Reaching the Next Level of Sensitivity in Oligonucleotide Bioanalysis: A Hybridization-Based Method on Simoa®

EBF Open Symposium 2022 -- Simoa®, Single Molecule Array technology, is known and recognized as an ultra-sensitive immunoassay technology that can detect extremely low level of proteins and nucleic acids that traditional ligand binding assay cannot reach. Simoa® is well established in biomarker realm, where the gains in sensitivity have allowed, for example, the detection of biomarkers of brain injury and neurological diseases at a much earlier stage in more accessible matrices such as blood, serum or plasma, allowing more frequent and less invasive sampling. However, in the area of pharmacokinetic (PK) testing in the regulated bioanalytical laboratory, Simoa® technology is still relatively new. A number of approaches exist for the bioanalysis of oligonucleotides, each with their strengths and challenges. The Simoa® single molecule detection technology brought a great opportunity to meet the challenge of detecting oligonucleotide therapeutics with the sensitivity required to fully evaluate their pharmacokinetics.