On May 30, 2025, the BCR/ABL Fusion Gene Detection Kit (Fluorescence In Situ Hybridization) and AML1/ETO Fusion Gene Detection Kit (Fluorescence In Situ Hybridization) independently developed by YZY MED were both approved by the National Medical Products Administration (NMPA), and obtained Class III medical device registration certificates. The simultaneous approval of the two certificates marks a milestone breakthrough of YZY MED in the field of molecular diagnosis of hematological tumors, indicates that the technological innovation of YZY MED in the field of molecular pathological diagnosis has been recognized at the national level again, and further consolidates the company’s leading position in the field of precision diagnosis and treatment of hematological tumors.
BCR/ABL fusion gene – the core of diagnosis and treatment for chronic myeloid leukemia (CML)
Gold standard for diagnosis: The positive Ph chromosome and BCR/ABL fusion gene are necessary conditions for the diagnosis of CML (Guidelines for the Diagnosis and Treatment of Chronic Myeloid Leukemia 2022), which can accurately distinguish CML from other myeloproliferative diseases.
Target for targeted therapy: The fusion protein encoded by BCR/ABL fusion gene has continuously activated tyrosine kinase activity, and gene detection can guide the targeted medication of TKI drugs (such as imatinib).
AML1/ETO fusion gene – the key to diagnosis and treatment for acute myeloid leukemia (AML-M2b)
Gold standard for subtyping: The positive rate of AML-M2b subtype is as high as 90% (the independent subtyping basis of WHO guidelines), realizing the “final conclusion” diagnosis.
Treatment and prognosis management: Positive patients have significantly improved sensitivity to chemotherapy, and usually can obtain a high remission rate and a relatively long survival period.
The approval of the two certificates marks that YZY MED has formed a complete closed loop in the field of precision diagnosis and treatment of hematological tumors, and has worked together with the listed and approved HER2, ALK and other solid tumor companion diagnostic reagents to build a molecular pathological FISH product matrix covering the dual tracks of “hematological tumors + solid tumors”:
Hematological tumors: BCR/ABL and AML1/ETO fusion gene detection help the precise subtyping of leukemia and individualized medication.
Solid tumors: Companion diagnostic reagents such as HER2 amplification and ALK fusion guide the selection of targeted therapy.
Relying on the trinity solution of “pretreatment reagents + fully automatic equipment + fast hybridization probes”, YZY MED has accumulatively obtained nearly 200 NMPA and CE certifications, comprehensively covering the disease fields such as tumors and genetic diseases, and promoting the FISH technology to move from “high-end detection” to “clinical popularization”.
