Innovative Medical Device Approval | A new non-invasive testing option for auxiliary lung cancer diagnosis

On October 26, 2026, the National Medical Products Administration announced the approval of the innovative product registration application for the “Human Chromosome 3 and 10 Abnormality Cell Detection Kit (Fluorescence in Situ Hybridization)” by Zhuhai Sanmed Biotech Co., Ltd. The registration number is Domestic Medical Device Registration Certificate 20263402205, and the approval date is October 23, 2026. The product is included in the NMPA list of approved innovative medical devices.

The kit consists of a probe mixture and a nucleic acid counterstain. It is intended for qualitative detection of mononuclear cells with amplification abnormalities of chromosome 3 and/or chromosome 10 in the peripheral blood of the pulmonary nodule population. For patients with nodules detected by chest CT imaging whose imaging results leave clinicians unable to determine whether invasive examination is needed, the product can be used for auxiliary diagnosis of lung cancer.

In terms of clinical value, the test can provide a non-invasive examination method for patients and more diagnostic information for clinical decision-making. Clinicians should still consider symptoms, signs, medical history and other laboratory tests when deciding whether to perform puncture biopsy. The NMPA stated that it will strengthen post-market supervision of the product to protect patient safety.