AlloDx (Shanghai) Biotech Co., Ltd.

AlloDx (Shanghai) Biotech Co., Ltd. — trading as AlloDx / 奥根诊断 — is a Chinese molecular diagnostics company founded in August 2018 and headquartered in Shanghai. It focuses on the research, development and clinical translation of next-generation diagnostic technologies, with a particular emphasis on organ transplantation and kidney disease. Its stated mission is to support precision medicine, AI-assisted diagnosis and health management through high-quality testing services and product solutions. The company has built an integrated R&D platform spanning omics marker discovery, raw-material and reagent development, instrument development, clinical validation and AI-driven data analysis. Its laboratory space exceeds 2,300 square meters and includes immunology testing, a P2 laboratory, standardized PCR, cell culture and protein purification areas; the group also holds an independent third-party medical laboratory license. According to its corporate profile, AlloDx holds 18 core invention patents and 23 software copyrights, and has co-authored 27 SCI papers. AlloDx's flagship product is a donor-derived cell-free DNA (dd-cfDNA) test, described by the company as the first domestically developed product of its kind in China with independent intellectual property, successfully launched and widely used clinically. The company states the product holds more than 90% of the domestic market and reaches nearly 50 transplant centers, with a sales network covering over 70% of target tertiary hospitals. Its research has been presented at American, European and international transplantation congresses, and has supported national expert consensus documents such as the expert consensus on clinical application of dd-cfDNA testing in kidney transplantation. Beyond dd-cfDNA, the product portfolio covers transplant injury monitoring, transplant-related antibodies, transplant matching, kidney disease genetics, pathogen infection differentiation, drug-metabolism typing, podocyte-related nephropathy testing, FSGS-related antibodies, complement factor level testing, and research kits and services. Named offerings include the CompliNeF™ Assay, CompliTCC™ sC5b-9 test, a soluble C5b-9 test kit, an anti-nephrin antibody test kit, hereditary kidney disease genetic testing, SuperNAT second-generation high-sensitivity nephrin antibody testing, free DNA quantification and urine free DNA extraction kits, Allok Seq® non-invasive rejection/infection panels for kidney, lung and liver transplants, and BK virus-associated nephropathy (BKVAN) non-invasive testing. The company has received recognition as a national high-tech enterprise and a Ministry of Science and Technology technology-based SME, and has been supported by the Shanghai technology-based SME innovation fund and the Ministry of Science and Technology's "Science and Technology Innovation 2030 — Four Major Chronic Diseases" major project. AlloDx describes itself as entering a new development cycle, continuing to pursue "focusing on real clinical needs and adhering to底层技术创新 (underlying technology innovation)" while combining AI and biotechnology.

AlloDx (Shanghai) Biotech Co., Ltd. was founded in August 2018 in Shanghai as a molecular diagnostics company dedicated to next-generation diagnostic technologies and their clinical translation. From the outset the company oriented itself toward organ transplantation and kidney disease, areas where precise, non-invasive monitoring of graft injury and immune status had long been a clinical unmet need. Over its first years the company assembled a full-chain innovation platform covering omics marker discovery, raw material and reagent development, instrument development, clinical research validation and AI-based data analysis. Its laboratories grew to more than 2,300 square meters, with dedicated areas for immunology testing, a P2 laboratory, standardized PCR, cell culture and protein purification, and the group obtained an independent third-party medical laboratory license. The company reports accumulating 18 core invention patents, 23 software copyrights and 27 co-authored SCI papers. The company's breakthrough product was a donor-derived cell-free DNA (dd-cfDNA) test, which it describes as the first domestically developed product of its kind in China with independent intellectual property, successfully launched and broadly adopted in clinical practice. The test is used to monitor graft injury non-invasively in transplant recipients. Its research has been presented at American, European and international transplantation congresses, and the company contributed technical support to national expert consensus documents, including the expert consensus on clinical application of dd-cfDNA testing in kidney transplantation. According to the corporate profile, the product holds more than 90% of the domestic market, covers nearly 50 transplant centers, and its sales network reaches more than 70% of target tertiary hospitals. Building on this foundation, AlloDx expanded its portfolio across transplant injury monitoring, transplant-related antibodies, transplant matching, kidney disease genetics, pathogen infection differentiation, drug-metabolism typing, podocyte-related nephropathy testing, FSGS-related antibodies, complement factor testing, and research kits and services. Notable launches and offerings include the CompliNeF™ Assay for C3NeF function, the CompliTCC™ sC5b-9 test, a soluble C5b-9 test kit, an anti-nephrin antibody test kit, hereditary kidney disease genetic testing, SuperNAT second-generation high-sensitivity nephrin antibody testing, free DNA quantification and urine free DNA extraction kits, Allok Seq® non-invasive rejection/infection panels for kidney, lung and liver transplants, and BK virus-associated nephropathy (BKVAN) non-invasive testing. In April 2026 the company presented its SuperNAT technology at WCN2026, the World Congress of Nephrology, where it reported engagement from international nephrology experts. The company and its subsidiaries have been recognized as a national high-tech enterprise and a Ministry of Science and Technology technology-based SME, and have received support from the Shanghai technology-based SME innovation fund and the Ministry of Science and Technology's "Science and Technology Innovation 2030 — Four Major Chronic Diseases" major project. AlloDx states that it is entering a new development cycle, continuing to follow its philosophy of "focusing on real clinical needs and adhering to underlying technology innovation," and aiming to leverage the combination of AI and biotechnology to build a data-driven, differentiated product matrix and become a Chinese force in precision diagnostics and intelligent medicine.

• AlloDx (Shanghai) Biotech Co., Ltd. founded in Shanghai.

• Presented SuperNAT technology at WCN2026, the World Congress of Nephrology.

• Launched the CompliTCC™ sC5b-9 test.

• Highlighted the CompliNeF™ Assay for reading C3NeF function from Bb retention.

Precision molecular diagnostics for organ transplantation and kidney disease, combining AI and biotechnology with a full-chain R&D platform.

• Donor-derived cell-free DNA (dd-cfDNA) test

  Flagship non-invasive test for monitoring graft injury in transplant recipients; described as China's first domestically developed product of its kind with independent intellectual property.

• CompliNeF™ Assay

  Assay for reading C3NeF function from Bb retention.

• CompliTCC™ sC5b-9 test

  Test for soluble C5b-9 (sC5b-9).

• Soluble C5b-9 test kit

  Kit for soluble C5b-9 testing.

• Anti-nephrin antibody test kit

  Kit for detecting anti-nephrin antibodies.

• Hereditary kidney disease genetic testing

  Genetic testing service for hereditary kidney disease.

• SuperNAT second-generation high-sensitivity nephrin antibody test

  Second-generation high-sensitivity nephrin antibody test.

• Free DNA quantification kit

  Kit for quantifying free DNA.

• Urine free DNA extraction kit

  Kit for extracting free DNA from urine.

• Allok Seq® non-invasive rejection/infection panel for kidney transplantation

  Non-invasive panel for rejection and infection in kidney transplantation.

• BK virus-associated nephropathy (BKVAN) non-invasive test

  Non-invasive test for BK virus-associated nephropathy.

• Lung transplant non-invasive rejection test

  Non-invasive rejection testing for lung transplant recipients.

• Liver transplant non-invasive rejection test

  Non-invasive rejection testing for liver transplant recipients.

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