On September 19, 2023, approved by the Tianjin Medical Products Administration, ProteinT's independently developed in vitro diagnostic reagent "polypeptide composite quality control material" was approved as a Class II medical device, registration certificate number: Jin Xie Zhu Zhun 20232400246. With this, all of ProteinT's tissue proteomics sample pre-processing full-process detection products have been approved, including: polypeptide composite quality control material (Jin Xie Zhu Zhun 20232400246), protein extraction stage—protein, polypeptide extraction or purification reagent (Jin Xie Bei 20230444), and peptide preparation stage—protein, polypeptide extraction or purification reagent (Jin Xie Bei No. 20230113), laying a solid foundation for clinical proteomics sample detection and data analysis, and leading clinical mass spectrometry detection of proteomics into the era of standardization!
This kit is used for quality control of the polypeptide extraction process after proteolytic digestion of tissue samples and is used in conjunction with the protein, polypeptide extraction or purification kit (Jin Xie Bei No. 20230113) to perform quality control on the four steps of protein extraction, purification, enzymatic digestion, and peptide purification. It can be applied to quality control in the sample pre-processing of mass spectrometry-based tumor tissue proteomics detection.
Since the application of liquid chromatography-tandem mass spectrometry (LC-MS/MS) technology in clinical laboratories, its advantages of high sensitivity, high specificity, and high throughput have enabled its rapid development in clinical testing, and it is being increasingly widely applied to the diagnosis of clinically related diseases. However, sample pre-processing is complex, and at present the vast majority of LC-MS/MS clinical testing methods are laboratory-developed methods. Because the instruments, reagents, and standards used by laboratories differ, different detection parameters need to be set, resulting in significant differences in laboratory-developed detection methods, which brings great difficulty to the standardization of LC-MS/MS detection.
The approval of multiple sample pre-processing kits from ProteinT resolves the shortcomings of the lack of standards and quality control in the LC-MS/MS clinical testing process, greatly improving the above obstacles and comparability issues encountered by different laboratories when using mass spectrometry to detect tissue proteins, helping to further improve the current clinical application of LC-MS/MS methods and accelerate the clinical translation of proteomics.
Featured Product
Postoperative Recurrence Risk Prediction for Stage I Lung Cancer Patients PT-L1™
ProteinT-Lung1™ (PT-L1™) uses liquid chromatography-tandem mass spectrometry (LC-MS/MS) technology to perform proteomics detection on patients' tumor tissues, and calculates patients' recurrence risk scores based on ProteinT's independently developed stage I lung cancer recurrence risk model to assess patients' 5-year postoperative recurrence risk. Based on PT-L1™ predictions, the 5-year disease-free survival rates for patients with low, medium, and high recurrence risk were 98.8%, 64.3%, and 13.3%, respectively, with a negative predictive value (NPV) as high as 98.75%. For patients with medium-to-high recurrence risk predicted by the model, the frequency of follow-up and re-examination should be increased, and reasonable intervention can achieve early diagnosis and treatment of recurrence, prolong survival, and avoid treatment delays; for patients with low recurrence risk, following the routine follow-up plan can reduce screening costs and alleviate patients' psychological stress and financial burden. This provides a basis for clinicians and patients to develop more personalized screening plans and intervention measures.
Good news keeps pouring in. As a national high-tech enterprise focusing on the frontier multi-omics field of precision medicine, the approval of several of ProteinT's self-developed in vitro diagnostic products marks that the safety and efficacy of the products have been recognized by the state. In the future, the company will continue to deepen its work in proteomics and other multi-omics fields, develop more technologically innovative products, and provide physicians and patients with higher-quality products and services.
