Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) a clinical stage biopharmaceutical company dedicated to tackling unmet medical needs in oncology, autoimmune and infectious diseases, is pleased to announce the recent publication of a joint effort for assessing a rapid-turnaround low-depth unbiased metagenomics sequencing workflow on Illumina platforms. This technology, PathsDx Test, was shown to be robust, rapid and sensitive for the diagnosis of infectious diseases.
The paper is titled, “Towards a rapid-turnaround low-depth unbiased metagenomics sequencing workflow on the Illumina platforms” has been published online in Medrxiv, which can be downloaded at the following website address: https://medrxiv.org/cgi/content/short/2023.01.02.22283504v1.
Dr Clark Cheng, Chief Medical Officer of Aptorum Group Limited commented, “We are pleased to announce the exceptional performance of PathsDx for the diagnosis of infectious diseases. The PathsDx Test has achieved so far over 95% for both sensitivity and specificity. Our clinical validation also shows that at least 93% of plasma samples agreed with the standard of care clinical diagnostic test results (compared to reported industry liquid biopsy test of 92.9%1). These results are remarkable as an initial stage of clinical validation. The remaining 7% are viruses with very small genome (5kb), which is a common challenge across the genomic industry, we have a workflow development plan currently to strive towards detecting these small genome viruses, eventually targeting close to full agreement. The trend of our validation results so far also suggests further improvement of our validation statistics (including the comparison of agreement with standard of case diagnostics) based on increases in further clinical validation samples. The effect of different sequencing times was evaluated with the 19-hour iSeq 100 paired end run, a more clinically palatable simulated iSeq 100 truncated run and the rapid 7-hour MiniSeq platform. Significantly, our results demonstrate the ability to detect both DNA and RNA pathogens with low-depth sequencing. In conclusion, it was demonstrated that iSeq 100 and MiniSeq platforms are compatible with unbiased low-depth metagenomics identification with the PathsDx Test workflow and its library preparation kits and can be chosen based on required turnaround times. We are also pleased to now have built up a pathogen genomic database of close to 20,000 species to support our software analytics in identifying, on an unbiased metagenomic basis, the pathogenic composition in the patient sample. With these remarkable results, we are actively expanding our validation sites in Singapore, Hong Kong and United States. We would also like to express our heartfelt appreciation of Illumina for supporting this project via intellectual, mechanical and technical input.”
About Aptorum’s PathsDx Program
PathsDx Test (formerly known as “RPIDD”) is an innovative liquid biopsy-driven rapid pathogen molecular diagnostics technology. PathsDx Test, 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. PathsDx Test is comprised of two proprietary metagenomics next-generation sequencing (mNGS) components: (i) HostEL for depletion of human background to enrich both pathogen DNA and RNA; (ii) AmpRE for one pot DNA/RNA library preparation for overall cost effective amplification. PathsDx Test 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 both DNA and RNA based viruses in an unbiased manner.
About Aptorum Group
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutic assets to treat diseases with unmet medical needs, particularly in oncology (including orphan oncology indications), autoimmune and infectious diseases. Aptorum has completed two phase I clinical trials for its ALS-4 (MRSA) and orphan drug designated SACT-1 (Neuroblastoma) small molecule drugs and commercializing its NLS-2 NativusWell® nutraceutical (menopause). The pipeline of Aptorum is also enriched through (i) the establishment of drug discovery platforms that enable the discovery of new therapeutics assets through, e.g. systematic screening of existing approved drug molecules, and microbiome-based research platform for treatments of metabolic diseases; and (ii) the co-development and ongoing clinical validation of its novel molecular-based rapid pathogen identification and detection diagnostics technology with Singapore’s Agency for Science, Technology and Research.
For more information about the Company, please visit www.aptorumgroup.com.
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