MJ MedTech Advances from Drug Development Enablement to Companion Diagnostics and Launches Digital & AI-Powered Pathology Solutions
September 28, 2022, MEDx (Suzhou) Translational Medicine Co., Ltd.(hereinafter referred to as: MEDx)Self-openingPD-L1 Testing Kit(Immunohistochemistry) (Trade Name:MedPath)Officially approved for market launch by the National Medical Products Administration (NMPA)。
Maipukang, as an NMPA-approved Class III PD-L1 companion diagnostic kit, conducted a clinical comparative study on more than 1,000 non-small cell lung cancer patient samples at four large authoritative clinical research centers: Fudan University Shanghai Cancer Center, Zhejiang Cancer Hospital, China-Japan Friendship Hospital, and Shanghai Chest Hospital. The results were compared with those of the imported PD-L1 detection kit (clone number: 28-8, Dako).The positive concordance rate was 96.58%.，Negative Concordance Rate: 98.31%，The overall agreement rate was 97.77%., demonstrating superior detection performance.
Meanwhile, in alignment with the practical needs of clinical application, MEDxActively conducted multi-indication expanded validation, and compared with the approved imported PD-L1 antibody reagent (clone 22C3, Dako). The results showed that the overall concordance rate was 97.6% for head and neck squamous cell carcinoma, 95.3% for gastric cancer, and 95.0% for esophageal squamous cell carcinoma. In addition, comparative studies on staining consistency across different platforms demonstrated that the overall concordance rate of Maipukang between the Ventana (Roche) Benchmark XT fully automated immunohistochemistry stainer and the Leica BOND fully automated immunohistochemistry stainer was 94.59%, indicating that this product can be extended for use on commonly used fully automated immunohistochemistry stainer platforms in clinical pathology departments.
MEDx, committed to becomingInnovator and Leader in Comprehensive Solutions for the Companion Diagnostics Industry。
The company was established in 2013., formerly known as the QIAGEN Asia Pacific Translational Medicine Research Center in Germany. QIAGEN has long been a global leader in life sciences research, applied testing, and clinical diagnostics.MEDx has established its technological and quality system foundations by “standing on the shoulders of giants,” leveraging this advantage to rapidly strengthen its product competitiveness and accelerate commercialization.
From 2013 to 2017,MEDx Has Experienced Its First Period of Rapid Growth, adhering to the principles of integrity and innovation while forging ahead, and upholding the new-era development philosophy that “science and technology are the primary productive force, talent is the primary resource, and innovation is the primary driving force.” With the company’s rapid growth, it has established specialized and scaled capabilities in scientific and technological innovation, technical platforms, talent pipelines, product portfolios, and quality systems. The completion of its Series A financing round demonstrates the company’s recognized strength in product innovation, business model, and operational management.
Leveraging its industry-leading integrated technology platforms in genomics, proteomics, cytomics, pathology, and big data, MEDx demonstrates strong technical advantages and a leadership position in the companion diagnostics and precision medicine sector.
MEDx focuses on its comprehensive translational medicine platform, which supports three core business segments: clinical drug translation, companion diagnostics (CDx) development, and medication guidance testing. Collaboration with pharmaceutical companies is one of MEDx’s core businesses and a prerequisite for developing companion diagnostics. Currently, MEDx partners with over 300 innovative pharmaceutical companies worldwide. The company has established an innovative CDO (Contract Diagnostic Organization) + CDx (Companion Diagnostics) business model, dedicated to empowering drug R&D and precision medicine, providing full coverage across the commercialization lifecycle, encompassing multi-dimensional biomarkers (nucleic acids, proteins, and cells), and leveraging a comprehensive multi-omics translational medicine technology platform. To strengthen product development and translational medicine testing services,MEDx has established a Molecular Center, Protein Center, Cell Center, Pathology Center, and Data Center.。
CDx Development and Commercialization, built on a solid foundation of partnerships with pharmaceutical companies, a top-tier product development team, and a comprehensive quality system. To date, MEDx has a total ofOver 20 Products Approved for Market Launch, the product portfolio supports precision medicine encompassing targeted therapy, immunotherapy, and cell therapy, including China’s first approved JAK2 V617F mutation detection kit and PD-L1 detection kits for immunotherapy, while also featuring a strategic layout in40+ CDx/IVD Product Pipeline。
For companies in China’s current companion diagnostics industry, it is already rare to master multidisciplinary, full-platform technical capabilities; even more exceptional isMEDx has achieved comprehensive integration of its technologies across the entire innovative drug R&D lifecycle.。
ForEarly-Stage Drug Development、Toxicology TestingandPreclinical Stage, MEDxPrimarily provides validation of targets and disease mechanisms. Upon completion of the new drug application submissionEntering the clinical research phase, MEDx provides companion diagnostic reagentsPatient Stratification and Screening Service，Clinical Validation and Efficacy Studies. The drug successfully passed clinical trials andAwardedApproved for Market LaunchPosterior, MEDx companion diagnostic kits assist clinicians inPrecision Diagnosis• Provide medication guidance to patients. The seamless integration of technology and business operations enables MEDx to conduct its activities with ease across all stages of the new drug R&D industry chain. Furthermore, MEDx maintains a comprehensive quality system, encompassing STARLIMS, CAP accreditation, CNAS ISO/IEC 17025, ISO 13485, and GMP compliance.
From technology to products and services, and from R&D to clinical application, MEDx provides one-stop comprehensive solutions for new drug development companies.Our full-platform product and service offerings attract pharmaceutical companies to collaborate at the very inception of innovative drug R&D projects, seamlessly transition into subsequent services upon entering the clinical phase, and earn the recognition and trust of these partners. This also helps secure the confidence of hospitals in later-stage clinical companion diagnostics and medication guidance.Pharmaceutical partnerships as the first growth curve, companion diagnostic products as the second growth curve, thus “One Enterprise Serving the Entire Innovative Drug Industry” business strategy is both MEDx’sCustomer Acquisition Channels, enabling its products and services to establish a strong presence within the industryExtremeHigh Barriers。
In 2022, MEDx entered the 3.0 era, in addition to Maipukang, which has just been approved for market launch, the company has also increased the application of AI technology across its various technical centers.
MEDx is highly optimistic about the application and development of AI technology in companion diagnostics., The advantage of artificial intelligence (AI) interpretation in tumor pathology companion diagnostics lies in its ability to continuously read histopathological slides and engage in self-learning, thereby progressively enhancing the accuracy of immunohistochemistry (IHC) companion diagnostic interpretations. Meanwhile, this technology also offers potential solutions to address the current shortage of clinicians in China. With the continuous advancement of medical technologies and new drugs, the volume of pathological images is increasing rapidly, imposing unprecedented pressure on clinicians and departmental reporting systems.AI technology enables rapid and accurate interpretation, alleviating physicians’ workload, improving diagnostic accuracy, and reducing patient wait times.。
To this end, MEDx has developed tumor pathology based on MapKang.IHC AI Interpretation Software and All-in-One System, the system integrates an artificial intelligence model trained on over 1,000 clinical tumor samples,Automated Interpretation of Whole-Slide Pathology Images. Large-scale training dataset and pathologists' interpretation resultsConsistency >90%。
In terms of the overall development plan, its second articleProduct Curve, MEDx willContinue to rapidly advance multiple product pipelines that have entered clinical trial stages, while simultaneously strengthening the commercialization of marketed products，Pharmaceutical Company Collaborations's first curve will joinDigital Marketingthe concept of building a platform marketing framework centered on translational medicine.
In addition,MEDx will take further actions in product and business globalization.. From laboratory M&A to product registration, the company has established a strategy for international expansion by recruiting overseas Chinese technical talent, inUnited States, European Union, Southeast AsiaExpand product sales and high-tech services.
MEDx believes that empowering new drug development and providing comprehensive precision medicine solutions are key competitive advantages over entering the market with a single technology. In the future, MEDx will shoulder its responsibilities as an industry innovator and leader, fully leveraging the critical role of AI technology in expanding companion diagnostics. It is committed to serving global pharmaceutical clients in new drug development and clinical trials, addressing two major pain points: the clinical translation of innovative drugs and precise medication for patients, thereby advancing precision medicine.