Tellgen Corporation (300642.SZ): Medical Device Registration for Myelodysplastic Syndrome Chromosome and Gene Abnormality Detection Kit Accepted for Review

Stock News
Jan 12

Tellgen Corporation (300642.SZ) announced that its controlling subsidiary, Wuhan Kanglu Biotechnology Co., Ltd. (referred to as "Kanglu Biotechnology" or the "controlling subsidiary"), has recently had its domestic in-vitro diagnostic reagent registration application accepted for review by the National Medical Products Administration (NMPA). The product involved is the "Myelodysplastic Syndrome Chromosome and Gene Abnormality Detection Kit (Fluorescence In Situ Hybridization Method)". This accepted product is primarily used for the detection of common chromosomal and gene abnormalities in Myelodysplastic Syndromes (MDS); the test results are intended for clinical reference only and should not serve as the sole basis for patient diagnosis. Clinicians should comprehensively evaluate the test results in conjunction with other clinical indicators and factors. Myelodysplastic Syndrome is a group of heterogeneous myeloid clonal diseases originating from hematopoietic stem cells, characterized by dysplastic development of myeloid cells, presenting as ineffective hematopoiesis, refractory cytopenia, and a high risk of progression to acute myeloid leukemia. Between 40% and 70% of patients with primary Myelodysplastic Syndrome exhibit chromosomal abnormalities at initial diagnosis. Abnormal karyotypes are one of the primary criteria in the Vienna diagnostic standards for Myelodysplastic Syndrome. Utilizing the Myelodysplastic Syndrome probe panel for fluorescence in situ hybridization testing can enhance the detection rate of cytogenetic abnormalities in some patients.

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