, hepatitis C, and hepatitis B viruses.

A representative at Grifols confirmed that the company has a minority stake in Singulex but declined to provide additional information.

Singulex's core technology, called single molecule counting (SMC) was acquired along with the firm's life science business by MilliporeSigma in 2015 and incorporated into the SMCxPRO system.

The Singulex Sgx Clarity system, which was CE-marked in 2017, also uses the SMC technology.

Singulex launched a CE-marked troponin assay on Clarity in 2017 that was reported to have potential utility for patient risk assessment, and has also been evaluated favorably in multiple peer-reviewed publications.

It's single-step, automated C. diff test toxin test was launched in October 2018. Poster presentations at ASM Microbe suggested that it had high sensitivity and specificity as well as a simpler workflow than other methods. The C. diff toxin test had also been evaluated favorably in a company-led study published last year in the Journal of Clinical Microbiology.

Singulex also provided clinical laboratory testing services for cardiac and vascular disorders, sold immunoassay tests and services, was developing a point of care testing device, and was in the process of obtaining US Food and Drug Administration clearance of its diagnostic system, as previously reported.

In 2014, Singulex partnered with Tecan to develop a multiplexed immunoassay system. And, the firm announced a collaboration to co-develop companion diagnostic assays with Qiagen in 2017, a deal which also purportedly gave Qiagen access to Singulex's CLIA lab.

According to the website Crunchbase, Singulex raised over $227 million in nine funding rounds since the company was founded.