Last updated: May 2026
Instrument Registration: The PCR POCT Platform referred to in this document has been granted Class III Medical Device Registration Certificate by the China National Medical Products Administration (NMPA). PCR POCT reagent kits and test panels (including but not limited to EGFR, NTRK, and HER2) are currently designated for Research Use Only (RUO). The Nanopore Sequencing Platform referred to herein and its associated reagent kits have not obtained any regulatory registration and are currently designated for Research Use Only (RUO).
Clinical & Economic Data: Clinical validation data and concordance rates with NGS and RT-PCR are based on studies conducted by multiple institutions under varying conditions. Results may differ across clinical environments. Economic projections are based on standardized scenarios and estimates; actual financial impact depends on local testing volume, reimbursement policies, and institutional cost structures.
Professional Judgment: This information is intended solely for educational and professional discussion purposes and does not constitute medical advice. Treatment decisions should be made by qualified medical professionals based on comprehensive clinical assessment and applicable local guidelines (e.g., CSCO Guidelines, NCCN Guidelines). This presentation is limited to professional information exchange and partnership exploration. It does not constitute an offer of sale, solicitation, or medical advice.
Enterprise Cooperation & Brand: The PCR POCT Platform is developed and manufactured by our strategic partner. The Nanopore Platform product series is developed and manufactured by our strategic partner. Novobay Biotech serves as the business development partner for both companies in market exploration — it is NOT a distributor, commercial agent or co-manufacturer.
Strategic Promotion: The PCR POCT Platform and Nanopore Platform are jointly promoted and distributed by their respective R&D manufacturers and Novobay Biotech through respective strategic partnerships. All parties cooperate to provide comprehensive technical support, clinical education, and market access solutions to healthcare providers and pathology experts.