Singulex is at the forefront of Single Molecule Counting, a novel technology recognised for its unprecedented sensitivity. The Singulex Clarity® C. diff toxin A/B assay is in development and scheduled to launch in 2018. This ultrasensitive toxin test is designed to be a one-step solution that matches the sensitivity and specificity of cell cytotoxicity neutralization assay (CCNA), the current gold standard, giving it the potential to eliminate the false positives of PCR and the false negatives of current, less sensitive toxin immunoassays.
Additional microbiology assays are in development on the Singulex Clarity system, a fully-automated in vitro diagnostics platform. In 2017, Singulex filed a 510(k) pre-market notification submission with the US Food and Drug Administration for the Singulex Clarity cTnI assay, which is CE marked and commercially available in Europe.
Singulex is also developing a point-of-care platform and exploring additional applications beyond the clinical setting, which have the potential to dramatically reduce healthcare costs by ruling in and ruling out disease earlier and providing a cost-effective way to monitor chronic conditions. For more information, visit Singulex.com.