Aptorum Group Limited announced further updates on the analytical and both the retrospective and prospective clinical validation of the RPIDD technology in patient samples, employed under both Illumina iSeq 100 and MiniSeq sequencing platforms. RPIDD, using its proprietary developed depletion and enrichment technologies, has been clinically validated in over 100 patient samples so far. In the completed retrospective clinical validation, both iSeq 100 and MiniSeq employing the RPIDD workflow demonstrated a 100% agreement with positive clinical data in identifying the causative pathogen (by employing standard of care (SOC) diagnostics when the Ct value of the samples is <30). In addition, under both iSeq 100 and MiniSeq platforms, RPIDD also showed a 100% agreement with the negative clinical molecular diagnosis data on the relevant clinical samples.

In prospective clinical validation of RPIDD, patients have been enrolled with febrile neutropenia and sepsis conditions and that over 50 samples have been collected and analyzed. The trial is still ongoing but so far general agreement has been observed compared with standard of care diagnostics results such as blood culture technology and/or PCR. Various bacteria and both DNA and RNA viruses have been detected in these patient samples, including (but not limited to) Hepatitis B and C virus, Cytomegalovirus, Epstein-Barr virus, Human Immunodeficiency virus, Dengue, Escherichia coli, Klebsiella pneumoniae and Herpesviridae, etc.

In the analytical validations of RPIDD, it has also been demonstrated that (a) analytical sensitivity of 100% in MiniSeq and 92.5% in iSeq 100 in the low-depth low-cost sequencing assay, and (b) analytical specificity of more than 95.0% in MiniSeq. RPIDD is an innovative liquid biopsy-driven rapid pathogen molecular diagnostics technology. RPIDD, through proprietary and patented technologies, is developed with the aim to, cost effectively through patient blood samples, enrich pathogenic DNA and RNA for pathogenic genome sequencing analysis through harnessing the power of Next-Generation Sequencing platforms and proprietary artificial intelligence-based software analytics with the goal to rapidly identify and detect any foreign pathogens (virus, bacteria, fungus, parasites) without bias through its genome composition and to identify other unknown pathogens and novel mutated pathogens.

RPIDD is comprised of two proprietary metagenomics next-generation sequencing (mNGS) components: (i) HostEL for depletion of human background under selective lysis to enrich both pathogen DNA and RNA; (ii) AmpRE for one pot DNA/RNA library preparation for overall cost reduction. RPIDD has been and continues to be validated in human clinical samples and so far, such testing has been able to detect pathogens – ranging from bacteria, fungi and viruses in an unbiased manner.