Multiplex targeted sequencing of small clinical samples

摘要

What is the "Gold Standard" competition for this project: - real time PCR for plasma, body fluids, fresh tissues; - immunohistochemistry (IHC) for fixed tissues. Brief Description of Patient Population (# of patients needing treatment, key segments): - immunocompromised patients (i.e. solid organ and hematopoletic transplant recipients). ～120 patients/month at SHC. Most patients require multiple viral Dx assays. Cost/Patient, or anticipated ASP (price): $15 reagent cost/patient (lower cost at higher multiplexing levels); $10 for DNA extraction from patient sample. Compare to singleplex real-time PCR at $30-50/per virus incl. extraction. Market Size: ～70,000 solid organ transplantations worldwide/year; ～50,000 hematopoietic stem cell transplantations worldwide/year. Product Benefits vs "Gold Standard": multiplexed detection (55 vs 1 at the time); greater sensitivity than metagenomic applications (min limit of 1,000-10,000 copies/ml for virus discovery-based assays). Product Limitations: - Targeted = known clinical viruses (however, can be easily expanded).