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Singulex and Qiagen have entered a strategic alliance whereby Qiagen will be able to offer its clients companion diagnostic development services based on Singulex’s Single Molecule Counting technology.

 

The companion diagnostics field got off to an auspicious start in January 2017 when Singulex Inc., the next-generation immunodiagnostics company based in Alameda, CA, announced it was entering a strategic alliance with Qiagen NV, the European diagnostics specialist with headquarters in Hilden, Germany, for the development of companion diagnostics. The deal gives Qiagen access to Singulex’s Single Molecule Counting (SMC) immunodiagnostic technology, thereby strengthening its existing immunoassay capabilities, as well as to Singulex’s CLIA-licensed laboratory in California.

 

Companion diagnostics are an essential component of precision medicine, the doctrine of delivering the right medicine to the right patient at the right time. By helping to identify which patients are most likely to respond favorably to a particular medicine, or conversely which are most likely to experience side effects, companion diagnostics offer obvious benefits to patients and health care providers alike, and in the R&D situation can help to smooth the progress of therapeutic candidates through the development and regulatory processes.

 

Singulex’s president and CEO, Guido Baechler, says the deal represents another proof point for the versatility of the SMC technology. Last year, Singulex granted Grifols SA, a leading producer of therapeutic plasma products, an exclusive worldwide license to use the SMC technology for the screening of blood and plasma.[See Deal] At the same time, Grifols made a $50 million equity investment in Singulex, bringing its total holding in the US company to 20%.

 

Singulex also entered into a license and supply agreement last year with Thermo Fisher Scientific Inc., which gave Singulex access to Thermo Scientific BRAHMS PCT (procalcitonin), a biomarker that is used in the US as an aid to assessing the risk of critically ill patients progressing to severe sepsis and septic shock, and the risk of mortality in patients diagnosed with sepsis. In Europe, procalcitonin is used to diagnose systemic bacterial infection and sepsis. Singulex is using its SMC technology to develop a rule in/rule out test for sepsis and systemic inflammatory response syndrome (SIRS). The company told In Vivo that it is also exploring opportunities to apply its technology outside of human diagnostics, such as in the food safety, veterinary and environmental areas.

 

Singulex’s SMC technology was originally developed for research applications, but the company is now concentrating on its exploitation for clinical diagnostics and other areas after granting in 2015 exclusive, worldwide rights to life science research applications to EMD Millipore, the life science business of Merck KGAA. (Also see "Singulex: Next-Gen Immunodiagnostics" - In Vivo, 25 Jul, 2016.) The technology is based on standard immunoassay chemistry combined with a digital detection system. Low-abundance analytes in biological fluids are captured using paramagnetic microparticles coated with specific antibodies. Following a magnetic separation step, bound analyte is identified by the addition of fluorescent dye-labeled detection antibodies. A capillary interrogation space illuminated by a laser permits individual analyte molecules to be counted as flashes of light.

 

The year 2017 is set to be a pivotal one for Singulex as it anticipates CE-mark clearance for its Sgx Clarity System around the end of the first quarter. The fully automated system, developed in collaboration with Tecan Group Ltd., is designed to bring the benefits of the SMC technology to hospital and reference laboratories. The company says it expects that the first indication in Europe will be a test to rule out cardiac ischemia in symptomatic patients to avoid unnecessary cardiac stress tests. In the US, Singulex is roughly halfway through clinical studies and hopes to receive approval for the cardiac troponin I indication to rule in a heart attack in early 2018. Clearance for additional assays, including Clostridium difficile, sepsis and other high-cost and high-impact diseases, is being sought in Europe and the US.

 

Meanwhile, Qiagen, which has just reported net sales for full-year 2016 up 4% at $1.34 billion, claims to be the leading provider of companion diagnostics development services to the pharmaceutical industry, and currently offers next-generation sequencing (NGS), PCR and multimodal testing technologies for precision medicine. (Also see "Taking Stock Of Qiagen" - In Vivo, 1 Nov, 2010.)


At present it has companion diagnostics programs that address a number of therapeutic areas, and involve many new drugs in clinical development. As well as the wide range of diagnostic technologies at its disposal, Qiagen’s offerings include global regulatory expertise and extensive experience in developing companion diagnostics products on behalf of pharma companies. (See sidebar, "Qiagen's Strategic Alliances, 2012–2017.") The addition of Singulex’s SMC technology to its portfolio will bring multimodal diagnostic solutions for its pharma partners, the German company told In Vivo

 

“The collaboration enables our pharma partners to select the proprietary Singulex technology platforms to support clinical trial investigations for any and all indications or disease areas that they are interrogating with novel or advanced immunoassay diagnostics combined with Qiagen molecular assay solutions,” a company spokesman said. Qiagen will provide its know-how, experience and development expertise to identify new solutions for patient stratification.

 

Singulex has shown strong endorsement and application in complementary markets and disease areas to Qiagen, such as cardiovascular disease, immunology and inflammation. Traditionally, Qiagen’s strength has been in oncology, infectious disease and immune monitoring. CNS disorders is another area of strong potential for the partnership focus, where the complexity of the disease calls for sequential diagnostic algorithms from multiple, highly sensitive platform technologies.

 

From modest beginnings 10 years ago, when the first personalized medicines, mainly oncology agents, were introduced, the field has expanded to include several therapeutic areas and the number of such combinations has grown considerably. (Also see "Companion Diagnostics: The Expanding Reach Of Personalized Medicine" - In Vivo, 14 Mar, 2017.) Personalized or precision medicines are those whose prescription is determined by the use of a companion diagnostic – defined by the FDA as an in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product.

Informa's Pharma Intelligence's Pharmaprojects lists around 50 pharmaceutical products that are being developed for use in association with a companion diagnostic.

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