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Singulex Readies Immunodiagnostics System for CE Mark Validation in Europe, Clinical Studies in US

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NEW YORK (GenomeWeb) – Singulex has shipped its first Singulex Clarity system — an immunodiagnostics platform based on single-molecule counting technology — to a laboratory in Barcelona, which will validate the instrument for use as a CE-marked in vitro diagnostic system in Europe.

In addition, Singulex is planning to begin clinical studies in the US this July designed to bring the Clarity system through US Food and Drug Administration 510(k) clearance, Singulex CEO Guido Baechler recently told GenomeWeb.

The company also plans to develop diagnostic tests based on the the detection of prostate specific antigen, Clostridium difficile toxin, and biomarkers associated with concussion and neurodegenerative disease, and as previously disclosed plans to launch a point-of-care device in Europe in 2019.

Earlier this month, the Spanish healthcare products firm Grifols invested $50 million for a 20 percent stake in Singulex. Baechler said that Grifols was interested in licensing Singulex's single-molecule counting technology to screen for infectious diseases. He added that Grifols will have a seat on Singulex's board, but in general will not have a major influence on the company's direction. "We're independent in our laboratory business and our IVD business," Baechler said.

Singulex offers laboratory-developed tests through its Alameda, California-based clinical laboratory, which has CLIA certification, as well as CAP and New York State Department of Health accreditation, and has so far assessed over 1 million patient samples, John Todd, Singulex's vice president of clinical research, told GenomeWeb.

But the Clarity launch will mark its first entrance into the IVD market. In both the US and Europe, the first assay will be for the protein cardiac troponin-l, elevated levels of which can indicate a risk for myocardial infarction, heart failure, or cardiovascular death.

In Europe, the company plans to launch this assay to detect troponin to avoid unnecessary cardiac stress tests. When patients go to the hospital because of chest pain or other symptoms that point to potential cardiovascular problems, they are often given a nuclear stress test, which measures blood flow to the heart while the patient is exerting him or herself. But those tests are not very sensitive and can have false positive rates of up to 20 percent for diagnosing coronary artery disease. 

Singulex's assay will determine if a patient has normal troponin levels and thus does not need a costly and invasive nuclear stress test.

In the US, Singulex will initially launch the test to help diagnose acute myocardial infarction. "It will be more of a rule-in test versus a rule-out test," Baecheler said.

Eventually, the company plans to validate claims around troponin as a rule-out and a rule-in test in both Europe and the US, but Baechler said that the timing of these validations is related to the availability of samples in the different countries, the ability to conduct the necessary studies, and the different regulatory requirements of each country.

A second area Singulex is targeting is detecting prostate specific antigen in patients who have been diagnosed with prostate cancer. The assay would be used to assess men who have already had surgery or finished a round of treatment to determine whether their PSA levels are high enough to warrant continued aggressive therapy or whether PSA levels are undetectable. Baechler said the firm is currently assessing offering PSA screening as a laboratory-developed test and would follow up with a clinical assay on the Clarity system, initially in Europe, likely in 2017.

Singulex also sees an opportunity in the infectious disease space, in detecting toxins from pathogenic C. difficile infections. Todd said that there is market for such tests because current PCR-based assays don't discriminate between pathogenic and nonpathogenic C. diff, since they focus on the strain rather than the toxins. Todd said that the company is in the middle of its clinical research program for detecting C. diff toxin and will first roll out testing services in its clinical lab and then develop an assay that it will bring through IVD validation on the Clarity system. Baechler anticipated offering a clinical laboratory-developed test by the end of 2017.

Further in the future, Singulex plans to develop tests that can discriminate between mild, moderate, and severe concussions, as well as other tests based on detecting biomarkers associated with neurodegenerative diseases. Last year, for instance, the firm struck up a deal to collaborate with the CHDI Foundation to develop biomarkers for Huntington's disease.

The company has moved beyond a lawsuit that it settled last year related to investigations of its contracted sales force BlueWave Healthcare Consultants for paying physicians in exchange for patient referrals. Baechler said that Singulex had ended its relationship with BlueWave six months prior to the settlement, and "implemented extensive enhancements across our organization to ensure improved compliance with government-funded healthcare programs."

The settlement, in which Singulex paid $1.5 million while BlueWave paid $47 million, "enabled us to confidently move beyond this matter and focus on innovations and delivery of quality services that are core to the growth of our business," Baechler said.

Ultimately, Singulex is looking to move its immunoassay technology into emergency rooms and physicians' offices with its point-of-care device. "There's a significant need for a highly sensitive point-of-care product," Baechler said. For that device, its first assay will be on troponin detection to help rule out acute myocardial infarction. The point-of-care device is "part of a bigger strategy that we want to drive toward — of constantly monitoring and giving feedback" of critical biomarkers, he said.

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